儿童和青少年股骨干骨折的干预治疗

Vrisha Madhuri, Vivek Dutt, Abhay D Gahukamble, Prathap Tharyan
{"title":"儿童和青少年股骨干骨折的干预治疗","authors":"Vrisha Madhuri,&nbsp;Vivek Dutt,&nbsp;Abhay D Gahukamble,&nbsp;Prathap Tharyan","doi":"10.1002/ebch.1987","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Fractures of the femoral shaft in children are relatively uncommon but serious injuries that disrupt the lives of children and their carers and can result in significant long-term disability. Treatment involves either surgical fixation, such as intramedullary nailing or external fixation, or conservative treatment involving prolonged immobilisation, often in hospital.</p>\n </section>\n \n <section>\n \n <h3> Objectives</h3>\n \n <p>To assess the effects (benefits and harms) of interventions for treating femoral shaft fractures in children and adolescents.</p>\n </section>\n \n <section>\n \n <h3> Search methods</h3>\n \n <p>We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (accessed 16 August 2013), the Cochrane Central Register of Controlled Trials (<i>The Cochrane Library</i> 2013 Issue 7), MEDLINE (1946 to August Week 1 2013), EMBASE (1980 to 2012 week 9), CINAHL (16 August 2013), clinical trials registries, conference proceedings and reference lists; and contacted trial authors and experts in the field.</p>\n </section>\n \n <section>\n \n <h3> Selection criteria</h3>\n \n <p>Randomised and quasi-randomised controlled trials comparing conservative and surgical interventions for diaphyseal fractures of the femur in children under 18 years of age. Our primary outcomes were functional outcome measures, unacceptable malunion, and serious adverse events.</p>\n </section>\n \n <section>\n \n <h3> Data collection and analysis</h3>\n \n <p>Two authors independently screened and selected trials, assessed risk of bias and extracted data. We assessed the overall quality of the evidence for each outcome for each comparison using the GRADE approach. We pooled data using a fixed-effect model.</p>\n </section>\n \n <section>\n \n <h3> Main results</h3>\n \n <p>We included 10 trials (six randomised and four quasi-randomised) involving a total of 527 children (531 fractures). All trials were at some risk of bias, including performance bias as care provider blinding was not practical, but to a differing extent. Just one trial was at low risk of selection bias. Reflecting both the risk of bias and the imprecision of findings, we judged the quality of evidence to be 'low' for most outcomes, meaning that we are unsure about the estimates of effect. Most trials failed to report on self-assessed function or when children resumed their usual activities. The trials evaluated 10 different comparisons, belonging to three main categories.</p>\n \n <p><i>Surgical versus conservative treatment</i></p>\n \n <p>Four trials presenting data for 264 children aged 4 to 12 years made this comparison. Low quality evidence (one trial, 101 children) showed children had very similar function assessed using the RAND health status score at two years after surgery (external fixation) compared with conservative treatment (spica cast): mean 69 versus 68. The other three trials did not report on function. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up 3 to 24 months) that surgery reduced the risk of malunion (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.15 to 0.59, 4 trials). Assuming an illustrative baseline risk of 115 malunions per 1000 in children treated conservatively, these data equate to 81 fewer (95% CI 47 to 97 fewer) malunions per 1000 in surgically-treated children. Conversely, low quality evidence indicated that there were more serious adverse events such as infections after surgery (RR 2.39, 95% CI 1.10 to 5.17, 4 trials). Assuming an illustrative baseline risk of 40 serious adverse events per 1000 for conservative treatment, these data equate to 56 more (95% CI 4 to 167 more) serious adverse events per 1000 children treated surgically. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with intramedullary nailing than with traction followed by a cast, and that surgery reduced the time taken off from school.</p>\n \n <p><i>Comparisons of different methods of conservative treatment</i></p>\n \n <p>The three trials in this category made three different comparisons. We are very unsure if unacceptable malunion rates differ between immediate hip spica versus skeletal traction followed by spica in children aged 3 to 10 years followed up for six to eight weeks (RR 4.0, 95% CI 0.5 to 32.9; one trial, 42 children; very low quality evidence)<i>.</i> Malunion rates at 5 to 10 years may not differ between traction followed by functional orthosis versus traction followed by spica cast in children aged 5 to 13 years (RR 0.98, 95% CI 0.46 to 2.12; one trial, 43 children; low quality evidence). We are very unsure (very low quality evidence) if either function or serious adverse events (zero events reported) differ between single-leg versus double-leg spica casts (one trial, 52 young children aged two to seven years). Low quality evidence on the same comparison 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.</p>\n \n <p><i>Comparisons of different methods of surgical treatment</i></p>\n \n <p>The three trials in this category made three different comparisons. Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using elastic stable intramedullary nailing or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) 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. However, there could be more difficulties in plate removal subsequently.</p>\n </section>\n \n <section>\n \n <h3> Authors' conclusions</h3>\n \n <p>There is insufficient evidence to determine if long-term function differs between surgical and conservative treatment. Surgery results in lower rates of malunion in children aged 4 to 12 years, but may increase the risk of serious adverse events. Elastic stable intramedullary nailing may reduce recovery time.</p>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> PLAIN LANGUAGE SUMMARY</h3>\n \n <p><b>Different methods of treating fractures of the shaft of the thigh bone in children and adolescents</b></p>\n \n <p>Although uncommon, fractures of the femoral shaft (thigh bone) in children may require prolonged treatment in hospital and sometimes surgery. This can cause significant discomfort and can disrupt the lives of the children and their familles. This review compared different methods of treating these fractures. Surgical treatment comprises different methods of fixing the broken bones, such as internally-placed nails, or pins incorporated into an external frame (external fixation). Non-surgical or conservative treatment usually involves different types of plaster casts with or without traction (where a pulling force is applied to the leg).</p>\n \n <p>We searched for studies in the medical literature until August 2013. The review includes 10 randomised or quasi-randomised controlled trials that recruited 527 children. Four trials compared different surgical versus non-surgical treatments; three compared different methods of non-surgical treatment and three compared different methods of surgical treatment. Generally we are unsure about the results of these trials because some were at risk of bias, some results were contradictory and usually there was too little evidence to rule out chance findings. Most trials failed to report on self-assessed function or when children resumed their usual activities.</p>\n \n <p><i>Comparing surgical versus non-surgical treatment</i></p>\n \n <p>Low quality evidence (one trial, 101 children) showed children had similar function at two years after having surgery, involving external fixation, compared with those treated with a plaster cast. The other three trials did not report this outcome. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up for 3 to 24 months) that surgery reduced the risk of malunion (the leg is deformed) compared with non-surgical treatment. However, low quality evidence (four trials) indicated that there were more serious adverse events such as infections after surgery. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with surgery involving an internal nail than with traction followed by a cast and that surgery reduced the time taken off from school.</p>\n \n <p><i>Comparing various non-surgical treatments</i></p>\n \n <p>Very low quality evidence means that we are very unsure if the rates of malunion differ or not between children treated with immediate plaster casts versus with traction followed by plaster cast (one trial, 42 children), or between children treated with traction followed by either a functional orthosis (a brace or cast that allows some movement) or a cast (one trial, 43 children). We are very unsure if either function or serious adverse events differ between young children (aged two to seven years) immobilised in single-leg versus double-leg casts (one trial, 52 children). However, single-leg casts appear to be easier to manage by parents and more comfortable for the child.</p>\n \n <p><i>Comparing various surgical treatments</i></p>\n \n <p>Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using internal nails or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic (less rigid) versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) 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. However, there could be more difficulties in plate removal subsequently.</p>\n \n <p><i>Conclusions</i></p>\n \n <p>This review found insufficient evidence to determine if long-term function differs between surgical and conservative treatment of thigh bone fractures in children aged 4 to 12 years. It found surgery resulted in lower rates of malunion but increased the risk of serious adverse events, such as infections. It found internal nailing may speed up recovery.</p>\n \n <p>The review found there was insufficient evidence from comparisons of different methods of non-surgical treatment to clearly show that any type of non-surgical treatment is better than any other. The same conclusion applies to comparisons of different methods of surgical treatment.</p>\n </section>\n </div>","PeriodicalId":12162,"journal":{"name":"Evidence-based child health : a Cochrane review journal","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2014-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/ebch.1987","citationCount":"43","resultStr":"{\"title\":\"Interventions for treating femoral shaft fractures in children and adolescents\",\"authors\":\"Vrisha Madhuri,&nbsp;Vivek Dutt,&nbsp;Abhay D Gahukamble,&nbsp;Prathap Tharyan\",\"doi\":\"10.1002/ebch.1987\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Fractures of the femoral shaft in children are relatively uncommon but serious injuries that disrupt the lives of children and their carers and can result in significant long-term disability. Treatment involves either surgical fixation, such as intramedullary nailing or external fixation, or conservative treatment involving prolonged immobilisation, often in hospital.