Surgical interventions for diaphyseal fractures of the radius and ulna in children

  • Review
  • Intervention

Authors


Abstract

Background

Diaphyseal forearm fractures in children are a common injury usually resulting from a fall. The treatment options include non-surgical intervention (manipulation and application of cast) and surgical options such as internal fixation with intramedullary nails or with plate and screws.

Objectives

To assess the effects (benefits and harms) of a) surgical versus non-surgical interventions, and b) different surgical interventions for the fixation of diaphyseal fractures of the forearm bones in children.

Search methods

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2011 Issue 1), MEDLINE (1948 to February week 4 2011), EMBASE (1980 to 2011 week 09), trial registers and reference lists of articles.

Selection criteria

Randomised or quasi-randomised controlled trials that compared surgical with non-surgical intervention, or different types of surgical intervention for the fixation of diaphyseal forearm fractures in children.

Data collection and analysis

All review authors independently examined the search results to identify trials for inclusion.

Main results

After screening of 163 citations, we identified 15 potentially eligible studies of which 14 were excluded and one is an ongoing trial. There were thus no studies suitable for inclusion in this review.

Authors' conclusions

There is a lack of evidence from randomised controlled trials to inform on when surgery is required and what type of surgery is best for treating children with fractures of the shafts of the radius, ulna or both bones.

Résumé scientifique

Surgical interventions for diaphyseal fractures of the radius and ulna in children

Contexte

Les fractures diaphysaires de l'avant-bras constituent une blessure fréquente chez les enfants, et sont souvent provoquées par une chute. Les options thérapeutiques comprennent l'intervention non chirurgicale (manipulation et application d'un plâtre) et les options chirurgicales telles que la fixation interne avec des clous médullaires ou avec une plaque et des vis.

Objectifs

Évaluer les effets (bénéfices et préjudices) a) des interventions chirurgicales en comparaison avec les interventions non chirurgicales, et b) des différentes interventions chirurgicales destinées à la fixation des fractures diaphysaires des os de l'avant-bras chez les enfants.

Stratégie de recherche documentaire

Nous avons effectué une recherche dans la base de données spécialisée du groupe Cochrane sur les traumatismes osseux, articulaires et musculaires (mars 2011), le registre Cochrane des essais contrôlés (The Cochrane Library, 2011 Numéro 1), MEDLINE (1948 à la 4e semaine du mois de février 2011), EMBASE (1980 à la 9e semaine de l'année 2011), des registres d’essais cliniques et des bibliographies d'articles.

Critères de sélection

Essais contrôlés randomisés ou quasi-randomisés comparant l'intervention chirurgicale et l'intervention non chirurgicale, ou différents types d'interventions chirurgicales pour la fixation des fractures diaphysaires de l'avant-bras chez les enfants.

Recueil et analyse des données

Tous les auteurs de revue ont examiné indépendamment les résultats de recherche pour identifier les essais à inclure.

Résultats principaux

Après passage au crible de 163 références bibliographiques, nous avons identifié 15 études potentiellement admissibles dont 14 ont été exclues et une correspondait à un essai en cours. Par conséquent, aucune étude ne remplissait les critères d’inclusion de cette revue.

Conclusions des auteurs

Il existe un manque de données issus d’essais contrôlés randomisés pour informer si une intervention chirurgicale est nécessaire et sur quel type d'intervention chirurgicale est le plus approprié pour traiter les enfants présentant des fractures diaphysaires du radius, de l'ulna ou de ces deux os.

Plain language summary

Surgical treatment for forearm fractures in children (fractures involving the shafts of the radius and ulna)

Fractures of the shafts of the forearm bones in children are common injuries and occur after a fall on an outstretched hand. There are two bones in the forearm: the radius and the ulna. After a fall either one or both bones may fracture.

The shape of forearm bones are important for the twisting motion of the hand, such as in receiving change from a shop keeper with an open palm (supination) or turning a key in a door (turning the palm facing down - pronation). Treatment of the forearm fracture aims to restore the shape of the bones such that supination and pronation ability is restored.

The first stage of treatment involves manipulating (setting) the bones to the correct shape. This is usually done under anaesthesia. The second stage involves stabilising the fractured bones either with a plaster cast (conservative treatment) or metal implants (surgical treatment).

