Percutaneous pinning for treating distal radial fractures in adults

  • Review
  • Intervention

Authors

  • Helen HG Handoll,

    Corresponding author
    1. University of Teesside, Centre for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, Middlesborough, Tees Valley, UK
    • Helen HG Handoll, Centre for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, University of Teesside, School of Health and Social Care, Middlesborough, Tees Valley, TS1 3BA, UK. h.handoll@tees.ac.uk. H.Handoll@ed.ac.uk.

    Search for more papers by this author
  • Manesh V Vaghela,

    1. University Hospital of Hartlepool, Department of Orthopaedics and Trauma, Hartlepool, UK
    Search for more papers by this author
  • Rajan Madhok

    1. University of Manchester, Cochrane Bone, Joint and Muscle Trauma Group, Manchester, UK
    Search for more papers by this author

Abstract

Background

Fracture of the distal radius is a common clinical problem. A key method of surgical fixation is percutaneous pinning, involving the insertion of wires through the skin to stabilise the fracture.

Objectives

To evaluate the evidence from randomised controlled trials for the use of percutaneous pinning for fractures of the distal radius in adults.

Search methods

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2006), the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and other databases, conference proceedings and reference lists of articles. No language restrictions were applied.

Selection criteria

Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared percutaneous pinning with conservative treatment, or different aspects of percutaneous pinning.

Data collection and analysis

Two authors independently assessed and extracted data from the included trials. Some pooling of data was undertaken for one comparison.

Main results

Thirteen trials, involving 940 generally older adults with dorsally displaced and potentially or evidently unstable distal radial fractures, were included. Methodological weaknesses among these trials included lack of allocation concealment and inadequate outcome assessment. Factors affecting the applicability of trial evidence included inconsistent fracture classification, variations in outcome assessment and incomplete reporting.

Six heterogeneous trials compared percutaneous pinning with plaster cast immobilisation. Across-fracture pinning, used in five trials, was associated with improved anatomical outcome and generally minor complications. There was some indication of similar or improved function in the pinning group. One quasi-randomised trial found an excess of complications after Kapandji pinning.

Three trials compared different methods of pinning. Two trials found a higher incidence of complications after Kapandji fixation compared with two methods of across-fracture fixation. The third trial provided inadequate evidence for modified Kapandji fixation versus Willenegger fixation.

Two small trials comparing biodegradable pins versus metal pins found a significant excess of complications associated with biodegradable material.

Two small trials compared plaster cast immobilisation for one week versus for six weeks after surgery. One trial found duration of immobilisation after trans-styloid fixation did not have a significant effect on outcome. More complications occurred in the early mobilisation group after Kapandji pinning in the second trial.

Authors' conclusions

Though there is some evidence to support its use, the precise role and methods of percutaneous pinning are not established. The higher rates of complications with Kapandji pinning and biodegradable materials casts some doubt on their general use.

摘要

背景

經皮穿刺鋼釘固定治療成年人之橈骨遠端骨折

橈骨遠端骨折是常見的臨床問題。經皮穿刺鋼釘固定是重要的手術方式,其方式是經由皮膚插入鋼釘來固定骨折處。

目標

研究目的在評估使用經皮穿刺鋼釘固定治療成年人橈骨遠端骨折之隨機臨床試驗所得到之實證。

搜尋策略

搜尋Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2006)、 Cochrane Central Register of Controlled Trials、MEDLINE, EMBASE及其他資料庫、會議發表及期刊引用文獻等等。無特定之語言限制。

選擇標準

選擇條件為成年人橈骨遠端骨折之隨機或準隨機臨床試驗,並包含有比較經皮穿刺鋼釘固定與保守治療方式、或不同方法之經皮穿刺鋼釘固定之研究。

資料收集與分析

由兩名作者分別評估及摘錄所囊括之臨床試驗,並作匯整比較。

主要結論

共有十三個臨床試驗,包括有940位老年人患有往背側移位和淺在或明顯之橈骨遠端骨折。這些臨床試驗之研究方法缺點包括了分組隱匿及不完整之結果評估。影響研究證據引用之因素包括有不一致的骨折分類方法、結果評估方法之差異及不完整的報告。 六個不同來源的臨床試驗比較經皮穿刺鋼釘固定與石膏固定方式之差異。5個臨床試驗以鋼釘貫穿骨折處之固定方式有效地改善解剖結構,且普遍而言僅有輕微併發症。在使用鋼釘穿刺的組別有著相似或較佳的功能恢復。有一個準隨機臨床試驗發現在Kapandji方法有異常高的併發症。 另有三個試驗比較不同方式的鋼釘穿刺固定,其中兩個發現:比起貫穿骨折處之固定方式,Kapandji方法有著較高之併發症比率。而另一個試驗乃在比較改良式Kapandji方法及Willenegger方法之差異,但證據不足。 兩個小型試驗比較可吸收骨釘及金屬鋼釘之差異,發現前者有較高之併發症比率。兩個小型試驗比較手術後石膏固定一週及六週之差異。其中之一發現在使用穿鋼釘越莖突之固定時,石膏固定時間之長短並不影響治療結果。而另一試驗則發現在使用Kapandji方法時,較短的術後固定時間有較高的併發症比率。

作者結論

儘管有部份證據支持經皮穿刺鋼釘固定之方法,但其真正角色及使用方法則有待確立。而Kapandji方法及可吸收骨釘之使用有較高之併發症比率,引發普遍使用的疑慮。

翻譯人

本摘要由林口長庚醫院陳昭宇翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

經皮穿刺鋼釘固定治療成年人之橈骨遠端骨折 就老年人而言,腕部骨折(橈骨或尺骨遠端,或兩均骨折),可能來自跌倒時,腕部反折過度伸展所致。常見治療方式包括骨折復位及石膏固定。對於嚴重位移之骨折,則可以考慮手術治療。經皮穿刺鋼釘固定為方法之一。手術時乃利用鋼釘穿越皮膚,將骨折固定在適當的位置直到癒合。大多數的方式是利用鋼釘貫穿骨折處將骨塊固定在一起,Kapandji方法則使用鋼釘置於可支持末端骨塊。本文回顧隨機臨床試驗中所提出有關使用經皮穿刺鋼釘固定的方法或不同方法間之比較與實證。 在十三個臨床試驗中總計包括940位具有或淺在不穩定骨折之老年人。由於方法學上之缺點,例如隨機取樣及結果評估方法之不足等,無法排除發生嚴重誤差之可能。 六個臨床試驗比較經皮穿刺鋼釘固定與石膏固定治療之差異,其中五個試驗使用鋼釘貫穿骨折處,有較佳之解剖結構之恢復;而其中三個似乎也呈現較佳之功能恢復。普遍而言,貫穿骨折處之固定方式的併發症極其輕微;而使用於其餘臨床試驗之Kapandji方式,比起保守治療,則有著較高之併發症比率。有兩個臨床試驗比較Kapandji方式及貫穿骨折處之固定方式。有兩個臨床試驗使用兩種特殊鋼釘固定方式,並與可吸收骨釘作比較。兩者皆發現使用可吸收骨釘,相較於金屬鋼釘,有著較高之併發症比率。有兩個臨床試驗比較術後石膏固定一週及六週之差別。其中一個臨床試驗發現使用貫穿骨折處之固定方式,術後固定時間之長短並不影響結果。相反地,其他臨床試驗則發現,以Kapandji方式,較短的術後固定時間,有較高之併發症比率。 文獻回顧結果顯示有一些證據支持經皮穿刺鋼釘固定方式的使用。但是,其真正的角色及使用方法則有待確立。而Kapandji方法及可吸收骨釘之使用有較高之併發症比率,在普遍使用上仍存有疑慮。

Plain language summary

Percutaneous pinning for treating distal radial fractures in adults

In older people, a 'broken wrist' (from a fracture at the lower end of one of the two forearm bones) can result from a fall onto an outstretched hand. Treatment usually involves reduction (putting the broken bone back into position) and immobilising the wrist in a plaster cast. Surgery may be considered for more seriously displaced fractures. One type of surgery is percutaneous pinning. This involves the insertion of pins through the skin (percutaneous) to hold the bones in a proper position while they heal. In most pinning methods, wires are placed across the fracture and used to fix the fragments together. In Kapandji pinning, the wires are placed to support the distal (lower end) fragment. This review looked at the evidence from randomised controlled trials testing the use of percutaneous pinning or comparing different aspects of percutaneous pinning.

Thirteen trials, involving 940 generally older adults with potentially or evidently unstable fractures, were included. Because of weak methodology such as using inadequate methods of randomisation and outcome assessment, the possibility of serious bias cannot be ruled out.

Six trials compared percutaneous pinning with plaster cast immobilisation. Pinning involving across-fracture fixation, used in five of these trials, improved anatomical outcome; and in three trials it appeared to improve function too. The complications associated with across-fracture fixation were generally minor. Kapandji pinning, used in the remaining trial, was associated with an excess of complications compared with conservative treatment. Three other trials compared different methods of pinning. Two of these found some evidence of an increased complication rate with Kapandji pinning compared with across-fracture methods. Two trials using two very different pinning techniques compared biodegradable (dissolvable) pins or wires versus metal pins or wires. Both trials found a significant excess of complications associated with the use of the biodegradable material. Two trials compared plaster cast immobilisation for one week versus for six weeks after surgery. One of these trials found the duration of immobilisation after across-fracture pinning did not have a significant effect on outcome. In contrast, more complications occurred in the early mobilisation group after Kapandji pinning in the other trial.

The review concluded that there is some evidence to support the use of percutaneous pinning. However, the precise role and methods of percutaneous pinning are not established. The higher rates of complications with Kapandji pinning and biodegradable materials casts some doubt on their general use.

Background

Note: This is one of five reviews that will cover all surgical interventions for treating distal radial fractures in adults. Each review will provide updated evidence for one of the several surgical categories that were presented together in the previously published review (Handoll 2003a). Following publication of the five reviews, Handoll 2003a will be republished as an 'umbrella' review summarising the evidence for surgical treatment for these fractures.

Description of the condition: distal radial fracture in adults
Fractures of the distal radius, often referred to as "wrist fractures", are common in both children and adults. They are usually defined as occurring within three centimetres of the radiocarpal joint of the radius, where the lower end of the radius interfaces with two (the lunate and the scaphoid) of the eight bones forming the carpus (the wrist). The majority are closed injuries, the overlying skin remaining intact.

In this review, we consider the treatment of distal radial fracture in adults only, in whom they are one of the most common fractures, predominantly in white and older populations in the developed world (Sahlin 1990; Singer 1998; Van Staa 2001). In women, the incidence of these fractures increases with age, starting at around 40 years of age. Before this age, the incidence is higher in men (Singer 1998). In contrast, between 60 to 94 years of age, females predominate. A recent multi-centre study in the United Kingdom of patients aged 35 years and above with Colles' fracture (see below) reported an annual incidence of 9/10,000 in men and 37/10,000 in women (O'Neill 2001).

Young adults usually sustain this injury as a result of high-energy trauma, such as a traffic accident. In older adults, especially females, the fracture more often results from low-energy or moderate trauma, such as falling from standing height. This reflects the greater fragility of the bone, resulting from disuse or post menopausal osteoporosis. It has been estimated that, at 50 years of age, a white woman in the USA or Northern Europe has a 15% lifetime risk of a distal radius fracture whereas a man has a lifetime risk of just over two per cent (Cummings 1985). More recent estimates (Van Staa 2001) of the lifetime risks of radius or ulna fracture at 50 years of age are similar: 16.6% for women versus 2.9% for men.

Distal radial fractures are usually treated on an outpatient basis with estimates of around 20% of patients (mainly older people) requiring hospital admission (Cummings 1985; O'Neill 2001). This figure will include all people receiving surgery.

Classification
Surgeons have classified fractures by anatomical configuration or fracture pattern, to help in their management. Simple classifications were based on clinical appearance and often named after those who described them. In the distal radius, the term "Colles' fracture" is still used for a fracture in which there is an obvious and typical clinical deformity (commonly referred to as a dinner fork deformity) - dorsal displacement, dorsal angulation, dorsal comminution, and radial shortening. The introduction of X-rays and other imaging methods made it clear that the characteristic deformity may be associated with a range of different patterns of fracture which may be important in determining the outcome of treatment, and therefore the way in which treatment is conducted. For example, the fracture through the distal radius in a Colles' fracture may be extra-articular (leaving the articular or joint surface of the radius intact) or intra-articular (the articular surface is disrupted, sometimes in a complex manner). Numerous classifications have been devised to define and group different fracture patterns (Chitnavis 1999). One of the most commonly used is that of Frykman which distinguishes between extra-articular fractures and intra-articular fractures of the radiocarpal and radio-ulnar joints, and the presence or absence of an associated distal ulnar fracture (Frykman 1967). Another commonly used system is the AO (Arbeitsgemeinschaft fur Osteosynthesefragen) system (Muller 1991) which divides the fractures into three major groups: group A (extra-articular), group B (simple/partial intra-articular), and group C (complex/complete intra-articular). These three groups are then subdivided yielding 27 different fracture types. Other classification systems have attempted to link fracture type more directly with fracture management. For instance, Cooney 1993 proposed a 'Universal Classification' based on fracture displacement, articular involvement, reducibility (whether the fracture can be reduced; that is whether the bone fragments can be put back in place) and stability (whether, once reduced, the fragments will remain so).

Description of the intervention: percutaneous pinning
In the last century, most distal radial fractures in adults were treated conservatively, by reduction of the fracture when displaced, and stabilisation in a plaster cast or other external brace. Clinicians have recognised for many years that, particularly in older people with weakened bones from osteoporosis, the results of such conservative treatment are not consistently satisfactory (for an updated review of the evidence: see Handoll 2003b). This has resulted in attempts to develop other strategies involving surgery aimed at more accurate reduction and more reliable stabilisation of these fractures.

One such strategy is percutaneous pinning, which involves the percutaneous (through the skin) insertion of pins, which may be threaded, and wires. This is less invasive and, usually, technically simpler than open surgery, where the fractured bone is exposed to direct view. For percutaneous pinning, the reduction of the fracture is closed (see Handoll 2003c); although pins - such as Kirschner wires - may be used to manipulate the fracture fragments. In a comprehensive account of percutaneous pinning of fractures of the distal radius, Rayhack 1993 refers to a "myriad of options, decisions and questions that must be addressed". These decisions include: the reduction technique; the method and extent of skin incision; the use and type of radiographic control; the configuration of the pins; the number, size and type of pins; whether the pin ends are left exposed out of the skin or not; and the type and duration of immobilisation after pinning. Later decisions involve the timing and methods for pin removal. A variety of different pinning techniques or methods have been described in the literature (Fernandez 1999; Rayhack 1993). In many of these, pins are placed in the bone and used to fix the distal radial fragment(s). In contrast, in Kapandji's double intrafocal technique (Kapandji 1988), and subsequent developments of this technique, pins are used to manipulate and then support or 'buttress' the distal radial fragment(s).

Complications
Complications from this injury are diverse and frequent (Altissimi 1986; Atkins 1989; Cooney 1980). Some are associated with the injury itself. As well as concomitant injuries to soft tissues, fracture displacement can further compromise blood vessels, tendons and nerves, with median nerve dysfunction being the most common complication (Belsole 1993). Late complications include midcarpal instability and post-traumatic arthritis which can occur several months or years after injury (Knirk 1986; Taleisnik 1984).

Complications can also result from treatment interventions and include residual finger stiffness, which may be due to faulty application of plaster casts (Gartland 1951), and pin track infection and soft tissue injury from percutaneous pinning. Complex regional pain syndrome type 1, generally termed reflex sympathetic dystrophy (RSD), but also referred to as algodystrophy, Sudeck's atrophy and sometimes shoulder-hand syndrome (Fernandez 1996) is a major complication requiring many months of physiotherapy to alleviate symptoms (pain and tenderness, impairment of joint mobility, swelling, dystrophy, vasomotor instability) in serious cases. The etiology of RSD is often unclear.

