Abstract
Background
Diaphyseal forearm fractures in children are common injuries, the vast majority of which are treated conservatively. There is a need to assess the role of modifiable factors such as techniques of reduction and casting in order to optimise functional recovery.
Objectives
To assess the effects of different conservative interventions for diaphyseal forearm fractures in children, including adolescents.
Search methods
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to November 2012), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2012 Issue 11), MEDLINE (1950 to November 2012), EMBASE (1980 to November 2012), CINAHL (1982 to November 2012), trial registries (to November 2012), conference proceedings and reference lists of articles.
Selection criteria
Randomised or quasi‐randomised trials comparing conservative interventions for diaphyseal forearm fractures in children were eligible for inclusion.
Data collection and analysis
Two review authors independently examined search results to identify eligible trials.
Main results
After screening 493 citations, 17 potentially eligible studies were identified. Of these 13 studies were excluded, two studies, both reported incompletely in conference abstracts only, await assessment and two are ongoing trials whose recruitment status is unknown.
Authors' conclusions
This review found no usable evidence from randomised trials to make recommendations concerning different conservative interventions for the treatment of diaphyseal fractures of the forearm bones in children. Publication in full of trials that have already been performed on this topic would be a useful start to changing this unsatisfactory situation.
Keywords: Adolescent; Child; Humans; Casts, Surgical; Diaphyses; Diaphyses/injuries; Fracture Fixation; Fracture Fixation/adverse effects; Fracture Fixation/instrumentation; Fracture Fixation/methods; Radius Fractures; Radius Fractures/therapy; Ulna Fractures; Ulna Fractures/therapy
Plain language summary
Conservative interventions for shaft fractures of the forearm bones in children
The forearm consists of two bones, the radius and the ulna. Fractures (broken bones) in the middle portion (shaft) of one or both of these bones are common injuries in children. Most of these fractures are treated conservatively (i.e. without surgery). Conservative treatment usually involves gently putting the broken bone back into place (reduction). Part of the arm is then put in a cast to protect and support the broken bones while they heal. There are different ways of immobilising the injured arm. For example, some casts include the elbow whereas others do not. When casts include the elbow, the elbow may be in a bent or extended position. While these fractures usually heal, the results are not always satisfactory and sometimes there are complications. This review aimed to find out which conservative treatment methods give the best results for children with these fractures by looking at the evidence from randomised controlled trials comparing different conservative interventions.
While we found two completed trials, both were published only in conference abstracts that failed to provide any usable data. We also found two ongoing trials. In all, the review found no evidence from randomised trials to inform on the best ways to treat these fractures.
Background
Description of the condition
Fractures of one or both forearm bones (radius and ulna) are common injuries in children. A survey of paediatric fractures in Edinburgh in 2000 found diaphyseal (shaft) fracture of the forearm bone was the sixth most common fracture, amounting to 5.4% of fractures in children under 16 years of age (Rennie 2007a). Nearly twice as many males as females incurred these fractures, which occurred at an average age of 7.8 years. The majority of fractures resulted from falls.
Diaphyseal or shaft fractures of the radius and ulna are defined as those occurring between the proximal (upper) and distal (lower) metaphyses of each bone. (Metaphyses are the diverging areas of bone between the diaphysis (shaft) and the physes (growth plates)). A commonly used method to classify diaphyseal forearm fractures in children is the descriptive labelling into 1) bone ‐ single, i.e. radius or ulna; 2) level of fracture ‐ upper, mid or lower third; and 3) pattern of fracture ‐ plastic deformation (the bone bends but does not break), greenstick (one side of the bone is broken while the other is bent), complete, and comminuted (splintered or crushed into several pieces) (Van Herpe 1976). Radius and ulna fractures are also classified as 22‐D and its subtypes according to the Pediatric Expert Group of the AO Foundation and the International Association for Pediatric Traumatology's AO Paediatric comprehensive classification of long bone fractures (Slongo 2006).
Injuries associated with these fractures include elbow or wrist trauma and neurological injuries. One serious complication arising from closed management is Volkmann's ischaemia, also referred to as a compartment syndrome, where there is a lack of blood flow due to increased tissue pressure, perhaps from overly tight bandages, often resulting in contractures of the forearm muscles. Other complications include infection in open injuries, nerve damage (neuropraxia), malunion, stiffness or rigidity (ankylosis) of the elbow or wrist joints, cross‐union, re‐fracture and reflex sympathetic dystrophy (now generally termed complex regional pain syndrome type 1).
Description of the intervention
Forearm fractures in children are traditionally and predominantly treated with closed reduction (external manipulation to restore alignment of fracture fragments) and immobilisation, usually with plaster casts that immobilise the elbow in flexion (Ouattara 2007). Loss of reduction (redisplacement) has been recorded in 7% to 13%, with rates as high as 62% for older children (Kay 1986).