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Objectives</h3>\\n \\n <p>To assess the effects (benefits and harms) of interventions for treating femoral shaft fractures in children and adolescents.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Search methods</h3>\\n \\n <p>We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (accessed 16 August 2013), the Cochrane Central Register of Controlled Trials (<i>The Cochrane Library</i> 2013 Issue 7), MEDLINE (1946 to August Week 1 2013), EMBASE (1980 to 2012 week 9), CINAHL (16 August 2013), clinical trials registries, conference proceedings and reference lists; and contacted trial authors and experts in the field.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Selection criteria</h3>\\n \\n <p>Randomised and quasi-randomised controlled trials comparing conservative and surgical interventions for diaphyseal fractures of the femur in children under 18 years of age. Our primary outcomes were functional outcome measures, unacceptable malunion, and serious adverse events.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Data collection and analysis</h3>\\n \\n <p>Two authors independently screened and selected trials, assessed risk of bias and extracted data. We assessed the overall quality of the evidence for each outcome for each comparison using the GRADE approach. We pooled data using a fixed-effect model.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Main results</h3>\\n \\n <p>We included 10 trials (six randomised and four quasi-randomised) involving a total of 527 children (531 fractures). All trials were at some risk of bias, including performance bias as care provider blinding was not practical, but to a differing extent. Just one trial was at low risk of selection bias. Reflecting both the risk of bias and the imprecision of findings, we judged the quality of evidence to be 'low' for most outcomes, meaning that we are unsure about the estimates of effect. Most trials failed to report on self-assessed function or when children resumed their usual activities. The trials evaluated 10 different comparisons, belonging to three main categories.</p>\\n \\n <p><i>Surgical versus conservative treatment</i></p>\\n \\n <p>Four trials presenting data for 264 children aged 4 to 12 years made this comparison. Low quality evidence (one trial, 101 children) showed children had very similar function assessed using the RAND health status score at two years after surgery (external fixation) compared with conservative treatment (spica cast): mean 69 versus 68. The other three trials did not report on function. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up 3 to 24 months) that surgery reduced the risk of malunion (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.15 to 0.59, 4 trials). Assuming an illustrative baseline risk of 115 malunions per 1000 in children treated conservatively, these data equate to 81 fewer (95% CI 47 to 97 fewer) malunions per 1000 in surgically-treated children. Conversely, low quality evidence indicated that there were more serious adverse events such as infections after surgery (RR 2.39, 95% CI 1.10 to 5.17, 4 trials). Assuming an illustrative baseline risk of 40 serious adverse events per 1000 for conservative treatment, these data equate to 56 more (95% CI 4 to 167 more) serious adverse events per 1000 children treated surgically. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with intramedullary nailing than with traction followed by a cast, and that surgery reduced the time taken off from school.</p>\\n \\n <p><i>Comparisons of different methods of conservative treatment</i></p>\\n \\n <p>The three trials in this category made three different comparisons. We are very unsure if unacceptable malunion rates differ between immediate hip spica versus skeletal traction followed by spica in children aged 3 to 10 years followed up for six to eight weeks (RR 4.0, 95% CI 0.5 to 32.9; one trial, 42 children; very low quality evidence)<i>.</i> Malunion rates at 5 to 10 years may not differ between traction followed by functional orthosis versus traction followed by spica cast in children aged 5 to 13 years (RR 0.98, 95% CI 0.46 to 2.12; one trial, 43 children; low quality evidence). We are very unsure (very low quality evidence) if either function or serious adverse events (zero events reported) differ between single-leg versus double-leg spica casts (one trial, 52 young children aged two to seven years). Low quality evidence on the same comparison 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.</p>\\n \\n <p><i>Comparisons of different methods of surgical treatment</i></p>\\n \\n <p>The three trials in this category made three different comparisons. Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using elastic stable intramedullary nailing or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) 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. However, there could be more difficulties in plate removal subsequently.