Internal fixation for treating distal radius fractures in adults

  • Protocol
  • Intervention

Authors


Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the effects (benefits and harms) of internal fixation for treating distal radius fractures in adults.

Our main comparisons will be:

  • internal fixation versus non-surgical treatment

  • different types of internal fixation

  • different types and durations of immobilisation after internal fixation

Background

Description of the condition

Fractures of the distal radius, often referred to as "wrist fractures", are common injuries in both children and adults. They represent 15% of fractures in adults dealt with in the emergency department (Sanders 1996). They are usually defined as fractures occurring in the distal radius within three centimetres of the radiocarpal joint. The majority are 'closed' injuries, with the overlying skin remaining intact.

Distal radial fractures in adults occur predominantly in white and older populations in the developed world (Sahlin 1990; Singer 1998; Van Staa 2001). There is a bimodal age distribution of these fractures although with a difference between the sexes. In women, the incidence of these fractures increases with age, more rapidly from the age of 40 years onwards (McQueen 2003); in people under 40 years of age, the incidence is higher in men (Singer 1998). A multicentre study in the United Kingdom of people aged 35 years and above with distal radius fracture reported an annual incidence of 9 per 10,000 men and 37 per 10,000 women (O'Neill 2001). 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 2% (Cummings 1985). This has been supported by more recent estimates of lifetime risk of radius or ulna fracture at 50 years of age of 16.6% for women versus 2.9% for men (Van Staa 2001).

Younger people usually sustain this injury as a result of high-energy trauma, such as a traffic accident; whereas in older people, the fracture more often results from low-energy or moderate trauma, such as a fall from standing height. This reflects the greater fragility of the bone in older adults because of osteoporosis.

The symptoms of a distal radius fracture include pain, deformity, swelling and crepitus (crackling, grating or popping sounds and sensations). Imaging investigations are typically used to confirm the diagnosis and plan treatment. Radiographs (X-rays) are the most common investigation, but computerised tomography (CT) and, occasionally, magnetic resonance imaging (MRI) are also used.

A review of the costs of upper extremity injuries in adults has estimated the direct costs, adjusted to 2007 values, of wrist fractures to be 1890 Euro per case (Polinder 2013). This study showed higher costs in women (2440 Euro) than men (1150 Euro). It is suggested that the higher average age and consequent osteoporosis associated with these injuries in females may predispose to a higher rate of surgery and complications and hence costs. Around 20% of people (mainly older people) with these fractures are estimated to require hospital admission (Cummings 1985; O'Neill 2001). This figure includes all people receiving surgery. Indirect costs of hand and wrist injuries in terms of loss of productivity are estimated to be greater than the direct costs (De Putter 2012).

Classification

Surgeons have classified fractures by anatomical configuration and fracture pattern to aid communication, research and guide management. Simple classifications, named after those who described them, were based on clinical appearance. In the distal radius, the term 'Colles’ fracture' is still used to describe a fracture in which there is an obvious and typical clinical deformity (commonly referred to as a 'dinner fork deformity') of dorsal translation, dorsal angulation, dorsal comminution (fragmentation) and shortening. The introduction of X-rays and other imaging modalities made it clear that the characteristic deformity may be associated with a range of different fracture patterns, which may be important determinants of outcome and therefore fracture management. For example, the fracture through the distal radius may be extra-articular (leaving the articular 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). Brief descriptions of six commonly cited classification systems (Cooney 1993; Fernández 1993; Frykman 1967; Melone 1993; Müller 1991; Older 1965) are presented in Table 1.

Table 1. Fracture classification systems
Name (reference ID)Brief outlineComment
AO (Arbeitsgemeinschaft fur Osteosynthesefragen)
(Müller 1991)

This system is organised in order of increasing fracture severity. It divides the fractures into three major groups:

  • group A (extra-articular);

  • group B (simple or partial intra-articular); and

  • group C (complex or complete intra-articular).

These three groups are then subdivided, yielding 27 different fracture types.

There is no assessment of the extent of fracture displacement.
Fernández
(Fernández 1993)

This system is based on the mechanisms of injury. There are five main groups:

  • type I (bending fractures);

  • type II (shearing fractures);

  • type III (compression fractures, with impaction);

  • type IV (avulsion fractures);

  • type V (combinations of bending, shearing, compression or avulsion mechanisms; all high velocity fractures).

These groups are further categorised by stability, displacement pattern, number of fragments (or comminuted) and associated lesions.