Plastic deformations of diaphyseal fractures of the forearm occur in children aged up to 10 years of age and are frequently missed. The treatment for these involves gradual reduction over a sandbag or rolled towel; this procedure is often successful in reversing the deformation. Vorlat 2003, in a study in children aged six years or over, reported that greater than 10 degrees of plastic deformation in either the radius or ulna resulted in an unacceptable outcome. Price 2001 has published limits of angulation and malrotation for an acceptable outcome in displaced fractures. These were 15 degrees and 45 degrees respectively in children aged under nine years, and 10 and 30 degrees respectively in children aged over nine years.There is a general consensus that greenstick and undisplaced fractures in children should be managed conservatively. In the greenstick fracture, where one cortex is broken and the opposite cortex is bent, the surgeon may purposefully complete the break as this may decrease the tendency for the fracture to deform.
There is debate on the degree of rotation of the forearm that is required for immobilisation after reduction of forearm fractures. Distal radius fractures (those close to the wrist) are usually immobilised in the prone position (palm faces downwards and the radius and ulna are crossed), whereas proximal radius fractures (those closer to the elbow) are generally immobilised in the supine position (palm faces upwards and the forearm bones are not crossed). Less commonly, proximal forearm fractures are immobilised in a cast extending above the elbow, with the elbow in extension.
Traditionally, the material favoured for casting is plaster of Paris. More recently, as many as eight synthetic casting materials have been reported in use (Bowker 1992). These are more expensive than plaster of Paris casts, but may be considered appropriate when there is a high probability of structural failure of a plaster cast (Marshall 1992).
How the intervention might work
In adults, almost all displaced diaphyseal fractures of forearm are now treated surgically. Children differ from adults because of their growth potential and the mechanical properties of their bones. Their bones have the ability to heal faster and are capable of a greater degree of remodelling, thereby allowing for minor degrees of malreduction (imperfect restoration of anatomy) during treatment. As described above, acceptable limits of angulation and malrotation between fracture fragments have been proposed (Price 2001).
This 'remodelling capacity' means that a satisfactory outcome from closed reduction and external immobilisation such as plaster of Paris casts and splints is achievable. Open fractures necessitate surgical intervention to debride (clean) the wound; however, even in these situations, closed treatment of fractures can be undertaken. Redisplacement may occur in unstable fractures and is usually discovered by inspection of radiographs carried out within the first two weeks (Bochang 2008).
Casting techniques involve the reduction of the displaced fracture and holding the fractured ends of the bone in place by neutralising deforming muscle forces. The position of bones is maintained by carefully moulding the cast (shaping the cast) to fit snugly around the forearm and applying appropriate corrective pressure. A well‐moulded cast which snugly fits the forearm is considered essential for maintaining reduction, and in order for healing without deformity to occur (Webb 2006). Theoretically, casting with the elbow in extension eliminates the deforming force of gravity and the supination pull of the biceps, thus helping to maintain the reduction, especially in children with unstable fractures (Bochang 2005b; Shaer 1999). However, elbow stiffness and sliding of the cast distally are recorded drawbacks of casting with the elbow in the extended position. There is some evidence that the 'cast index', which is a measure of the moulding of a cast at the fracture site, can be used to predict redisplacement of forearm fractures (Singh 2008).
Usually, surgical intervention is indicated where closed reduction is unsuccessful or for unstable fractures. Surgical intervention for these fractures is examined in another Cochrane review (Abraham 2011).
Why it is important to do this review
The vast majority of these common injuries in children are managed conservatively. However, the results are not always satisfactory and it is important to assess the role of modifiable factors, such as the positions of the elbow and of the forearm in the cast, in order to prevent treatment failures and complications, and to ensure good functional recovery.
Objectives
To assess the effects of different conservative interventions for treating diaphyseal forearm fractures in children, including adolescents.
Methods
Criteria for considering studies for this review
Types of studies
We planned to include randomised or quasi‐randomised controlled trials (trials where the method of allocating participants to a treatment is not strictly random and where allocation can be predicted: e.g. by date of birth, hospital record number, alternation).
Types of participants
Children, including adolescents, with diaphyseal fractures of the forearm (either of the radius or ulna, or both) would have been included. We excluded Monteggia and Galeazzi fractures. Fractures of the distal radius and ulna are excluded also: these are reviewed in Abraham 2008.
Types of interventions
Conservative interventions eligible for inclusion in this review include the following categories.
Method of reduction for displaced fractures.
'Completing the fracture' (extending the fracture to the opposite cortex or breaking the intact opposite cortex) of greenstick fractures versus control.
Extent of cast: above elbow versus below elbow.
Forearm position in cast: e.g. extension versus flexion casting techniques; supination versus pronation flexion casting techniques.
Type of cast material: synthetic versus plaster of Paris.
Duration of immobilisation.