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Authors' conclusions</h3>\\n \\n <p>There is insufficient evidence to determine if long-term function differs between surgical and conservative treatment. Surgery results in lower rates of malunion in children aged 4 to 12 years, but may increase the risk of serious adverse events. Elastic stable intramedullary nailing may reduce recovery time.</p>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> PLAIN LANGUAGE SUMMARY</h3>\\n \\n <p><b>Different methods of treating fractures of the shaft of the thigh bone in children and adolescents</b></p>\\n \\n <p>Although uncommon, fractures of the femoral shaft (thigh bone) in children may require prolonged treatment in hospital and sometimes surgery. This can cause significant discomfort and can disrupt the lives of the children and their familles. This review compared different methods of treating these fractures. Surgical treatment comprises different methods of fixing the broken bones, such as internally-placed nails, or pins incorporated into an external frame (external fixation). Non-surgical or conservative treatment usually involves different types of plaster casts with or without traction (where a pulling force is applied to the leg).</p>\\n \\n <p>We searched for studies in the medical literature until August 2013. The review includes 10 randomised or quasi-randomised controlled trials that recruited 527 children. Four trials compared different surgical versus non-surgical treatments; three compared different methods of non-surgical treatment and three compared different methods of surgical treatment. Generally we are unsure about the results of these trials because some were at risk of bias, some results were contradictory and usually there was too little evidence to rule out chance findings. Most trials failed to report on self-assessed function or when children resumed their usual activities.</p>\\n \\n <p><i>Comparing surgical versus non-surgical treatment</i></p>\\n \\n <p>Low quality evidence (one trial, 101 children) showed children had similar function at two years after having surgery, involving external fixation, compared with those treated with a plaster cast. The other three trials did not report this outcome. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up for 3 to 24 months) that surgery reduced the risk of malunion (the leg is deformed) compared with non-surgical treatment. However, low quality evidence (four trials) indicated that there were more serious adverse events such as infections after surgery. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with surgery involving an internal nail than with traction followed by a cast and that surgery reduced the time taken off from school.</p>\\n \\n <p><i>Comparing various non-surgical treatments</i></p>\\n \\n <p>Very low quality evidence means that we are very unsure if the rates of malunion differ or not between children treated with immediate plaster casts versus with traction followed by plaster cast (one trial, 42 children), or between children treated with traction followed by either a functional orthosis (a brace or cast that allows some movement) or a cast (one trial, 43 children). We are very unsure if either function or serious adverse events differ between young children (aged two to seven years) immobilised in single-leg versus double-leg casts (one trial, 52 children). However, single-leg casts appear to be easier to manage by parents and more comfortable for the child.</p>\\n \\n <p><i>Comparing various surgical treatments</i></p>\\n \\n <p>Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using internal nails or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic (less rigid) versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) 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. However, there could be more difficulties in plate removal subsequently.</p>\\n \\n <p><i>Conclusions</i></p>\\n \\n <p>This review found insufficient evidence to determine if long-term function differs between surgical and conservative treatment of thigh bone fractures in children aged 4 to 12 years. It found surgery resulted in lower rates of malunion but increased the risk of serious adverse events, such as infections. It found internal nailing may speed up recovery.</p>\\n \\n <p>The review found there was insufficient evidence from comparisons of different methods of non-surgical treatment to clearly show that any type of non-surgical treatment is better than any other. The same conclusion applies to comparisons of different methods of surgical treatment.</p>\\n </section>\\n </div>\",\"PeriodicalId\":12162,\"journal\":{\"name\":\"Evidence-based child health : a Cochrane review journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2014-12-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1002/ebch.1987\",\"citationCount\":\"43\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Evidence-based child health : a Cochrane review journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/ebch.1987\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Evidence-based child health : a Cochrane review journal","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/ebch.1987","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 43

