Summary of findings
Description of the condition
The femur is the thigh- or upper-leg bone. The shaft, or diaphysis, is the long central portion of the femur that lies between the top end (proximal femur) at the hip and the lower end (distal femur) at the knee. Shaft or diaphyseal fractures of the femur are uncommon but significant injuries in children, constituting less than 2% of all skeletal injuries in children (Flynn 2006). The injury requires prolonged immobilisation or surgery that can result in significant morbidity. It is the most common orthopaedic injury amongst children requiring hospital admission (Loder 2006). These fractures are sustained more commonly in early childhood and adolescence (Flynn 2006). In normal children a significant force is required to sustain this injury and consequently displaced fractures are common. The commonest causes of femoral shaft fractures are falls and road traffic accidents; however, in children under walking age, abuse needs to be considered (Bridgman 2004).
A common method used to classify diaphyseal femur fractures in children is descriptive labelling into: 1) transverse, spiral or oblique; 2) comminuted (multiple fragments) or non-comminuted; and 3) open (fractured bone is exposed to the outside) or closed fractures (Flynn 2006). Open fractures are further subclassified as Gustilo and Anderson Type I to III based on the velocity of injury, contamination and soft tissue disruption (Gustilo 1976). Type III of the Gustilo and Anderson classification is further subdivided as A, B and C based on severity of soft tissue injury, energy of trauma, periosteal stripping and need for vascular reconstruction (Gustilo 1984). According to the Arbeitsgemeineschaft fur Osteosynthesefragen (AO) paediatric comprehensive classification of long bone fractures (Slongo 2007), femoral shaft fractures are classified as category 32-D. Sub-categories 32-D 4.1 (complete transverse with an obliquity of 30º or less) and 32-D 5.1 (complete oblique or spiral more than 30º) are simple fractures. Wedge/multi-fragmentary fractures are subcategorised into 32-D 4.2 (multi-fragmentary transverse 30º or less) and 32 D 5.2 (multi-fragmentary oblique or spiral more than 30º). Fracture instability can result from oblique/spiral fracture geometry, comminution and soft tissue disruption.
Description of the intervention
These fractures may be treated conservatively (without surgery) or surgically. The choice of treatment is influenced by age and other modifiers such as the size of the child, the ability to tolerate a spica cast, stability of fracture reduction, fracture pattern, the weight of the child, the nature of injury (open/pathological fractures), the presence or absence of neighbouring injuries, polytrauma and open injuries.
Displaced fractures can be reduced (the fractured parts are put back into place) using closed (traction, manipulation) or open (the bone is surgically exposed, allowing direct repositioning) techniques.
The main types of conservative interventions are:
- Pavlik harness: this is a sling with chest, shoulder and leg straps commonly used for developmental dysplasia of the hip. It is useful for immobilising the fracture in flexion and abduction and is comfortable for children under six months of age.
- Bryant's traction: this allows an infant to be placed on a splint bed frame with traction on the lower limbs at 90º to the hips, with the knees mildly flexed. Monitoring the vascular status is vital to avoid complications and this form of traction can be used in children under three years of age and less than 20 pounds in weight.
- Hip spica casting: a plaster cast is applied from the subcostal region to the toes on the affected side, with or without preliminary traction. A safe and effective position is 30º of abduction, 30º to 40º of flexion and external rotation at the hip.
- Functional cast bracing is another type of cast which allows movement of the adjacent joints (hip and knee). It is considered more suitable for lower shaft fractures.
The main types of surgical interventions are:
- Intramedullary nailing: one or more titanium or stainless steel nails are inserted into the medullary canal of the femur. Flexible intramedullary nailing uses pre-bent nails that are introduced from either side of the femur on the diaphyseal side of the growth plate. In contrast, the rigid trochanteric nail is inserted down through the greater trochanter, thus through the growth plate, and into the medullary canal.
- External fixation: pins inserted, usually percutaneously (through the skin) or with small incisions, into the femur, are attached to an external frame.
- Plate fixation: a metal plate is fixed by screws to the femur.
Treatment choices in children younger than two years are generally Bryant's traction, a Pavlik harness and immediate spica casting. Treatment for children aged between three and five years is often an immediate spica cast with a move towards flexible nailing in certain societies. Occasionally for an unstable fracture an initial period of traction may be required prior to application of a spica cast to prevent shortening, more so in older children. In children older than six years, flexible intramedullary nailing is currently favoured. The main disadvantage is that these nails are less suitable for unstable fracture patterns and in heavier children. In contrast, the rigid trochanteric nail, which affords stronger fixation, is generally preferred in children over the age of 12 years as they have minimal residual longitudinal growth potential at the greater trochanter. Thus growth disturbance is not an issue. External fixation and plating are reserved for specific indications across all age groups such as open or unstable fractures or multiple injuries.
How the intervention might work
Union occurs rapidly in a fractured shaft of femur in children and these injuries have a good remodelling potential, whereby the bone naturally returns to its normal shape. This remodelling potential allows for some tolerance regarding the initial deformity of the healed bone. For example, acceptable angulation in the coronal plane (deformity either out to the back or front of the normal line along the length of the femur), and in the sagittal plane (deformity to either side along the length of the femur) ranges from 30º at birth, to 15º at 10 years (Flynn 2006). Similarly, remodelling with up to 15 mm of shortening can be compensated in children up to 12 years by growth acceleration (Malkawi 1986). Rotational malposition of greater than 10º especially in the upper one third of the femur is considered malaligned (Resch 1989). Malalignment, angulation and leg-length discrepancy are the main consequences of failed treatment for these fractures. These can manifest as in-toeing (foot points inwards) or out-toeing (foot points outwards), shortening, and rotated limbs.
A Pavlik harness, different methods of traction (Bryant's, skin and skeletal traction), functional bracing and hip spica maintain the length and alignment of the femur while union occurs. By allowing movement of the adjacent joints, functional bracing may allow earlier mobilisation and return to normal activities. All these methods rely on the ability of the bone to remodel in children.
There has been a noticeable shift away from conservative management in recent years for paediatric femoral shaft fractures. Economic considerations and convenience have played a role in this swing to operative management since it allows shorter hospital stays and less care during recuperation. Surgery, however, comes at the risk of surgical complications, including infection, neurovascular injury and damage to the growth plate. Often a second operation is required for implant removal.
By stabilising the fracture, intramedullary nails should enable earlier weight-bearing. Flexible nails allow a small degree of motion at the fracture site that helps to produce bridging callus formation. Rigid intramedullary nails act as load-sharing devices, providing adequate fixation for larger and heavier children and adolescents.
External fixation may be associated with pin track infection. Although the surgery required is less invasive, the external frame may be less acceptable to patients. There is also some risk of subsequent fracture at a pin site for a short period after external fixator removal.
Plate fixation provides immobilisation by placement of screws on either side of the fracture; however soft tissue stripping for their application may lead to overgrowth. Additionally rigid fixation may inhibit callus formation through 'stress shielding' and delay bony union. Potentially, minimally invasive bridge plating with contemporary locked plates avoids some of these disadvantages and is gaining popularity in the treatment of older children.They have been advocated for pathological and complex fractures (Hedequist 2008).
Why it is important to do this review
Femoral shaft fractures in children and adolescents, although comparatively rare, are serious injuries almost invariably requiring hospital admission and often causing prolonged disruption to the life of the child and their family. These fractures may also result in lifelong deformity and disability. There is no universally accepted protocol for the treatment of these fractures (Kocher 2010). In particular, the recent shift to operative management in some age groups needs to be validated, especially for resource-compromised settings. There is a clear need for a systematic review of the evidence in order to inform clinical practice in this area.
To assess the effects (benefits and harms) of interventions for treating femoral shaft fractures in children and adolescents.