Types of outcome measures
Primary outcomes
Measures, preferably validated, of musculoskeletal function in children such as the PODCI (Paediatric Outcome Data Collection Instrument) (Daltroy 1998) or Daruwalla Score (Daruwalla 1979).
Treatment failure (composite outcome defined as either the need for a second procedure (reduction or surgical intervention) or the presence of a malunion (defined as radiological angular or rotational deformity beyond acceptable range for age) (Beaty 2001).
Serious adverse effect: compartment syndrome, elbow and forearm (supination and pronation) ankylosis, complex regional pain syndrome type 1 and refractures.
Secondary outcomes
Minor functional impairment (e.g. stiffness of elbow, wrist and hand).
Minor complications (e.g. cast slippage, skin breakage).
Costs and use of resources (economic analysis, if reported).
We will consider grouping outcomes under short term (less than three months) and longer term (preferably one year or more) follow‐up.
Search methods for identification of studies
Electronic searches
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (November 2012), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2012 Issue 11), MEDLINE (1950 to November Week 3 2012), EMBASE (1980 to 2012 Week 47), and CINAHL (1982 to November 2012). We also searched the WHO International Clinical Trials Registry Platform and the metaRegister of Controlled Trials (mRCT) for ongoing and recently completed trials (Novemebr 2012). No language restrictions were applied.
In MEDLINE, a subject‐specific strategy was combined with the sensitivity‐maximizing version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (Lefebvre 2011). Search strategies for The Cochrane Library, MEDLINE, EMBASE, and CINAHL are shown in Appendix 1.
We searched available online conference proceedings of the Paediatric Orthopaedic Society of India (POSI), Pediatric Orthopaedic Society of North America (POSNA), the paediatric section of Asia Pacific Orthopaedic Association (APOA), and the European Paediatric Orthopaedic Society (EPOS) for randomised controlled trials of conservative interventions in diaphyseal fractures of forearm bones in children (November 2012).
Searching other resources
We checked reference lists of relevant articles and wrote to experts in the field and the contact authors of identified trials for information on existing or ongoing trials.
Data collection and analysis
The intended methodology for data collection and analysis was described in our published protocol (Madhuri 2010).
Selection of studies
Two review authors (AG and VD) independently assessed potentially eligible trials for inclusion. Full texts of trials that fulfilled our inclusion criteria and those that were unclear from perusal of the abstracts were obtained. Any disagreements were resolved through discussion and, where necessary, consultation with a third review author (VM). Where necessary, we attempted to contact trial authors for clarification of study methods and characteristics.
Data extraction and management
Should trials be included in a future update, all review authors will independently extract information on study characteristics and results using a piloted data extraction form. Any disagreement will be resolved through discussion. We will attempt to contact trial authors where there are incomplete details on study methods or data.
Assessment of risk of bias in included studies
Should trials be included in a future update, all review authors will independently assess the risk of bias in each included trial using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011) on the following seven domains: sequence generation, allocation concealment, blinding (participants and personnel), blinding (outcome assessment), incomplete outcome data, selective outcome reporting, and other biases. We will consider subjective outcomes (e.g. pain, patient‐reported function) and 'hard' outcomes (e.g. adverse events) separately in our assessment of blinding and completeness of outcome data. Other biases will include assessment of bias resulting from major imbalances in key baseline characteristics (e.g. isolated versus combined fractures, age and gender); and performance bias such as resulting from lack of comparability in the experience of care providers. We will attempt to contact the trial authors for clarification when methodological details are unclear. We will resolve differences by discussion.
For each of these seven domains, we will assign a judgement regarding the risk of bias as 'low', 'high' risk, or 'unclear' based on the criteria summarised in Table 8.5.d of the Cochrane Handbook (Higgins 2011). We will use these judgements when assessing limitations in study design of the trials contributing to important outcomes in 'Summary of findings' tables.
Measures of treatment effect
When quantitative data become available, we plan to calculate risk ratios (RR) and 95% confidence intervals (95% CI) for dichotomous outcomes and mean differences (MD) with 95% confidence intervals for continuous outcomes.
Unit of analysis issues
Though the unit of randomisation in these trials is usually the individual patient, trials including children with bilateral fractures may present results for fractures or limbs rather than for individual patients. Should such unit of analysis issues arise in future and appropriate corrections have not been made, we will consider presenting the data for such trials 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 excluding incorrectly reported trials from the analysis.
Dealing with missing data
Should trial results be available in a future update, we will attempt to perform intention‐to‐treat analysis in which all randomised participants are analysed in the groups to which they were originally assigned. If there is discrepancy in the number randomised and the numbers analysed in each treatment group, we will calculate the percentage loss to follow‐up in each group and report this information. If drop‐outs exceed 10% for any trial, we shall assign the worst outcome to those lost to follow‐up for dichotomous outcomes and assess the impact of this in sensitivity analyses with the results of completers. Where necessary, we will calculate missing standard deviations from other available data such as standard errors (Higgins 2008). However, we will not impute missing values in order to present these in the analyses. We will not make assumptions about loss to follow‐up for continuous data and plan to analyse results for those who completed the trial.