摘要

背景:儿童股骨干骨折相对不常见,但严重的损伤会扰乱儿童及其护理人员的生活,并可能导致严重的长期残疾。治疗包括手术固定,如髓内钉或外固定,或保守治疗,包括长期固定,通常在医院。目的评价儿童和青少年股骨干骨折干预治疗的效果(利与弊)。我们检索了Cochrane骨、关节和肌肉创伤组专门注册(2013年8月16日访问)、Cochrane中央对照试验注册(Cochrane图书馆2013年第7期)、MEDLINE(1946年至2013年8月第1周)、EMBASE(1980年至2012年第9周)、CINAHL(2013年8月16日)、临床试验注册、会议记录和参考文献列表;并联系了试验作者和该领域的专家。选择标准:比较保守和手术治疗18岁以下儿童股骨骨干骨折的随机和准随机对照试验。我们的主要结局是功能性结局测量、不可接受的骨不愈合和严重不良事件。数据收集和分析两位作者独立筛选和选择试验,评估偏倚风险并提取数据。我们使用GRADE方法评估每个比较的每个结果的证据的总体质量。我们使用固定效应模型汇总数据。我们纳入了10项试验(6项随机试验和4项准随机试验),共涉及527名儿童(531例骨折)。所有的试验都存在一定的偏倚风险,包括表现偏倚,因为护理人员盲法并不实际,但程度不同。只有一项试验存在低选择偏倚风险。考虑到偏倚的风险和研究结果的不准确性,我们认为大多数结果的证据质量为“低”,这意味着我们对效果的估计不确定。大多数试验都没有报告自我评估的功能或儿童恢复正常活动的时间。这些试验评估了10种不同的比较,分为三个主要类别。手术与保守治疗4项试验对264名4 - 12岁儿童进行了比较。低质量证据(一项试验,101名儿童)显示,与保守治疗(spica石膏)相比,在手术(外固定)后两年使用RAND健康状态评分评估儿童的功能非常相似:平均69比68。其他三个试验没有关于功能的报道。有中等质量的证据(4项试验,264名儿童,年龄4至12岁,随访3至24个月)表明手术降低了畸形愈合的风险(风险比(RR) 0.29, 95%可信区间(CI) 0.15至0.59,4项试验)。假设保守治疗儿童的基线风险为每1000例115例畸形愈合,这些数据相当于每1000例手术治疗儿童的畸形愈合减少81例(95% CI为47 - 97)。相反,低质量的证据表明手术后感染等更严重的不良事件(RR 2.39, 95% CI 1.10 ~ 5.17, 4项试验)。假设保守治疗的基线风险为每1000例40例严重不良事件,这些数据相当于每1000例接受手术治疗的儿童多发生56例(95% CI为4 ~ 167例)严重不良事件。有低质量的证据(一项试验,101名儿童)表明,仅采用外固定和石膏石膏的手术对儿童和家长的满意度相似。然而,有低质量的证据(一项试验,46名儿童)表明,与牵引后石膏相比,更多的家长对髓内钉治疗感到满意,而且手术减少了缺课时间。不同保守治疗方法的比较这一类的三个试验进行了三个不同的比较。我们非常不确定在3 - 10岁的儿童进行6 - 8周的随访后,立即髋关节骨裂与骨骼牵引后骨裂的不可接受的不愈合率是否存在差异(RR 4.0, 95% CI 0.5 - 32.9;一项试验,42名儿童;非常低质量的证据)。在5 - 13岁的儿童中,5 - 10年的畸形愈合率在牵引后使用功能性矫形器与牵引后使用spica石膏之间可能没有差异(RR 0.98, 95% CI 0.46 - 2)。 12;一项试验,43名儿童;证据质量低)。我们非常不确定(非常低质量的证据)单腿和双腿spica石膏是否有功能或严重不良事件(零事件报告)差异(一项试验,52名2至7岁的幼儿)。关于同一比较的低质量证据表明,单腿石膏对父母来说不那么尴尬,对孩子来说更舒适,并且可能需要更少的护理时间。不同手术治疗方法的比较这一类的三个试验进行了三个不同的比较。非常低质量的证据意味着我们非常不确定使用弹性稳定髓内钉或外固定固定的儿童骨折的不愈合率、严重不良事件、返回学校的时间或家长满意度是否存在差异(一项试验,19名儿童)。