This review aimed to examine the evidence from randomised controlled trials comparing conservative versus surgical methods and trials comparing different surgical methods for treatment of these fractures. We hoped to find which are the best methods in terms of function and complications. In spite of a thorough search we found no evidence from properly conducted studies to help inform decisions on treatment of these fractures.

Résumé simplifié

Traitement chirurgical des fractures de l'avant-bras chez les enfants (fractures affectant la diaphyse du radius et de l'ulna)

Les fractures de la diaphyse des os de l'avant-bras constituent une blessure fréquente chez les enfants, et sont provoquées par une chute sur une main tendue. L'avant-bras comporte deux os : le radius et l'ulna. L'un et/ou l'autre de ces os peuvent se fracturer en réponse à une chute..

La forme des os de l'avant-bras est importante pour le mouvement de torsion de la main, par exemple lorsque l'on prend la monnaie que nous tend un commerçant avec la paume ouverte (supination) ou que l'on tourne une clé dans une porte (avec un mouvement de rotation de la paume vers le bas - pronation). Le traitement des fractures de l'avant-bras a pour objectif de restaurer la forme des os de manière à restaurer la capacité de supination et de pronation.

La première phase du traitement comprend la manipulation (mise en place) des os pour qu'ils reprennent leur forme correcte. Cette étape est généralement réalisée sous anesthésie. La deuxième phase comprend la stabilisation des os fracturés soit à l'aide d'un plâtre (traitement conservateur) soit à l'aide de prothèses métalliques (traitement chirurgical).

Cette revue avait pour objectif d'examiner les données d'essais contrôlés randomisés comparant les méthodes conservatrices et chirurgicales et d'essais comparant différentes méthodes chirurgicales pour le traitement de ces fractures. Nous espérions trouver les méthodes les plus appropriées en termes de fonction et de complications. Malgré une recherche minutieuse, nous n'avons pas trouvé d'éléments probants issus d'études convenablement menées permettant de favoriser la prise de décisions éclairées sur le traitement de ces fractures.

Notes de traduction

Traduit par: French Cochrane Centre 1st December, 2011
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

Background

In children, diaphyseal or shaft fractures of one or both of the two forearm bones (radius and ulna) usually result from falling onto an outstretched hand (Worlock 1986). A large epidemiological study of fractures in children aged 12 and under in Nottingham, UK in 1981 reported that diaphyseal fractures of the radius and ulna constituted 6.5% of fractures in this population (Worlock 1986). A more recent epidemiological study conducted in Edinburgh reported a rate of 5.4% of all fractures in children under 16 years of age (Rennie 2007). This study reported around twice as many males as females sustained these fractures, at an average age of 7.8 years.

Description of the condition

A fracture of the forearm is an acute painful condition requiring pain relief and plaster cast splintage. Pain reduces gradually over the course of two weeks. Splintage also helps to prevent increasing deformity while the fracture unites. Once fracture union occurs and motion at the fracture site ceases, splintage can be discontinued and function of the forearm is gradually restored.

Fracture of the ulna shaft can occur with dislocation of the radial head proximally at the elbow (Monteggia fracture). Reduction of the ulna deformity allows relocation of this dislocation. A similar dislocation of the distal radio-ulnar joint can occur with fractures of the distal radius (Galeazzi fracture).

The forearm functions as a joint allowing for forward rotation (pronation: palm faces downwards) or backward rotation (supination: palm faces upwards) (Gray 1918). This increases the functions a hand can perform, such as turning a key to lock or unlock a door. This ability to pronate and supinate depends, amongst other things, on the shape of the radial diaphysis. Interventions for radius and ulna diaphyseal fractures which restore the pre-fracture shape of these bones should therefore result in better forearm pronation-supination function than interventions that result in residual deformity.

In children, a deformed bone can remodel with growth over time. This remodelling potential is greatest in children under the age of five, where remodelling up to 30 degrees of deformity in the forearm is possible. The potential for bone remodelling is considerably reduced in older children, especially as they approach skeletal maturity. The extent of deformity and anticipated capacity for remodelling are likely to influence the treatment decisions.