Why it is important to do this review
Percutaneous pinning is one of the key methods for surgical fixation of distal radial fractures. It is attractive because it is minimally invasive and relatively simple and quick to perform compared with the other surgical methods employed for these fractures. It is unclear whether percutaneous pinning produces superior results to conservative treatment, and if so, what is the best method to achieve this. The answers to these questions are likely to depend particularly on fracture configuration and bone quality.

Objectives

We aimed to evaluate the evidence from randomised controlled trials for the use of percutaneous pinning for fractures of the distal radius in skeletally mature people.

We aimed to compare the relative effects (benefits and harms) of the following for adults with these injuries.

  • Any method of percutaneous pinning versus conservative treatment involving plaster or brace use.

  • Any method of percutaneous pinning versus any other method of percutaneous pinning.

  • Any technique or type of material or device used for percutaneous pinning versus any other technique or type of material or device at surgery or post-operatively.

  • Any type or duration of post-operative immobilisation versus any other type or duration of immobilisation including none.

  • Any method or timing of pin or wire removal versus any other method or timing of pin or wire removal including no removal.

We considered these effects primarily in terms of patient-assessed functional outcome and satisfaction, and other measures of function and impairment, pain and discomfort, the incidence of complications, anatomical deformity and use of resources.

We planned to study the outcomes in different age groups and for different types of fractures, especially whether they are extra-articular or intra-articular.

Methods

Criteria for considering studies for this review

Types of studies

Any randomised or quasi-randomised (method of allocating participants to a treatment which is not strictly random e.g. by date of birth, hospital record number, alternation) controlled clinical trials of percutaneous pinning for treating distal radial fractures in adults were considered.

Types of participants

Patients of either sex who have completed skeletal growth, with a fracture of the distal radius. Percutaneous pinning may be considered as primary treatment or take place after the failure of initial conservative management, generally within two to three weeks. Trials with a mixed population of adults and children were included provided the proportion of children was clearly small (< 5%); otherwise they would have been excluded unless separate data for adults could have been obtained.

Types of interventions

This includes the following comparisons.
(1) Surgical interventions involving percutaneous pinning by itself versus conservative interventions such as plaster cast immobilisation.
(2) Different methods of percutaneous pinning in the treatment of fractures of the distal radius. Thus comparisons evaluating:
(a) different types of devices used for pinning;
(b) use of different surgical techniques associated with percutaneous pinning, including type and extent of skin incision and measures to assist pin removal;
(c) type and duration of immobilisation after percutaneous pinning;
(d) type and timing of pin or wire removal.

Excluded were trials comparing percutaneous pinning with other methods of surgical fixation, such as external fixation, or trials evaluating the use of supplementary percutaneous pinning in addition to another method of surgical fixation. We also excluded trials on pin site maintenance or other measures to prevent wound infection (already covered in Temple 2004).

Types of outcome measures

Our primary outcome of choice is the number of people with an uncomplicated and speedy restoration of a pain-free fully-functioning wrist and arm with acceptable anatomic restoration and appearance. However, compatible with the general assessment and presentation of outcome within the orthopaedic literature, we reported outcome in the following four categories.

Primary outcomes
(1) Functional outcome and impairment

  • Patient functional assessment instruments such as Short Form-36 (SF-36), the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) and the Patient-Rated Wrist Evaluation (PRWE) (MacDermid 2000)

  • Return to previous occupation, including work, and activities of daily living

  • Grip strength

  • Pain

  • Range of movement (wrist and forearm mobility): range of movement for the wrist is described in terms of six parameters: flexion (ability to bend the wrist downwards) and extension (or upwards); radial deviation (ability to bend the wrist sideways on the thumb side) and ulnar deviation (on the little finger side); and pronation (ability to turn the forearm so that the palm faces downwards) and supination (palm faces upwards)

(2) Clinical outcome

  • Residual soft tissue swelling

  • Early and late complications associated with distal radial fractures or their treatment, including reflex sympathetic dystrophy (RSD) and post traumatic osteoarthritis

  • Cosmetic appearance

  • Patient satisfaction with treatment or outcome

Secondary outcomes
(3) Anatomical outcome (anatomical restoration and residual deformity)
Radiological parameters include radial length or shortening and shift, dorsal angulation, radial inclination or angle, ulnar variance, and for intra-articular fractures: step off and gap deformity of the articular surface (Fernandez 1996; Kreder 1996a). Composite measures include malunion and total radiological deformity. Definitions of four of the most commonly reported radiological parameters are presented in Table 1.

Table 1. Definitions of some radiological parameters
ParameterDefinitionNormal value
Dorsal angulation (dorsal or volar or palmar tilt)Angle between a) the line which connects the most distal points of the dorsal and volar cortical rims of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Side view of wrist.Palmar or volar tilt: approximately 11-12 degrees.
Radial lengthDistance between a) a line drawn at the tip of the radial styloid process, perpendicular to the longitudinal axis of the radius and b) a second perpendicular line at the level of the distal articular surface of the ulnar head. Frontal view.Approximately 11-12 mm.
Radial angle or radial inclinationAngle between a) the line drawn from the tip of the radial styloid process to the ulnar corner of the articular surface of the distal end of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Frontal view.Approximately 22-23 degrees.
Ulnar varianceVertical distance between a) a line drawn parallel to the proximal surface of the lunate facet of the distal radius and b) a line parallel to the articular surface of the ulnar head.Usually negative variance (e.g. -1 mm) or neutral variance.

(4) Resource use
Hospital stay, number of outpatient attendances and other costs.

Timing of outcome assessment
Results were collected for the final follow-up time for which these were available. Where reported, interim trial results were also checked to see if a marked and important difference in the timing of recovery had occurred.

Search methods for identification of studies

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2006), the Cochrane Central Register of Controlled Trials (in The Cochrane Library 2006, Issue 3) (see Appendix 1), MEDLINE (1966 to September week 1 2006), EMBASE (1988 to 2006 week 36), CINAHL (1982 to September week 2 2006). No language restrictions were applied.

In MEDLINE (OVID-WEB) the search strategy was combined with all three sections of the optimal MEDLINE search strategy for randomised trials (Higgins 2005) (see Appendix 2).

Similar search strategies were used for EMBASE (OVID-WEB) and CINAHL (OVID-WEB): see Appendix 3.

We also searched Current Controlled Trials at www.controlled-trials.com (accessed September 2006) and the UK National Research Register at www.update-software.com/national/ (up to Issue 3, 2006) for ongoing and recently completed trials.

Searching other resources

We searched the reference list of articles. We also included the findings from handsearches of the British Volume of the Journal of Bone and Joint Surgery supplements (1996 onwards) and abstracts of the American Society for Surgery of the Hand annual meetings (2000 to 2006: www.assh.org/), the American Orthopaedic Trauma Association annual meetings (1996 to 2005: http://www.hwbf.org/ota/am/) and American Academy of Orthopaedic Surgeons annual meeting (2004 to 2006: http://www.aaos.org/education/anmeet/libscip.asp). We also included handsearch results from the final programmes of SICOT (1996 & 1999) and SICOT/SIROT (2003), and the British Orthopaedic Association Congress (2000, 2001, 2002 and 2003), and various issues of Orthopaedic Transactions and issues of Acta Orthopaedica Scandinavica Supplementum.

We scrutinised weekly downloads of "Fracture" articles in new issues of 17 journals (Acta Orthop Scand; Am J Orthop; Arch Orthop Trauma Surg; Clin J Sport Med; Clin Orthop; Emerg Med Clin North Am; Foot Ankle Int; Injury; J Accid Emerg Med; J Am Acad Orthop Surg; J Arthroplasty; J Bone Joint Surg Am; J Bone Joint Surg Br; J Foot Ankle Surg; J Orthop Trauma; J Trauma; Orthopedics) from AMEDEO (www.amedeo.com).

Data collection and analysis

Selection of studies
All review authors independently assessed potentially eligible trials identified via the search for inclusion using a pre-piloted form. Any disagreement was resolved by discussion.

Data extraction and management
Two of the review authors (HH and MV) extracted trial details and data using a data extraction form. All disagreements were resolved by discussion. We contacted trialists of trials that were not reported in full journal publications for additional information and data. Contact with other trial authors was dictated by the vintage of the publication, a general impression of the expected gain, and anticipated or known difficulty in locating trial authors.

Results were collected for the final follow-up time for which these were available. We also recorded where clinically important differences had been reported at intermediate follow-up assessments but were no longer apparent at final follow up.

One author (HH) entered the data into RevMan.

Assessment of methodological quality
In this review, risk of bias is assessed in terms of methodological quality.

Two of the review authors (HH and MV) independently assessed the methodological quality of the included trials using a pre-piloted form. Any disagreement was resolved by discussion. Titles of journals, names of authors or supporting institutions were not masked at any stage. A modification of the quality assessment tool used in the previous 'umbrella' review (Handoll 2003a) was used. In this, each item was graded either 'Y', '?' or 'N', respectively indicating that the quality criteria were met for the item ("Yes"), or possibly or only partially met for the item ("Possible, partial"), or not met ("No"). The rating scheme covering 11 aspects of trial validity, plus brief notes of coding guidelines for selected items, is given in Table 2.

Measures of treatment effect
Where available, quantitative data, both dichotomous and continuous, that are reported in individual trial reports for outcomes listed in the inclusion criteria are presented in the analyses. Relative risks and 95% confidence intervals are calculated for dichotomous outcomes and mean differences and 95% confidence intervals calculated for continuous outcomes.

Table 2. Methodological quality assessment scheme
ItemsScoresNotes
(1) Was the assigned treatment adequately concealed prior to allocation?Y = method did not allow disclosure of assignment.
? = small but possible chance of disclosure of assignment or unclear.
N = quasi-randomised, or open list or tables.
Cochrane code (see Handbook): Clearly yes = A; Not sure = B; Clearly no = C.
(2) Were the outcomes of participants who withdrew described and included in the analysis (intention to treat)?Y = withdrawals well described and accounted for in analysis.
? = withdrawals described and analysis not possible, or probably no withdrawals.
N = no mention, inadequate mention, or obvious differences and no adjustment.
 
(3) Were the outcome assessors blinded to treatment status?Y = effective action taken to blind assessors.
? = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted.
N = not mentioned or not possible.
 
(4) Were important baseline characteristics reported and comparable?Y = good comparability of groups, or confounding adjusted for in analysis.
? = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data.
N = large potential for confounding, or not discussed.
Although many characteristics including hand dominance are important, the principal confounders are considered to be age, gender, type of fracture.
(5) Were the trial participants blind to assignment status after allocation?Y = effective action taken to blind participants.
? = small or moderate chance of unblinding of participants.
N = not possible, or not mentioned (unless double-blind), or possible but not done.
 
(6) Were the treatment providers blind to assignment status?Y = effective action taken to blind treatment providers.
? = small or moderate chance of unblinding of treatment providers.
N = not possible, or not mentioned (unless double-blind), or possible but not done.
 
(7) Were care programmes, other than the trial options, identical?Y = care programmes clearly identical.
? = clear but trivial differences, or some evidence of comparability.
N = not mentioned or clear and important differences in care programmes.
Examples of clinically important differences in other interventions are: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation.
(8) Were the inclusion and exclusion criteria for entry clearly defined?Y = clearly defined (including type of fracture).
? = inadequately defined.
N = not defined.
 
(9) Were the outcome measures used clearly defined?Y = clearly defined.
? = inadequately defined.
N = not defined.
 
(10) Were the accuracy and precision, with consideration of observer variation, of the outcome measures adequate; and were these clinically useful and did they include active follow up?Y = optimal.
? = adequate.
N = not defined, not adequate.
 
(11) Was the timing (e.g. duration of surveillance) clinically appropriate?Y = optimal. (> 1 year)
? = adequate. (6 months - 1 year)
N = not defined, not adequate. (< 6 months)
 

Unit of analysis issues
No unit of analysis issues arose in this review.

Dealing with missing data
Where appropriate, we performed intention-to-treat analyses to include all patients randomised to the intervention groups. In our protocol for this review we indicated that we would where appropriate investigate the effect of missing data (drop outs and exclusions) by conducting best and worse case scenarios. So far, we have found no included dataset where this would have been appropriate. We were alert to the potential mislabelling or non identification of standard errors and standard deviations. There were no confidence interval data available to calculate missing standard deviations, and we did not assume values in order to present standard deviations in the analyses.

Assessment of heterogeneity
Heterogeneity was assessed by visual inspection of the forest plot (analysis) along with consideration of the test for heterogeneity and the I² statistic (Higgins 2003).

Assessment of reporting biases
There were insufficient data to assess publication bias; for example, by preparing a funnel plot.

Data synthesis (meta-analysis)
Where appropriate, results of comparable groups of trials were pooled. As stipulated in the protocol we used the fixed-effect model and 95% confidence intervals.

Subgroup analysis and investigation of heterogeneity
There were no data available to carry out our pre-specified subgroup analyses by age and gender and type of fracture (primarily, extra-articular versus intra-articular fractures). As stipulated beforehand, presentation in separate subgroups was performed where there was a fundamental difference in pinning method (such as transfixation versus Kapandji's intrafocal method). If, in a future update, we wish to test whether subgroups are statistically significantly different from one another, we plan to test the interaction using the technique outlined by Altman and Bland (Altman 2003).

Sensitivity analysis
There were no data available to carry out pre-specified sensitivity analyses examining various aspects of trial and review methodology, including the effects of missing data, study quality (specifically allocation concealment, outcome assessor blinding and reportage of surgical experience), and inclusion of trials only reported in abstracts.

Interpretation of the evidence
We have graded the findings of the treatment comparisons according to the six categories of effectiveness used by contributors to Clinical Evidence (BMJ 2006) (see Table 3) to assist our interpretation of the evidence.

Table 3. Categories of effectiveness (definitions)
RankCategoryDefinition
1BeneficialInterventions for which effectiveness has been demonstrated by clear evidence from randomised controlled trials, and for which expectation of harms is small compared with the benefits.
2Likely to be beneficialInterventions for which effectiveness is less well established than for those listed under "beneficial".
3Trade off between benefits and harmsInterventions for which clinicians and patients should weigh up the beneficial and harmful effects according to individual circumstances and priorities.
4Unknown effectivenessInterventions for which there is currently insufficient data or data of inadequate quality.
5Unlikely to be beneficialInterventions for which lack of effectiveness is less well established than for those listed under "likely to be ineffective or harmful"
6Likely to be ineffective or harmfulInterventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence.

Results

Description of studies

See: Characteristics of included studies; Characteristics of excluded studies.

Results of the search
The search for trials predated the development of this review, which is essentially a reworked update of part of a previously published review (Handoll 2003a) covering all surgical intervention for these fractures. We have not documented the numbers of references retrieved by electronic searches; updates of MEDLINE, EMBASE and CINAHL are now generated on a weekly basis. Of 24 potentially eligible studies put forward for study selection, 13 were included, five were excluded and six are in 'Studies awaiting assessment'.

Aside from the two most recently published trials (Azzopardi 2005; Strohm 2004), the other included trials were present in the review covering all surgical intervention for these fractures (Handoll 2003a). Azzopardi 2005 appeared as an ongoing trial in Handoll 2003a.

Included studies
Eleven of the 13 included studies were fully reported in medical journals. Trial reports of the other two trials (Korner 1999; Verhulst 1990) were only available as abstracts. Seven of the included trials were initially located by handsearching. The rest were located in the following ways: The Cochrane Bone, Joint and Muscle Trauma Group Specialist Register (2); EMBASE (1); and MEDLINE (3).

Details of the methods, participants, interventions and outcomes of individual trials are provided in the 'Characteristics of included studies' table.

Setting
The publication dates of the main reports of these trials span 16 years; Verhulst 1990 being the earliest. Aside from Lenoble 1995, which had two centres, the studies were all single centre studies, mainly conducted in teaching hospitals. They each took place in one of seven countries (Belgium (3), France (3), Germany (2), India (1), Morocco (1), Spain (1), UK (2)). Translations were obtained for the two trials in French (Fikry 1998; Milliez 1992).