The injury mechanism is not always apparent.
There is no consideration of the extent of displacement.
Frykman
(Frykman 1967)
This system 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 (ulnar styloid) fracture.
There are eight types labelled I to VIII (1 to 8): the higher the number, the greater complexity of the fracture.
There is no assessment of the extent or direction of fracture displacement, or of comminution.
Melone
(Melone 1993)
This system identifies five fracture types, based on four major fracture components: the radial shaft, the radial styloid, and the dorsal-medial and volar-medial fragments.This is for intra-articular fractures only.
Older
(Older 1965)
This system divides fractures into four types, labelled I to VI (1 to 4) of increasing severity.
The types are defined according to extent of displacement (angulation and radial shortening) and comminution.
There is no consideration of radio-ulnar joint involvement.
' Universal Classification' (Cooney 1993)This system divides fractures into four main types, labelled I to VI (1 to 4), distinguishing between extra-articular and intra-articular fractures and displaced and non-displaced fractures. Displaced fracture types II and IV are further subdivided based on 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).This does not distinguish between the radiocarpal and radio-ulnar joints. Additionally, there is a 'trial by treatment'.

Complications

Complications from distal radius fractures are not uncommon and can occur from the injury itself or from its treatment. Concomitant soft tissue injury is common, with reports of ligament injury in up to 50% of cases (Geissler 1996; Lindau 1997), the triangular fibrocartilage complex (TFCC) in 40% to 70% of cases (Geissler 1996; Lindau 2000) and compromise to surrounding blood vessels. The median nerve can be injured by trauma or compressive neuropathy may develop later, with rates reported of 10% in surgically managed fractures (Ho 2011). Chronic regional pain syndrome type 1 (CRPS-1) is a poorly understood complication that occurs in approximately 1% of non-surgically managed fractures and 5% of surgically managed fractures (Atkins 2003). The severity of symptoms can vary but pain, swelling and stiffness can take months to resolve and prolonged therapy may be required. Tendon irritation and rupture have been reported with both non-surgical (conservative) and surgical intervention. Extensor pollicis longus (thumb extensor tendon) ruptures can occur in minimally displaced fractures treated in a cast, with rates reported at 3% (Bonatz 1996). Malunion, which may result from redisplacement of an initially reduced fracture, can result in changes in the radiocarpal, midcarpal and radioulnar joints that lead to pain (Patton 2004), loss of motion (Kazuki 1993) and reduction in grip strength (Patton 2004), along with the development of later degenerative changes (Park 2002; Taleisnik 1984).

Description of the intervention

In the last century, most distal radius fractures in adults were treated non-surgically ('conservatively') by reduction (the alignment of the bony fragments to original anatomical positions) of the fracture when displaced and stabilisation in a plaster cast or other external brace for several weeks (Charnley 2003). The results of such treatment, particularly in older people with bones weakened by osteoporosis, were not consistently satisfactory (Handoll 2003). This resulted in attempts to develop other strategies involving surgery aimed at more accurate reduction and more reliable stabilisation.

One method of surgery is internal fixation, which is usually preceded by open reduction, and generally involves open surgery where the fractured bone is exposed to direct view and the fixation device (such as a metal plate) applied directly. The three other main strategies for surgical treatment described in the literature (Fernandez 1995) are percutaneous pinning (this involves the percutaneous (through the skin) insertion of pins and wires); external fixation (metal pins or screws are inserted into bone, generally via small incisions of the skin, on either side of the fracture are fixed externally, such as by incorporation into a plaster cast or securing into an external fixator frame); and bone grafts or substitutes (these are inserted into bony defects). These three methods are covered in the following Cochrane Reviews: percutaneous pinning (Handoll 2007a), external fixation (Handoll 2007b; Handoll 2008a), and bone grafts or substitutes (Handoll 2008b). Given the invasive and technically demanding nature of open surgery, internal fixation is often reserved for more severe injuries. There is significant ongoing interest in the role of internal fixation as it continues to evolve with the development of new implant designs (Martineau 2007; Simic 2003).