Description of the intervention

Surgical intervention is aimed at reduction and then surgical stabilisation of the fracture.

Fracture reduction reduces the deformity following a fracture by normalising the alignment of the radius and ulna. Reduction can either be closed (externally by manipulation under X-ray control) or open (by surgical exposure, visualisation and instrumentation).

Surgical stabilisation of the fracture involves holding the reduction such that the restored alignment following reduction is maintained. Devices for surgical stabilisation can be either internal to the forearm or external such as an external fixator. Internal devices can either be intramedullary nails, typically nowadays these are elastic stable intramedullary nails (ESIN), or a combination of plates and screws.

In children, the trend has generally been to remove orthopaedic implants once the operated bone has fully healed. This is usually undertaken a year or so after operation before new bone formation buries the implant completely. Removal of intramedullary nails is much easier than plates or other implants that are fixed to the bone. Access to the ends of intramedullary nails is usually in safe zones, where neurovascular structures (nerves and blood vessels) are not at risk. Conversely plate removal requires a surgical dissection though inter-nervous or inter-muscular planes. These planes are often scarred and less discrete following previous open reduction and internal fixation. Thus repeat surgery, for the removal of plates and screws, requiring dissection may endanger neurovascular structures and result in complications.

How the intervention might work

Surgical stabilisation prevents motion at the fracture site, thereby preventing displacement and recurrence of deformity at the fracture site. Anatomical restoration should help to maximise function of the forearm once rehabilitation from the injury is complete.

Generally intramedullary nailing consists of a manipulation (closed reduction) with percutaneous insertion (through a small incision in the skin) of the Elastic Stable Intramedullary Nail (ESIN). This technique allows for the formation of callus from the fracture haematoma which subsequently ossifies. The fracture ends are manipulated to approximate the shape of the pre-fracture radial shaft before being secured using an ESIN.

Open reduction and internal fixation (ORIF) involves surgical dissection and exposure of the fracture. The two ends of the fractured bone are perfectly matched like a jigsaw. This type of reduction is both macroscopic and microscopic allowing for the restoration of the microscopic, cellular and matrix bone anatomy, without the need for bridging callus. The reduced bone is then stabilised using an implant, typically a plate with screws.

Why it is important to do this review

The indications for surgical interventions, for diaphyseal fractures of the radius and ulna in children, are not clear. Similarly, the relative effects of various methods of surgery, particularly intramedullary nailing and plate fixation are not established.

Objectives

We aimed to evaluate the evidence from randomised and quasi-randomised controlled trials comparing the effects (benefits and harms) of a) surgical versus non-surgical interventions, and b) different surgical interventions for the fixation of fractures of the forearm in children.

Methods

Criteria for considering studies for this review

Types of studies

We planned to include any randomised or quasi-randomised (for example, allocation by date of birth or alternation) controlled trials which compared a) surgical versus non-surgical interventions and b) different surgical interventions for fractures of the forearm in children.

Types of participants

Children (babies, infants, young children or adolescents) who had a displaced diaphyseal fracture of the radius or ulna diagnosed radiographically. In addition, planned for inclusion were children with diaphyseal fractures of both bones. Excluded were Monteggia and Galeazzi fractures. Fractures of the distal radius and ulna were excluded also: these are reviewed in Abraham 2008.

Types of interventions

Realignment of displaced fractures (reduction) can be achieved by closed (manipulation) or open (surgical exposure) means. Non-surgical or conservative treatment usually comprises immobilisation using splints or casts. Methods of surgical stabilisation include external fixation, such as with an external fixator, or internal fixation, such as intramedullary nailing or a combination of plates and screws.

Types of outcome measures

We sought the following outcome measures:

Primary outcomes

1. Function including activities of daily living and impairments such as loss of forearm rotation and wrist range of motion
2. Complications from treatment including refracture/periprosthetic fracture, infection and nerve or tendon injuries
3. Secondary treatment including surgery for implant removal

Secondary outcomes

1. Quality of life measures
2. Resource use and other costs
3. Redisplacement and residual deformity
4. Patient (child) satisfaction and adherence (compliance); parent satisfaction and adherence to treatment plan

Search methods for identification of studies

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (March 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Wiley Online Library 2011 Issue 1), MEDLINE (OvidSP 1948 to February week 4 2011) and EMBASE (OvidSP 1980 to 2011 Week 09). In MEDLINE, the subject specific search was combined with the sensitivity-maximizing version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (Lefebvre 2008) (see Appendix 1). This strategy was modified for use in the Cochrane Central Register of Controlled Trials and EMBASE (see Appendix 1).