We compared interventions within the following broad categories:
- Surgical versus conservative treatment
- Different methods of conservative treatment
- Different methods of surgical treatment
Criteria for considering studies for this review
Types of studies
Randomised or quasi-randomised controlled 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 and adolescents below the age of 18 years with femoral shaft fractures.
Types of interventions
Trials comparing different interventions used for treating femoral shaft fractures in children and adolescents.
- Pavlik harness
- Bryant's traction
- Immediate hip spica cast
- Traction followed by spica cast
- Functional bracing (cast brace)
- External fixation
- Compression/locked plate
- Flexible intramedullary nailing
- Rigid intramedullary nail
Types of outcome measures
- Functional outcome measures, such as the Pediatric Outcomes Data Collection Instrument (PODCI: PODCI 2005) (and also known as the Pediatric Orthopaedics Society of North America (POSNA) outcomes instruments scale (Daltroy 1998)), the RAND child health status scale and the Activity Scale for Kids (ASK; Young 2000).
- Unacceptable malunion (angular, rotational and shortening), leg-length discrepancy, limp.
- Serious adverse events: compartment syndrome, deep infections, non-union, nerve injury, knee ankylosis, persistent pain or need for second surgical intervention other than routine implant removal.
- Time for recuperation or return to usual activities.
- Child satisfaction.
- Parent satisfaction.
- Resource use and other costs.
Timing of outcome measure
Whenever possible, we collected data for outcomes assessed at follow-up in the short term (less than three months) and longer term (longer than three months and ideally at least at one year).
Search methods for identification of studies
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (accessed 16 August 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013 Issue 7), MEDLINE (1946 to August Week 1 2013), MEDLINE In-Process & Other Non-Indexed Citations (15 August 2013), EMBASE (1980 to 2012 week 9) and CINAHL (16 August 2013). We applied no language restrictions. In MEDLINE, we combined a subject-specific strategy with the sensitivity- and precision-maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (Lefebvre 2011) (see Appendix 1). Search strategies for the Cochrane Central Register of Controlled Trials, EMBASE and CINAHL are also shown in Appendix 1. We also searched the WHO International Clinical Trials Registry Platform and the metaRegister of Controlled Trials (mRCT) for ongoing and recently completed trials (to August 2013). We handsearched all available online conference proceedings of the following societies:
- Paediatric Orthopaedic Society of India (annual meetings 2001 - 2013)
- Pediatric Orthopaedic Society of North America (annual meetings 2007 - 2013)
- The paediatric section of Asia Pacific Orthopaedic Association (the 8th Combined Congress of the Spine and Pediatric Sections, 2013)
- The European Paediatric Orthopaedic Society (annual meetings 2006 - 2013)
- British Society for Children's Orthopaedic Surgery abstracts published in the Bone and Joint Journal (formerly the Journal of Bone & Joint Surgery British Volume) Orthopaedic Proceedings (2002 - 2013)
Searching other resources
We searched reference lists of articles. We also contacted 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 2011), which was based on the Cochrane Handbook of Systematic Reviews of Interventions (Higgins 2011a).
Selection of studies
Two authors (AG and VD) independently assessed potentially eligible trials for inclusion. We obtained the full text of trials that fulfilled our inclusion criteria and those that were unclear from perusal of the abstracts. We resolved disagreements by discussion and consultation with a third author (VM).
Data extraction and management
All authors independently extracted information on study characteristics and results using a piloted data extraction form, resolving any disagreement through discussion. We attempted to contact trial authors where there were incomplete details on study methods or data. VD and VM entered the data into Review Manager 5 (RevMan) software (Review Manager 2014), and PT independently checked this.
Assessment of risk of bias in included studies
All authors independently assessed the risks of bias in each included trial using The Cochrane Collaboration's 'Risk of bias' assessment tool (Higgins 2011b) on the following six domains: sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases. We considered subjective outcomes (e.g. participant-reported function, parent and child satisfaction) and objective outcomes (unacceptable malunion, serious adverse events, time to return to usual activities) separately in our assessment of blinding and completeness of outcome data. Other potential biases assessed were major imbalances in key baseline characteristics (e.g. isolated versus combined fractures, age and gender); and performance bias such as that resulting from lack of comparability in the experience of care providers. We tried to contact the trial authors for clarification when methodological details were unclear. We resolved differences by discussion.
For each of these six domains, we assigned a judgement regarding the risk of bias as low risk, high risk or unclear risk, based on the criteria summarised in Table 8.5.c of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011b) (see Appendix 2). We recorded these assessments in the standard 'Risk of bias' tables in RevMan, and summarised them in 'Risk of bias' summary figures and graphs. We used these judgements when assessing limitations in study design of the trials contributing to important outcomes in 'Summary of findings' tables.
Measures of treatment effect
We calculated risk ratios (RRs) and 95% confidence intervals (95% CIs) for dichotomous outcomes, and mean differences (MDs) with 95% CIs for continuous outcomes, wherever available.
Unit of analysis issues
Although the unit of randomisation in these trials is usually the individual participant, trials including children with bilateral fractures may present results for fractures or limbs rather than for individuals. Where such unit of analysis issues arose and appropriate corrections had not been made, or could not be obtained from trial authors, we pooled the data from such trials where the disparity between the units of analysis and randomisation was small. Had the disparity been moderate or large, and had data been pooled, we would have performed a sensitivity analysis to examine the effects of excluding incorrectly reported trials from the analysis.
Dealing with missing data
We attempted to obtain missing data from trial authors. Where possible, we extracted data to allow an intention-to-treat (ITT) analysis in which all randomised participants are analysed in the groups to which they were originally assigned. If there was discrepancy in the number randomised and the numbers analysed in each treatment group, we calculated the percentage loss to follow-up in each group and reported this information. Had drop-outs exceeded 10% for any trial, and if the differential drop-out rate in the intervention arms was significant, we would have assigned the worst outcome to those lost to follow-up for dichotomous outcomes and assessed the impact of this in sensitivity analyses with the results of completers. Where possible, we calculated missing standard deviations from other available data such as standard errors (Higgins 2011c). However, we did not impute missing values in order to present these in the analyses. We did not make any assumptions about loss to follow-up for continuous data and analysed results for those who completed the trial.
Assessment of heterogeneity
We judged the appropriateness of pooling data by assessing clinical heterogeneity in terms of the trial participants, interventions and outcomes of the included studies. For pooled data we assessed heterogeneity between trials by visual examination of the forest plot, primarily to check for overlapping confidence intervals, and used 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 based our judgements of substantial heterogeneity on the guidance provided in Deeks 2011; in general we interpreted an I² value of 50% or more to denote substantial heterogeneity, although we acknowledge that this cut-off is arbitrary. We therefore interpreted I² values between 30% and 60% as significant depending on whether the inconsistency in results was due to differences in the direction of effects estimates between trials, rather than if inconsistency in results was due to differences in the magnitude of effect estimates favouring an intervention (Deeks 2011).
Assessment of reporting biases
We attempted 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.
We assessed all included studies for adequacy of reporting of data for pre-stated outcomes and for selective reporting of outcomes. We incorporated judgements about reporting biases in the risk of bias assessments for each trial.
Had there been at least 10 trials included in a meta-analysis for primary outcomes, we would have assessed the likelihood of potential publication bias using funnel plots.
We analysed data using Review Manager 5 (Review Manager 2014). Since all the included trials studied different sets of comparisons, and not all these trials reported the same outcomes, we were not able to synthesise data for the comparisons of different conservative interventions and between surgical interventions. However, we synthesised data for surgical versus conservative interventions where comparable data for outcomes were subgrouped by the specific comparison used in the trials, to derive pooled, weighted risk ratios in Mantel-Haenszel fixed-effect meta-analyses. We would have used the random-effects model for data synthesis when heterogeneity was identified as significant and could not be explained by subgroup analyses. Had I² values revealed substantial inter-trial variability in effect estimates not accounted for by chance (I² values 75% or more), or had trials differed substantially in clinical or methodological attributes, we would have presented the results of the trials in a forest plot, without summating their effect estimates.