在接受动态和静态外固定治疗的儿童中,严重不良事件的发生率和恢复完全负重的时间也是如此(一项试验,52名儿童)。非常低质量的证据(一项试验,47名儿童)意味着我们不知道髓内钉与肌下钢板之间愈合不良、严重不良事件和恢复体重的时间是否有实际差异。然而,随后的钢板移除可能会有更多的困难。作者的结论:没有足够的证据来确定手术和保守治疗之间的长期功能是否不同。在4至12岁的儿童中,手术导致的畸形愈合率较低,但可能增加严重不良事件的风险。弹性稳定髓内钉可缩短恢复时间。不同保守治疗方法或不同手术治疗方法的比较证据不足,无法对纳入试验中比较的治疗方法的相对效果得出结论。儿童和青少年股骨骨干骨折的不同治疗方法虽然不常见,但儿童股骨骨干(大腿骨)骨折可能需要长期住院治疗,有时需要手术治疗。这可能会引起严重的不适,并可能扰乱儿童及其家庭的生活。这篇综述比较了治疗这些骨折的不同方法。外科治疗包括固定骨折的不同方法,例如内置钉子或与外部框架结合的销钉(外固定)。非手术或保守治疗通常包括不同类型的石膏模型,有或没有牵引(在腿部施加拉力)。我们检索了2013年8月之前的医学文献。该综述包括10项随机或准随机对照试验,共招募了527名儿童。四项试验比较了不同的手术与非手术治疗;3例比较非手术治疗的不同方法,3例比较手术治疗的不同方法。一般来说,我们对这些试验的结果不确定,因为有些试验有偏倚的风险,有些结果是矛盾的,而且通常证据太少,不能排除偶然发现的可能性。大多数试验都没有报告自我评估的功能或儿童恢复正常活动的时间。低质量证据(一项试验,101名儿童)显示,与石膏石膏治疗的儿童相比,手术后两年包括外固定的儿童功能相似。其他三个试验没有报告这一结果。有中等质量的证据(4项试验,264名儿童,年龄4至12岁,随访3至24个月)表明,与非手术治疗相比,手术降低了畸形愈合(腿部变形)的风险。然而,低质量的证据(四项试验)表明,术后有更严重的不良事件,如感染。有低质量的证据(一项试验,101名儿童)表明,仅采用外固定和石膏石膏的手术对儿童和家长的满意度相似。然而,有低质量的证据(一项试验,46名儿童)表明,与牵引后石膏手术相比,更多的家长对采用内钉手术感到满意,而且手术减少了缺课时间。 非常低质量的证据意味着我们非常不确定在立即石膏石膏治疗与牵引后石膏石膏治疗(一项试验,42名儿童)之间的儿童畸形愈合率是否不同,或者在牵引后使用功能性矫形器(允许一定活动的支架或石膏)或石膏治疗(一项试验,43名儿童)之间的儿童畸形愈合率是否不同。我们非常不确定使用单腿和双腿石膏固定的幼儿(2 - 7岁)的功能或严重不良事件是否有差异(一项试验,52名儿童)。然而,单腿石膏似乎更容易由父母管理,对孩子来说更舒适。非常低质量的证据意味着我们非常不确定使用内钉或外固定物固定骨折的儿童的不愈合率、严重不良事件、返回学校的时间或家长满意度是否存在差异(一项试验,19名儿童)。与静态外固定相比,采用动态(刚性较低)外固定治疗的儿童的严重不良事件发生率和恢复完全负重的时间也存在同样的差异(一项试验,52名儿童)。非常低质量的证据(一项试验,47名儿童)意味着我们不知道髓内钉与肌下钢板之间愈合不良、严重不良事件和恢复体重的时间是否有实际差异。然而,随后的钢板移除可能会有更多的困难。结论:本综述没有足够的证据来确定4 - 12岁儿童大腿骨骨折手术和保守治疗的长期功能是否不同。研究发现,手术导致愈合不良的几率较低,但增加了感染等严重不良事件的风险。研究发现,内钉可以加速恢复。回顾发现,没有足够的证据来比较不同的非手术治疗方法,以清楚地表明任何一种非手术治疗比其他任何一种更好。同样的结论也适用于不同手术治疗方法的比较。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Interventions for treating femoral shaft fractures in children and adolescents