Participants
The 13 included trials involved a total of 940 participants, most of whom were female and older adults. Two studies (Korner 1999; Verhulst 1990), both reported in abstract only, provided no information on gender or age of their study populations; although Verhulst 1990 referred to an "elderly" population. Nine studies had more female participants, ranging between 68% and 89% of their study populations. There were more male than female participants in Fikry 1998, and probably in Stoffelen 1998; however, the disparities in the data provided in the three papers reporting this trial meant that we could not establish this. The trial population of Fikry 1998 was also markedly younger (mean age 34 years) than the other studies, whose trial populations had mean ages ranging from 55 years (Allain 1999; Milliez 1992) to 71.5 years (Azzopardi 2005). The youngest (15 years) and oldest recorded (92 years) participants appeared in the same trial (Strohm 2004). It is clear that the vast majority of participants in the included trials were skeletally mature: five trials excluded children either by explicitly setting a lower age limit or stipulating that the participants should be adults or skeletally mature. Two trials (Azzopardi 2005; Rodriguez-Merchan 97) further restricted the trial population to more mature adults: above 60 and 45 years respectively. An upper age limit of 60 years was applied in Rodriguez-Merchan 97 and 80 years in Stoffelen 1998.

Fractures
A variety of descriptions was used to define the types of fracture in the included trials. Nonetheless, explicit reference to dorsally displaced or Colles' fractures was made in all trials except Casteleyn 1992, in which it was also clear that the fractures were dorsally displaced. Thus volar displaced fractures such as Barton's (Smith 1988) were not included. Trials often used descriptive terms such as displaced, unstable and comminuted, and referred to classification systems such as Frykman (Frykman 1967) or the AO system (Muller 1991). While Strohm 2004 included a few people with open fractures, it is likely that all the fractures in the other trials were closed, and certain in those trials (Allain 1999; Azzopardi 2005; Casteleyn 1992; Lenoble 1995; Milliez 1992) stipulating the exclusion of open fractures. Two trials (Azzopardi 2005; Rodriguez-Merchan 97) described radiological criteria for defining an unstable fracture, thus defining the extent of displacement required for trial entry. None of the trials testing definitive treatment explicitly included fractures that had redisplaced after a primary reduction. Of the 10 trials applying or reporting fracture type according to an established (not own) classification system, two trials grouped fractures according to more than one classification system. The Frykman system was used by seven trials, the AO system by four trials and Castaing system by one trial. Six trials (Allain 1999; Casteleyn 1992; Korner 1999; Lenoble 1995; Milliez 1992; Strohm 2004) explicitly included both extra-articular and intra-articular fractures, although the extent of intra-articular involvement was often limited; such as the exclusion of radiocarpal joint articular fractures in Casteleyn 1992, and of fractures with more than two articular fractures in Allain 1999 and Lenoble 1995. Three trials only included or involved extra-articular fractures (Azzopardi 2005; Gupta 1999; Stoffelen 1998), whereas two trials (Rodriguez-Merchan 97; Shankar 1992) included intra-articular fractures only. The involvement of the articular surface of the distal radius fracture was not clear in either Fikry 1998, where dislocated radiocarpal joint fractures were excluded, or Verhulst 1990, which only referred to Colles' type fractures.

Comparisons
The 13 included trials have been grouped according to the comparisons addressed by each trial. While most of the trials evaluated definitive treatment, two trials (Allain 1999; Milliez 1992) tested the duration of immobilisation after surgery.

Any method of percutaneous pinning versus conservative treatment involving plaster or brace use

Percutaneous pinning versus plaster cast immobilisation alone
Six trials (Azzopardi 2005; Gupta 1999; Rodriguez-Merchan 97; Shankar 1992; Stoffelen 1998; Verhulst 1990) involving 420 patients compared internal fixation involving percutaneous pinning with plaster cast immobilisation. A concise summary of the participants, fracture type, timing and details of the interventions for the six trials is given in Table 4.

Table 4. Percutaneous pinning versus conservative treatment: participants & interventions
      
TrialParticipantsFracture type and classificationTiming of surgery and reduction methodFixationConservative treatment
Azzopardi 200557; 89% female (of 54); mean age 71.5 years.Unstable (dorsal angulation 20+ degrees) extra-articular fractures. AO type A3; Frykman I and II.Timing not stated.
Closed reduction.
Crossed pins, one from the radial styloid and the other from the dorso-ulnar side of the distal fragment into the distal radial shaft. Cast immobilisation for 5 weeks.Closed reduction and plaster cast for 5 weeks.
Gupta 199950; 74% female; mean age 56 years.Colles'. All extra-articular.
Frykman I and II.
Timing not stated.
Closed reduction.
Crossed pins, one from the radial styloid and the other from the dorso-ulnar side of the distal fragment into the distal radial shaft. Cast immobilisation for 6 weeks.Closed reduction and plaster cast for 6 weeks (change in position and new plaster at 3 weeks).
Rodriguez-Merchan 9740; 73% female; mean age 57 years.Comminuted unstable fractures. All intra-articular. Displaced (10+ degrees dorsal angulation / 3+ mm radial shortening). Frykman III to VIII.Probably next day after presentation at hospital. Closed reduction.Crossed pins, two pins from the radial side and one from the ulnar side of the distal fragment into the distal shaft. Cast immobilisation for 7 weeks.Closed reduction and plaster cast for 7 weeks.
Shanker 199245; 88% female; age range 17-88 years.Comminuted intra-articular fractures. Frykman IV to VIII.Timing not stated.
Closed reduction.
Two pins inserted obliquely from the radial side across the inferior radio-ulnar joint and into the ulnar medial cortex. Pins incorporated into plaster. Cast immobilisation for 5-6 weeks.Closed reduction and plaster cast for 5-6 weeks.
Stoffelen 199898; % female unknown (discrepancies between trial reports but fewer females); mean age 58 years.Colles'. Extra-articular fractures with dorsal displacement. Frykman I and II.Timing not stated.
Probably closed reduction.
Triple intrafocal Kapandji pinning: 3 pins, inserted at the fracture site and driven into the radial shaft, act as buttresses to the distal fragment.
Cast immobilisation for 1 week.
Closed reduction. Above-elbow plaster cast for 3 weeks; below-elbow for 3 weeks.
Verhulst 1990130; % female unknown; "elderly".Colles'.Timing not stated.
Closed reduction.
Single Kirschner wire (pin) inserted through radial styloid, across fracture and into the distal radial shaft. Cast immobilisation for 4 weeks (mean).Closed reduction and plaster cast for 5 weeks (mean).

Each trial employed a different pinning technique or duration of immobilisation, or both. Various numbers of pins were used to transfix the distal radius fragment to the radial shaft in four trials (Azzopardi 2005: 2 pins; Gupta 1999: 2 pins; Rodriguez-Merchan 97: 3 pins; Verhulst 1990; 1 pin). In Shankar 1992, two pins were placed obliquely through the distal radial fragments across the inferior radio-ulnar joint and fixed in the ulna. Stoffelen 1998 used Kapandji's triple intrafocal technique, where three pins introduced at the fracture site and driven into the radial shaft support the fracture fragment. Stoffelen 1998 also differed from the other five trials in that there was a difference in the duration of plaster immobilisation between the two intervention groups (Kapandji's pinning group: 1 week; conservative treatment group: 6 weeks).

Any method of percutaneous pinning versus any other method of percutaneous pinning

Kapandji fixation versus trans-styloid fixation
One trial (Lenoble 1995) compared Kapandji fixation with two or three Kirschner wires followed by immediate mobilisation versus trans-styloid fixation with two Kirschner wires followed by plaster cast immobilisation for about 45 days in 120, mainly female (68% of those followed up) skeletally mature people (mean age: 57 years) with either an extra-articular or intra-articular dorsally displaced fracture.

Kapandji fixation versus Py's isoelastic pinning
Fikry 1998 compared Kapandji intrafocal pinning with three Kirschner wires versus with Py's isoelastic pinning, where two wires were inserted across the fracture and along the medullary canal, in 110 people. Both groups had immobilisation in a forearm cast for four weeks. The majority of the 88 participants with complete data at follow up were male (75%) with an average age of 34 years. All had dorsally displaced fractures, with or without displacement of the ulnar styloid. Though some involvement of the articular surface of the distal radius was possible in Fikry 1998, dislocated radiocarpal joint fractures were excluded.

Modified Kapandji fixation versus Willenegger fixation
In Strohm 2004, one patient group was treated with a modified Kapandji method, involving intrafocal pinning with two Kirschner wires combined with a third wire inserted via the radial styloid used to fix the fracture, followed by six weeks of immobilisation in a volar splint. Physiotherapy, with the volar splint removed, was started at three weeks. The other patient group received Willenegger pinning, where two wires introduced via the styloid process were inserted across the fracture, followed by immobilisation in a forearm cast for six weeks. The 100, mainly female (85%), participants with an average age of 65 years had Colles' type fractures, either extra- and intra-articular (AO types A2, A3 or C1).

Any technique or type of material or device used for percutaneous pinning versus any other technique or type of material or device at surgery or post-operatively

Biodegradable pins or wires versus metal pins or wires
Two trials (Casteleyn 1992; Korner 1999) evaluated the use of biodegradable pinning in 70 people with extra-articular and intra-articular fractures. None of the 30, mainly female (77%) and older (mean age 61 years), participants of Casteleyn 1992 had radiocarpal joint fractures. Few details of the study population were available for Korner 1999. Different pinning techniques were used in the two trials: Kapandji's intrafocal pinning with two wires was used in Casteleyn 1992, while two pins or Kirschner wires were inserted via the radial styloid and across the fracture (modified Willenegger method) in Korner 1999. There was no cast immobilisation in Casteleyn 1992; there was no mention of post-surgical care in Korner 1999.

Any type or duration of post-operative immobilisation versus any other type or duration of immobilisation including none

Duration of post-operative immobilisation after percutaneous pinning
The duration of immobilisation (plaster cast immobilisation for one week versus for six weeks) after surgery was tested by two trials (Allain 1999; Milliez 1992) in 120 people with extra-articular or intra-articular fractures. The participants were mainly female (74%) with a mean age of 55 years. Trans-styloid fixation with two Kirschner wires was used in Allain 1999. Kapandji intrafocal pinning with three Kirschner wires was used in Milliez 1992. In both trials, the early mobilisation group was advised against heavy work and lifting heavy loads but did not appear to receive any other specific instructions to those given after cast removal in both groups.

Any method or timing of pin or wire removal versus any other method or timing of pin or wire removal including no removal
There were no included trials for this topic.

Excluded studies
Five studies were excluded for reasons stated in the 'Characteristics of excluded studies' table. Four studies were found not to be randomised trials and one trial was abandoned.

Ongoing studies
There are no ongoing studies.

Studies awaiting assessment
Details of the six trials pending assessment are given below.

  • Gravier 2005: published abstract of trial comparing trans-styloid versus intrafocal pinning contains insufficient information for inclusion. Trial author has indicated that a full report has been submitted for publication.

  • Hargreaves 2004: published report of trial comparing buried versus protruding wires does not provide separate data for adults and has unit of analysis problems. Lead author has contacted his coauthor for details of the trial results but these have yet to appear.

  • Russe 2000: published abstract of the full study population for a multicentre trial comparing bioabsorbable versus metal wires provides insufficient information for inclusion. Translations from German now obtained for two of the four abstracts pertaining to the trial and a request for further information has been sent.

  • Shannon 2003: published abstract of trial evaluating new "spring loaded" technique provides insufficient information for inclusion. No response obtained yet from authors.

  • Snow 2006: registered trial, completed in 2004, comparing plaster cast immobilisation in dorsi versus palmar (volar) flexion after percutaneous K-wire fixation. Pre-publication report received after completion of the first version of the review. Trial selected for inclusion in the next version of the review.

  • Waheed 2004: published abstract of trial comparing buried versus protruding wires provides insufficient information for inclusion. No response obtained yet from authors.

Risk of bias in included studies

The quality of trial methodology based on trial reports was disappointing. Inevitably, much of the quality assessment related to trial reporting and both trials (Korner 1999; Verhulst 1990) reported only in conference abstracts failed to satisfy most of the 11 quality criteria (Table 2). The results, together with some notes on specific aspects, of the quality assessment for the individual trials are shown in Table 5. Information specific to the first three items of the quality assessment is given in the methods section of the 'Characteristics of included studies' table. A summary of the results for individual items of quality assessment is given below.

Table 5. Quality assessment results for individual trials (see Table 03 for scheme)
Study IDItems 1, 2, 3 & 4Items 5, 6, 7 & 8Items 9, 10 & 11Notes
 1 = Allocation concealment
2 = Intention-to-treat analysis
3 = Outcome assessor blinding
4 = Comparable baseline characteristics
5 = Participant blinding
6 = Treatment provider blinding
7 = Identical care programmes
8 = Clearly defined inclusion criteria
9 = Well defined outcome measures
10 = Optimal outcome assessment
11 = Optimal timing of follow up (> 1 year)
In brackets: date of last follow up
Comments and explanations for specific items
Allain 1999N, Y, Y, ?N, N, Y, YY, ?, ? (1 year)Item 4: the 6 weeks group were slightly older and less active
Azzopardi 2005?, ?, N, YN, N, Y, YY, Y, ? (1 year)Item 2: no information on which treatment groups the 6 people lost to follow up belonged
Casteleyn 1992?, Y, N, YN, N, Y, YY, ?, ? (1 year) 
Fikry 1998?, N, N, NN, N, ?, YY, ?, Y (20 months minimum)Item 4: baseline characteristics not reported for whole trial population
Gupta 1999N, Y, N, ?N, N, ?, ?Y, ?, ? (6 months)Changed ratings for items 1, 2, 4 & 8 on receipt of further information from trialist.
Item 8: changed from N to ? on finding that all fractures were extra-articular
Korner 1999?, ?, N, NN, N, N, N?, N, ? (median 25 months)Abstract only
Item 11: we judged it was possible that some people were followed up for one year or under, but likely that most were followed up for at least six months
Lenoble 1995?, N, N, NN, N, N, YY, ?, Y (2 years)Item 4: baseline characteristics not reported for whole trial population
Item 7: set differences in methods of reduction, K-wire insertion, and use of immobilisation could be considered as cointerventions
Milliez 1992N, ?, N, ?N, N, ?, YY, ?, N (3 months)Item 2: problems with percentages not giving whole numbers
Rodriguez-Merchan 97Y, ?, N, ?N, N, ?, YY, ?, ? (1 year)Item 7: difference in anaesthesia (general or brachial block for pinning group; local for plaster cast group); though these could be considered cointerventions.
Shankar 1992?, ?, N, ?N, N, ?, ?Y, ?, ? (6 months)Item 7: no details given on operator experience
Stoffelen 1998N, N, N, NN, N, N, Y?, ?, ? (1 year)Item 2: imbalance in the numbers (50; 48) of participants in the two groups contradicts the method of randomisation (alternation)
Item 4: significant differences bewteen the two groups in gender and high-energy injuries
Strohm 2004?, ?, N, NN, N, N, ?Y, ?, ? (median 10 months, range 6 to 22 months)Item 2: aside from age, the baseline data for entire population were not provided
Verhulst 1990?, N, N, NN, N, N, N?, ?, Y (2 years)Abstract only
Item 2: unexplained imbalance in participant numbers of the two groups (45; 85)

Allocation concealment (item 1)
Only one trial (Rodriguez-Merchan 97), which used blinded consecutively numbered envelopes, was considered to have satisfied the criteria for secure allocation concealment (item 1). Of those trials using inadequate methods or providing no information on which to judge this item, two gave some details of their method of randomisation (Azzopardi 2005: coin toss; Casteleyn 1992: use of sealed cards), whereas six trials provided no information (Fikry 1998; Korner 1999; Lenoble 1995; Shankar 1992; Strohm 2004; Verhulst 1990). Blinded randomisation was, however, claimed by Strohm 2004. The remaining trials used quasi-randomised methods based on admission sequence or alternation (Gupta 1999; Milliez 1992; Stoffelen 1998), or patient chart numbers (Allain 1999).

Intention-to-treat analysis (item 2)
Clear statements of participant flow with evidence of intention-to-treat analysis were available for three trials (Allain 1999; Casteleyn 1992; Gupta 1999). There were serious problems in four trials. In two of these (Fikry 1998; Lenoble 1995), both with a high loss (20%) to follow up, baseline data were not provided for the whole study population. In both Stoffelen 1998 and Verhulst 1990, there was no explanation on the imbalances in the numbers randomised into the two groups, and no information on loss to follow up.