Assessment of heterogeneity
Should this apply to a future update, we will judge the appropriateness of pooling by assessing clinical heterogeneity in terms of the trial participants, interventions and outcomes of the included studies. We plan to assess heterogeneity between trials by visual examination of the forest plot, primarily to check for overlapping confidence intervals, and using the Chi² test for homogeneity and the I² statistic to assess inconsistency (the percentage of the variability in effect estimates that is due to heterogeneity rather than random error). We intend to base our judgements of substantial heterogeneity on the advice provided by Deeks 2008 on interpreting Chi² and I² values.
Assessment of reporting biases
We plan to reduce reporting bias by: a) performing a comprehensive search for published, unpublished and ongoing trials; b) placing no language restrictions on the search strategy; c) checking for multiple trial reports of the same trial; d) attempting to obtain the protocol or the trial registration document of trials; and e) contacting the authors in cases where the pre‐specified primary (favourable or adverse) outcomes are not reported.
If data become available for any listed outcome measure from at least 10 trials, we plan to assess the likelihood of potential publication bias using funnel plots.
Data synthesis
If possible in future and considered appropriate, results of comparable groups of trials will be pooled using both fixed‐effect and random‐effects models. The choice of the model to report will be guided by a 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 studies that are included. Ninety‐five per cent confidence intervals will be used throughout. We will consider not pooling data where there is considerable heterogeneity (I² ≥ 75%) that cannot be explained by differences across the trials in terms of clinical or methodological features or by subgroup analyses (see below); instead we will present the results in a forest plot.
Continuous data measured using the same scale will be combined using the mean difference. The standardised mean difference (SMD) will be used where data are measured on different scales that cannot be calculated back to a common scale. If the scales used in the trials differ in the direction of scoring, then the mean values from one set of scales will be multiplied by ‐1 in order to ensure that the direction of scores across trials is comparable (Deeks 2008). We plan to attempt to interpret the combined standardised mean differences by re‐expressing them as odds ratios and numbers needed to treat or harm using the methods described in Schünemann 2008.
Subgroup analysis and investigation of heterogeneity
If data permit in future, the following subgroup analysis are planned for each comparison:
Fracture of radius or ulna versus fracture of both bones
Site of fracture: upper, mid or lower third
Age: less than 5 years, 6 to 10 years and more than 11 years
To test whether the subgroups are statistically significantly different from one another, we will examine the overlap of the confidence intervals for the summary estimates and the results of the test for subgroup differences facility in the RevMan software.
Sensitivity analysis
In future updates, and where possible, we plan to conduct sensitivity analyses to investigate the robustness of the results for the primary outcomes by excluding trials at high risk of bias. We also plan to undertake sensitivity analyses if trials report dropout rates of 10% or greater, to ascertain differences in outcomes of intention‐to‐treat (ITT) analysis (all dropouts will be assigned to the worst outcome for dichotomous outcomes) and analysis of completers. Lastly, where significant heterogeneity is detected and there are one or two outlying studies whose results conflict with the other studies as well as having different clinical or methodological characteristics, we plan to perform sensitivity analyses with and without these outlying studies.
Summarising and interpreting results
Should sufficient data become available in a future update, we plan to use the GRADE approach to interpret findings (Schünemann 2008) and use the current versions of the GRADE Profiler to import data from RevMan to create 'Summary of findings' tables for each comparison. These tables will provide information concerning the quality of the evidence, the magnitude of effect of the interventions examined, and the sum of available data on all primary outcomes and for the secondary outcomes of wrist and hand stiffness, re‐fractures, reflex sympathetic dystrophy and satisfaction outcome scores from each included study in the comparison.
Results
Description of studies
See the Characteristics of included studies and Characteristics of excluded studies.
Results of the search
The search was completed in November 2012. We screened a total of 493 records from the following databases: Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (10 records); Cochrane Central Register of Controlled Trials (41), MEDLINE (101), EMBASE (197), CINAHL (138), the WHO International Clinical Trials Registry Platform (3) and Current Controlled Trials (3). We did not identify any potentially eligible studies from other sources (available online conference proceedings of POSI, POSNA, APOA and EPOS).
The search resulted in the identification of 17 potentially eligible studies, for which [where possible] full reports were obtained. Upon study selection, no studies were included, 13 were excluded (Alpar 1981; Atkin 1995; Baitner 2007; Bochang 2005a; Bohm 2006; Boyer 2002; Ho 2010; Gebuhr 1992; Kropman 2010; Van Leemput 2007; Lim 2007; Schmuck 2010; Zionts 2005), two studies await classification (Bae 2012; Yousef 2006) and two studies are ongoing (NCT00314600; NCT00398242).
Included studies
There were no included studies.