We also searched Current Controlled Trials and the WHO International Clinical Trials Registry for ongoing and recently completed trials (May 2011) (see Appendix 1).

No language restrictions were applied.

Searching other resources

We searched reference lists of articles and contacted researchers in this field.

Data collection and analysis

Selection of studies

The initial searches were carried out by all authors, assisted by the Cochrane Bone, Joint and Muscle Trauma Group's editorial base. All authors assessed potentially eligible trials for inclusion and any disagreement was resolved through discussion. Titles of journals, names of authors or supporting institutions were not masked at any stage.

Data extraction and management

Should trials be included in a future update, all authors will independently perform data extraction using a pre-piloted form. Any disagreement will be resolved through discussion.

Assessment of risk of bias in included studies

We had planned for all authors to independently assess the risk of bias of the included studies using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2008). This tool incorporates assessment of randomisation (sequence generation and allocation concealment), blinding (participants, personnel and outcome assessors), completeness of outcome data, selection of outcomes reported and other sources of bias. We will consider also other sources of bias, specifically bias from major imbalances in key baseline characteristics (e.g. age, gender, and concomitant ulna shaft fracture); and performance bias from systematic differences in the care provided (e.g. care provider experience, and rehabilitation). Risk of bias associated with a) blinding and b) completeness of outcomes for patient-reported outcomes and objective outcomes would have been done separately.

Measures of treatment effect

When quantitative data become available, we plan to calculate risk ratios with 95% confidence intervals for dichotomous outcomes, and mean differences with 95% confidence intervals for continuous outcomes.

Unit of analysis issues

The unit of randomisation in these trials is usually the individual patient. Exceptionally, as in the case of trials including children with bilateral fractures, data for trials are presented for fractures or limbs rather than individual patients. In future updates, where such unit of analysis issues arise and appropriate corrections have not been made, we will consider presenting the data for such trials only where the disparity between the units of analysis and randomisation is small. Where data are pooled, we plan to perform a sensitivity analysis to examine the effects of pooling these incorrectly analysed trials with the other correctly analysed trials.

Dealing with missing data

Where appropriate, we would have performed intention-to-treat analyses to include all children randomised to the intervention groups. We would have investigated the effect of drop outs and exclusions by conducting worse and best scenario analyses. We indicated that we would be alert to the potential mislabelling or non-identification of standard errors and standard deviations, and, unless missing standard deviations could be derived from confidence interval data, we would not assume values in order to present these in the analyses.

Assessment of heterogeneity

Should this be relevant in a future update, we intend to assess heterogeneity 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

If sufficient data become available, we will attempt to assess publication bias by preparing a funnel plot. Our search of 'grey literature' and pursuit of trials listed in clinical trial registers should help to address publication bias.

Data synthesis

If possible in future and considered appropriate, results of comparable groups of trials will be pooled. Initially we will use the fixed-effect model and 95% confidence intervals. We will also consider using the random-effects model, especially where there is unexplained heterogeneity.

Subgroup analysis and investigation of heterogeneity

Our pre-specified subgroup analyses are by age (under 5 years; 5 to 10 years; 11 years or above), gender and the presence of a fracture of the ulna. To test whether the subgroups are statistically significantly different from one another, we will test the interaction using the technique outlined in Altman 2003 or use the test for subgroup differences facility in RevMan.

Sensitivity analysis

In future updates, and where possible, we plan sensitivity analyses examining various aspects of trial and review methodology, including the effects of missing data, risk of bias (specifically relating to allocation concealment, outcome assessor blinding and reportage of surgical experience), and inclusion of trials only reported in abstracts.