Numerous techniques and devices are used for internal fixation. The surgical approach to the distal radius for plating may be volar (palm side of the forearm) or dorsal (back of the forearm). Intra-operative imaging in the form of X-rays is commonly used to aid visual assessment of reduction. Stabilisation with plates is the most common type of internal fixation and there are many different types on the market. These may be either locking (the screw heads themselves screw into the plate to act mechanically as one fixed-angle device) or non-locking. Fragment-specific fixation employs one or more smaller plates to stabilise defined fracture fragments rather than using one plate for all fragments (Gavaskar 2012). Intramedullary nails have been used to try to minimise disruption to the surrounding tendons by having the implant contained within the bone. Postoperative decisions include the use and duration of immobilisation, and the need for removal of implants.

How the intervention might work

Patient factors, including age, fracture pattern and bone quality (presence and extent of osteoporosis), influence the decision to undertake internal fixation and the method employed. Common to all surgical methods is the promise of stable fixation after reduction to restore the anatomy to as close to normal. Bone quality may, however, be insufficient to hold the screws while healing takes place and internal fixation has mainly been used in younger, more active patients (Knirk 1986). The advent of locking plates with their greater ability to maintain hold in osteoporotic bone has meant that internal fixation has been used increasingly in older people. We consider three specific comparisons in this section: internal fixation versus conservative treatment; volar versus dorsal plating; and early versus delayed mobilisation after internal fixation.

Internal fixation versus conservative treatment

Conservative treatment, comprising closed reduction and cast immobilisation, of distal radius fractures can be successful, but anatomical restoration may not be optimal and some fracture redisplacement within the cast is common. The latter occurs more frequently in older patients who present with bone shortening, angulation and comminution on the initial radiographs (Mackenney 2006). Reduction of the redisplaced fracture may be attempted if early on (within two weeks of injury). However, while there remains a general perception that anatomical restoration improves outcome following fracture (Ruedi 2007) and that functional outcomes correlate with residual deformity (McQueen 1988), the findings of recent studies challenge these perceptions for the majority of distal radius fractures (Bentohami 2013; Finsen 2013). Bentohami 2013 reported "no effect of radiographic parameters on the functional outcome" of extra-articular distal radial fractures and Finsen 2013 found that the final alignment of the distal radius had only a small influence on the clinical outcome of 'Colles’ type' distal radius fractures. Nonetheless, some patients with malunion have a very poor outcome and may go on to have a corrective osteotomy (where a segment of bone is removed to improve alignment) that aims to improve function and relieve pain (Patton 2004).

Open reduction where the fracture fragments are directly visualised and manoeuvred should improve anatomical restoration and internal fixation such as via plate fixation should provide better stability than cast immobilisation and thus reduce the frequency of redisplacement and malunion. Improved stabilisation may allow earlier mobilisation and reduce the complications (e.g. stiffness and inconvenience of protracted immobilisation in a cast while the fracture heals). However, surgery is associated with an increased risk of surgery-related complications such as infection and tendon rupture, and there is an increased risk of fixation failure in osteoporotic bone.

Volar versus dorsal plating

Internal fixation via a dorsal approach can irritate the extensor tendons (for straightening the fingers) resulting in tenosynovitis and rupture, along with reduced flexion (bending the wrist downwards) from the dorsal scarring (Bassett 1987). This is most likely due to a combination of issues including the minimal soft-tissue cover, the close proximity of the tendons to the bone and the convex nature of the distal radius, all of which leave the tendon prone to abrading over the implant (Carter 1998; Downing 2008; Jakob 2000; Ring 1997). Unfortunately, these complications do not all resolve following implant removal (Fitoussi 1997).

The volar approach (from the front of the wrist) has gained popularity in recent years (Downing 2008). However, this can also irritate the extensor tendons from screw penetration of the dorsal cortex (Al-Rashid 2006; Benson 2006). The flexor tendons (for bending the fingers) are also at risk from this approach, though it is considered that this usually occurs from incorrect implant placement (Arora 2007; Downing 2008). Screws can also be inadvertently placed into the radiocarpal joint through a volar approach as the joint surface is less easily visualised than with the dorsal approach (Arora 2007). This may also lead to less accurate reduction of dorsal articular fragments.

Early versus delayed mobilisation post internal fixation

Early mobilisation is thought to improve outcome following fracture (Ruedi 2007). Hypothetically, early mobilisation such as within two weeks post surgery, should speed recovery and avoid the problems of joint stiffness, swelling and the additional inconvenience often associated with wrist immobilisation such as in a cast. However, while the use of internal fixation in the treatment of distal radius fractures has been built on the principle that stable anatomical fixation and early mobilisation improves outcomes (Downing 2008), delayed mobilisation such as four to six weeks, may be considered better as it is likely to help safeguard the fixation and reduction and enable fracture healing. Decisions over timing are likely to be affected by factors influencing the stability of a fracture or surgical fixation; these include fracture comminution and osteoporosis commonly seen in older people (Mackenney 2006).