Excluded studies
Details of the 13 excluded studies are given in the Characteristics of excluded studies. The primary reasons for exclusion were study design (three were retrospective studies (Alpar 1981; Baitner 2007; Lim 2007); and four were prospective non‐randomised studies (Bochang 2005a; Ho 2010; Schmuck 2010; Zionts 2005)); and population (three studies included adults (Atkin 1995; Gebuhr 1992; Van Leemput 2007); and three studies involved children with distal third forearm (wrist) fractures only (Bohm 2006; Boyer 2002; Kropman 2010)).
Studies awaiting classification
Both studies awaiting classification are reported only in conference abstracts, although trial registration details are also available for Bae 2012. Details of these two trials are given in the Characteristics of studies awaiting classification.
Yousef 2006 randomised 87 children with greenstick fractures to 3M soft cast tape (SC) or to traditional plaster of Paris. Twenty‐six children (30%) withdrew consent or were lost to follow‐up. So far, we have been unsuccessful in our attempts to obtain a full report, further details of the methods or usable outcomes of relevance to this review.
Bae 2012 is a recently completed randomised controlled trial comparing bivalved versus circumferential cast for displaced forearm fractures. The study investigators aimed to recruit 224 children but actually recruited 205. The authors have been contacted and we have received confirmation that no other publication is available at present.
Ongoing studies
The characteristics of the two ongoing trials, which are conducted by the same research group, are given in the Characteristics of ongoing studies. Both trials aim to recruit 60 children under 16 years of age and have the same primary outcome measure: the range of supination and pronation at the end of treatment. The first registered trial (NCT00314600) compares the role of above elbow cast versus below elbow cast in undisplaced, uncomplicated, fresh fractures of the diaphyseal region of both bones of the forearm. In contrast, the second trial (NCT00398242) compares the role of above elbow versus below elbow plaster casts in the last three weeks of treatment of stable fractures of the diaphyseal region of both bones of the forearm. When last checked (8 Febuary 2013), the trial registration entries for both trials stated: "The recruitment status of this study is unknown because the information has not been verified recently".
Risk of bias in included studies
There were no included studies.
Effects of interventions
There were no included studies.
Discussion
No trials are included in this review. Our comprehensive search identified two completed trials that are reported in conference abstracts only and two ongoing trials whose recruitment status is unknown. We anticipate that a full report of Bae 2012, which compared bivalved versus circumferential casts for treating greenstick fractures, will become available. However, we have been unsuccessful in our attempts so far to contact the authors of Yousef 2006 for further information on their trial comparing soft cast versus plaster of Paris cast for treating greenstick fractures. We have been unsuccessful too in finding out further information on the two ongoing studies, which compare above elbow versus below elbow casts for midshaft forearm fractures. In NCT00314600, the fractures are undisplaced, while in NCT00398242, the fractures are stable and the trial comparison applies to the last three weeks of conservative treatment. Both trials are conducted by the same group of investigators, who also conducted a surgical trial on these fractures that is listed as ongoing in Abraham 2011. Abraham 2011 reports that, while the recruitment target was not achieved, there are plans to publish this surgical trial.
Currently, there is a lack of good quality evidence to guide management in conservative treatment of forearm fractures. It is important that this lack of evidence is viewed in the context of the rising popularity of operative management, which may alter the characteristics of patients being offered conservative management in the future (Schmittenbecher 2005). This increases the need for good quality evidence to assess the outcomes of conservative interventions in forearm fractures in children and thus inform on best practice for conservative management. With the emergence and promise of minimally invasive surgical techniques, future studies need to define clearly the indications for surgery. It should be noted that the Cochrane review on surgical interventions for these fractures also found a lack of good quality evidence to guide operative treatment (Abraham 2011). Similar to Abraham 2011, which also found an unpublished trial, we strongly suggest that all trialists publish their findings in full.
Authors' conclusions
Implications for practice.
There is a lack of evidence from randomised controlled trials to inform on decisions regarding the different aspects of conservative management of forearm diaphyseal fractures in children.
Implications for research.
Well‐designed randomised trials with adequate power are required to guide conservative management of diaphyseal forearm fractures in children. Meanwhile, the full reporting of currently ongoing and completed but unpublished trials could still provide useful evidence to inform practice. This includes evidence on the use of bivalved casts compared with circumferential casts for greenstick fractures, and the use of above elbow compared with below elbow casts for non‐displaced fractures or, after initial treatment with an above elbow cast, for stable previously displaced fractures.
Acknowledgements
We would like to thank the editorial team for their valuable comments on the review. We are most grateful to Helen Handoll for her helpful comments and assistance with the methodological issues and for editing the final version of the review. We also wish to acknowledge with gratitude the advice, guidance, editorial comments and administrative support from Lindsey Elstub.
We thank Lesley Gillespie for developing, and Joanne Elliott for carrying out, the searches for this review. We are grateful for the constructive comments about the protocol from Helen Handoll and Alastair Murray, and thank Lindsey Elstub and Amy Kavanagh for guidance when developing the protocol.