We intended to combine continuous data measured using the same scale using the mean difference. We planned to use the standardised mean difference (SMD) in meta-analyses where data were measured on different scales that could not be converted to a common scale. If the scales used in the trials had differed in the direction of scoring, we would have multiplied the mean values from one set of scales by -1 in order to ensure that the direction of scores across trials were comparable (Deeks 2008). We would have attempted to interpret the combined standardised mean differences by re-expressing them as odds ratios and numbers needed to treat (or harm) for an additional beneficial (or harmful) outcome, using the methods described in Schünemann 2011.
Subgroup analysis and investigation of heterogeneity
Had there been sufficient trials to enable data synthesis, we would have undertaken the following subgroup analyses:
- Polytrauma versus isolated injuries;
- Open versus closed injuries;
- Age groups: two years or less, three to five years, 6 to 11 years and 12 to 18 years;
- Fracture pattern: stable versus unstable;
- Short-term (3 months) versus long-term follow-up (more than one year) as determined by the pattern of reporting.
However, we only presented available data for trials comparing surgical versus conservative treatments, subgrouped by the specific comparison. For fixed-effect meta-analyses, we assessed subgroup differences by interaction tests (Altman 2003). Had we used random-effects meta-analyses, we would have used non-overlapping confidence intervals to indicate a statistically significant difference in treatment effect between the subgroups.
We conducted sensitivity analyses to investigate the robustness of the results for the primary outcomes by excluding trials at high risk of bias for the one comparison where it was possible to pool data, and used the results of this sensitivity analysis to grade study limitations when making overall assessments of study quality for the 'Summary of findings' tables.
We had also planned to undertake sensitivity analyses if trials reported drop-out rates of 10% or greater, to ascertain differences in outcomes of ITT analysis (all drop-outs would have been assigned to the worst outcome for dichotomous outcomes) and analysis of completers.
For pooled data, if significant heterogeneity had been detected that arose from one or two outlying studies with results that conflicted with the other studies with clinical or methodological characteristics that differed from the other trials, we would have performed analyses with and without these outlying studies as part of a sensitivity analysis.
Summarising and interpreting results
We used the GRADE approach to interpret findings (Schünemann 2011) and used GRADE Profiler (GRADE 2004) to import data from Review Manager 5 (Review Manager 2014) to create 'Summary of findings' tables for each comparison if possible and relevant. These tables 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 time for recuperation/return to normal activities, resource use and costs, and parent and child satisfaction. We consider these outcomes critically important for patient care and decision-making.
Description of studies
Results of the search
The search was completed in August 2013. We screened a total of 1044 records from the following databases: Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (31 records); Cochrane Central Register of Controlled Trials (107), MEDLINE (297), EMBASE (287), and CINAHL (322). We also identified two records from searching the WHO International Clinical Trials Registry Platform.
The search resulted in the identification of 22 potentially eligible studies (some published in multiple reports), for which we obtained full-text reports where possible. Of these, we included 10 trials (Bar-On 1997; Domb 2002; Hsu 2009; Leu 2012; Malo 1999; Mehdinasab 2008; Park 2012; Shemshaki 2011; Siddiqui 2008; Wright 2005) and excluded another 10 studies (Agarwal 2004; Ali 2005; Altay 2011; Ansari 2011; Buechsenschuetz 2002; Curtis 1995; Flynn 2004; Flynn 2011; Gupta 2007; Ramseier 2007). Two trials, both of which were reported in conference abstracts only, currently await assessment (Shaikh 2012; Ucar 2013); see Characteristics of studies awaiting classification. We did not identify any ongoing trials. All trial reports were in English aside from Malo 1999, which was reported in a French language journal and was translated by the French Cochrane Centre.
Details of the process of screening and selecting studies for inclusion in the review are illustrated in Figure 1.
|Figure 1. Study flow diagram|
Details of the methods, participants, interventions and outcome measures of individual trials are provided in the Characteristics of included studies and are summarised below. We attempted unsuccessfully to contact trial authors of six trials (Bar-On 1997; Hsu 2009; Leu 2012; Malo 1999; Mehdinasab 2008; Park 2012) for clarification of study methods and characteristics.
Nine trials were single-country trials, recruiting children from Canada (Malo 1999), Iran (Mehdinasab 2008; Shemshaki 2011), Israel (Bar-On 1997), Korea (Park 2012), Pakistan (Siddiqui 2008), the Philippines (Hsu 2009), and the USA (Domb 2002; Leu 2012). Wright 2005 had four centres in four countries (Canada, Australia, USA and New Zealand). Trial recruitment usually took place over several years. The earliest participant was recruited into Malo 1999 (recruiting between July 1982 and June 1984) and the latest recruited into Shemshaki 2011 (recruiting between February 2009 and January 2010). Recruitment spanned seven years in Wright 2005: October 1994 to October 2000.
The 10 included trials randomised 527 children with 531 fractures. Respectively, Bar-On 1997, Domb 2002 and Park 2012 included one, one and two participants with bilateral femoral fractures. Overall, the age of the participants included in this review ranged from 3 to 17.4 years. Bar-On 1997 did not report the sex of the participants; in the other nine studies, the number of boys was at least twice that of the girls. All children had sustained closed femoral shaft fractures, except in Hsu 2009, which included 12 children with grade I open fractures, and Park 2012, which included three open fractures (two 'grade I', and one 'grade II').
The trials were grouped by comparison as follows :
Surgical versus conservative treatment
Each of the four trials comparing surgical versus conservative treatment differed in the interventions under comparison, as described below.
- External fixation versus immediate hip spica cast (Wright 2005): a multi-centre trial of 108 children aged 4 to 10 years;
- Intramedullary pin fixation plus spica cast versus skeletal traction followed by spica cast (Mehdinasab 2008): 70 children aged 6 to 11 years;
- Elastic stable intramedullary nail (ESIN) versus traction followed by spica cast (Shemshaki 2011): 46 children aged 6 to 12 years;
- Elastic stable intramedullary nailing (ESIN) versus dynamic skeletal traction spica casting (DSTSC) (Hsu 2009): 51 children aged 5 to 12 years.
Different methods of conservative treatment
- Immediate hip spica cast versus skin traction followed by spica cast (Siddiqui 2008): 42 children aged 3 to 10 years;
- Traction followed by functional orthosis versus traction followed by spica cast (Malo 1999): 43 children aged 5 to 13 years;
- Single-leg versus double-leg spica cast (Leu 2012): 52 children two to seven years.
Different methods of surgical treatment
- Elastic stable intramedullary nail (ESIN) versus external fixation (Bar-On 1997): 19 children (20 fractures) aged 5.2 to 13.2 years;
- Dynamic external fixation versus static external fixation (Domb 2002): 52 children (53 fractures) aged 3 to 12 years;
- Intramedullary nailing versus submuscular plating (Park 2012): 47 children (49 fractures) aged 11 to 17.4 years.
There were no eligible trials examining the use of Pavlik's harness or Bryant's traction. Both of these methods are used for infants. There were also no eligible trials examining locked femoral plating, which is often used for unstable and upper femur fractures, or rigid trochanteric intramedullary nailing, which is typically used for adolescents.
Wright 2005 and Leu 2012 reported on functional status and used the RAND child health status scale (Eisen 1980) and the Activities Scale for Kids (Young 2000) (ASK; www.activitiesscaleforkids.com/) score, respectively.