Why it is important to do this review

Distal radius fractures are one of the most common injuries in adults. However, there is a lack of consensus on their management (Lichtman 2010). Because of the significant increase in the use of internal fixation (e.g. Mattila 2011 reported a 13-fold increase between 1998 and 2008 in Finland), it is important to assess the role that internal fixation plays in managing these injuries and which type of internal fixation method should be used to reliably restore function with the lowest risk of complications. In particular, there is a need to examine the evidence for the increased use of internal fixation using locking plates for older people (Day 2012).

Objectives

To assess the effects (benefits and harms) of internal fixation for treating distal radius fractures in adults.

Our main comparisons will be:

  • internal fixation versus non-surgical treatment

  • different types of internal fixation

  • different types and durations of immobilisation after internal fixation

Methods

Criteria for considering studies for this review

Types of studies

We will include randomised controlled trials (RCTs) and quasi-RCTs (which use a method of allocating participants to a treatment that is not strictly random, e.g. by hospital number) evaluating internal fixation for distal radius fractures.

Types of participants

Skeletally mature people of either sex with a fracture of the distal radius. We will include trials containing adults and children provided the proportion of children is small (less than 5%), or we can obtain separate data for adults. We will include trials containing different fracture types only if separate data are available for participants with distal radial fractures. Also we will include trials recruiting people whose fractures have redisplaced within two weeks of conservative management.

Types of interventions

Internal fixation may include supplementary fixation or stabilisation, such as with wires, bone graft or external fixation, as long as internal fixation was clearly the primary method. We will include studies looking at the following comparisons:

  • Internal fixation (with or without supplementary fixation) versus conservative (non-surgical) treatment

  • Different types of internal fixation:

    • Different fixation method: intramedullary nails versus plates; fragment specific versus fixed angle plates; locked versus non-locking plates

    • Different approach to plate fixation: volar versus dorsal

    • Different materials: bioabsorbable versus metal implants

  • Immobilisation after internal fixation:

    • Type: removable splint versus cast

    • Duration: short term (up to three weeks) versus longer term (more than three weeks)

For each comparison, the more traditional (e.g. conservative treatment, non-locking plates, dorsal approach, metal implants, longer post-surgical immobilisation) or, if uncertain, the more commonly used intervention (e.g. plates, fixed angle plates) will be used as the control.

We will exclude comparisons of internal fixation with other fixation methods (e.g. percutaneous pinning). This is the subject of another Cochrane Review in progress (Jariwala 2014).

Types of outcome measures

Primary outcomes
  • Limb-specific patient-reported outcome measures of function: such as the Disability of the Arm, Shoulder and Hand questionnaire (DASH) (MacDermid 2000), the Patient Evaluation Measure (PEM) (Forward 2007), the Patient Related Wrist Evaluation (PRWE) (MacDermid 2000)

  • General measures of health-related quality of life such as the Short Form-36 (SF-36) (MacDermid 2000)

  • Adverse events – we will attempt to differentiate these into:

    • Serious adverse events requiring substantive treatment such as surgery or prolonged therapy (e.g. deep infection, tendon rupture, symptomatic malunion, CRPS-1, long-term pain)

    • Minor adverse events (e.g. short-term pain, superficial infection, asymptomatic malunion)

Secondary outcomes
  • Hand and wrist function measures such as the Jebsen-Taylor score (Sears 2010) or the Gartland and Werley score (Gartland 1951)

  • Grip strength

  • 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)

  • Return and time to return to usual occupation and activities of daily living

  • Patient satisfaction with cosmetic appearance

  • Pain - assessed by self report such as analgesic requirements or score on a visual analogue scale

Other outcomes

We will record radiological parameters including radial length, dorsal and radial angulation, ulnar variance and intra-articular step or gap (see Table 2). (Note: these may not correlate with patient-reported measures).

Table 2. Definitions of key 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 to 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 to 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 to 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.

We will look for any use of resources data including hospital stay, outpatient attendances and other costs.

Timing of outcome measurement

The timing of outcome measures will be divided into short term (within three months), medium term (over three months to one year) and long term (over one year). Most immediate or resolvable adverse events will manifest within the short-term time frame and the long-term time frame should allow assessment once fracture union has occurred in most people.