Appendices
Appendix 1. Search strategies
The Cochrane Library (Wiley Online Library)
#1 MeSH descriptor: [Radius] this term only (128) #2 MeSH descriptor: [Ulna] this term only (33) #3 Enter terms for search#1 or #2#1 or #2 (145) #4 MeSH descriptor: [Fractures, Bone] this term only (1021) #5 MeSH descriptor: [Fracture Fixation] explode all trees (1002) #6 MeSH descriptor: [Fracture Healing] this term only (330) #7 #4 or #5 or #6 (1982) #8 #3 and #7 (26) #9 MeSH descriptor: [Radius Fractures] this term only (198) #10 MeSH descriptor: [Ulna Fractures] this term only (34) #11 ((forearm or radius or radial or ulna*) near/3 fractur*) (478) #12 #8 or #9 or #10 or #11 (488) #13 (forearm* or midshaft* or shaft* or diaphys*) (4598) #14 #12 and #13 (169) #15 MeSH descriptor: [Pediatrics] explode all trees (453) #16 MeSH descriptor: [Infant] explode all trees (11670) #17 MeSH descriptor: [Child] explode all trees (8) #18 MeSH descriptor: [Adolescent] this term only (68808) #19 MeSH descriptor: [Adult] explode all trees (572) #20 #18 not #19 (68780) #21 (paediatr* or pediatr* or neonate* or bab* or infant* or child* or teenage* or adolescen*) (145489) #22 #15 or #16 or #17 or #20 or #21 (145496) #23 #14 and #22 (41) [Trials]
MEDLINE (OvidSP interface)
1 Radius/ or Ulna/ or Forearm Injuries/ (11886) 2 Fractures, Bone/ or exp Fracture Fixation/ or Fracture Healing/ (84279) 3 and/1‐2 (1932) 4 Radius Fractures/ or Ulna Fractures/ (7738) 5 ((forearm or radius or radial or ulna$1) adj3 fractur$).tw. (5340) 6 or/3‐5 (10226) 7 (forearm$1 or shaft$1 or midshaft$1 or diaphys$).tw. (48587) 8 and/6‐7 (3025) 9 exp Pediatrics/ (40918) 10 exp Infant/ (894858) 11 exp Child/ (1473943) 12 Adolescent/ not exp Adult/ (455352) 13 (paediatr$ or pediatr$ or neonate$ or bab$3 or infant$ or child$ or teenage$ or adolescen$).tw. (1303978) 14 or/9‐13 (2359844) 15 and/8,14 (1029) 16 Randomized controlled trial.pt. (342334) 17 Controlled clinical trial.pt. (85694) 18 randomized.ab. (244919) 19 placebo.ab. (136550) 20 Drug therapy.fs. (1588363) 21 randomly.ab. (175193) 22 trial.ab. (253825) 23 groups.ab. (1145730) 24 or/16‐23 (2960405) 25 exp Animals/ not Humans/ (3812817) 26 24 not 25 (2515366) 27 and/15,26 (101)
EMBASE (OvidSP interface)
1 Radius/ or Ulna/ (11638) 2 Fracture/ or exp Fracture Fixation/ or exp Fracture healing/ (118852) 3 1 and 2 (2027) 4 Radius Fracture/ or Ulna Fracture/ (7860) 5 ((forearm or radius or radial or ulna$1) adj3 fractur$).tw. (6361) 6 or/3‐5 (11525) 7 (forearm$1 or midshaft or shaft$1 or diaphys$).tw. (57970) 8 and/6‐7 (3262) 9 exp Pediatrics/ (67809) 10 exp Infant/ (507671) 11 exp Child/ (1627620) 12 Adolescent/ not exp Adult/ (445536) 13 (paediatr$ or pediatr$ or neonate$ or bab$3 or infant$ or child$ or teenage$ or adolescen$).tw. (1578228) 14 or/9‐13 (2409251) 15 and/8,14 (1083) 16 exp Randomized Controlled trial/ (332920) 17 exp Double Blind Procedure/ (111920) 18 exp Single Blind Procedure/ (16668) 19 exp Crossover Procedure/ (35555) 20 Controlled Study/ (3908074) 21 or/16‐20 (3988013) 22 ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw. (657934) 23 (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw. (160260) 24 ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw. (148974) 25 (cross?over$ or (cross adj1 over$)).tw. (63688) 26 ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw. (201855) 27 or/22‐26 (982083) 28 or/21,27 (4475162) 29 limit 28 to human (2717747) 30 and/15,29 (197)
CINAHL (Ebsco)
S1 (MH "Radius") OR (MH "Ulna") OR (MH "Forearm Injuries") (1,025) S2 (MH "Fracture Fixation") OR (MH "Fracture Healing") OR (MH "Fractures") (15,352) S3 S1 and S2 (290) S4 (MH "Radius Fractures") OR (MH "Ulna Fractures+") (1,262) S5 TX ( forearm or radius or radial or ulna* ) and TX fractur* (2,356) S6 S3 or S4 or S5 (2,356) S7 TX forearm* or shaft* or midshaft* or diaphys* (5,495) S8 S6 and S7 (685) S9 (MH "Pediatrics+") (8,929) S10 (MH "Infant+") (139,482) S11 (MH "Child+") (351,464) S12 (MH "Adolescence+") not (MH "Adult+") (112,484) S13 TX paediatr* or pediatr* or neonate* or bab*3 or infant* or child* or teenage* or adolescen* (662,349) S14 S9 or S10 or S11 or S12 or S13 (662,386) S15 S8 and S14 (298) S16 (MH "Clinical Trials+") (151,619) S17 (MH "Evaluation Research+") (18,975) S18 (MH "Comparative Studies") (69,409) S19 (MH "Crossover Design") (9,918) S20 PT Clinical Trial (74,367) S21 (MH "Random Assignment") (33,861) S22 S16 or S17 or S18 or S19 or S20 or S21 (243,484) S23 TX ((clinical or controlled or comparative or placebo or prospective or randomi?ed) and (trial or study)) (418,558) S24 TX (random* and (allocat* or allot* or assign* or basis* or divid* or order*)) (59,422) S25 TX ((singl* or doubl* or trebl* or tripl*) and (blind* or mask*)) (647,033) S26 TX ( crossover* or 'cross over' ) or TX cross n1 over (12,452) S27 TX ((allocat* or allot* or assign* or divid*) and (condition* or experiment* or intervention* or treatment* or therap* or control* or group*)) (74,631) S28 S23 or S24 or S25 or S26 or S27 (986,171) S29 S22 or S28 (1,046,051) S30 S15 and S29 (138)