All included trials except Domb 2002 and Leu 2012 reported rates of malunion, but specific criteria used to define malunion were not reported in four trials (Bar-On 1997; Malo 1999; Mehdinasab 2008; Shemshaki 2011). Siddiqui 2008 defined malunion as an unsatisfactory outcome with shortening greater than 2 cm and angulation within 20º in the sagittal plane and greater than 15º in the coronal plane at the time of cast removal. Wright 2005 defined malunion assessed at two years as any of: limb-length discrepancy (as assessed by computed tomography (CT)) of greater than 2 cm, greater than 15º of anterior or posterior angulation, or greater than 10º of varus or valgus angulation (as assessed from radiographs).
Time for recuperation or return to usual activities was reported by Bar-On 1997 (time to achieve full weight-bearing, full range of movement, and return to school), Domb 2002 (time to resume full weight-bearing), Mehdinasab 2008 (time to independent walking), Shemshaki 2011 (time to start walking independently, and return to school) and Wright 2005 (duration of treatment: number of days child wore external fixator or hip spica).
Child satisfaction was measured formally in Wright 2005, and parent satisfaction was reported in Bar-On 1997, Shemshaki 2011 and Wright 2005. However, the method used to assess this outcome was not reported in Bar-On 1997. Aspects relating to child and parental satisfaction were recorded using a custom scoring tool in Leu 2012.
In Hsu 2009, resource use and other costs (excluding surgeons fees and costs borne by families) were formally calculated and reported as total cost in dollars. Aspects of resource use were reported in other trials. These included length of hospital stay (Hsu 2009; Malo 1999; Mehdinasab 2008; Shemshaki 2011; Wright 2005) and caregiver's time off work (Leu 2012).
The reasons for exclusion for the 10 studies are described in the Characteristics of excluded studies. Of the two RCTs, Ansari 2011 randomised only adults, while separate data were unavailable for the few children with femur fracture in Agarwal 2004. The remaining eight studies were not RCTs; these included Curtis 1995, which was claimed to be randomised but, on closer scrutiny, was not randomised because allocation of interventions was at the discretion of the surgeon, and data were gathered from retrospective chart review.
Risk of bias in included studies
None of the trials was at low risk of bias for all domains. Wright 2005 was free of risk of bias in all domains bar one (performance bias, where the risk of bias was unclear) (see Figure 2 and Figure 3).
|Figure 2. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies|
|Figure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included study|
Bar-On 1997, Domb 2002, Mehdinasab 2008 and Park 2012 were quasi-randomised trials where allocation was predictable and were therefore judged as being at high risk of selection bias. Only Wright 2005 was judged as being at low risk of selection bias. The other trials were at unclear risk of selection bias. In two trials (Malo 1999; Siddiqui 2008), this applied to both random sequence generation and allocation concealment: Malo 1999 described drawing by lots but gave no explanation for the imbalance in allocation (15 versus 28); and Siddiqui 2008 gave no information on the method of randomisation. The other three trials (Hsu 2009; Leu 2012; Shemshaki 2011) described a suitable method of sequence generation but there was insufficient mention of adequate safeguards for concealing allocation.
All trials were open-label in design due to the different comparisons used, and were judged to be at high risk of performance bias. Two trials (Malo 1999; Shemshaki 2011) used independent outcome assessors and were judged to be at low risk of detection bias for objective outcomes. The remainder were judged unclear for the risk of detection bias for objective outcomes such as malunion, serious adverse events and the time for recuperation or to return to usual activities. Bar-On 1997, Leu 2012, Shemshaki 2011 and Wright 2005 were judged to be at high risk of detection bias for participant-reported outcomes; the remaining trials did not report subjective outcomes.
Incomplete outcome data
Bar-On 1997, Mehdinasab 2008 and Park 2012 were judged to be at unclear risk of attrition bias because of incomplete information, including that relating to participants with bilateral fractures in Bar-On 1997 and Park 2012. In Mehdinasab 2008 and Park 2012, there was also no information on group allocation of four excluded participants. The other seven trials were judged to be at low risk of attrition bias.
Although two trials (Leu 2012; Shemshaki 2011) were registered, it was retrospective in both cases. Although outcomes mentioned in the methods section or the objectives of all the trials were reported, we considered that six trials (Bar-On 1997; Domb 2002; Hsu 2009; Malo 1999; Mehdinasab 2008; Siddiqui 2008) were at unclear risk of bias where outcomes such as malunion were inadequately defined or pre-specified, or obvious outcomes (e.g. complications) were not reported.
Other potential sources of bias
Effects of interventions
Surgical versus conservative interventions
Only Wright 2005 assessed functional outcomes: they found that RAND scores did not differ between external fixation and spica cast recipients at two years (mean 69 versus 68; mean difference (MD) 1.00, 95% CI -2.15 to 4.15; 101 children; Analysis 1.1).
Malunion rates were reported in all four trials. Surgical interventions significantly reduced the absolute risk of malunion by 84% (95% CI 76% to 92%) and the relative risk of malunion by 71% when compared with conservative interventions (7/130 versus 31/134; RR 0.29, 95% CI 0.15 to 0.59; 264 children, 4 to 24 months follow-up; Analysis 1.2, Figure 4).
|Figure 4. Forest plot of comparison: 1 Surgical versus conservative treatment, outcome: 1.2 Malunion|
Serious adverse events, which were reported in all four trials, were more common in the surgical group (19/130 versus 8/134; RR 2.39, 95% CI 1.10 to 5.17; 264 children; Analysis 1.3). In Wright 2005, there were two refractures after removal of the external fixator and five hospital readmissions for repeat closed reduction and adjustment to the external fixator in the surgical group, and six children received surgery after unacceptable loss of reduction in the conservative treatment group. Not included in the analysis were 20/45 (44%) children treated with external fixation in Wright 2005 who developed pin track infections, all of which resolved uneventfully with antibiotics. In Mehdinasab 2008, six children in the surgery group had pain and discomfort at the pin end site (pin-end irritation) until the pins were extracted. Not included was one child in this group who had a superficial infection that was treated by antibiotics. Three children in the surgery group of Shemshaki 2011 had infection; there was no indication of the severity of these infections or their treatment. Not included was one child in this group who had a transitional nerve injury that repaired spontaneously. Hsu 2009 reported one case of nail migration and two cases of skin irritation in the surgery group and two pin-tract infections (traction pin) for the conservative treatment group; the severity of these complications was not reported but all resolved without surgery.
Time for recuperation or return to usual activities was reported using various measures in three trials, with data presented for two in Analysis 1.4. Although Wright 2005 did not report on time to resume normal activities, a proxy (duration of treatment) showed a longer time wearing the external fixator than the spica cast (77 versus 58 days: MD 19.00 days, 95% CI 9.21 to 28.79; 101 children; Analysis 1.4). Mean time to independent walking was less for surgery group participants in both Mehdinasab 2008 (60.2 versus 75.3 days) and Shemshaki 2011 (35.2 versus 80.0 days). The time to return to school was also significantly shorter in the surgical group of Shemshaki 2011 (31.5 versus 64.3 days; MD -32.80 days, 95% CI -42.50 to -23.10 days; 46 children; Analysis 1.4).
Wright 2005 recorded child and parent satisfaction using an 11-point ordinal scale, with 'very happy' or 'very satisfied' at the top end respectively. Children's and parents' satisfaction did not differ significantly between intervention (child satisfaction: MD 0.80, 95% CI -0.61 to 2.21; 101 children; Analysis 1.5; parent satisfaction: MD 0.10, 95% CI -0.49 to 0.29; 101 children; Analysis 1.6). In Shemshaki 2011, all parents of children (23/23) treated with surgery rated the treatment as excellent or good compared with 17/23 (74%) treated with traction followed by spica cast (RR 1.34, 95% CI 1.05 to 1.73, 46 children; Analysis 1.7).