Search methods for identification of studies

Electronic searches

We will search the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to present), the Cochrane Central Register of Controlled Trials (in The Cochrane Library, current issue), MEDLINE (1946 to present), EMBASE (1974 to present) and CINAHL (1982 to present). We will also search Current Controlled Trials (http://clinicaltrials.gov), the WHO International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/). No language restrictions will be applied.

In MEDLINE (Ovid Online), we will combine the search strategy with the sensitivity-maximising version of the Cochrane Highly Sensitive Search Strategy for identifying RCTs (Lefebvre 2011; see Appendix 1). We have listed the search strategies for The Cochrane Library and EMBASE in Appendix 1.

Searching other resources

We will manually search the reference lists of published included studies for other relevant articles. We will handsearch various relevant meeting abstracts, including: British Society for Surgery of the Hand and the British Orthopaedic Association Congress using supplements of the The Bone and Joint Journal (previously the Bone and Joint Journal - British); American Society for Surgery of the Hand; American Academy of Orthopaedic Surgeons; American Orthopaedic Trauma Association ; and the Federation of European Societies for Surgery of the Hand.

Data collection and analysis

Selection of studies

Two authors (DRD and DJA) will independently screen the search results for potentially eligible studies using a proforma. We will resolve any disagreements by discussion and, if necessary, by consulting the other authors (CPH and ACW). Once we have excluded any irrelevant studies after an initial screening, we will obtain the full text of the remaining studies and DRD and DJA will independently perform study selection, in consultation with the CPH and ACW should any disagreement not be resolved through discussion. We will document reasons for inclusion or exclusion of studies at this stage. We will not limit by language and will attempt to find a translation for any potentially eligible non-English language papers. If this is not possible, we will list these studies in the 'Studies awaiting classification' section.

Data extraction and management

Two authors (from DRD, DJA and CPH) will independently extract data from the included trials using a piloted data extraction form. We will resolve any disagreements by discussion and, if necessary, by consulting the other author (AW). Data will be entered into Review Manager software (RevMan) (Review Manager 2012) by CPH. We will attempt to contact authors of published trials for any missing information and of unpublished trials for additional information.

Assessment of risk of bias in included studies

Two authors (DRD and DJA) will independently assess the risk of bias of the included trials using the Cochrane risk of bias tool (Higgins 2011a), which has seven domains: random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; selective outcome reporting; incomplete outcome data; and other potential sources of bias. We will consider the risks of specific bias relating to surgical trials, including differences in the level of experience of surgeons delivering the interventions under comparison and the funding of trials by industry. We will consider subjective outcomes (e.g. self-reported function and quality of life outcomes, pain) and objective outcomes (e.g. complications, re-operation) separately in our assessment of blinding and completeness of outcome data. Each item will be evaluated as at low, high or unclear risk of bias informed by the criteria listed in Higgins 2011a. We will resolve any disagreements by discussion or arbitration by a third author. We will not mask titles of journals, names of authors or supporting institutions.

Measures of treatment effect

We will present dichotomous outcomes as risk ratios with 95% confidence intervals (CIs) and continuous outcomes as mean differences with 95% CIs. We will present standardised mean differences with 95% CIs when pooling continuous data based on different scales or scores.

Unit of analysis issues

The unit of randomisation in these trials is usually the individual patient. Exceptionally, as in the case of trials including people with bilateral fractures, data for trials may be presented for fractures or limbs rather than individual patients. Where such unit of analysis issues arise and appropriate corrections have not been made, we will present the data for such trials only where the disparity between the units of analysis and randomisation is small. If data are pooled, we will perform a sensitivity analysis to examine the effects of excluding any trials with analyses that have not been corrected for this unit of analysis issue.

We will avoid unit of analysis issues related to repeated observations of the same outcome, such as results presented for several periods of follow-up.

Dealing with missing data

For trials published since 2000, we will attempt to contact the original trial authors to request missing data. Where possible, we will analyse data on an intention-to-treat basis as per initial randomisation. We will investigate loss of participants from the trials with an analysis of best and worst case scenarios. We will be alert to the potential mislabelling or non-identification of standard errors and standard deviations. We will derive missing standard deviations from other statistics (CIs, standard errors, exact P values) if these are available; otherwise we will not assume or impute missing values. We will undertake sensitivity analyses, such as best and worst case scenario analyses, to assess the effect of missing data on final results.