Characteristics of studies
Characteristics of excluded studies [ordered by study ID]
Study | Reason for exclusion |
---|---|
Alpar 1981 | This was a retrospective study including all forearm fractures. This was not a randomised or quasi‐randomised controlled trial. |
Atkin 1995 | This study included isolated ulnar shaft fractures. This was a prospective randomised control trial but the included population were all adults. |
Baitner 2007 | This was a retrospective study involving diaphyseal and metaphyseal forearm fractures. This was not a randomised or quasi‐randomised controlled trial. |
Bochang 2005a | This included fractures of both forearm bones including distal forearm (not diaphyseal) fractures. This was not a randomised or quasi‐randomised controlled trial. |
Bohm 2006 | This was a blinded, randomised, controlled trial but it included only distal third forearm fractures in children up to the age of 12 years. |
Boyer 2002 | This was a blinded, randomised, controlled trial but it included only distal third forearm fractures in children up to the age of 12 years. |
Gebuhr 1992 | This was a randomised, controlled trial of cast versus functional brace for isolated ulnar shaft fracture. The study population were mostly adults. Only one group had a few children and the comparison group had no children in it. |
Ho 2010 | This was a comparison of closed reduction of forearm shaft fractures carried out by physician extenders versus orthopaedic residents. It was not a randomised or quasi‐randomised controlled trial. |
Kropman 2010 | This was a blinded, randomised, controlled trial but it included only distal third forearm fractures in children . |
Lim 2007 | This was a retrospective study of open fractures of shaft of radius and ulna in children. |
Schmuck 2010 | This was a prospective descriptive study of the greenstick fractures of the middle third of forearm. This was not a randomised or quasi randomised controlled trial. |
Van Leemput 2007 | This was a randomised controlled trial of isolated fractures of ulna shaft comparing 3 different non‐operative treatments. The study population consisted only of adults. |
Zionts 2005 | This was a study of displaced diaphyseal both bones forearm fracture. This was a prospective descriptive study of closed treatment with cast. This was not a randomised or quasi‐randomised controlled trial. |
Characteristics of studies awaiting assessment [ordered by study ID]
Bae 2012.
Methods | Randomised trial of bivalved and circumferential casting for displaced forearm fractures in children Allocation: Randomised, parallel assignment, non‐blinded |
Participants |
Number: 205 children with displaced radial and ulnar fractures: 104 in bivalved group and 101 in circumferential cast group Inclusion criteria: ‐ displaced distal radius or mid‐diaphyseal forearm fracture requiring closed reduction and cast immobilisation ‐ age 4 to 16 years ‐ skeletally immature Exclusion criteria: ‐ open fracture ‐ acute fracture > 1 week old ‐ refracture injury ‐ fracture requiring initial surgical treatment as deemed by treating orthopaedic surgeon ‐ significant soft tissue swelling ‐ associated neurovascular compromise ‐ plastic deformation injuries ‐ gender: both |
Interventions | Intervention: Bivalved plaster of Paris cast Control: Circumferential plaster of Paris cast |
Outcomes |
Outcomes reported in conference abstract:
Clinical and radiological assessment at 1, 2, 4 and 6 weeks post‐reduction. Listed outcomes at trial registration: Primary outcomes: Loss of radius fracture reduction [Time frame: 4 weeks post‐randomisation]. Secondary outcome(s): Compartment syndrome or neurovascular compromise, saw burns and/or lacerations [Time frame: 4 weeks post‐randomisation]. |
Notes |
Country: US Setting: Boston Children's Hospital Funding: Not stated Notes: The trial investigators planned enrolment of 224 children. However, the abstract reports 205 children were included in the study. We have written and personally spoken to the authors and further details are awaited. So far, only abstract in the conference proceedings is available. |
Yousef 2006.