Blinding of outcome assessors (item 3)
This was only confirmed in Allain 1999 where all participants were independently reviewed by a physician who was not involved in their treatment and who was unaware of the duration of post-operative immobilisation. Total blinding of outcome assessment is impractical for trials testing surgical interventions but it is possible for some outcomes and more so at longer term follow-up.

Comparability of baseline characteristics (item 4)
Two trials (Azzopardi 2005; Casteleyn 1992) provided sufficient information indicating the similarity in the baseline characteristics of gender, age and type of fracture. Potentially important imbalances between treatment groups in participant characteristics were found in Allain 1999 (age and activity) and Stoffelen 1998 (gender and high-energy injuries).

Blinding of patients and treatment providers (items 5 and 6)
These are unlikely in these studies and none was claimed.

Care programme comparability (item 7)
Comparability of care programmes comprising interventions (such as type of anaesthesia, timing of the interventions, comparability of the experience of the health professionals applying the interventions (operator bias), and rehabilitation) other than the trial interventions proved hard to confirm. However, it was considered highly likely in three trials (Allain 1999; Azzopardi 2005; Casteleyn 1992). Distinctive differences between the two groups where an intervention other than the trial intervention was used exclusively in one group can change the actual comparison under test. For instance, in Strohm 2004, physiotherapy was provided after three weeks of immobilisation to the modified Kapandji pinning group only.

Description of inclusion criteria (item 8)
Most of the included trials provided sufficient trial inclusion and exclusion criteria to define the study population. This item was rated 'N' ("not defined") where no details of the type of fractures were available ("Colles'" was not considered enough).

Definition of outcome measures and quality of outcome measurement (items 9 and 10)
The definition of outcome measurement was clear enough to give a good idea of what was recorded in 10 of the 11 trials written up as full reports. Only Azzopardi 2005 was rated as having 'optimal' quality outcome measurement, which included use of a validated patient assessed quality of life instrument and active follow-up. Of note, but not rated, was the grading or scoring of overall functional outcome according to scoring systems in several trials. These systems, which often included anatomical and clinical outcomes, included modifications of other scoring systems such as that of Gartland and Werley (Gartland 1951). Also, noted but not rated, were instances where adjustments were made for hand dominance. The variety of schemes used and other outcome measures reported by the trials is evident from inspection of the 'Characteristics of included studies' table.

Length of follow up (item 11)
Follow up ranged from three months (Milliez 1992) to two years (Lenoble 1995; Verhulst 1990), but was of variable duration in Fikry 1998, Korner 1999 and Strohm 2004.

Effects of interventions

Any method of percutaneous pinning versus conservative treatment involving plaster or brace use

Percutaneous pinning versus plaster cast immobilisation alone
Percutaneous pinning was compared with plaster immobilisation in six trials (Azzopardi 2005; Gupta 1999; Rodriguez-Merchan 97; Shankar 1992; Stoffelen 1998; Verhulst 1990). Five trials applied across-fracture pinning whereas Stoffelen 1998 used Kapandji's triple intrafocal technique with early mobilisation and is thus considered separately for most outcomes (functional and anatomical) in the following.

The functional scoring systems used by three of the trials (Gupta 1999; Rodriguez-Merchan 97; Shankar 1992), all derived from Gartland and Werley's scheme (Gartland 1951), also rated deformity and various complications. Consistently (test for heterogeneity: I² = 0%) superior functional grades were obtained in the pinning group in three of the fracture fixation trials (Gupta 1999; Rodriguez-Merchan 97; Shankar 1992): see Analysis 01.01 Functional grading: not excellent (Pins through fracture). 29/68 versus 54/67; relative risk (RR) 0.53, 95% confidence interval (CI) 0.39 to 0.71; also Analysis 01.02 Functional grading: fair or poor (Pins through fracture). 8/68 versus 25/67; RR 0.31, 95% CI 0.15 to 0.64). Azzopardi 2005 found no significant differences between the two groups in the physical or mental score domains of the Short-Form 36 at four months (see Analysis 01.03) nor in either unilateral (reported P = 0.43) or bilateral (reported P = 0.74) activities of daily living scores at one year. Two people, both in the conservative treatment group, out of 11 former labourers in Rodriguez-Merchan 97 did not return to their former work (see Analysis 01.04). The failure to state the numbers of participants in the two treatment groups at one-year follow up meant that the results of individual functional outcomes for Azzopardi 2005 could not be presented in the Analyses. Results for individual functional outcomes were often incomplete for the other four trials. Grip strength, presented as a percentage of the grip strength of the unaffected arm, was greater in the pinning group in both Azzopardi 2005 (77% versus 72%; reported P = 0.54) and Rodriguez-Merchan 97 (85% versus 65%; P not reported) and demonstrably significantly better in the pinning group in Shankar 1992 (see Analysis 01.05 Under half grip strength at 6 months. 0/23 versus 11/22; RR 0.04, 95% CI 0.00 to 0.67). There were no statistically significant differences between the two groups in pain scores at one year (0.7 versus 1.2 on a 0 (no pain) to 10 (worst pain) point scale; reported P = 0.16) in Azzopardi 2005 or in the numbers of participants with occasional pain at long-term follow up in Rodriguez-Merchan 97 (see Analysis 01.06. 2/20 versus 4/20; RR 0.50, 95% CI 0.10 to 2.43). Azzopardi 2005 reported no statistically significant differences between the two groups in the components of wrist movement at one year except for ulnar deviation (93% versus 76% of normal; reported P = 0.009). All components of wrist movement were significantly better in the pinning group in Gupta 1999 (see Analysis 01.07). The overall range of wrist motion was reported to be better in the pinning group in Rodriguez-Merchan 97 (80% versus 60% of normal), as were the components of wrist movement in Shankar 1992 (statistical significant differences were reported for extension and ulnar deviation). Verhulst 1990 reported that the range of motion along the three axes showed no statistically significant differences between the two groups.

The difference in the mean functional scores (pain, functional status, range of motion and grip strength were rated) of the two groups of Stoffelen 1998 was not significant, and similar numbers in the two groups had a satisfactory outcome (see Analysis 01.02). Although eight of the conservative treatment group achieved an excellent grade, none did in the pinning group (see Analysis 01.01 Functional grading: not excellent (Pins supporting fracture). 48/48 versus 42/50; RR 1.19, 95% CI 1.05 to 1.34), the spread of the functional scores shown in a graph in the trial report seems to indicate that little should be made of this. Stoffelen 1998 also found no significant differences between the two treatment groups in grip strength or finger movements at final follow up.

Complications suffered by the participants of all six trials are presented in Analysis 01.08. Null events have also been entered when reported. Redisplacement requiring secondary treatment only occurred in the conservative treatment group (0/115 versus 22/154; RR 0.09, 95% CI 0.02 to 0.37). Complications associated with the pins (K-wires) and pin insertion were few and generally minor in consequence except for the removal of K-wires after a pin-track infection in Azzopardi 2005 and the K-wire migration in Gupta 1999 that caused a redisplacement of the fracture. There was no report of tendon rupture or injury. Complications relating to the median nerve, such as carpal tunnel syndrome, were more common, but not statistically significantly so, in the conservative treatment group (3/161 versus 11/202; RR 0.53, 95% CI 0.19 to 1.46). All six cases of superficial radial nerve injury, one of which persisted, occurred in the pinning group in Stoffelen 1998; these may have resulted from injuries caused by the radially-sited pin. The incidence of RSD was similar in the two groups. There was a high incidence of short-term RSD in Stoffelen 1998; this persisted in twice as many participants of the pinning group (4/48 versus 2/50). There was one case of shoulder hand syndrome in Shankar 1992. Slightly more patients (21/48 versus 29/50) in the conservative treatment group had diminished finger function at six weeks in Stoffelen 1998.

Anatomical results were better in the pinning group compared with the plaster group in all five fracture fixation trials. Redisplacement requiring secondary treatment (reduction or reduction and K-wire fixation) occurred only in conservatively treated fractures in four trials (see Analysis 01.08 Complications). The sole redisplacement in the pinning group was caused by K-wire (pin) migration in Gupta 1999. Healing of all fractures was confirmed in Gupta 1999 and Shankar 1992 and is likely in the other trials. There was a greater incidence of wrist deformity, depicted by angulated malunion, articular incongruity or an articular step in excess of two millimetres, in the conservative treatment group in Rodriguez-Merchan 97 (see Analysis 01.09). Significantly more people in the conservative treatment group had prominence of the ulnar styloid, stated as indicating radial collapse, in Shankar 1992 (see Analysis 01.09. 0/23 versus 12/22; RR 0.04, 95% CI 0.00 to 0.61). Verhulst 1990 reported that a quarter of pinning group participants had cosmetic deformity of the wrist compared with over a half of those treated conservatively. Moreover the gross appearance of the wrist was worse in participants of the conservative treatment group. Significantly better overall anatomical grades were achieved by the pinning group in Gupta 1999 (see Analysis 01.10). Losses in radial angulation, radial length and dorsal angulation from the reduced position were reported as being significantly greater in the conservative treatment group in Gupta 1999, Shankar 1992 and Verhulst 1990. Complete data for anatomical measures were only available for five-weeks follow up in Azzopardi 2005 and at final follow up for Gupta 1999 show better values for the pinning group in dorsal and radial angulation, and radial length (see Analysis 01.11).

In contrast, Stoffelen 1998 did not report superior anatomical results for the Kapandji's pinning group. Whilst radial shift (lateral) was less in the pinning group (mean values: 0.5 mm versus 1.5 mm), radial shortening was greater (mean values: 2 mm versus < 1 mm). Stoffelen 1998 claimed that these differences were statistically significant. Stoffelen 1998 made no specific mention of the apparently greater, though indicated as not statistically different, difference in dorsal angulation between the two groups.

Any method of percutaneous pinning versus any other method of percutaneous pinning

Kapandji fixation versus trans-styloid fixation
In Lenoble 1995, Kapandji fixation followed by immediate mobilisation was compared with trans-styloid fixation followed by around six weeks of plaster cast immobilisation in 120 people. Neither baseline data nor results were provided for three participants who died, 15 who were lost to follow up and six with missing data. Standard deviations were not provided for functional and anatomical outcomes presented as continuous outcomes.

Lenoble 1995 reported there was no statistically significant difference between the two groups in either grip or pinch strength, both presented as a percentage of the uninjured wrist (one-year results: mean grip strength 84% versus 83%; mean pinch strength 89% versus 87%). More participants of the Kapandji group were reported to suffer pain but the difference between the groups in the mean visual analogue scale values was not statistically significant (two-year results: 7.6 versus 6.9 on a 0 (no pain) to 100 (unbearable pain) point scale). Wrist mobility was reported to be significantly better in the Kapandji group up until the removal of the K-wires at six to eight weeks (all values as percentage of uninjured arm, flexion: 59% versus 46%; extension: 58% versus 44%; radial deviation: 60% versus 38%; ulnar deviation: 61% versus 52%; pronation: 80% versus 62%; supination: 76% versus 64%) but not subsequently. Lenoble 1995 considered that better early range of motion results for the Kapandji group related to the early mobilisation of this group and occurred at the cost of increased pain.

There were more complications in the Kapandji group (see Analysis 02.01). In particular, there were more Kapandji group participants with persistent symptoms related to the superficial radial nerve (8/54 versus 3/42; RR 2.07, 95% CI 0.59 to 7.34), and an identical result for bone-scan confirmed RSD. Lenoble 1995 suggested that the radial nerve complications were related to Kirschner wire removal; these are closer to the sensory branches of the radial nerve in Kapandji pinning. The redisplaced fracture in the trans-styloid fixation group was treated with an external fixator. There were no cases of tendon or vascular injury or median nerve dysfunction. All four cases of pin-track infection were superficial.

Similar long-term results for anatomical outcomes in the two groups were evident from graphs presented in the trial report. The mean ulnar variance, which was positive in both groups, was approximately one millimetre greater in the Kapandji group; the increase in ulnar variance from the reduction position was said to be statistically more significant in this group. One of the six over-reduced (by 15 degrees in the anterior direction) fractures in the Kapandji group developed a more extreme anterior tilt whilst the two over-reduced fractures in the trans-styloid group did not worsen. The four cases of DISI (dorsal intercalated segment instability) and seven cases of VISI (volar intercalated segment instability) were reported as being "evenly" distributed through the two groups.

Kapandji fixation versus Py's isoelastic pinning
Fikry 1998 compared Kapandji intrafocal pinning with Py's isoelastic pinning in 110 people but presented results only for the 88 participants who were available at 27 months follow up.

Function, rated with the Jakim scoring system (Jakim 1991), was presented in two categories; subjective (pain and function) and objective (mobility, grip strength and deformity). The results for subjective function were almost the same for the two groups (see Analysis 03.01) but the difference in the objective results was statistically significant (see Analysis 03.02), as was the difference in the combined function and radiological results (see Analysis 03.03). A superior result was claimed for the Py's pinning group but the mean values for the objective and overall scores presented in Table III of the trial report show the converse (see Analyses 03.02 and 03.03). Thus, two set of values have been presented in the four analyses showing mean Jakim scores: the first set of values are those in the report; in the second set the results for the two groups are reversed, based on the assumption that the rows in the Table were presented in the reverse order. Though slightly fewer Py's pinning patients had an unsatisfactory outcome according to the grading of the overall outcome into four categories (excellent, good, fair, poor), the difference between the two groups did not reach statistical significance (see Analysis 03.04, overall outcome grades: not excellent 20/42 versus 16/46; RR 1.37, 95% CI 0.82 to 2.27; and overall outcome grades: fair or poor 7/42 versus 6/46; RR 1.28, 95% CI 0.47 to 3.50).

Kapandji intrafocal pinning was associated with significantly more complications (see Analysis 03.05). Fikry 1998 suggested that the excess of secondary fracture displacements (7/42 versus 2/46; RR 3.83, 95% CI 0.84 to 17.44) and wire displacements (6/42 versus 0/46; RR 14.21, 95% CI 0.82 to 244.80) in the Kapandji group was linked to posterior comminution of the original fracture. The iatrogenic fracture in the Py's pinning group was successfully treated by a plate; Fikry 1998 suggested that a missed epiphyseal fracture generated a weakness that resulted in the shearing of the epiphyseal fragment when the posterior pin was inserted. Similar numbers of participants suffered tendon rupture or RSD; all participants with ruptured tendons had successful secondary tendon transfer, and all those with RSD required prolonged rehabilitation.

Anatomical results including dorsal and radial angulation, radial length, articulation of the radio-ulnar joint, incongruity ("step-off") and signs of arthritis were scored according to Jakim's scoring system (Jakim 1991). A superior result was claimed for the Py's pinning group but again the mean values for the radiological section presented in the report show the converse (see Analysis 03.06). As noted above, more secondary displacement of fractures occurred in the Kapandji group.

Modified Kapandji fixation versus Willenegger fixation
In Strohm 2004, intrafocal pinning with two Kirschner wires and fracture fixation with a third wire was compared with Willenegger pinning in 100 participants. While both groups had wrist immobilisation for six weeks, a volar splint was used in the first group and a forearm cast in the second. Moreover, the modified Kapandji group started physiotherapy after three weeks.

Strohm 2004 reported that the modified Kapandji group had significantly higher modified Martini scores (this composite score included pain, subjective assessment, strength, work and sports, wrist and forearm mobility, radiological results and complications) at a median of 10 months follow up: 34 versus 28 on a scale 0 (worst) to 38 (best); reported P < 0.005). There were no significant differences between the two groups in the numbers of people with complications (see Analysis 04.01). Two participants of the Willenegger group had an undefined "conversion procedure". Both cases of RSD resolved after treatment; and both cases of carpal tunnel syndrome were operated on. Strohm 2004 reported there was no significant difference between the two groups in operating times but that imaging time was significantly less in the modified Kapandji group (89.5 versus 156 seconds; reported P < 0.004).