Results

Description of studies

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

Results of the search

We screened 162 citations up to March 2011 from the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register (10 records), The Cochrane Library (17), MEDLINE (82) and EMBASE (53). A search of the Current Controlled Trials platform yielded one further trial (Colaris). Only 15 studies were considered potentially eligible after initial screening. Of these, two were RCTs (Agarwal 2004; Colaris). We have been unable to find the full paper by Agarwal despite help from the Cochrane Group and have also been unsuccessful in obtaining data or further information on trial methods from the listed authors. Efforts to contact the main author failed and the co-author does not have the data (Hammer 2010). This study (Agarwal 2004) therefore has been excluded. The Colaris study is not yet complete at the time of writing and has therefore been included in the Characteristics of ongoing studies, to be assessed for future updates of this review.

Included studies

None of the completed and published studies identified in the detailed searches fulfilled the inclusion criteria.

Excluded studies

Fourteen studies were excluded (see the Characteristics of excluded studies for details).

Risk of bias in included studies

There were no completed studies included in this review.

Effects of interventions

There were no completed studies included in this review.

Discussion

A thorough search of the medical literature failed to reveal any completed and published randomised or quasi-randomised trials comparing different methods, whether surgical or non-surgical, for the treatment of radius and ulna diaphyseal fractures in children. We, however, identified one completed randomised controlled trial (Agarwal 2004), which compared elastic intramedullary nailing with plate fixation of long bone fractures in 66 children, of whom 49 had forearm fractures, that was reported only in conference abstracts. Regrettably, it seems very unlikely that a full report of this trial will ever become available. This leaves us with our other find of an ongoing randomised controlled trial (Colaris), which has completed recruitment but failed to make its recruitment target. Nonetheless, we anticipate that a full report of this study, which compares one versus two elastic stable intramedullary nails, will be available for a future update of this review.

While it is possible that there may be other randomised trials on this topic that remain unpublished and have gone unnoticed in our search, we suggest that the submission for publication of such rare studies would be unlikely to meet with rejection from editors of most orthopaedic journals. We strongly encourage all trialists to publish the results of their trials in full.

Authors' conclusions

Implications for practice

We would like to emphasise our finding of a lack of evidence from randomised controlled trials to inform on the available choices for treatment of diaphyseal fractures of the radius and ulna in children. Specifically, there is no best quality evidence to inform practice in terms of when to operate and on the choice of method of surgical stabilisation.

Implications for research

Diaphyseal fractures in children are common and there remains a need for studies to help inform key treatment decisions. Ideally such studies would be well conducted randomised trials with adequate follow-up to assess for healing, functional recovery, refracture rates and the complications associated with implant removal. Such studies should be preceded by evidence-based discussions amongst specialists and other stakeholders in this area that aim to establish the priority topics in current practice that would merit investigation in multi-centre randomised controlled trials. It should be noted that treatment outcomes of single bone forearm fractures (isolated radius or ulna diaphyseal fractures) may be importantly different from those for fractures of both forearm bones. Thus, at minimum, all studies with mixed populations should present separate data for these different fracture populations.

Acknowledgements

Lindsey Elstub has been extremely supportive to the authors during the lengthy process from conception to finish. We wish to acknowledge the advice, feedback and administration she has provided. The searches with updates were provided by Lesley Gillespie and Joanne Elliott, for which we are very grateful.

We also like to thank the following for their help with feedback during editorial and external review of the protocol and review: Helen Handoll, Alastair Murray, Ben Vandemeer and Janet Wale.

Data and analyses

Download statistical data

This review has no analyses.

Appendices

Appendix 1. Search strategies

The Cochrane Central Register of Controlled Trials (Wiley Online Library)

#1 MeSH descriptor Radius, this term only (117)
#2 MeSH descriptor Ulna, this term only (28)
#3 (#1 OR #2) (670)
#4 MeSH descriptor Fractures, Bone, this term only (748)
#5 MeSH descriptor Fracture Fixation explode all trees (237)
#6 MeSH descriptor Fracture Healing, this term only (129)
#7 (#4 OR #5 OR #6) (1382)
#8 (#3 AND #7) (22)
#9 MeSH descriptor Radius Fractures, this term only (150)
#10 MeSH descriptor Ulna Fractures, this term only (27)
#11 ((forearm or radius or radial or ulna*) near3 fractur*) (356)
#12 (#8 OR #9 OR #10 OR #11) 396)
#13 (shaft or diaphys*) (481)
#14 (#12 AND #13) in Clinical Trials (17)