Background

Fractures of the femoral shaft in children are relatively uncommon but serious injuries that disrupt the lives of children and their carers and can result in significant long-term disability. Treatment involves either surgical fixation, such as intramedullary nailing or external fixation, or conservative treatment involving prolonged immobilisation, often in hospital.

Objectives

To assess the effects (benefits and harms) of interventions for treating femoral shaft fractures in children and adolescents.

Search methods

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (accessed 16 August 2013), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2013 Issue 7), MEDLINE (1946 to August Week 1 2013), EMBASE (1980 to 2012 week 9), CINAHL (16 August 2013), clinical trials registries, conference proceedings and reference lists; and contacted trial authors and experts in the field.

Selection criteria

Randomised and quasi-randomised controlled trials comparing conservative and surgical interventions for diaphyseal fractures of the femur in children under 18 years of age. Our primary outcomes were functional outcome measures, unacceptable malunion, and serious adverse events.

Data collection and analysis

Two authors independently screened and selected trials, assessed risk of bias and extracted data. We assessed the overall quality of the evidence for each outcome for each comparison using the GRADE approach. We pooled data using a fixed-effect model.

Main results

We included 10 trials (six randomised and four quasi-randomised) involving a total of 527 children (531 fractures). All trials were at some risk of bias, including performance bias as care provider blinding was not practical, but to a differing extent. Just one trial was at low risk of selection bias. Reflecting both the risk of bias and the imprecision of findings, we judged the quality of evidence to be 'low' for most outcomes, meaning that we are unsure about the estimates of effect. Most trials failed to report on self-assessed function or when children resumed their usual activities. The trials evaluated 10 different comparisons, belonging to three main categories.

Surgical versus conservative treatment

Four trials presenting data for 264 children aged 4 to 12 years made this comparison. Low quality evidence (one trial, 101 children) showed children had very similar function assessed using the RAND health status score at two years after surgery (external fixation) compared with conservative treatment (spica cast): mean 69 versus 68. The other three trials did not report on function. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up 3 to 24 months) that surgery reduced the risk of malunion (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.15 to 0.59, 4 trials). Assuming an illustrative baseline risk of 115 malunions per 1000 in children treated conservatively, these data equate to 81 fewer (95% CI 47 to 97 fewer) malunions per 1000 in surgically-treated children. Conversely, low quality evidence indicated that there were more serious adverse events such as infections after surgery (RR 2.39, 95% CI 1.10 to 5.17, 4 trials). Assuming an illustrative baseline risk of 40 serious adverse events per 1000 for conservative treatment, these data equate to 56 more (95% CI 4 to 167 more) serious adverse events per 1000 children treated surgically. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with intramedullary nailing than with traction followed by a cast, and that surgery reduced the time taken off from school.