Any technique or type of material or device used for percutaneous pinning versus any other technique or type of material or device at surgery or post-operatively

Biodegradable pins or wires versus metal pins or wires
Two trials (Casteleyn 1992; Korner 1999) compared biodegradable pins with Kirschner wires in 70 people. Casteleyn 1992 used Kapandji's intrafocal pinning with two wires whereas two pins or wires were inserted across the fracture, via the radial styloid, in Korner 1999. Despite the differences in the pinning techniques, the results for the two trials are presented together in the analyses but no pooling has been performed. (The possibility that the subcutaneous protrusion of the ends of the pins in the Kapandji pinning technique could increase the specific complications of biodegradable implants was raised in Casteleyn 1992; this could also have applied to Korner 1999.)

Functional recovery in the Kirschner wire group was reported to have been quicker in Casteleyn 1992 although the eventual difference between the two groups (based on a five point scale) was reported as not being statistically significant, and no participant had any restriction in activities of daily living. The range of motion was satisfactory in both groups; again there was no statistically significant difference between them (see Analysis 05.01). Korner 1999 did not report whether the greater loss in range of motion in the biodegradable pinning group was statistically significant: mean loss compared to contralateral wrist: 30 versus 20 degrees (extension/flexion); 35 versus 30 degrees (pronation/supination).

In both trials there was an excess of complications in the biodegradable pinning group (see Analysis 05.02). Difficulties during pin insertion in Korner 1999 (8/19 versus 0/21; RR 18.70, 95% CI 1.15 to 303.59) contributed to the longer duration of the operation in the biodegradable pinning group (mean duration: 40.5 versus 23.5 minutes). Secondary surgery was performed for the two tendon ruptures (Kirschner wiring group) and for one of the two cases of carpal tunnel syndrome; both of the latter were attributed to swelling brought on by the biodegradable rod. Painful scars, sinus formation and severe osteolytic reactions (9/15 versus 0/21; RR 19.00, 95% CI 1.20 to 299.63) were also related to the degradation and resorption of the biodegradable material in Casteleyn 1992. One of the people with a sinus showed a non-specific foreign-body reaction with abundant giant cells. Most of the severe osteolytic reactions were most obvious around three to six months post-operatively, but had resolved or regressed by one year. Casteleyn 1992 pointed out that the main putative advantage of biodegradable implants, namely that they do not need to be removed, was offset by the "management cost and inconvenience of the late inflammatory reactions".

Final anatomical results were considered satisfactory in both groups in Casteleyn 1992, who found no statistically significant differences between the two groups (see Analysis 05.03). One person in the biodegradable pinning group in Korner 1999 had a secondary displacement requiring revision (see Analysis 05.02).

Any type or duration of post-operative immobilisation versus any other type or duration of immobilisation including none

Duration of post-operative immobilisation after percutaneous pinning
Two trials (Allain 1999; Milliez 1992) compared plaster cast immobilisation for one week versus six weeks after surgery in 120 people. Given the different methods of percutaneous pinning (trans-styloid fixation in Allain 1999 and Kapandji intrafocal pinning in Milliez 1992) and clear heterogeneity in the results of the few comparable outcomes (all complications) with data, pooled results are not presented for this comparison.

Overall, there was little difference between the two treatment groups in functional outcome in either trial. Allain 1999 reported there were no significant differences between the two groups in the mean duration of sick leave (7 weeks) for the 39 trial participants who worked, in the numbers (14) with functional discomfort during domestic chores, or in the numbers of "sportsmen" with residual discomfort (3 of 22). One participant, who had RSD, of the six weeks group was the only one of 19 people in Milliez 1992 who had not returned to work by three months. At final follow up (1 year: Allain 1999; 3 months: Milliez 1992), differences in grip strength, which was greater in the early mobilisation group in both trials (Allain 1999: 25 kg versus 21 kg; Milliez 1992: 55% versus 44% of normal side), were reported not to be statistically significant. Allain 1999 reported there was no significant difference between the two groups in the mean pain scores (13 versus 12.5 (15 = no pain)) or use of analgesics. Though, as calculated from percentages in the trial report, fewer people in the early mobilisation groups had pain at follow up in Milliez 1992 (see Analysis 06.01; 4/27 versus 10/30; RR 0.44, 95% CI 0.16 to 1.25); the difference between the two groups was not statistically significant. All the mean values for the six parameters for range of movement in Allain 1999 were greater in the early mobilisation group but only the difference in the ulnar deviation was reported as being statistically significant (39 versus 37 degrees; reported P = 0.03). There were no statistically significant differences in flexion (74% versus 77% of normal side) or extension (72% versus 74% of normal side) in Milliez 1992, although the results were marginally better in the group immobilised for six weeks.

None of the differences between the two treatment groups in the reported clinical outcomes were statistically significant for either trial. Analysis 06.02 presents the numbers of participants with various complications. These were fewer overall with similar numbers in the two groups in Allain 1999. Surgery was necessary for the person of the six weeks group who had ruptures of two tendons, and an anterior approach to wire removal was required for a displaced wire in another person in the same group. Three of the four cases of persistent radial nerve paraesthesia or hypoaesthesia appeared only after Kirschner wire removal. In Milliez 1992, all the complications occurred in the early group with the exception of one case of RSD, referred to above. One of the five wire displacements in the early mobilisation group in Milliez 1992 was associated with a tendon rupture, one resulted from poor technique (wiring was done by "junior" operators) and two from osteoporotic bone. In Milliez 1992, the wrists of three people with "treatment failure", one due to the need for tendon repair and two due to the risk of secondary displacement, were immobilised. There was no significant difference between the two treatment groups of in Allain 1999 in the numbers of people who were disappointed with their outcome (see Analysis 06.03: 3/30 versus 1/30; RR 3.00, 95% CI 0.33 to 27.23).

Similar radiological results in the two treatment groups were reported by both trials. As it is likely that the unusually small "standard deviations" provided in Allain 1999 were standard errors, the results for dorsal and radial angulation and radial length with standard deviations calculated from the supposed standard errors are shown in Analysis 06.04. These results are compatible with the claim of no statistical significance. The three radiological parameters listed in Milliez 1992 are defined in the 'Characteristics of included studies' table. However, the results at three months seem to be for dorsal angulation (volar tilt: 6.9 versus 6.5 degrees), radial inclination (21.4 versus 21.3 degrees) and ulnar variance (1.4 mm versus 1.1 mm).

Allain 1999 concluded that additional immobilisation was not necessary after trans-styloid fixation, whereas Milliez 1992 concluded that early mobilisation after Kapandji intrafocal fixation should only be used in patients with good quality bone stock who would comply with the instructions after surgery.

Discussion

This review of one of the most common surgical interventions for one of the most common fractures has only 13 trials, involving a total of 940 participants, and evaluates six comparisons, with data pooling for one comparison. There is either no or limited evidence to inform the many choices for percutaneous pinning; this variation is illustrated by the questions addressed by and the interventions used in the included trials, as well as those for the six trials in 'Studies awaiting assessment'.

Limitations of the review methods
As this review abided by the criteria and methods set out in a published protocol, we have restricted our comments to two issues. The first is whether trials have been missed or inappropriately excluded in our search and selection processes. The second concerns decisions concerning pooling and subgroup analysis.

Our search was comprehensive and built on searches carried out over many years prior to the separate development of this review (Handoll 2003a). It has included the handsearch of conference proceedings and checks for ongoing trials. An inclusive and benefit-of-doubt approach during trial searches has been maintained throughout by the lead author (HH). Additionally, trial authors of unpublished trials have been sent requests for information and trial reports. While it is possible that we have missed some potentially eligible trials, it is questionable whether these would have ultimately been included if they had remained unpublished and substantially under-reported. We guarded against study selection bias by the independent selection of eligible trials by all three review authors.

We restricted pooling to one comparison. As stated beforehand, we treated Kapandji intrafocal pinning as a distinctly separate method of pinning to across-fracture methods. The decision not to pool data from trials of these two different pinning approaches is supported by the clear and statistically significant differences in effect (e.g. see Analysis 01.02. Test for interaction: two tail Z-test = 0.02). Though the five across-fracture trials were heterogeneous, such as in the type of fracture, the pooled results for the few available outcomes were statistically homogeneous. It was not possible to conduct subgroup analyses to explore other trial characteristics or sensitivity analyses, including those to explore the effects of the high loss to follow up in some trials.

Limitations of the review evidence
Overall, the available evidence is limited in scope and quantity, and is of uncertain validity. There is a potential for chance findings from these 13 small trials and, in addition, any apparent comparability of results of interventions tested within some trials should not be interpreted as evidence of no effect or no difference. Systematic bias, in the form of selection, performance, exclusion or assessment bias, or a combination of these could not be ruled out for any trial. Incomplete reporting of methods and results was a major problem in many of these trials, and especially Korner 1999 and Verhulst 1990 which were available in conference abstracts only. Another limitation was the inadequate assessment of outcome, particularly of function and in the long-term. Non-validated outcome measures, such as those based on the Gartland and Werley scoring system (Gartland 1951), that combine aspects of function, pain, deformity and complications are particularly crude indicators of outcome. Considerable caution is needed when interpreting these, and more so when the scores have been categorised. Many trials predated the development of validated patient functional assessment instruments such as Short Form-36 (SF-36), the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) and the Patient-Rated Wrist Evaluation (PRWE) (MacDermid 2000). These help to standardise functional assessment in a meaningful way and assist interpretation (Amadio 2001).

Applicability of the review evidence
Generalising the findings of the included trials, should these be valid, is hampered by inadequate reporting of study details, such as the type and severity of the fracture, and bone quality. The variety of fracture classification systems, with associated issues of reliability and validity further complicates this area (Jupiter 1997). For example, the two fracture classifications used by trials in this review (the AO and Frykman) place different emphases on various fracture patterns and anatomical components. Studies have revealed unsatisfactory interobserver reliability and intraobserver reproducibility for both classification systems (Andersen 1996; Kreder 1996b), and neither was useful for predicting clinical outcome (Flinkkila 1998). Two trials in this review stipulated criteria for anatomical displacement of the fracture for trial entry. However, Kreder 1996a found quite broad margins of error ("tolerance limits") for anatomical measurements in general. This with other factors, such as variations in anatomical reference points, again hinders treatment comparison.

Fracture instability was the inherent or explicit criterion for many of the included trials, but it is not established how best to predict this. A recent study of 4024 patients concluded that patient age, metaphyseal comminution of the fracture and ulnar variance were the most important factors in predicting instability of distal radial fractures (MacKenney 2006).

Comparisons
A summary of the conclusions of effectiveness drawn from the findings of each comparison is provided in Table 6. Here, the effectiveness of each intervention relative to the 'control' intervention in each comparison is graded according to the categories of effectiveness (1: Beneficial; 2: Likely to be beneficial; 3: Trade off between benefits and harms; 4: Unknown effectiveness; 5: Unlikely to be beneficial; 6: Likely to be ineffective or harmful) described in Table 3. Some notes in justification of the grading, some qualifying statements and other comments are also provided.

Table 6. Categories of effectiveness of interventions by comparison
ComparisonCategoryJustificationQualifiersComments
Any method of percutaneous pinning versus conservative treatment involving plaster or brace use.   Few details were usually provided for the conservative treatment intervention which always involved plaster cast immobilisation. There remains a possibility of sub-optimal application of plaster casts in some trials.
Percutaneous pinning (across fracture) versus conservative treatment3: Trade off between benefits and harms (across-fracture pining)Across-fracture pinning reduces redisplacement requiring secondary treatment (usually remanipulation under anaesthesia in the plaster cast group) and yields better anatomical results. However, the evidence of a better functional outcome from pinning is weak. The complications associated with pinning were generally minor.a. Indications (fracture types) for treatment, type, technique and timing of across-fracture percutaneous pinning not established.
b. Incomplete functional and long term outcome.
 
Percutaneous pinning (Kapandji) versus conservative treatment5: Unlikely to be beneficial (Kapandji pinning)While the evidence from one small flawed trial was limited, there was a marked excess of complications in Kapandji pinning group with no indication of a better anatomical or functional result.The excess complications in Kapandji pinning group included possible injury from pin placement.Mobilisation was after 1 week in Kapandji group.
Any method of percutaneous pinning versus any other method of percutaneous pinning    
Kapandji fixation versus trans-styloid fixation4: Unknown effectivenessNot enough evidence; small flawed trial (20% loss to follow up).Excess complications in Kapandji pinning group (pin placement?).Immediate mobilisation in the Kapandji group.
Kapandji fixation versus Py's isoelastic pinning4: Unknown effectivenessNot enough evidence; contradictory report of one small trial.Avoidance of dorsally comminuted fractures for Kapandji pinning seems relevant.Further refinements of the Kapandji pins have occurred - prompted in part by these considerations.
Modified Kapandji fixation versus Willeneger fixation4: Unknown effectivenessNot enough evidence; small flawed trial (19% loss to follow up). Modified Kapandji fixation is actually a combination of two approaches (intrafocal and transfracture fixation). Physiotherapy was started after 3 weeks in this group. This changes the actual question being covered.
Any technique or type of material or device used for percutaneous pinning versus any other technique or type of material or device at surgery or post-operatively    
Biodegradable pins or wires versus metal pins or wires5: Unlikely to be beneficial (biodegradable implants)The extra demands at surgery, excess of complications associated with biodegradable material.Limited evidence: two small trials of two different pinning techniques. A third trial reporting fewer complications with biodegradable material is pending assessment awaiting quantitative data from the trial authors.The putative advantages - avoidance of needing to take metal pins out and associated risk of damage - seem to be outweighed on the present evidence. Also some cost implications.
Any type or duration of post-operative immobilisation versus any other type or duration of immobilisation including none    
Duration of immobilisation after percutaneous pinning4: Unknown effectivenessNot enough evidence; two small quasi-randomised trials involving different methods of percutaneous pinning.Excess complications in the early mobilisation for Kapandji pinning.Percutaneous pinning was across-fracture in one trial and Kapandji pinning in the other.

Any method of percutaneous pinning versus conservative treatment involving plaster or brace use

Percutaneous pinning versus plaster cast immobilisation alone
The six trials for this comparison were heterogeneous in terms of patient and fracture characteristics, pinning techniques and aftercare (see Table 4). As specified in the protocol, the results of Stoffelen 1998, which used the Kapandji pinning technique, for functional and anatomical outcomes were presented separately.

The better anatomical result, both in maintaining the reduced fracture position and in final anatomy, found in the across-fracture pinning group is likely to be valid. The extent of improvement varied. The two trials (Rodriguez-Merchan 97; Shankar 1992) with potentially the most unstable fractures (all participants had comminuted intra-articular fractures) had higher proportions of conservatively-treated participants with redisplacements requiring secondary treatment and deformity. Azzopardi 2005 found the improvement in radiological parameters to be "marginal". Superior functional results were found in the pinning group in three trials but these are partly based on non-validated scoring systems that also rated deformity, and small numbers of participants. Neither Azzopardi 2005 nor Verhulst 1990 found significantly improved functional outcome in their "elderly" populations. Complications of pinning were generally minor. In all, there is some evidence to suggest superior results of percutaneous pinning to stabilise fracture fragments compared with conservative treatment. However, the available evidence is insufficient to address questions such as those regarding the fracture pattern and the type of pinning.

Stoffelen 1998 was compromised by poor methodology and inconsistent reporting in the three trial reports. Kapandji pinning with early mobilisation (one week of plaster immobilisation) for dorsally displaced extra-articular fractures was not associated with better anatomical or functional results to plaster cast immobilisation for six weeks, three weeks of which involved an above-elbow cast. There was a high rate of complications, in particular of RSD and finger stiffness, in Stoffelen 1998; of note were the six cases of radial nerve injury from pin placement. The available evidence from this trial is insufficient to show the effectiveness of the Kapandji approach.