MEDLINE (OvidSP)

1     Radius/ or Ulna/ or Forearm Injuries/ (10940)
2     Fractures, Bone/ or exp Fracture Fixation/ or Fracture Healing/ (75992)
3     and/1-2 (1778)
4     Radius Fractures/ or Ulna Fractures/ (6805)
5     or/3-4 (7942)
6     ((forearm or radius or radial or ulna$1) adj3 fractur$).tw. (4551)
7     or/5-6 (9024)
8     (forearm or shaft or midshaft or diaphys$).tw. (41160)
9     and/7-8 (2654)
10     exp Pediatrics/ (37196)
11     exp Infant/ (832486)
12     exp Child/ (1359668)
13     Adolescent/ not exp Adult/ (416670)
14     (paediatr$ or pediatr$ or neonate$ or bab$3 or infant$ or child$ or teenage$ or adolescen$).tw. (1176311)
15     or/10-14 (2173073)
16     and/9,15 (872)
17     Randomized controlled trial.pt. (300417)
18     Controlled clinical trial.pt. (81837)
19     randomized.ab. (207921)
20     placebo.ab. (122109)
21     Drug therapy.fs. (1427896)
22     randomly.ab. (151069)
23     trial.ab. (214457)
24     groups.ab. (1009219)
25     or/17-24 (2634820)
26     exp Animals/ not Humans/ (3543352)
27     25 not 26 (2233968)
28     and/16,27 (82)

EMBASE (OvidSP)

1     Radius/ or Ulna/ (9773)
2     Fracture/ or exp Fracture Fixation/ or exp Fracture Healing/ (101940)
3     1 and 2 (1671)
4     Radius Fracture/ or Ulna Fracture/ (6636)
5     3 or 4 (7777)
6     ((forearm or radius or radial or ulna$1) adj3 fractur$).tw. (5355)
7     5 or 6 (9741)
8     (shaft or diaphys$).tw. (19550)
9     7 and 8 (893)
10     exp Pediatrics/ (57963)
11     exp Infant/ (457420)
12     exp Child/ (1449902)
13     Adolescent/ not exp Adult/ (402011)
14     (paediatr$ or pediatr$ or neonate$ or bab$3 or infant$ or child$ or teenage$ or adolescen$).tw. (1357992)
15     10 or 11 or 12 or 13 or 14 (2135713)
16     9 and 15 (291)
17     exp Randomized Controlled trial/ (290476)
18     exp Double Blind Procedure/ (101826)
19     exp Single Blind Procedure/ (13968)
20     exp Crossover Procedure/ (30289)
21     Controlled Study/ (3460885)
22     or/17-21 (3527135)
23     ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw. (535863)
24     (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw. (132542)
25     ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw. (130488)
26     (cross?over$ or (cross adj1 over$)).tw. (55289)
27     ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw. (158921)
28     or/23-27 (803148)
29     or/22,28 (3901636)
30     limit 29 to human (2361931)
31     30 and 16 (53)

Current Controlled Trials

  1. children AND fracture

  2. paediatric AND fracture

  3. pediatric AND fracture

WHO International Clinical Trials Registry

Advanced Search facility: multiple searches carried out in both the ‘Title’, or ‘Condition’ fields (separately), limiting to ‘Clinical trials in children’

Recruitment status: all.

  1. forearm and fracture

  2. torus and fracture

  3. buckle and fracture

  4. radius and fracture

  5. ulna and fracture

History

Protocol first published: Issue 3, 2009
Review first published: Issue 11, 2011

Contributions of authors

Alwyn Abraham:

  1. Conception and design of study

  2. Analysis and interpretation of data.

  3. Drafting the review

  4. Guarantor of the review

Sujit Kumar:

  1. Conception and design of study

  2. Commenting on the draft critically for intellectual content

  3. Final approval of the document to be published.

Sameena Chaudhry:

  1. Analysis and interpretation of data

  2. Commenting on the draft critically for intellectual content

  3. Final approval of the document to be published.

Talal Ibrahim:

  1. Analysis and interpretation of data.

  2. Commenting on it critically for intellectual content.

  3. Final approval of the document to be published.

Declarations of interest

None known.