All four trials reported on length of hospital stay, full data being available from three trials. Since the latter were significantly heterogeneous, these were not pooled ( Analysis 1.8). In Wright 2005, the surgical group (external fixation) stayed around two days longer in hospital (5.9 versus 4.1 days; MD 1.80 days, 95% CI -0.32 to 3.92 days; 101 children), whereas in Shemshaki 2011, the surgical group (elastic intramedullary nailing) spent around 13 days less time in hospital (6.9 versus 20.5 days; MD -13.60 days, 95% CI -16.25 to -10.95 days; 46 children). Hsu 2009 found a significantly increased length of stay in the surgery (elastic intramedullary nailing) group (17 versus 6 days; MD 11.00 days, 95% CI 7.77 to 14.23 days; 51 children) which was attributable to a significantly longer time to surgery in the surgery group that was primarily due to "financial constraints in acquiring the necessary supplies". Mehdinasab 2008 reported a considerably shorter hospital stay for the surgical group (4.6 versus 23.7 days).
Hsu 2009 reported the total costs for surgery using the elastic intramedullary nailing (hardware, supplies, anaesthesia, radiographs, medicines including antibiotics, and hospital stay; and excluding physicians' fees or patient-borne costs) were higher than for conservative treatment with dynamic skeletal traction spica casting ($844 versus $216) at 2008 costs.
Comparisons of different conservative interventions
Immediate hip spica cast versus skin traction followed by spica cast
Siddiqui 2008 only reported on 'unsatisfactory' outcome, which was based on prespecified criteria for malunion (shortening or unacceptable angulation) at cast removal or a complication requiring a change in management. Since the latter was correction for unacceptable angulation by wedging the cast, this outcome is presented as malunion at cast removal (six to eight weeks from injury) in this review. More children in the immediate hip spica cast group had malunion at cast removal than those in the skeletal traction followed by hip spica cast at cast removal, but the small sample size did not preclude the probability that this was due to chance (4/21 versus 1/21; RR 4.00, 95% CI 0.49 to 32.87, 42 children; Analysis 2.1). No other outcomes sought in this review were reported.
Traction followed by functional orthosis versus traction followed by spica cast
Malo 1999 found similar malunion rates assessed at five or more years in the functional orthosis and spica cast groups (6/15 versus 11/27; RR 0.98, 95% CI 0.46 to 2.12; 42 children, Analysis 3.1). Functional outcomes and development of serious complications were not reported in this study.
Length of hospital stay, a measure of resource use, was the only secondary outcome reported in Malo 1999. Duration of hospitalisation was similar in the two groups (mean duration was 26.3 days in the orthosis group and 26.8 days in the spica cast group; MD -0.50 days, 95% CI -4.68 to 3.68 days; 45 children, Analysis 3.2).
Single-leg versus double-leg spica cast
Leu 2012 did not find a significant difference in ASK scores at cast removal (mean 44 days in both groups) between the single-leg and double-leg casts (mean 26.15% versus 24.58%; Analysis 4.1). Four children had a change in treatment: one child in the single-leg cast group had a recast for loss of fracture reduction; one in the double-leg cast group has surgery on immediate loss of reduction on first application of the cast, and two children had their casts converted to single-casts on request by their parents ( Analysis 4.2). None of the children had any serious adverse events, such as compartment syndrome or major skin problems ( Analysis 4.3). Malunion was not reported but there were no statistically significant differences between the two groups in radiological outcomes of extent of shortening (reported P = 0.40) or angulation (reported P = 0.28).
Leu 2012 reported the results of the individual questions of a 10-question custom survey completed by the families on 'Ease of patient function and care giving' after cast removal. The results of four questions are presented in Analysis 4.4; these show that single-leg casts tended to allow more comfort when sitting and greater ease on leaving the family home. Fewer caregivers needed to take time off work in the single-cast group (11/21 versus 15/19; RR 0.66, 95% CI 0.41 to 1.06; 40 children, Analysis 4.5) and for less time (mean 10.38 versus 19.0 days; reported P = 0.049).
Comparisons of different surgical interventions
Elastic stable intramedullary nailing (ESIN) versus external fixation
Although Bar-On 1997 did not report on functional outcomes, all children had unrestricted activity at final follow-up (mean 14 months; range 12 to 22 months). None of the nine children treated with ESIN but four of 10 children treated with external fixation had malunion (malalignment) at final follow-up: RR 0.12, 95% CI 0.01 to 2.00; Analysis 5.1). The criteria for malunion were not reported. None of the children had a limp; two children in the external fixation group had a limb-length discrepancy of 1 cm. There were fewer children with serious adverse events in the ESIN group (2/9 versus 5/10; RR 0.44, 95% CI 0.11 to 1.75; Analysis 5.2).
Children in the ESIN group returned to school on average eight weeks earlier than those in the external fixation group (ESIN: mean 5 weeks (range 2 to 12 weeks); external fixation: mean 13 weeks (3 to 32 weeks)), and were also fully weight-bearing three weeks earlier (ESIN: mean 7 weeks (range 3 to 10 weeks); external fixation: mean 10 weeks (5 to 17 weeks)). All parents of children treated with ESIN reported satisfaction with treatment while two parents of the eight children with isolated fractures treated with external fixation said they would select non-surgical treatment if faced again with the same decision. Resource use and costs were not reported in this trial.
Dynamic external fixation versus static external fixation
Domb 2002 did not report on functional outcomes or final malunion. One child in the dynamic fixator group and three children in the static fixator group had serious adverse events (1/25 versus 3/28 fractures; RR 0.37, 95% CI 0.04 to 3.36; Analysis 6.1).
Of the secondary outcomes sought for this review, Domb 2002 reported only on the time to resume full weight-bearing, which was longer in the dynamic external fixation group (73.31 versus 62.9 days, MD 10.41 days, 95% CI -0.99 to 21.81 days; 53 children, Analysis 6.2). Of note is that, contrary to the intended method, dynamisation was performed not at the time of early callus formation (mean 23 days) but at an average of 50 days (range 20 to 121 days) , which thus indicates some deviation from original intention.
Trochanteric-entry intramedullary nailing versus submuscular plating
Park 2012 did not report on functional outcomes. No malunion was seen in either group (43 children) at final mean follow-up of 21 months ( Analysis 7.1). Two children in the nail group had a serious adverse event, both of which required a re-operation, whereas there were none in the plating group (2/21 versus 0/22; RR 5.23, 95% CI 0.27 to 102.87; 43 children, Analysis 7.2).
Park 2012 found a significantly shorter time to weight-bearing in the nailing group compared with the plating group: mean 57.3 versus 89.2 days; reported P value < 0.05). Hardware removal was not a listed outcome in our protocol. However, it is noteworthy that all 16 removals of nails that had occurred by the end of follow-up were uneventful while there were serious difficulties encountered in removing three of the 17 plates.
Summary of main results
This review summarises the evidence from 10 trials (527 children) that conducted 10 different sets of comparisons, across three main comparison groups. We were able to pool data only from the four trials comparing surgical versus conservative intervention for the review's primary outcomes of malunion and serious adverse events. Most of the trials were at risk of bias in one or more domains; all were at risk of performance bias because of the impracticalities of blinding care providers. The sample sizes in all the trials, except Wright 2005 for their primary outcome of malunion, were also not sufficient to rule out chance effects.
Comparison of surgical and conservative intervention
Four trials (maximum data for 264 children, aged between 4 and 12 years) compared surgery versus conservative treatment, using different combinations of interventions. Surgery was either external fixation (one trial) or nailing (three trials) and conservative treatment was either spica cast, skeletal traction followed by casting (two trials) or dynamic skeletal traction spica casting. Only one trial reported functional outcomes. The evidence for this comparison is presented in Summary of findings for the main comparison.