Any method of percutaneous pinning versus any other method of percutaneous pinning

Kapandji fixation versus trans-styloid fixation
One trial (Lenoble 1995) compared two or three-pin Kapandji pinning with two-pin trans-styloid fixation in dorsally displaced fractures. These were stated to be the two most commonly used methods in France for such fractures. Final anatomical and functional results were similar in both groups, though better early mobility but more pain occurred in the Kapandji pinning group reflecting their earlier mobilisation. The exclusion of 20% of participants from the analyses, already small numbers and other methodological shortcomings weakens the validity of the trial's results. However the higher, while not statistically significantly so, numbers with superficial radial nerve symptoms in the Kapandji pinning group is plausibly related to the pin placement of this method.

Kapandji fixation versus Py's isoelastic pinning
Contradictory anatomical and functional results, based on an unvalidated scoring scheme were reported in the only trial comparing these two methods (Fikry 1998) for dorsally displaced fractures. There was insufficient evidence to draw any conclusions of difference between the two groups. However, the suggestion in Fikry 1998 that the higher numbers of complications, specifically fracture and wire displacement, in the three-pin Kapandji pinning group were associated with fractures with dorsal comminution seems pertinent to the use of this method. Others have also advised the restriction of the Kapandji pinning to non-comminuted fractures (Fernandez 1999) as well as noting the further refinements of the method such as the use of "arum" pins which may improve results and lessen tendon-related complications (Fernandez 1999; Rayhack 1993).

Modified Kapandji fixation versus Willenegger fixation
The modified Kapandji method used in Strohm 2004 is essentially a combination of fracture fixation and intrafocal pinning. The comparison in Strohm 2004 should not be viewed as simply testing two approaches for pinning because of other differences such as the additional physiotherapy starting after three weeks in the modified Kapandji group. The serious methodological flaws, in particular the use of an unvalidated and composite scoring scheme, variable follow up times and exclusion of 19% of participants from the analyses, of Strohm 2004 mean that the promising results for the "Kapandji" method should not be taken as proven. The smaller mean duration of radiographic exposure for the modified Kapandji group is curious given that it seems the more complicated of the two pinning procedures.

Any technique or type of material or device used for percutaneous pinning versus any other technique or type of material or device at surgery or post-operatively

Biodegradable pins or wires versus metal pins or wires
The use of biodegradable pins was tested in two small trials (Casteleyn 1992; Korner 1999) using two very different pinning techniques. There was insufficient evidence to detect a difference in anatomical and functional outcome between the two groups. What were evident, however, were the extra demands at surgery of insertion of biodegradable pins, and the significant excess of complications associated with biodegradable material. Thus the recommendation, expressed by both studies, not to use biodegradable pins for these fractures (in adults) seems justified. This conclusion may be moderated should evidence become available for a trial, involving 115 participants, currently in 'Studies awaiting assessment'.

Any type or duration of post-operative immobilisation versus any other type or duration of immobilisation including none

Duration of post-operative immobilisation after percutaneous pinning
The two small quasi-randomised trials (Allain 1999; Milliez 1992) evaluating duration of immobilisation after percutaneous pinning used very different pinning techniques. Thus it is likely that the findings of one trial may not apply to the other. No statistically significant differences between one and six weeks plaster cast immobilisation in functional, clinical or radiological results were found in either trial; except for a clinically irrelevant difference of in ulnar deviation in Allain 1999. However, more complications occurred in the early mobilisation group after Kapandji pinning in Milliez 1992. As Allain 1999 acknowledged, the small numbers involved are not enough to conclude that one week immobilisation, reducing the inconvenience and problems through disuse associated with prolonged immobilisation, was sufficient after trans-styloid fixation for certain fracture patterns. Early mobilisation is put forward as a key advantage of Kapandji fixation (Kapandji 1988) and often applied. Whilst the excess of complications in the early mobilisation group in Milliez 1992 is of concern, there is not enough good quality evidence to determine whether this aspect of the Kapandji method is appropriate.

Any method or timing of pin or wire removal versus any other method or timing of pin or wire removal including no removal
At present there are no included trials for this topic.

Authors' conclusions

Implications for practice

Only a few and provisional conclusions relating to clinical management can be drawn from the available randomised trials.

For dorsally displaced fractures, across-fracture percutaneous pinning helps to maintain reduced positions and thereby reduce deformity and malunion compared with plaster cast immobilisation alone. There is limited evidence that its use improves function. Complications are usually minor and, to some extent, avoidable. However, uncertainty remains about the indications for percutaneous pinning, the best technique to employ, and the extent and duration of immobilisation. Kapandji pinning, involving the support rather than fixation of the distal fracture fragment, appears to be associated with a less favourable outcome, particularly an excess of probable iatrogenic complications. More recent refinements of this technique have yet to be evaluated. There was some evidence of an excess of complications which, coupled with the extra demands at surgery, are likely to outweigh the putative advantages - avoidance of metal wire extraction and the associated risk of damage - of biodegradable pins.

Implications for research

Given that a distal radius fracture in adults is a common injury and given that there is very limited knowledge about the best method of treatment, either conservative or surgical, further research is called for (Handoll 2003a). However, rather than embark on yet more small single centre trials, particularly those with inadequate methodology that are unlikely to provide the good quality generalisable evidence required, the identification of the priority questions for the management of these fractures is required (Handoll 2003d). The updating of the evidence summaries for other surgical interventions of these fractures is likely to inform this process.

Acknowledgements

We thank Lesley Gillespie for her help with the search strategy. We thank the following for helpful comments at the editorial and external review of the protocol: Bill Gillespie, Lesley Gillespie, Peter Herbison, Jesse Jupiter and Janet Wale. We thank Lindsey Shaw for her help during editorial processing of the protocol. We thank the following for helpful comments at the editorial and external review of the review: Bill Gillespie, Jesse Jupiter, Vicki Livingstone and Janet Wale. We thank Joanne Elliott and Lindsey Shaw for their help during editorial processing of the review.

We thank Sonia Stewart for her help with translation. We are very grateful to those trialists, in particular Rakesh Gupta, who provided clarification and further information on their trials.

Data and analyses

Download statistical data

Comparison 1. Percutaneous pinning versus plaster cast
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Functional grading: not excellent4 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 Pins through fracture3135Risk Ratio (M-H, Fixed, 95% CI)0.53 [0.39, 0.71]
1.2 Pins supporting fracture198Risk Ratio (M-H, Fixed, 95% CI)1.19 [1.05, 1.35]
2 Functional grading: fair or poor4 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 Pins through fracture3135Risk Ratio (M-H, Fixed, 95% CI)0.31 [0.15, 0.64]
2.2 Pins supporting fracture198Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.49, 1.89]
3 Short Form 361 Mean Difference (IV, Fixed, 95% CI)Totals not selected
3.1 Physical score at 4 months (0: worst to 100: best health)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
3.2 Mental score at 4 months (0: worst to 100: best health)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
4 Non return to work (labourers)1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
5 Under half grip strength at 6 months1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
6 Pain (occasional)1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
7 Range of movement1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
7.1 Flexion (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
7.2 Extension (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
7.3 Radial deviation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
7.4 Ulnar deviation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
7.5 Supination (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
7.6 Pronation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
8 Complications6 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 Redisplacement150Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.13, 70.30]
8.2 Redisplacement resulting in secondary treatment (reduction or reduction and K-wire fixation)4269Risk Ratio (M-H, Fixed, 95% CI)0.09 [0.02, 0.37]
8.3 K-wire migration2180Risk Ratio (M-H, Fixed, 95% CI)8.68 [1.19, 63.23]
8.4 K-wire extrusion150Risk Ratio (M-H, Fixed, 95% CI)Not estimable
8.5 K-wire removal due to metal sensitivity145Risk Ratio (M-H, Fixed, 95% CI)2.88 [0.12, 67.03]
8.6 Pin track infection4189Risk Ratio (M-H, Fixed, 95% CI)3.62 [0.61, 21.32]
8.7 Stab wound infection1130Risk Ratio (M-H, Fixed, 95% CI)13.09 [0.69, 247.92]
8.8 Joint infection/osteomyelitis140Risk Ratio (M-H, Fixed, 95% CI)Not estimable
8.9 Tendon injury/rupture294Risk Ratio (M-H, Fixed, 95% CI)Not estimable
8.10 Median nerve compression/neuropathy/contusion /CTS5363Risk Ratio (M-H, Fixed, 95% CI)0.53 [0.19, 1.46]
8.11 Superfical radial nerve injury2152Risk Ratio (M-H, Fixed, 95% CI)13.53 [0.78, 233.82]
8.12 Reflex sympathetic dystrophy/Sudeck's atrophy3188Risk Ratio (M-H, Fixed, 95% CI)0.84 [0.45, 1.59]
8.13 Persistent reflex sympathetic dystrophy198Risk Ratio (M-H, Fixed, 95% CI)2.08 [0.40, 10.85]
8.14 Shoulder hand syndrome295Risk Ratio (M-H, Fixed, 95% CI)0.32 [0.01, 7.45]
8.15 Diminished finger function (at 6 weeks)198Risk Ratio (M-H, Fixed, 95% CI)0.75 [0.51, 1.12]
9 Deformity (clinical and radiological)2 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
9.1 Angulated malunion1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
9.2 Articular incongruity1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
9.3 Articular step off > 2 mm1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
9.4 Residual deformity - prominence of ulnar styloid1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
10 Anatomical grading1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
10.1 Not excellent1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
10.2 Fair or poor1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
11 Anatomical measurements2 Mean Difference (IV, Fixed, 95% CI)Totals not selected
11.1 Dorsal angulation (degrees)2 Mean Difference (IV, Fixed, 95% CI)Not estimable
11.2 Radial angulation (degrees)2 Mean Difference (IV, Fixed, 95% CI)Not estimable
11.3 Radial length (mm)2 Mean Difference (IV, Fixed, 95% CI)Not estimable
11.4 Ulnar variance (mm)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
Analysis 1.1.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 1 Functional grading: not excellent.

Analysis 1.2.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 2 Functional grading: fair or poor.

Analysis 1.3.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 3 Short Form 36.

Analysis 1.4.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 4 Non return to work (labourers).

Analysis 1.5.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 5 Under half grip strength at 6 months.

Analysis 1.6.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 6 Pain (occasional).

Analysis 1.7.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 7 Range of movement.

Analysis 1.8.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 8 Complications.

Analysis 1.9.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 9 Deformity (clinical and radiological).

Analysis 1.10.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 10 Anatomical grading.

Analysis 1.11.

Comparison 1 Percutaneous pinning versus plaster cast, Outcome 11 Anatomical measurements.

Comparison 2. Kapandji intrafocal pinning (2 or 3 wires) versus trans-styloid fixation (2 wires)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Complications1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 Redisplacement requiring secondary treatment1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.2 Superficial pin-track infection1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.3 Tendon complications1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.4 Superficial radial nerve - symptoms1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.5 Median nerve dysfunction1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.6 Confirmed reflex sympathetic dystrophy (bone scan)1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
Analysis 2.1.

Comparison 2 Kapandji intrafocal pinning (2 or 3 wires) versus trans-styloid fixation (2 wires), Outcome 1 Complications.

Comparison 3. Kapandji intrafocal pinning (3 wires) versus Py isoelastic pinning (2 wires)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Subjective results: pain and function (normal = 30 points)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
1.1 In paper1 Mean Difference (IV, Fixed, 95% CI)Not estimable
1.2 Reversed results1 Mean Difference (IV, Fixed, 95% CI)Not estimable
2 Objective results: mobility, grip strength, deformity (normal = 30 points)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
2.1 In paper1 Mean Difference (IV, Fixed, 95% CI)Not estimable
2.2 Reversed results1 Mean Difference (IV, Fixed, 95% CI)Not estimable
3 Overall results: radiological, subjective and objective (normal = 100 points)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
3.1 In paper1 Mean Difference (IV, Fixed, 95% CI)Not estimable
3.2 Reversed results1 Mean Difference (IV, Fixed, 95% CI)Not estimable
4 Overall outcome grades1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
4.1 Not excellent1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
4.2 Fair or poor1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
5 Complications1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
5.1 Secondary displacement1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
5.2 Fracture caused by pinning1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
5.3 Wire displacement1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
5.4 Superficial infection1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
5.5 Tendon rupture1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
5.6 Reflex sympathetic dystrophy (Syndrome algoneurodystrophique)1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
6 Radiological results (normal = 40 points)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
6.1 In paper1 Mean Difference (IV, Fixed, 95% CI)Not estimable
6.2 Reversed results1 Mean Difference (IV, Fixed, 95% CI)Not estimable
Analysis 3.1.

Comparison 3 Kapandji intrafocal pinning (3 wires) versus Py isoelastic pinning (2 wires), Outcome 1 Subjective results: pain and function (normal = 30 points).

Analysis 3.2.

Comparison 3 Kapandji intrafocal pinning (3 wires) versus Py isoelastic pinning (2 wires), Outcome 2 Objective results: mobility, grip strength, deformity (normal = 30 points).

Analysis 3.3.

Comparison 3 Kapandji intrafocal pinning (3 wires) versus Py isoelastic pinning (2 wires), Outcome 3 Overall results: radiological, subjective and objective (normal = 100 points).

Analysis 3.4.

Comparison 3 Kapandji intrafocal pinning (3 wires) versus Py isoelastic pinning (2 wires), Outcome 4 Overall outcome grades.

Analysis 3.5.

Comparison 3 Kapandji intrafocal pinning (3 wires) versus Py isoelastic pinning (2 wires), Outcome 5 Complications.

Analysis 3.6.

Comparison 3 Kapandji intrafocal pinning (3 wires) versus Py isoelastic pinning (2 wires), Outcome 6 Radiological results (normal = 40 points).

Comparison 4. Modified Kapandji pinning (3 wires) versus Willenegger pinning (2 wires)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Complications1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 "Conversion procedure" (secondary treatment)1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.2 Wire migration1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.3 Nerve irritation1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.4 Carpal tunnel syndrome1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.5 Tendon injury or rupture1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.6 Reflex sympathetic dystrophy1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
1.7 Signs of swelling1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
Analysis 4.1.

Comparison 4 Modified Kapandji pinning (3 wires) versus Willenegger pinning (2 wires), Outcome 1 Complications.

Comparison 5. Biodegradeable pins versus Kirschner wires
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Range of movement1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
1.1 Flexion (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
1.2 Extension (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
1.3 Radial deviation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
1.4 Ulnar deviation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
1.5 Supination (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
1.6 Pronation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
2 Complications2 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 Operational difficulties in pin or wire insertion1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.2 Secondary displacement requiring revision1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.3 Superficial wound infection1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.4 Tendon rupture1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.5 Carpal tunnel syndrome1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.6 Reflex sympathetic dystrophy1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.7 Secondary surgery1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.8 Painful scars1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.9 Sinus formation1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.10 Severe osteolytic reactions1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.11 Arthrosis (radiological signs)1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
3 Anatomical measurements1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
3.1 Dorsal angulation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
3.2 Radial angulation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
3.3 Radio-ulnar index (mm)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
Analysis 5.1.

Comparison 5 Biodegradeable pins versus Kirschner wires, Outcome 1 Range of movement.

Analysis 5.2.

Comparison 5 Biodegradeable pins versus Kirschner wires, Outcome 2 Complications.

Analysis 5.3.

Comparison 5 Biodegradeable pins versus Kirschner wires, Outcome 3 Anatomical measurements.

Comparison 6. Early (after 1 week cast immobilisation) versus later (after 6 weeks) mobilisation post surgery
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain: usually or during effort (rounded data derived from percentages)1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2 Complications2 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 Displaced wires or pins2 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.2 Treatment failure (change of treatment)1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.3 Superficial pin-track infection1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.4 Tendon rupture2 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.5 Persistent radial nerve paraesthesia or hypoaesthesia1 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
2.6 Reflex sympathetic dystrophy2 Risk Ratio (M-H, Fixed, 95% CI)Not estimable
3 Patient dissatisfaction with outcome1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
4 Anatomical measurements (at 1 year): standard errors conversion1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
4.1 Dorsal angulation - volar tilt (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
4.2 Radial angulation (degrees)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
4.3 Radial length (mm)1 Mean Difference (IV, Fixed, 95% CI)Not estimable
Analysis 6.1.

Comparison 6 Early (after 1 week cast immobilisation) versus later (after 6 weeks) mobilisation post surgery, Outcome 1 Pain: usually or during effort (rounded data derived from percentages).