Assessment of heterogeneity

We will assess heterogeneity by visual inspection of the forest plot (analysis) along with consideration of the test for heterogeneity and the I² statistic (Higgins 2003). We will base our interpretation of the I² results on Higgins 2011b: 0% to 40% might not be important; 30% to 60% may represent moderate heterogeneity; 50% to 90% may represent substantial heterogeneity; and 75% to 100% may represent very substantial heterogeneity.

Assessment of reporting biases

Provided sufficient data are available (at least 10 trials), we will attempt to assess publication bias by preparing a funnel plot. We will evaluate funnel plot asymmetry visually in the first instance. Our search of 'grey literature' and pursuit of trials listed in clinical trial registers should help also to assess publication bias.

Data synthesis

If appropriate, we will pool results of comparable groups of trials using both fixed-effect and random-effects models. Our choice of model to report will be guided by careful consideration of the extent of heterogeneity and whether it can be explained, in addition to other factors, such as the number and size of included studies. We will use 95% CIs throughout. We will consider not pooling data where there is considerable heterogeneity (I² > 75%) that cannot be explained by the diversity of methodological or clinical features among trials or where the outcome measures differ. Where it is inappropriate to pool data, we will still present trial data in the analyses or tables for illustrative purposes and will report these in the text.

Subgroup analysis and investigation of heterogeneity

Where appropriate and data allow, we will perform subgroup analysis by age (under 50; 50 or above), sex, fracture type (primarily extra-articular versus intra-articular fractures) and displacement (dorsal or volar), and treatment method (e.g. routine use of supplementary fixation or bone substitutes; major differences in conservative treatment or postoperative immobilisation).

We will investigate whether the results of subgroups are significantly different by inspecting the overlap of CIs and by performing the test for subgroup differences available in RevMan (Review Manager 2012).

We will discuss and agree our prior expectations of the direction and size of treatment effect for different subgroups before performing subgroup analysis.

Sensitivity analysis

Where possible, we plan to undertake sensitivity analyses examining various aspects of trial and review methodology, including the effects of missing data, of excluding trials at high or unclear risk of bias (specifically, selection bias from lack of allocation concealment, and detection bias from lack of outcome assessor blinding), trials only reported in abstracts, trials with unit of analysis problems related to the inclusion of participants with bilateral wrist fractures, and trials that do not report on surgeons' level of experience; and the selection of the statistical model (fixed-effect versus random-effects).

Assessing the quality of the evidence

We will use the GRADE (Grades of Recommendation, Assessment, Development and Evaluation Working Group) approach to assess the quality of evidence (Chapter 12.2,  Schünemann 2011). For details of the GRADE approach and factors that influence the assessment, see Table 3, Table 4, Table 5 and Table 6.

Table 3. Levels of quality of a body of evidence in the GRADE approach
  1. Copy of Table 12.2.a from Schünemann 2011

Methodology Quality rating
RCTs; or double-upgraded observational studiesHigh
Downgraded RCTs; or upgraded observational studiesModerate
Double-downgraded RCTs; or observational studiesLow
Triple-downgraded RCTs; or downgraded observational studies; or case series, or case reportsVery low
Table 4. Factors that may decrease the quality level of a body of evidence
  1. Copy of Table 12.2.b from Schünemann 2011.

Factors that may decrease the quality level of a body of evidence
1. Limitations in the design and implementation of available studies suggesting high likelihood of bias
2. Indirectness of evidence (indirect population, intervention, control, outcomes)
3. Unexplained heterogeneity or inconsistency of results (including problems with subgroup analyses)
4. Imprecision of results (wide CIs)
5. High probability of publication bias
Table 5. Factors that may increase the quality level of a body of evidence
  1. Copy of Table 12.2.c from Schünemann 2011

Factors that may increase the quality level of a body of evidence
1. Large magnitude of effect
2. All plausible confounding would reduce a demonstrated effect or suggest a spurious effect when results show no effect
3. Dose-response gradient
Table 6. GRADE Working Group grades of evidence
Quality of evidenceExplanation
HighFurther research is very unlikely to change our confidence in the estimate of effect
ModerateFurther research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
LowFurther research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very lowWe are very uncertain about the estimate
'Summary of findings' tables

Where there is sufficient evidence, we will prepare 'Summary of findings' tables for the main comparisons. These will include the following outcomes: internal fixation versus conservative treatment; volar versus dorsal plating; intramedullary nailing versus plate fixation; fragment-specific fixation versus fixed-angle plates; and early postoperative mobilisation versus immobilisation.