Low quality evidence (one trial, 101 children, aged between 4 and 10 years) showed that RAND child health status scores may not differ significantly between surgery (external fixation) and conservative treatment (immediate spica cast). There were no data on functional outcome measures for the other three trials making this comparison.
Moderate quality evidence (four trials) showed that rates of unacceptable malunion were reduced in surgical interventions. Assuming an illustrative baseline risk of 115 malunions per 1000, the results equated to 81 fewer (95% CI 47 to 97 fewer) malunions per 1000 children treated with surgery.
Low quality evidence (four trials) showed that serious adverse events differed significantly between the two groups, being higher overall in the surgical group. Assuming an illustrative baseline risk of 40 serious adverse effects per 1000 for conservative treatment, these resulted equated to 56 more (95% CI 4 to 167 more) serious adverse events per 1000 surgically-treated children. Notably, the variety and severity of the adverse events differed considerably in the four trials.
There is low quality evidence (one trial, 46 children) that surgery (Elastic stable intramedullary nail (ESIN)) may reduce the time for children to return to school compared with conservative treatment (traction followed by spica cast).
There is low quality evidence (one trial, 46 children) that parental satisfaction may be greater in surgery (with ESIN) than conservative treatment (traction followed by spica cast). However, another study (101 children) found that parental satisfaction was almost the same in the two treatment groups (external fixation versus spica cast).
There is low quality evidence that child satisfaction probably did not differ significantly between surgery (external fixation) versus conservative treatment (immediate spica cast).
There were conflicting results for length of hospital stay from the four studies, which meant that we cannot draw any conclusions on this outcome. We do not know if the total costs are higher for surgery versus conservative treatment, but the study comparing ESIN with conservative treatment with dynamic skeletal traction spica casting found hospital costs, excluding physicians' fees, in the Philippines (2008) were 400% higher for surgery.
None of the other comparisons reported data on resource uses, costs or other financial considerations
Comparisons of different conservative interventions
The three small randomised trials in this category made three different comparisons. Only one trial reported functional outcomes. We have not presented 'Summary of findings' tables for these comparisons.
Very low quality evidence (one trial, 42 children, aged between 3 and 10 years) means that we do not know if malunion at cast removal, measured at six to eight weeks, actually differs between immediate hip spica casts versus skin traction followed by spica casts.
Very low quality evidence (one trial, 43 children, aged between 5 and 15 years) means that we do not know if long-term malunion actually differs between traction followed by functional orthosis versus traction followed by spica casts. Very low quality evidence from the same trial indicates little difference in length of stay in hospital, but otherwise there is no evidence on resource use or costs.
Very low quality evidence (one trial, 52 children, aged between two and seven years) means that we do not know if function, measured using the Activity Scale for Kids (ASK) score, at cast removal or serious adverse events (zero reported for both interventions) actually differs between single-leg versus double-leg spica casts. Low quality evidence from the same trial indicates that single-leg casts are less awkward to manage by parents, more comfortable for the child and may require less time off work by the caregiver.
Comparisons of different surgical interventions
The three small quasi-randomised trials in this category made three different comparisons. None reported functional outcomes nor child satisfaction with treatment. We have not presented 'Summary of findings' tables for these comparisons.
Very low quality evidence (one trial, 19 children, aged between 5.2 and 13.2 years) means that we do not know if malunion, measured at 12 to 22 months, serious adverse events, time to return to school or parental satisfaction actually differ between ESIN versus external fixation.
Very low quality evidence (one trial, 52 children, aged between 3 and 12 years) means that we do not know if serious adverse events and time to resume full weight-bearing actually differ between dynamic external fixation versus static external fixation. The disparity between the planned (early callus formation) and actual timing (mean 50 days compared with 23 days) of dynamisation hampers interpretation of the results of this trial.
Very low quality evidence (one trial, 47 children, aged between 11 and 17.4 years) means that we do not know if malunion, serious adverse events and time to resume weight- bearing actually differ between intramedullary nailing versus submuscular plating. The difficulties encountered in extracting three plates subsequently (18%), however, sound a cautionary note for the use of submuscular plating.
Overall completeness and applicability of evidence
This review attempted to categorise choices available for treating shaft of femur fractures in children and adolescents and examined the available evidence to inform such choices. Only a limited number of these choices were addressed by randomised controlled trials. Most of the studies did not involve infants, toddlers and older adolescents. No included trials evaluated key interventions such as Pavlik's harness or Bryant's traction. Critical outcomes such as functional outcome measures were underreported in the included trials. Important outcome measures such as time to return to normal activity, resource use, direct and indirect costs from societal and individual perspectives; opportunity costs, and satisfaction with treatment were also not reported, or were inadequately reported. The timing of final outcome assessment, such as at cast removal in Leu 2012 and Siddiqui 2008, was also inadequate in several trials, and failed to provide a full picture of final function and, especially given that children's bones remodel over time, the incidence of unacceptable malunion.
The range of interventions assessed in the included trials provide evidence to inform clinical decision- making and cover the interventions that can be offered via specialist orthopaedic teams in high-, middle- and low-income settings. However, the choice of intervention to be used will require a shared decision- making approach where the suitability of the intervention, depending on the clinical presentation, has to be balanced by considerations of the potential benefits and harms, as well as the value placed on early return to usual activities, the burdens associated with interventions, and the financial implications of each intervention , as these are likely to differ between and within settings, and between individual parent-child dyads.
The available evidence applies to closed fractures only: most of the trials excluded open fractures except Bar-On 1997, Hsu 2009 and Park 2012. However, Bar-On 1997 recruited no children with open fractures and Park 2012 recruited only three children with open fractures: two Gustilo grade I and one Gustilo grade II. Hsu 2009 recruited 12 children (24%) with grade I open fractures but excluded those with more severe grades.
Quality of the evidence
We assessed the overall quality of the evidence using the GRADE approach (Schünemann 2011). This approach integrates evaluations regarding serious study limitations, with judgements regarding unexplained inconsistency in the results; indirectness; deviations from accepted practice in the way interventions and comparisons were given, the populations studied, the choice of outcomes and the methods of ascertainment; imprecision in the effect estimates in terms of statistical significance as well as clinical importance; and the likelihood that publication bias affected the estimates.
Surgical versus conservative treatment
The description and explanation for our assessment for the quality of the evidence for this comparison is provided in the Footnotes of the Summary of findings for the main comparison. The evidence for all of the outcomes was low quality ("further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate") except for malunion, where we judged the evidence to be moderate quality ("further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate").
Comparisons of different conservative interventions
The evidence for malunion in a comparison of immediate hip spica casts versus skin traction followed by spica casts was downgraded one level for serious study limitations, mainly reflecting unclear risks of selection bias and high risk of performance bias, and two levels for imprecision. Thus, we concluded that the evidence was of very low quality, meaning that we are very uncertain about the estimate for malunion.
The evidence for malunion in a comparison of traction followed by functional orthosis versus traction followed by spica casts was downgraded one level for serious study limitations, mainly reflecting unclear risks of selection bias and high risk of performance bias, and two levels for imprecision. The evidence for resource use, presented in terms of length of hospital stay, was downgraded one level for serious study limitations, one level for indirectness, and one level for imprecision.Thus, we concluded that the evidence was of very low quality, meaning that we are very uncertain about these estimates.
For function and serious adverse events, the evidence for the comparison of single-leg versus double-leg spica casts was downgraded one level for serious study limitations, mainly reflecting high risks of bias associated with lack of blinding, one level for indirectness reflecting the short follow-up, and one level for imprecision. The evidence for the outcomes relating to cast wear and time off by the caregiver was downgraded two levels for serious study limitations reflecting high risks of bias associated with lack of blinding and attrition. Despite the plausibility of the results for outcomes during cast wear, as implied by the low quality rating we are uncertain about the estimates.