Analysis 6.2.

Comparison 6 Early (after 1 week cast immobilisation) versus later (after 6 weeks) mobilisation post surgery, Outcome 2 Complications.

Analysis 6.3.

Comparison 6 Early (after 1 week cast immobilisation) versus later (after 6 weeks) mobilisation post surgery, Outcome 3 Patient dissatisfaction with outcome.

Analysis 6.4.

Comparison 6 Early (after 1 week cast immobilisation) versus later (after 6 weeks) mobilisation post surgery, Outcome 4 Anatomical measurements (at 1 year): standard errors conversion.

Appendices

Appendix 1. Search strategy for The Cochrane Library (Wiley InterScience)

#1 MeSH descriptor Radius Fractures explode all trees in MeSH products
#2 MeSH descriptor Wrist Injuries explode all trees in MeSH products
#3 (#1 OR #2)
#4 ((distal near radius) or (distal near radial)) in Title, Abstract or Keywords in all products
#5 (colles or smith or smiths) in Title, Abstract or Keywords in all products
#6 wrist* in Title, Abstract or Keywords in all products
#7 (#4 OR #5 OR #6)
#8 fractur* in Title, Abstract or Keywords in all products
#9 (#7 AND #8)
#10 (#3 OR #9)

Appendix 2. Search strategy for MEDLINE (OVID-WEB)

1. exp Radius Fractures/
2. Wrist Injuries/
3. (((distal adj3 (radius or radial)) or wrist or colles or smith$2) adj3 fracture$).ti,ab.
4. or/1-3

Appendix 3. Search strategies for CINAHL and EMBASE (OVID-WEB)

CINAHLEMBASE
1. Radius Fractures/
2. Wrist Injuries/
3. or/1-2
4. (((distal adj3 (radius or radial)) or wrist or colles or smith$2) adj3 fracture$).ti,ab.
5. or/3-4
6. exp Clinical Trials/
7. exp Evaluation Research/
8. exp Comparative Studies/
9. exp Crossover Design/
10. clinical trial.pt.
11. or/6-10
12. ((clinical or controlled or comparative or placebo or prospective or randomi#ed) adj3 (trial or study)).tw.
13. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw.
14. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw.
15. (cross?over$ or (cross adj1 over$)).tw.
16. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw.
17. or/12-16
18. or/11,17
19. and/5,18
1. (((distal adj3 (radius or radial)) or wrist or colles$2 or smith$2) adj3 fracture$).tw.
2. Colles Fracture/ or Radius Fracture/ or Wrist Fracture/ or Wrist Injury/
3. or/1-2
4. exp Randomized Controlled trial/
5. exp Double Blind Procedure/
6. exp Single Blind Procedure/
7. exp Crossover Procedure/
8. or/4-8
9. ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw.
10. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw.
11. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw.
12. (cross?over$ or (cross adj1 over$)).tw.
13. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw.
14. or/9-13
15. or/8,14
16. Animal/ not Human/
17. 15 not 16
18. and/3,17

What's new

DateEventDescription
25 July 2008AmendedConverted to new review format.

History

Protocol first published: Issue 3, 2006
Review first published: Issue 3, 2007

Contributions of authors

This review was initiated by Helen Handoll (HH) who prepared the first draft of the protocol. This was critically reviewed by the other two authors, Rajan Madhok (RM) and Manesh Vaghela (MV). HH searched for trials and contacted trial authors. All three authors performed study selection. HH and MV reviewed the included trials. HH completed the first draft of the review in RevMan. All versions were scrutinised by the other two authors. Helen Handoll is the guarantor of the review.

Declarations of interest

None known.

Sources of support

Internal sources

  • University of Teesside, Middlesbrough, UK.

  • North Tees and Hartlepool NHS Trust, UK.

  • University of Manchester, Manchester, UK.

External sources

  • No sources of support supplied

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Allain 1999

MethodsRandomised by odd or even chart number
Assessor blinding: yes
Intention-to-treat analysis: likely
Loss to follow up: none
ParticipantsTeaching (probably) hospital, France
60 participants
Inclusion criteria: dorsally displaced extra-articular or non-comminuted intra-articular fracture of the distal radius. Skeletally mature.
Exclusion criteria: open fracture, anteriorly displaced fracture, fracture-dislocation, > 2 articular fragments, styloid fragment too small to allow fixation with trans-styloid K-wires, multiple trauma, previous fracture of wrist or elbow.
Classification: AO (types A2, A3, C1, C2) (extra- and intra-articular)
Sex: 45 female
Age: mean 55 years, range 18 - 87 years
Assigned: 30/30 [1 week / 6 weeks]
Assessed: 30/30 (at 1 year)
InterventionsTiming of intervention: timing of operation not stated.
Closed reduction and operation under regional or general anaesthesia. Trans-styloid fixation: 2 K-wires inserted (2 cm skin incision) through radial styloid and across fracture and fixed into the opposite cortex of the proximal radius.
(1) Short arm circular cast for 1 week. No heavy work before 6 weeks but daily activities recommended.
(2) Short arm circular cast for 6 weeks.
In both groups, hand was raised to prevent pain and oedema for the first few days, and fingers and elbow mobilised immediately post-surgery. Wrist mobilisation encouraged after cast removal but no physiotherapist involvement. Wires removed at 45 days.
OutcomesLength of follow up: 1 year; also assessed at post-op and 4 weeks and 45 days.
(1) Functional: time to return to work; return to sporting activities (without discomfort); functional discomfort during domestic chores; grip strength; pain (VAS 0 to 15 cm: no pain); use of analgesics; range of movement (flexion, extension, radial and ulnar deviation, pronation, supination).
(2) Clinical: complications: superficial infection (no deep infection), pin migration, RSD, radial nerve paraesthesia or hypoaesthesia (persistent; 3 of the 4 participants did not have this before K-wire removal), tendon rupture. Patient satisfaction.
(3) Anatomical: X-ray post-op, 45 days (before and after K-wire removal) and 1 year. Radial angle, radio-ulnar index (ulnar variance: no data), volar tilt, radial length.
Notes 
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?NoC - Inadequate

Azzopardi 2005

MethodsRandomised by the tossing of a coin
Assessor blinding: no, except radiological outcome
Intention-to-treat analysis: claimed but the treatment groups of the six people lost to follow up were not identified
Loss to follow up: 9 (3 deaths and 6 lost to follow up)
ParticipantsHospital, UK
57 participants
Inclusion criteria: unstable extra-articular fracture of the distal radius: AO-A3 or Frykman I and II. Informed consent.
Exclusion criteria: age < 60 years, dementia or psychiatric illness, previous ipsi- or contra-lateral wrist fracture, intra-articular fracture, open fracture, volar angulated fracture (Smith's fracture), stable fracture with dorsal angulation < 20 degrees and minimal dorsal comminution.
Classification: AO type A3 or Frykman I and II (extra-articular)
Sex: (of 54) 48 female
Age: (of 54) mean 71.5 years, range 60 - 80 years
Assigned: 30/27 [X-pins / POP]
Assessed: ?/? (at 1 year)
Interventions

Timing of intervention: timing of operation not stated.
Closed reduction under general anaesthesia and fluoroscopic guidance.
(1) Percutaneous pinning: using 2 crossed, smooth K-wires, 1.6 mm diameter, inserted through small stab incisions under fluoroscopic guidance. One wire through the styloid process, the other through Lister's tubercle or the dorso-ulnar border of distal fragment. Both wires engaging opposite cortex. Blunt dissection to bone. Pins left protruding percutaneously and wrist immobilised in "well-moulded" short-arm cast.
(2) Conservative treatment: three-point fixation obtained in a "well-moulded" short-arm cast.

Wires and plasters were removed after 5 weeks.

OutcomesLength of follow up: 1 year; also assessed at 1, 2 and 5 weeks and 4 months.
(1) Functional: activities of daily living (unilateral and bilateral tasks); SF-36 health status; grip strength; pain (VAS 0 to 10 cm: worst pain); range of movement (flexion, extension, radial and ulnar deviation, pronation, supination).
(2) Clinical: complications: remanipulation after redisplacement, pin track infection (wire removal), tendon or neurovascular injury (none).
(3) Anatomical: X-ray at all follow-up times. Dorsal angulation, radial angle, radial length, ulnar variance.
Notes

Study entry in the National Research Register UK indicated inclusion criteria of 50 years (not 60 years) and neurovascularly intact, with an intended study size of 100 patients.

Lead trialist has indicated that he will supply missing data on his return to the UK in 2007.

Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?UnclearB - Unclear

Casteleyn 1992

MethodsRandomised using sealed cards
Assessor blinding: not stated
Intention-to-treat analysis: likely
Loss to follow up: 2 (deaths)
ParticipantsTeaching hospital, Belgium
30 participants
Inclusion criteria: closed wrist fracture: Frykman type I, II, V or VII. Informed consent.
Exclusion criteria: no other injuries
Classification: Frykman (I, II, V, VII) (extra- and intra-articular)
Sex: 23 female
Age: mean 61 years, range 22 - 85 years
Assigned: 15/15 [biodegradable pins/ K-wires]
Assessed: 14/14 (13/13 anatomical and ROM) (1 year)
Interventions

Timing of intervention: timing of operation not stated.
Closed reduction using finger traps and operation under regional or general anaesthesia. All fractures pinned percutaneously (stab incisions) using Kapandji's intrafocal technique.
(1) Biodegradable pins: holes pre-drilled, depth measured to select correct length of rod. Two PGA (polyglycodic acid - biodegradable) rods inserted and gently tapped home.
(2) Kirschner wires: two 2 mm K-wires inserted into fracture gap (one dorsally and the other laterally) and drilled into the opposite cortex of the radial shaft. Then cut to be under the skin. Removed after 6 weeks using local anaesthesia.

No cast applied and patients encouraged to move their wrist freely from first post-operative day.

OutcomesLength of follow up: 1 year; also assessed day 1 post-op and 1, 3 and 6 months.
(1) Functional: overall functional score (subjective and objective evaluation; own system); range of movement (flexion, extension, radial and ulna deviation, pronation, supination),
(2) Clinical: complications: rupture of EPL tendon, RSD (1 case that resolved by 1 year), secondary surgery, painful scars, sinus formation, CTS, osteolytic reaction.
(3) Anatomical: X-rays at all follow-up times. Dorsal angulation, radial angle, radial shortening & radio-ulnar index. Fracture union.
NotesPre-operative and post reduction position not given.
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?UnclearB - Unclear

Fikry 1998

MethodsMethod of randomisation not stated
Assessor blinding: not reported
Intention-to-treat analysis: unlikely, 22 who were lost to follow up were excluded
Loss to follow up: 22
ParticipantsHospital, Morocco
110 participants
Inclusion criteria: dorsally displaced distal radius fractures, with or without separation of ulnar styloid fragment.
Exclusion criteria: comminuted fracture, dislocated radiocarpal fracture, associated carpal injuries, injuries to elbow or forearm on same side, major open injury. Patients not willing or able to follow rehabilitation.
Classification: not given (extra-articular; some intra-articular fractures were possible)
Sex: (of 88) 22 female
Age: (of 88) mean 34 years, range 18 - 66 years
Assigned: ?/? [Kapandji / Py ]
Assessed: 42/46 (at 27 months)
Interventions

Timing of intervention: timing of operation not stated
K-wire insertion was probably percutaneous. Pins inserted under general or regional anaesthesia. Reduction was done during the operation.
(1) Kapandji intrafocal pinning. 3 K-wires inserted at fracture site. Image intensifier used.
(2) Py's isoelastic pinning. 2 K-wires inserted through radial epiphysis, across fracture and along medullary canal up to radial head. Image intensification not used: grinding of wire against the cortical bone used to determine wire placement.

Where present, ulnar styloid fractures were transfixed using a nylon suture. Wires were cut below the skin and hidden - ends were covered by a small bore drainage tube. All were placed in forearm plaster cast for 4 weeks and received instruction for shoulder and finger exercises. Pins removed at around 8 weeks under local or regional anaesthesia.

OutcomesLength of follow up: 20 to 52 months (mean 27 months)
(1) Functional: part of scoring system (Jakim 1991): subjective (pain and function), objective (grip, mobility, deformity) and overall grades
(2) Clinical: complications: secondary displacement, fracture caused by wiring (the patient had a plate inserted), displaced wires (4 of 6 removed early), superficial infection, tendon rupture, RSD, arthritis (no data)
(3) Anatomical: X-ray at final follow up. Radial length, radial angle, volar angle, loss of reduction, arthritic change, step-off, radioulnar joint articulation within overall scale (Jakim 1991)
Notes

Paper in French. Translated into English by Sonia Stewart and Linda Digance.

Conclusions given in summary for the Jakim scores cited the superiority of Py's method; these were not consistent with the data in Table III in the paper.

Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?UnclearB - Unclear

Gupta 1999

MethodsRandomised by alternation of consenting patients
Assessor blinding: not reported
Intention-to-treat analysis: likely
Loss to follow up: none
ParticipantsTeaching hospital, India
50 participants
Inclusion criteria: Colles' fracture, fused epiphysis. Patient consent.
Exclusion criteria: not given
Classification: Frykman: all extra-articular
Sex: 37 female
Age: mean 56 years; range 22 - 80 years
Assigned: 25/25 [X-pins / POP]
Assessed: 25/25 (at 6 months)
InterventionsTiming of intervention: timing of operation not stated
Closed reduction under traction
(1) Percutaneous pinning: crossed-pin fixation using K-wires under local anaesthesia: first wire inserted through tip of radial styloid, second wire through the dorso-ulnar corner of the distal radius. Then below elbow plaster cast, with wrist at approximately 10 degrees extension and neutral deviation, for 6 weeks. Wires removed at fracture union.
(2) Conservative: plaster cast. Wrist in palmar flexion and ulnar deviation for 3 weeks and then, after cast change, in neutral position for 3 weeks.
OutcomesLength of follow up: 6 months; also assessed at "regular" but unspecified intervals including around 8 weeks.
(1) Functional: overall grading (Sarmiento 1980 - actually Sarmiento 1975); range of movement (flexion, extension, radial deviation, ulnar deviation, pronation, supination).
(2) Clinical: complications: pin track infection, K-wire extrusion, redisplacement (also K-wire migration); none of: CTS, shoulder hand syndrome, Sudeck's atrophy, tendon rupture.
(3) Anatomical: X-ray at reduction, around 8 weeks and 6 months. Radial shortening, dorsal angulation, radial angulation. Overall grading (Stewart 1984).
NotesInformation on method of randomisation and loss to follow up (none), type of fracture, baseline characteristics and standard deviations for continuous outcomes obtained from the trialist in 2006.
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?NoC - Inadequate

Korner 1999

MethodsMethod of randomisation not stated
Assessor blinding: not stated
Intention-to-treat analysis: likely but incomplete information
Loss to follow up: 4
ParticipantsTeaching hospital, Germany
40 participants
Inclusion criteria: distal radius fracture
Exclusion criteria: not given
Sex: not given
Age: not given
Classification: AO (at least A2, A3, B1: intra-articular and extra-articular)
Assigned: 19/21 [biodegradable pins/ K-wires]
Assessed: 17/19 (median 25.4 months)
InterventionsTiming of intervention: not stated
(1) Biodegradable pins
(2) Kirschner wires
Pins and K-wires inserted according to Willenegger (probably Willenegger 1959: two pins placed through radial styloid and across fracture) "in a modified manner".
There was no information on post-surgical care.
OutcomesLength of follow up: median 25.4 months
(1) Functional: ROM (flexion/extension, supination/pronation)
(2) Clinical: complications: operational difficulties with pin or wire insertion, superficial wound infection, secondary displacement requiring revision, arthrosis. Duration of operation.
(3) Anatomical: X-ray at final follow up. Redisplacement requiring revision, radiological signs of arthrosis.
NotesReport only available in poster abstract.
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?UnclearB - Unclear