Acknowledgements

We thank Angela Page, Clinical Support Librarian at Wrightington Hospital, for helping to devise the search strategy and for acquiring articles of interest. Also we are grateful to Helen Handoll for guiding the protocol process, and Joanne Elliott and Laura MacDonald from the Cochrane Bone, Joint and Muscle Trauma Group for their input into this protocol.

Appendices

Appendix 1. Search strategies

The Cochrane Library (Wiley Online Library)

#1 MeSH descriptor: [Radius Fractures] explode all trees
#2 ((radius or radial) near/3 fracture*):ti,ab,kw (Word variations have been searched)
#3 #1 or #2
#4 distal:ti,ab,kw (Word variations have been searched)
#5 #3 and #4
#6 ((wrist or colles or smith*) near/3 fracture*):ti,ab,kw (Word variations have been searched)
#7 DRF:ti,ab,kw (Word variations have been searched)
#8 #5 or #6 or #7
#9 MeSH descriptor: [Orthopedic Fixation Devices] explode all trees
#10 MeSH descriptor: [Fracture Fixation] explode all trees
#11 pin or pins or pinned or pinning or nail* or screw* or rod or rods or plate or plates or plating or plated or wire* or fix* or ORIF:ti,ab,kw (Word variations have been searched)
#12 #9 or #10 or #11
#13 #8 and #12 in Other Reviews and Trials

MEDLINE (Ovid Online)

1 exp Radius Fractures/
2 ((radius or radial) adj3 fracture*).tw.
3 1 or 2
4 distal. tw.
5 3 and 4
6 ((wrist or colles’ or smith*) adj3 fracture*).tw.
7 DRF.tw.
8 5 or 6 or 7
9 exp Orthopaedic Fixation Devices/
10 exp Fracture Fixation/
11 (pin*1 or nail* or screw*1 or rod*1 or plate*1 or wire* or plating or fix* or ORIF).tw.
12 9 and 10 and 11
13 8 and 12
14 Randomized controlled trial.pt.
15 Controlled clinical trial.pt.
16 randomized.ab.
17 placebo.ab.
18 Drug therapy.fs.
19 randomly.ab.
20 trial.ab.
21 groups.ab.
22 or/14-21
23 exp Animals/ not Humans/
24 22 not 23
25 13 and 24

EMBASE (Ovid Online)

1 Radius Fracture/
2 ((radius or radial) adj3 fracture*).tw.
3 1 or 2
4 distal.tw.
5 3 and 4
6 Colles Fracture/ or Wrist Fracture/
7 ((wrist or colles or smith*) adj3 fracture*).tw.
8 DRF.tw.
9 or/5-8
10 exp Orthopedic Fixation Device/
11 exp Fracture Fixation/
12 (pin*1 or nail* or screw*1 or rod*1 or plate*1 or wire* or plating or fix* or ORIF).tw.
13 and/10-12
14 9 and 13
15 Randomized controlled trial/
16 Clinical trial/
17 Controlled clinical trial/
18 Randomization/
19 Single blind procedure/
20 Double blind procedure/
21 Crossover procedure/
22 Placebo/
23 Prospective study/
24 ((clinical or controlled or comparative or placebo or prospective* or randomi#ed) adj3 (trial or study)).tw.
25 (random* adj7 (allocat* or allot* or assign* or basis* or divid* or order*)).tw.
26 ((singl* or doubl* or trebl* or tripl*) adj7 (blind* or mask*)).tw.
27 (cross?over* or (cross adj1 over*)).tw.
28 ((allocat* or allot* or assign* or divid*) adj3 (condition* or experiment* or intervention* or treatment* or therap* or control* or group*)).tw.
29 RCT.tw.
30 or/15-29
31 Case Study/ or Abstract Report/ or Letter/
32 30 not 31
33 14 and 32

Contributions of authors

CPH, DRD, DJA, DN and ACW drafted the protocol. ACW is the guarantor of this Cochrane Review.

Declarations of interest

CH, DN, ACW or their employing institutions have received funding from companies for research and educational activities unrelated to the development of this review. DRD and DJA have no known conflicts of interest.

Sources of support

Internal sources

  • Angela Page, UK.

    Library support, Wrightington Hospital

External sources

  • No sources of support supplied

Ancillary