Comparisons of different surgical interventions
The three comparisons were separately tested by three small quasi-randomised trials. For all reported outcomes, the evidence was downgraded two levels for serious study limitations, mainly reflecting high risks of selection and performance biases, and one level for imprecision. Thus, we concluded that the evidence was of very low quality, meaning that we are very uncertain about the results.
Potential biases in the review process
This review followed the criteria and methods set out in our published protocol (Madhuri 2011),and followed recommendations in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a). Our search was comprehensive and included the handsearching of conference proceedings and checks for ongoing trials. Additionally, we sent requests for information and full trial reports to authors of trials that were reported only in conference proceedings, or where there was a doubt regarding completeness of the data. It is possible that we have missed some potentially eligible trials but, if so, these may still not be suitable for inclusion, particularly if unpublished and inadequately reported. We guarded against study selection bias by the independent selection of eligible trials by two authors. We also adhered to the standard methods required of Cochrane Reviews (MECIR 2011).
Agreements and disagreements with other studies or reviews
We identified two systematic reviews from searching the Database of Reviews of Effectiveness (Centre for Reviews and Dissemination) in The Cochrane Library, and the Cochrane Database of Systematic Reviews, using the terms "femoral" AND "shaft" AND "fractures".
Alho 1996 was a meta-analysis of retrospective case series. Wright 2000 searched MEDLINE till 1996 for English language reports and selected 15 cohort studies of children and adolescents with femoral fractures, but identified no randomised controlled trials (RCTs). Wright 2000 concluded that early application of a hip spica cast was associated with a shorter duration of hospital stay and low rates of malunion compared with traction. The RCT in our review compared early spica with skeletal traction followed by spica cast, but was under-powered to detect significant differences between the two interventions. Wright 2000 also concluded that internal fixation gave low rates of malunion compared with early hip spica casting but was associated with high rates of over-lengthening. Mehdinasab 2008, included in the present review, reported low quality evidence that intramedullary pin followed by spica casting may reduce malunion rates compared to traction followed by spica cast. We are not aware of any systematic reviews of RCTs addressing the objectives of this present review.
Implications for practice
This review did not find evidence from RCTs to inform clinical decisions regarding the management of femoral shaft fractures in those under three years or over 15 years of age, or those with open fractures.
There is insufficient evidence to determine if long-term function differs between surgical and conservative treatment. Moderate quality evidence indicates that overall malunion rates would be lower in surgical interventions compared with conservative interventions in children aged between 3 and 12 years. Low quality evidence indicates that this benefit may be offset by increased incidence of serious adverse events. Elastic stable intramedullary nailing may reduce recovery time, such as return to school. The choice of intervention selected will also have to factor in the preference of the child and parents for surgical versus conservative interventions, the effects of disruption on their lives, as well as local costs for the interventions and their affordability.
There is insufficient evidence from comparisons of different methods of conservative treatment or of different methods of surgical treatment to draw conclusions on the relative effects of the treatments compared in the included trials.
Implications for research
Further, methodologically sound, randomised trials are required to inform on the appropriate selection of interventions in children and adolescents with femoral shaft fractures. Future trials should conform to international standards in their design, conduct and reporting, should use standard definitions for outcomes, and estimate adequate sample sizes to ensure that potentially useful interventions are accurately identified. Assessing long-term functional outcome, return to normal activities and parent and child satisfaction are crucial; as is cost analysis, especially for contrasting interventions. Parrticularly given the high incidence of reported radiographically-defined malunion in conservatively-treated children, research is needed to validate radiographic standards for malunion and to establish the extent of the relationship between malunion and later problems and long term functional outcome.
The selection of priority areas for research should take into account the current coverage of the evidence, current practice and differences in practice, and should involve consultation with patients and their families as to their preferences and values. Multicentre trials that reflect professional consensus on treatment uncertainties should facilitate sufficient recruitment and also implementation. Although the identification of priority topics requires input from others, we suggest two priority topics for research are:
We acknowledge with gratitude the constructive comments and guidance on the protocol provided by Lindsey Elstub, Joanne Elliott, Mario Lenza, Neil Wilson and Helen Handoll. We also thank the senior author of Bar-On 1997 for unpublished data, and Philippe Ravaud and Florence Aim of the French Cochrane Centre for translating Hsu 2009 from French. We thank Joanne Elliott for providing search results for the review and feedback on this aspect. We would also like to thank Lindsey Elstub, Helen Handoll, Laura MacDonald, Cathie Sherrington and Neil Wilson for their feedback and editorial help with the review.
Data and analyses
- Top of page
- Summary of findings [Explanations]
- Authors' conclusions
- Data and analyses
- Contributions of authors
- Declarations of interest
- Sources of support
- Differences between protocol and review
- Index terms
Appendix 1. Search strategies
Cochrane Central Register of Controlled Trials (Wiley Online Library)
#1 MeSH descriptor: [Femoral Fractures] this term only (183)
#2 MeSH descriptor: [Femur] this term only (522)
#3 MeSH descriptor: [Fractures, Bone] this term only (1097)
#4 MeSH descriptor: [Fracture Fixation] explode all trees (1077)
#5 MeSH descriptor: [Fracture Healing] this term only (358)
#6 #3 or #4 or #5 (2124)
#7 #2 and #6 (32)
#8 ((femur* or femor*) near/4 (fracture* or fixat* or stabili*)):ti,ab,kw (1211)
#9 #1 or #7 or #8 (1220)
#10 MeSH descriptor: [Pediatrics] explode all trees (473)
#11 MeSH descriptor: [Infant] explode all trees (12193)
#12 MeSH descriptor: [Adolescent] this term only (70293)
#13 (paediatr* or pediatr* or neonate* or bab*3 or infant* or child* or teenage* or adolescen*):ti,ab,kw (140155)
#14 #10 or #11 or #12 or #13 (140164)
#15 (#9 and #14) in Trials (107)
1 Femoral Fractures/ (12732)
2 Femur/ (30265)
3 Fractures, Bone/ or exp Fracture Fixation/ or Fracture Healing/ (86520)
4 2 and 3 (2024)
5 ((femur* or femor*) adj4 (fracture* or fixat* or stabili*)).tw. (17746)
6 or/1,4-5 (24918)
7 exp Pediatrics/ (42918)
8 exp Infant/ (935710)
9 exp Child/ (1543840)
10 Adolescent/ not exp Adult/ (479309)
11 (paediatr* or pediatr* or neonate* or bab*3 or infant* or child* or teenage* or adolescen*).tw. (1461444)
12 or/7-11 (2546681)
13 6 and 12 (3635)
14 Randomized controlled trial.pt. (383304)
15 Controlled clinical trial.pt. (88946)
16 randomized.ab. (298690)
17 placebo.ab. (160672)
18 Drug Therapy.fs. (1741540)
19 randomly.ab. (211731)
20 trial.ab. (314769)
21 groups.ab. (1348102)
22 or/14-21 (3370535)
23 exp Animals/ not Humans/ (4021928)
24 22 not 23 (2888552)
25 13 and 24 (297)
1 Femur Fracture/ or Femur Shaft Fracture/ (16187)
2 Femur/ or Femur Shaft/ (32128)
3 Fracture/ or Fracture Treatment/ or Fracture Fixation/ or Fracture Healing/ (89328)