Sources of support

Internal sources

  • Leicester Royal Infirmary, Leicester, UK.

External sources

  • No sources of support supplied

Differences between protocol and review

We used the Cochrane Highly Sensitive Search Strategy in the MEDLINE sensitivity-maximizing version for identifying randomised trials.

Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    ESIN = elastic stable intramedullary nailing

Agarwal 2004This was a randomised controlled trial, conducted during 2000 to 2002, that compared elastic intramedullary nailing (ESIN) with plate fixation of long bone fractures in 66 children, of whom 49 (24 versus 25) had forearm fractures. The trial was reported in three conference abstracts but we were unable to obtain the full trial report or any further data despite extensive efforts by the authors and our local medical librarian. Correspondence with a co-author revealed that only the main author had the data but we were unsuccessful in contacting the main author. The abstracts contained insufficient data for inclusion.
Bhaskar 2001This was a retrospective study of 32 unstable forearm fractures in children. Traditional both bone plating was carried out in 20 subjects and ulna only plating in 12. This study was excluded because it wasn't a comparative study of ESIN versus plating.
Collinge 2000Not children. Randomised trial comparing intramedullary nailing versus open reduction and plating in adults.
Fernandez 2005Not a randomised or quasi-randomised controlled trial. Retrospective comparison of ESIN versus plating.
Hertlein 2000Not a randomised or quasi-randomised controlled trial. "Case control study" comparing primary intramedullary nailing versus conservative treatment.
Johari 1999Not a randomised or quasi-randomised controlled trial. Prospective case series investigating the remodelling of forearm fractures after closed treatment.
Jubel 2005Not a randomised or quasi-randomised controlled trial. Study assessed the outcomes of ESIN for forearm fractures in children.
Kucukkaya 2004Not a randomised or quasi-randomised controlled trial. Retrospective case series of open intramedullary fixation in the treatment of paediatric radius/ulna shaft fractures.
Lascombes 2005Not a randomised or quasi-randomised controlled trial. Report of a retrospective and prospective series of forearm fractures in children.
Luhmann 1998Not a randomised or quasi-randomised controlled trial. Retrospective review of forearm fractures treated with intramedullary fixation (smooth Kirschener wires or Rush rods).
Majed 2007Not a randomised or quasi-randomised controlled trial. Retrospective comparison of Nancy nail versus intramedullary-wire fixation.
Myers 2004Not a randomised or quasi-randomised controlled trial. Retrospective case series of patients with forearm fractures of both bones treated by single bone fixation.
Roy 1990Not a randomised or quasi-randomised controlled trial. A narrative review article.
Schmittenbecher 2008Not a randomised or quasi-randomised controlled trial. Retrospective study of children with forearm shaft fractures treated with ESIN.

Characteristics of ongoing studies [ordered by study ID]

Colaris

Trial name or titleTreatment of unstable both-bone midshaft forearm fractures in children: A randomized trial between 1 and 2 elastic stable intramedullary nails
Methods

Allocation: Randomised, non-blinded.

Information from lead trialist: "Sealed envelopes in four different hospitals. Envelopes stored on the OR. We used block randomisation with different block sizes." "Independent examiner at follow-up but no blinding."

ParticipantsInclusion criteria: Stable both-bone forearm fracture; age < 16 years old; unstable dislocation.
Exclusion criteria: Fracture older than 1 week; no informed consent; refracture; open fracture (Gustillo 2 and 3)
Interventions1 or 2 elastic stable intramedullary nails
OutcomesFollow-up: 9 months (protocol indicated removal of nails at 8 months)
Pronation and supination, complications, function, aesthetics, complaints in daily living, X-rays
Starting dateJanuary 2006
Contact informationJoost W Colaris, M.D., HAGA/Erasmus Medical Centre, joostcolaris@hotmail.com
NotesContact made with Joost Caloris who reported (23/06/2011) that there were 12 to 15 children in each group (they did not achieve their intended sample size of 60 children). Analysis is planned in Autumn 2011.

Ancillary