Comparisons of different methods of conservative treatment

The three trials in this category made three different comparisons. We are very unsure if unacceptable malunion rates differ between immediate hip spica versus skeletal traction followed by spica in children aged 3 to 10 years followed up for six to eight weeks (RR 4.0, 95% CI 0.5 to 32.9; one trial, 42 children; very low quality evidence). Malunion rates at 5 to 10 years may not differ between traction followed by functional orthosis versus traction followed by spica cast in children aged 5 to 13 years (RR 0.98, 95% CI 0.46 to 2.12; one trial, 43 children; low quality evidence). We are very unsure (very low quality evidence) if either function or serious adverse events (zero events reported) differ between single-leg versus double-leg spica casts (one trial, 52 young children aged two to seven years). Low quality evidence on the same comparison 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 methods of surgical treatment

The three trials in this category made three different comparisons. Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using elastic stable intramedullary nailing or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) 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. However, there could be more difficulties in plate removal subsequently.

Authors' conclusions

There is insufficient evidence to determine if long-term function differs between surgical and conservative treatment. Surgery results in lower rates of malunion in children aged 4 to 12 years, but may increase the risk of serious adverse events. Elastic stable intramedullary nailing may reduce recovery time.

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.

PLAIN LANGUAGE SUMMARY

Different methods of treating fractures of the shaft of the thigh bone in children and adolescents

Although uncommon, fractures of the femoral shaft (thigh bone) in children may require prolonged treatment in hospital and sometimes surgery. This can cause significant discomfort and can disrupt the lives of the children and their familles. This review compared different methods of treating these fractures. Surgical treatment comprises different methods of fixing the broken bones, such as internally-placed nails, or pins incorporated into an external frame (external fixation). Non-surgical or conservative treatment usually involves different types of plaster casts with or without traction (where a pulling force is applied to the leg).

We searched for studies in the medical literature until August 2013. The review includes 10 randomised or quasi-randomised controlled trials that recruited 527 children. Four trials compared different surgical versus non-surgical treatments; three compared different methods of non-surgical treatment and three compared different methods of surgical treatment. Generally we are unsure about the results of these trials because some were at risk of bias, some results were contradictory and usually there was too little evidence to rule out chance findings. Most trials failed to report on self-assessed function or when children resumed their usual activities.

Comparing surgical versus non-surgical treatment

Low quality evidence (one trial, 101 children) showed children had similar function at two years after having surgery, involving external fixation, compared with those treated with a plaster cast. The other three trials did not report this outcome. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up for 3 to 24 months) that surgery reduced the risk of malunion (the leg is deformed) compared with non-surgical treatment. However, low quality evidence (four trials) indicated that there were more serious adverse events such as infections after surgery. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with surgery involving an internal nail than with traction followed by a cast and that surgery reduced the time taken off from school.

Comparing various non-surgical treatments

Very low quality evidence means that we are very unsure if the rates of malunion differ or not between children treated with immediate plaster casts versus with traction followed by plaster cast (one trial, 42 children), or between children treated with traction followed by either a functional orthosis (a brace or cast that allows some movement) or a cast (one trial, 43 children). We are very unsure if either function or serious adverse events differ between young children (aged two to seven years) immobilised in single-leg versus double-leg casts (one trial, 52 children). However, single-leg casts appear to be easier to manage by parents and more comfortable for the child.

Comparing various surgical treatments

Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using internal nails or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic (less rigid) versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) 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. However, there could be more difficulties in plate removal subsequently.

Conclusions

This review found insufficient evidence to determine if long-term function differs between surgical and conservative treatment of thigh bone fractures in children aged 4 to 12 years. It found surgery resulted in lower rates of malunion but increased the risk of serious adverse events, such as infections. It found internal nailing may speed up recovery.

The review found there was insufficient evidence from comparisons of different methods of non-surgical treatment to clearly show that any type of non-surgical treatment is better than any other. The same conclusion applies to comparisons of different methods of surgical treatment.

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