Methods | Randomised, parallel group, controlled trial Period: September 1999 to June 2000 |
Participants |
Number: 87 children Gender: Both; 46 females and 41 males Inclusion criteria: Referred to clinic with forearm greenstick fractures Exclusion criteria: Not stated |
Interventions |
Intervention: 3M soft cast tape (SC) (N = 29 completed) Control: Traditional plaster of Paris (N = 32 completed) |
Outcomes |
Outcomes reported in the conference abstract:
|
Notes |
Country: UK Setting: Hospital clinic; King’s Mill Hospital, Suttton Funding: Not stated Notes:26/87 (30%) randomised withdrew consent or were lost to follow‐up. Only abstract in supplement available. No usable outcomes in abstract. The first author no longer works at the hospital and we are attempting to contact his co‐authors. |
Characteristics of ongoing studies [ordered by study ID]
NCT00314600.
Trial name or title | 'Above elbow cast in non‐dislocated both‐bone midshaft forearm fractures in children: necessity or needless cruelty? A randomized trial' |
Methods | Allocation: randomised, non‐blinded trial |
Participants |
Inclusion criteria:
‐ Midshaft forearm fracture of both bones
‐ Age < 16 years
Exclusion criteria:
‐ Dislocation
‐ Fracture older than 1 week
‐ No informed consent
‐ Refracture
‐ Open fracture (Gustillo 2 and 3)
‐ Torus fractures of both ulna and radius Age minimum: N/A Age maximum: 15 years Gender: both |
Interventions | Comparison: above elbow versus below elbow cast |
Outcomes | Primary outcome(s): pronation and supination Secondary outcome(s): complications, function, aesthetics, complaints in daily living, x‐rays |
Starting date | January 2006 |
Contact information | Joost W Colaris, M.D. Telephone: 0031‐642220265 Email: joostcolaris@hotmail.com |
Notes | Sample size of 60. Recruitment status unknown. |
NCT00398242.
Trial name or title | 'Treatment of stable both bone midshaft forearm fractures in children: a randomized trial between treatment with above elbow cast and a combination of above and below elbow arm cast.' |
Methods | Allocation: randomised, single blind, trial |
Participants |
Inclusion criteria:
‐ forearm fracture of both bones
‐ age < 16 years
‐ dislocation
‐ stable
Exclusion criteria:
‐ fracture older than 1 week
‐ no informed consent
‐ refracture
‐ open fracture (Gustillo 2 and 3) Age minimum: 0 Age maximum: 15 years Gender: both |
Interventions | Comparison: Above elbow versus below elbow cast for the last three weeks of treatment |
Outcomes | Primary outcome(s): pronation and supination range Secondary outcome(s): complications, function, aesthetics, complaints in daily living, radiographs |
Starting date | January 2006 |
Contact information | Joost W Colaris, M.D. Telephone: 0031‐642220265 Email: joostcolaris@hotmail.com |
Notes | Sample size of 60. Recruitment status unknown. |
Differences between protocol and review
We have indicated that we will use the updated risk of bias assessment tool (Higgins 2011) should trials be included in a future update.
Contributions of authors
Vrisha Madhuri: conceived the review, drafted and revised the review and is the guarantor of the review. Vivek Dutt: screened search results, identified eligible studies, extracted data, drafted and revised the review and approved the final version. Abhay Gahukamble: screened search results, identified eligible studies, extracted data, helped write the review and approved the final version. Prathap Tharyan: revised the protocol and the review, provided input on methodological issues and approved the final version.
Sources of support
Internal sources
-
Christian Medical College, Vellore, India.
Salaries of all authors; logistic support
External sources
-
Indian Council of Medical Research, India.
Core funding for the South Asian Cochrane Centre
Declarations of interest
None known.
New
References
References to studies excluded from this review
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Bae 2012 {published data only (unpublished sought but not used)}
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NCT00314600 {unpublished data only}
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NCT00398242 {unpublished data only}
- Colaris JW. Treatment of stable both‐bone midshaft forearm fractures in children. http://clinicaltrials.gov/ct2/show/NCT00398242 (accessed 03 December 2012).
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