Lenoble 1995

MethodsMethod of randomisation not stated: "random selection in the operating theatre"
Assessor blinding: not reported
Intention-to-treat analysis: problems. Baseline characteristics not presented for all trial participants
Lost to follow up: 24 (15 lost, 6 missing data, 3 died) at follow up
Participants2 teaching hospitals, France
120 participants
Inclusion criteria: closed dorsally displaced extra- or intra-articular distal radial fractures with posteromedial fragment. Skeletally mature.
Exclusion criteria: anteriorly displaced fractures, open fractures, fracture-dislocations, multiple trauma, previous fracture of wrist or elbow, fractures with > 2 intra-articular fragments, comminuted fractures that could not be stabilised by K-wire fixation.
Classification: Frykman (1/2, 3/4, 5/6, 7/8), Castaing, AO (extra-articular: A2, A3; and intra-articular: C1,C2)
Sex: (of 96) 65 female
Age: (of 96) mean 57 years; range 18 - 88 years
Assigned: ?/? [Kapandji / Trans-styloid]
Assessed: 54/42 (at 2 years)
InterventionsTiming of intervention: not stated.
Regional or general anaesthesia used, with radiological control of reduction and K-wire positioning. Used 1.8 mm K-wires.
(1) Kapandji fixation. Closed manual reduction. Intra-focal placement by hand of 2 or 3 K-wires via 1 cm incisions (vessels, nerves and tendons were retracted), advanced to impact into opposite cortex, and buried under skin. Immediate mobilisation. Wires removed 45 days (40-60 days) under local or regional anaesthesia.
(2) Trans-styloid fixation. Closed reduction by traction, 2 K-wires inserted percutaneously through the radial styloid anteriorly and posteriorly to reach the opposite cortex, using powered drilling. Wrist immobilisation in short arm plaster for 45 days (37 to 54 days). Wires removed 45 days (40-60 days) under local or regional anaesthesia.
OutcomesLength of follow up: 24 months; also 45 days and 3, 6 and 12 months
(1) Functional: grip and pinch strength; pain (VAS 0 to 100: unbearable pain); range of movement (flexion, extension, radial and ulnar deviation, pronation, supination).
(2) Clinical: complications: redisplacement, pin track infection (all superficial), RSD, radial nerve symptoms (2 developed RSD), tendon injury (none), vascular complications (none), median nerve dysfunction (none), DISI or VISI (carpal instability), osteoarthritis (no new).
(3) Anatomical: X-ray at pre-reduction, post-op, and each follow-up time. Radial and palmar tilt, ulnar variance, radial shortening and step deformity. Over-reduction in anterior direction.
NotesThe aim of the trial was to assess the results of the two most commonly used methods in France for dorsally displaced distal radial fractures, at that time. Hence, differences in procedures, especially mobilisation, between the interventions.
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?UnclearB - Unclear

Milliez 1992

MethodsRandomised by admission sequence (alternation?)
Assessor blinding: not reported
Intention-to-treat analysis: potential problems
Loss to follow up: 3 due to treatment failure
ParticipantsTeaching hospital, France
60 participants
Inclusion criteria: closed displaced distal radial fracture, intra- and extra-articular; patient consent.
Exclusion criteria: age < 16 years, previous fracture, ipsilateral limb injury, dependent, disrupted volar radial cortex, anterior displacement, immediate vascular or nerve complications.
Classification: not given
Sex: 44 female
Age: mean 55 years, range 19 - 91 years
Assigned: 30/30 [1 week / 6 weeks]
Assessed: 27/30 (at 3 months)
InterventionsTiming of intervention: timing of operation not stated.
Closed manipulation. Kapandji wiring: 3 pin K-wire fixation under X-ray control using the Kapandji intrafocal method. Regular incisions under tourniquet control. Pins cut level with skin and covered.
(1) Plaster splint 1 week, then early mobilisation (carrying object < 1 kg)
(2) Plaster splint 1 week, then 5 weeks cast immobilisation.
Pins removed at 6 weeks.
OutcomesLength of follow up: 3 months; also assessed at post-op, 1, 3 and 6 weeks and 2 months.
(1) Functional: return to work (19 participants), grip strength, pain (none, during effort, during usual activities), range of movement (flexion, extension).
(2). Clinical: complications: treatment failure, wire displacement, tendon injury or rupture, RSD.
(3) Anatomical: X-ray post-op and 3 months. Bascule sagittale (dorsal angulation), index radio-cubital inferieur (change in ulnar variance), bascule frontal (change in radial angulation).
NotesPaper in French - translation obtained.
Potential for performance bias and iatrogenic complications arising from K-wire fixation by junior operators.
Only percentages are given for the pain categories: these do not yield exact numbers and thus there is some question regarding how these were derived in the paper.
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?NoC - Inadequate

Rodriguez-Merchan 97

MethodsRandomised using blinded consecutively numbered envelopes
Assessor blinding: not stated
Intention-to-treat analysis: likely
Loss to follow up: none, probably
ParticipantsTeaching hospital, Spain
40 participants
Inclusion criteria: comminuted unstable fracture of distal radius [dorsal angulation >/= 10 degrees or radial shortening >/= 3 mm, or both] as a result of a fall. Frykman III to VIII (intra-articular).
Exclusion criteria: < 45 or > 65 years
Classification: Frykman (III to VIII)
Sex: 29 female
Age: mean 57 years; range 46 - 65 years
Assigned: 20/20 [X-pins / POP]
Assessed: 20/20 (at 1 year)
Interventions

Timing of intervention: probably reduction on first day, surgery on next day.
(1) Closed reduction under general anaesthesia or brachial block. Percutaneous pinning with fluoroscopic assistance using 3 K-wires. Two 0.45 mm K-wires inserted from radial styloid proximally towards the ulna and one inserted from the ulnar side proximally towards the radius. forearm cast applied. Pins and cast removed after 7 weeks.
(2) Closed manipulation under local anaesthesia, split below-elbow cast (20 degrees palmar flexion, 10 degrees ulnar deviation). (Remanipulation at 1 week if dorsal angulation > 10 degrees, radial shortening > 3 mm. New cast applied.) Patients given instructions to mobilise their fingers. Cast removed after 7 weeks.

If fracture healed, arm was then bandaged in crepe and patients given instructions for mobilisation.

OutcomesLength of follow up: 1 year; also assessed at 1, 3 and 7 weeks.
(1) Functional: probably at 1 year but not stated clearly. Overall grading (Horne 1990 - actually Stewart 1985 modification of Gartland and Werley 1951) based on subjective and objective scores. Also grip strength, range of movement (overall), pain, deformity.
(2) Clinical: complications: remanipulation (at 1 week), pin track infection, joint infection or osteomyelitis, median nerve injury, Sudeck’s atrophy, tendon injuries, non-union, angulated malunion.
(3) Anatomical: measured at post reduction and all other follow-up times. Dorsal angulation, radial angulation, radial length.
NotesThere is no specific mention in the trial report of incorporation of the wire or pin ends into the plaster.
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?YesA - Adequate

Shankar 1992

MethodsMethod of randomisation not stated
Assessor blinding: unlikely, not reported
Intention to treat analysis: not known
Loss to follow up: none, inferred
ParticipantsHospital, UK
45 participants
Inclusion criteria: comminuted Colles' fracture, Frykman fracture IV-VIII (intra-articular)
Exclusion criteria: not given
Classification: Frykman (IV-VIII) (intra-articular)
Sex: 40 female
Age: range 17 - 88 years (mostly "elderly")
Assigned: 23/22 [X-pins / POP]
Assessed: 23/22 [6 months]
Interventions

Timing of intervention: not stated. All procedures carried out under general anaesthesia and image intensifier control.
(1) Percutaneous pinning: two 1.6 mm percutaneous Kirschner wires inserted from radial side into the medial cortex of distal ulna. The pins were left protruding 1.5 cm and incorporated into a plaster cast (slight palmar flexion and ulnar deviation). Wires and plaster removed at 5-6 weeks.
(2) Conservative treatment: forearm plaster cast (slight palmar flexion, ulnar deviation and pronation), for 5-6 weeks

All participants were admitted for overnight limb elevation. All had active physiotherapy after removal of plaster cast (and wires).

OutcomesLength of follow up: 6 months; also 5-6, 10 and 16 weeks.
(1) Functional: Overall grading - modified McBride scoring system (residual deformity, subjective (pain, limitations), objective, complications - derived from Gartland and Werley 1951). Grip strength, range of movement (flexion, extension, radial and ulnar deviation, pronation, supination).
(2) Clinical: complications: remanipulation, carpal tunnel syndrome, shoulder hand syndrome, residual deformity (ulnar styloid prominence), pin track infection, premature removal of pins at 3 weeks due to metal sensitivity, non-union.
(3) Anatomical: X-ray post-op, 10 and 16 weeks. Radial angle and length, dorsal and volar angle, and union.
NotesThe pinning technique was stated as being based on that described by DePalma 1952 but there were significant differences.
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?UnclearB - Unclear

Stoffelen 1998

MethodsMethod of randomisation: alternation
Assessor blinding: unlikely, not reported
Intention-to-treat analysis: imbalance of 2 in the numbers allocated to each group indicates a potential problem
Loss to follow up: not stated
ParticipantsTeaching hospital, Belgium
98 participants
Inclusion criteria: extra-articular distal radius fractures with dorsal displacement - Colles' type (Frykman I and II) (extra-articular)
Exclusion criteria: children, age > 80 years, bilateral fractures, severe injuries to ipsilateral or contralateral extremity, multiple injuries, severe brain injury
Classification: Frykman (I and II)
Sex: 41 female (but discrepancies between reports)
Age: mean 58 years
Assigned: ?/? but stated as 48/50 [X-pins / POP]
Assessed: 48/50 (at 1 year)
InterventionsTiming of intervention: not stated
(1) Percutaneous triple intrafocal Kapandji pinning (distal fragment was not transfixed; pins acted as a buttress to articular surface) followed by 1 week of plaster immobilisation until pain subsided. (By deduction: pins in place for 6 weeks)
(2) Closed reduction, followed by an above-elbow plaster cast for 3 weeks, then below-elbow plaster cast for 3 weeks
OutcomesLength of follow up: 1 year; also assessed at 6 weeks, and 3 and 6 months.
(1) Functional: overall grading (Cooney score) including pain, functional status, range of movement. Grip strength. Finger and hand flexibility and function
(2) Clinical: complications: nerve injuries (6 weeks): median nerve contusions, superficial radial nerve injuries; nerve injuries at 6 months (1 in the K-wire group), reflex sympathetic dystrophy (temporary, and persisting at 1 year), diminished finger function.
(3) Anatomical: X-ray at all follow-up times. Radial shortening, dorsal tilt, radial angle, lateral shift.
Notes

Reference (no. 26 in one paper) to the Cooney scoring system is incorrect.

Unacknowledged duplicate publication. No response from trialist to request for clarification of baseline characteristics (which differed between the trial reports) sent on 27/07/2000.

Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?NoC - Inadequate

Strohm 2004

MethodsMethod of randomisation not stated (claimed to be blinded)
Assessor blinding: unlikely, not reported
Intention to treat analysis: not known, baseline data not given for all participants
Loss to follow up: 19 (2 deaths)
ParticipantsTeaching hospital, Germany
100 participants
Inclusion criteria: Colles' type fracture, open or closed. AO types A2, A3 and C1. Informed consent.
Exclusion criteria: not given
Classification: AO (types A2, A3 and C1) (extra- and intra-articular); also classification of soft-tissue damage
Sex: 85 female
Age: mean 65 years, range 15 - 92 years
Assigned: 50/50 [Kapandji / Willenegger]
Assessed: 40/41 (median 10 months)
Interventions

Timing of intervention: all acute treatment with surgery provided straightaway.
Closed reduction performed under image intensification. Brachial plexus block or general anaesthesia on an outpatient basis. All wires were 1.8 or 2.0 mm.
(1) Modified Kapandji fixation. After reduction, intra-focal placement by hand, using drill sleeve, of 2 K-wires via stab incisions. Then a third wire inserted through a stab insertion over the radial styloid process in a conventional manner (through the fracture). Wires bent and buried under skin. Limb immobilised for 3 weeks in a volar splint. Then for the next 3 weeks: physiotherapy consisting of active and passive exercises for the wrist and forearm performed with the splint only removed for physiotherapy.
(2) Willenegger fixation. After reduction, 2 small stab incisions made over the styloid process of the radius and 2 K-wires inserted through and advanced proximally, and anchored in the opposite cortex of the radius. Wires ends bent over and buried. Wrist immobilised for 6 weeks in a functional position (15 degrees of dorsiflexion in below-the-elbow cast)

Standard post-operative care used for the two wiring methods. Wires removed under local anaesthesia after 6 weeks.

Outcomes

Length of follow up: median 10 months (range 6 to 20 months)
(1) Functional: modified Martini grading system (pain, subjective assessment, strength, work and sports, range of movement, radiological outcomes, complications: 0: worst to 38: best).
(2) Clinical: complications: nerve irritation, signs of swelling, wire migration, "conversion procedure" (other operation), RSD, carpal tunnel syndrome, tendon injury or rupture.
(3) Anatomical: X-ray times not known. Part of Martini grading system: radial shortening, "tilting of joint surface at the radiocarpal joint", and radiocarpal joint subluxation and arthodesis.

Operating time and imaging time were also recorded.

Notes

Trialist has indicated his intention to reply to queries sent in March 2006.

Three participants (2 versus 1) were graded as having "a deep and contaminated wound, contusion of the skin and muscles from outside by direct injury, imminent compartment syndrome, and a moderately severe to severe fracture type".

Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?UnclearB - Unclear

Verhulst 1990

  1. a

    <: less than
    >: more than
    AO: Arbeitsgemeinschaft fur Osteosynthesefragen / Association for the Study of Internal Fixation (or ASIF)
    CTS: carpal tunnel syndrome
    DISI: dorsal intercalated segment instability
    EPL: extensor pollicis longus (tendon)
    hypoaesthesia: decrease in sensation
    K-wires: Kirschner wires
    paraesthesia: numbness, tingling, "pins and needles" sensation
    POP: plaster of Paris
    ROM: range of movement (wrist and forearm)
    RSD: reflex sympathetic dystrophy
    VAS: visual analogue scale
    VISI: volar intercalated segment instability
    X-pins: crossed percutaneous pinning

MethodsMethod of randomisation not stated (unexplained imbalance in numbers in the 2 treatment groups)
Assessor blinding: not reported
Intention-to-treat analysis: not known
Loss to follow up: not stated
ParticipantsHospital, Belgium
130 participants
Inclusion criteria: Colles' type fracture
Exclusion criteria: not given
Classification: not given
Sex: not given
Age: "elderly population"
Assigned: 45/85 [K-wire / POP]
Assessed: ?/? (at 2 years)
InterventionsTiming of intervention: not stated
Closed reduction.
(1) Percutaneous pinning: reduction and fixation of reduced fragments using a single Kirschner wire inserted percutaneously (stab incision) through tip of radial styloid. Immobilised for 4 weeks (mean). Pin removed at 6 weeks (mean)
(2) Conservative treatment: reduction and immobilisation for 5 weeks (mean).
OutcomesLength of follow up: 2 years; also assessed at 6 weeks and 2 months.
(1) Functional: time to return to normal activities and work; range of movement (along 3 axes).
(2) Clinical: complications: re-reduction, wire migration, superficial stab wound infection, CTS. Wrist deformity, time of immobilisation.
(3) Anatomical: X-ray at above times. Radial shortening, radial and dorsal angulation, radial width.
NotesAbstract only. No indication of criteria for mobilisation. Cast immobilisation assumed.
Numbers derived from percentages.
Risk of bias
ItemAuthors' judgementDescription
Allocation concealment?UnclearB - Unclear

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Biedermann 2001Not a randomised comparison as confirmed by Dr Biederman.
Delattre 1994Not a randomised comparison. Mainly retrospective.
Galli 2002It is not clear whether this is a prospective, and if so, a randomised comparison. There was no response received from the trialists.
Harper 2000The contact person for this trial, Prof Harper, revealed that this trial, previously listed in Ongoing studies, was abandoned.
Seifert 1998Very unlikely to be a randomised comparison. Trial report in German was checked by Jan Rasmus Kuester who indicated that it was "rather retrospective" but wrote to the authors for confirmation. No further information received.

Ancillary