4 2 and 3 (2540)
5 ((femur* or femor*) adj4 (fracture* or fixat* or stabili*)).tw. (20559)
6 or/1,4-5 (29301)
7 exp Pediatrics/ (71896)
8 exp Infant/ (529301)
9 exp Child/ (1703687)
10 Adolescent/ not exp Adult/ (465163)
11 (paediatr* or pediatr* or neonate* or bab*3 or infant* or child* or teenage* or adolescen*).tw. (1674415)
12 or/7-11 (2528651)
13 and/6,12 (3882)
14 Randomized controlled trial/ (353771)
15 Clinical trial/ (887803)
16 Controlled clinical trial/ (404378)
17 Randomization/ (63137)
18 Single blind procedure/ (18070)
19 Double blind procedure/ (116998)
20 Crossover procedure/ (38092)
21 Placebo/ (223384)
22 Prospective study/ (246361)
23 ((clinical or controlled or comparative or placebo or prospective* or randomi#ed) adj3 (trial or study)).tw. (713794)
24 (random* adj7 (allocat* or allot* or assign* or basis* or divid* or order*)).tw. (174815)
25 ((singl* or doubl* or trebl* or tripl*) adj7 (blind* or mask*)).tw. (157338)
26 (cross?over* or (cross adj1 over*)).tw. (67509)
27 ((allocat* or allot* or assign* or divid*) adj3 (condition* or experiment* or intervention* or treatment* or therap* or control* or group*)).tw. (222673)
28 RCT.tw. (12318)
29 or/14-28 (1851009)
30 Case Study/ or Abstract Report/ or Letter/ (902012)
31 29 not 30 (1813676)
32 13 and 31 (287)
S1 (MH "Femoral Fractures") (2,224)
S2 (MH "Femur") (4,682)
S3 MH Fractures OR MH Fracture Fixation OR MH Fracture Healing (16,762)
S4 S2 and S3 (555)
S5 ( femur* N4 fracture* or femur* N4 fixat* or femur* N4 stabili* ) or ( femor* N4 fracture* or femor* N4 fixat* or femor* N4 stabili* ) (4,118)
S6 S1 or S4 or S5 (4,357)
S7 (MH "Pediatrics+") (10,080)
S8 (MH "Infant+") (148,652)
S9 (MH "Child+") (376,247)
S10 MH Adolescence NOT MH Adult (130,333)
S11 TX (paediatr* or pediatr* or neonate* or bab*3 or infant* or child* or teenage* or adolescen*) (713,657)
S12 S7 or S8 or S9 or S10 or S11 (713,704)
S13 S6 and S12 (874)
S14 (MH "Clinical Trials+") (165,068)
S15 (MH "Evaluation Research+") (19,689)
S16 (MH "Comparative Studies") (72,882)
S17 (MH "Crossover Design") (10,801)
S18 PT Clinical Trial (74,400)
S19 (MH "Random Assignment") (35,418)
S20 S14 or S15 or S16 or S17 or S18 or S19 (261,753)
S21 TX ((clinical or controlled or comparative or placebo or prospective or randomi?ed) and (trial or study)) (453,418)
S22 TX (random* and (allocat* or allot* or assign* or basis* or divid* or order*)) (62,773)
S23 TX ((singl* or doubl* or trebl* or tripl*) and (blind* or mask*)) (687,750)
S24 TX ( crossover* or 'cross over' ) or TX cross n1 over (13,537)
S25 TX ((allocat* or allot* or assign* or divid*) and (condition* or experiment* or intervention* or treatment* or therap* or control* or group*)) (78,957
S26 S21 or S22 or S23 or S24 or S25 (1,055,070)
S27 S20 or S26 (1,118,691)
S28 S13 and S27 (322)
Appendix 2. Assessment of risk of bias tool
Appendix 3. Details of Dynamic Skeletal Traction Spica Casting (DSTSC)
From Hsu 2009:
"For phase II DSTSC, patients were placed in Buck’s traction on admission and then immediately placed in a DSTSC apparatus using ketamine sedation. Under sterile conditions, a Kirschner wire (0.062 in) was placed through the distal tibia anterior to the fibula at a distance 5–7 cm proximal to the tip of the lateral malleolus for skeletal traction. Xeroform (InvaCare, Elyria, OH) gauze was then applied followed by a felt pad which was secured using disc plates and Jurgan pin balls (Jurgan Development & Mfg, Madison, WI) to prevent lateral pin migration. The Kirschner wire was then attached to a traction bow and placed under tension. While maintaining manual traction, the patient was placed in a half hip spica cast with the fractured side and normal leg both casted above the knee. Femurs were positioned according to fracture level and were abducted 35–45°, externally rotated 10–15°,and flexed 20–30° (up to 45° for proximal fractures). The knee joint was free on the normal side and kept in full extension on the fracture side. The length of the traction brace was adjusted based on the child’s size, and the device was incorporated into a spica cast with plaster. Sheet wadding was applied to the brace at points of contact with the cast to facilitate later removal. The traction brace was aligned with the proper rotation along the longitudinal axis of the extremity, and then a traction bow was attached to the brace along with a tensioning device and 18-gauge wire. Traction was provided by a coiled steel spring, and the device was tensioned by turning the wing nut until the desired amount overlap was achieved on radiographs. Traction force was measured using a handheld, spring-loaded scale, and approximately 3.5–5.5 kg of traction was needed to achieve proper fracture overlap. The injured leg was supported by a cloth hammock while in the traction device and a few drops of 70% alcohol were placed at the pin sites through the overlying dressings. After discharge, patients were evaluated in the outpatient clinic and traction was adjusted until healing was sufficient to remove the apparatus and pin under sedation (about three to four weeks). Healing was typically achieved after eight to ten weeks, and after removal of the DSTSC system, patients used crutches if necessary to aid in walking for one month".
Contributions of authors
Vrisha Madhuri: conceived the review, drafted and wrote the protocol and review, assessed risk of bias, checked extracted data and corrected the final draft.
Vivek Dutt: drafted and wrote the protocol and the review, selected trials, extracted data, assessed risk of bias, entered data, interpreted data and corrected the final draft.
Abhay Gahukamble: drafted the protocol, selected trials, extracted data, assessed risk of bias.
Prathap Tharyan: checked the protocol, checked excluded studies, extracted and entered data, assessed risk of bias, interpreted data, constructed 'Summary of findings' tables and wrote the final version of the review.
All authors approved the final version of the review.
Declarations of interest
Vrisha Madhuri: was Course Chairman for an AO paediatric course 2013 and was Co-Chairman in 2009. There were no personal or institutional financial gains; however local travel and accomodation were arranged by the education wing of the AO Foundation India. An honorarium for the days of the course was paid by the International AO Education but it was not received personally or by the institution; it went into the AO Education Fund India. AO Foundation and their education activities are related to Synthes company, which manufactures implants for fixing femur fractures.
Vivek Dutt: none known
Abhay D Gahukamble: none known
Prathap Tharyan: none known
Sources of support
- Christian Medical College, Vellore, India.Salaries of all authors; logistic support
- South Asian Cochrane Network and Centre, Vellore, India.Protocol development and review completion workshops
- Effective Health Care Research Consortium, UK.Funding for the South Asian Cochrane Centre to build capacity to undertake systematic reviews via a programme grant to the Liverpool School of Tropical Medicine (Paul Garner) from UKaid (Department for International Development) in aid of developing countries. PT is a programme partner.
Differences between protocol and review
1. Child/parent satisfaction: it was felt that the expectations of the child may be different from that of the parent. In some trials, the outcomes were separately reported, hence this single outcome was split into two outcomes.
2. We re-ordered the presentation of the comparisons in analyses, results and discussion compared to the order used in the protocol, in order to evaluate and discuss the comparisons in a clinically meaningful manner.
Medical Subject Headings (MeSH)
Casts, Surgical; Femoral Fractures [surgery; *therapy]; Fracture Fixation [adverse effects; *methods]; Fracture Fixation, Intramedullary [methods]; Fractures, Malunited [epidemiology; prevention & control]; Parents [psychology]; Randomized Controlled Trials as Topic; Recovery of Function; Traction [psychology]
MeSH check words
Adolescent; Child; Child, Preschool; Female; Humans; Male
* Indicates the major publication for the study