Kerkhoffs G M M J, Handoll H H G, de Bie R, Rowe B H, Struijs P A A
Department of Orthopaedic Surgery, Academic Medical Center, G4-259, Amsterdam, Netherlands, PO Box 22700.
Cochrane Database Syst Rev. 2002(3):CD000380. doi: 10.1002/14651858.CD000380.
BACKGROUND: Inversion injuries, primarily sprains, of the ankle are one of the most commonly treated injuries. The three main treatment modalities for acute lateral ankle ligament injuries are immobilisation with plaster cast or splint, 'functional treatment' comprising early mobilisation and the use of an external support (e.g. ankle brace or taping), and surgical repair or reconstruction. OBJECTIVES: We aimed to compare surgical versus conservative treatment for acute injuries of the lateral ligament complex of the ankle in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (December 2001), the Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001), MEDLINE (1966 to May 2000), EMBASE (1980 to May 2000), CURRENT CONTENTS (1993 to 1999), BIOSIS (to 1999), reference lists of articles, and contacted organisations and researchers in the field. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing surgical with conservative interventions for treating acute injuries to the lateral ligament complex of the ankle in adults. DATA COLLECTION AND ANALYSIS: At least two, usually three, reviewers independently assessed methodological quality and extracted data. Where appropriate, results of comparable studies were pooled using fixed and random effects models and relative risks with 95% confidence intervals for dichotomous outcomes calculated. Heterogeneity between trials was tested using a standard chi-squared test. We undertook sensitivity analyses to explore the effects of inclusion of quasi-randomised trials and subgroup analyses by the two main methods of conservative treatment. MAIN RESULTS: Seventeen studies, involving a total of 1950 mostly young active adult males, were included. All trials had methodological flaws. In particular, allocation was rated as effectively concealed in only one trial and there was no report of masking outcome assessors to the interventions in any trial. Outcome measures were variously defined and data for pooling for individual outcomes were only available for a maximum of 11 studies. While there were statistically significant differences for three primary outcomes (non-return to pre-injury level of sports; undefined pain or pain on activity; and subjective or functional instability) in favour of the surgical treatment group using the fixed effects model, these findings failed to demonstrate robustness in sensitivity analyses. Exclusion of the data from explicitly quasi-randomised trials or, given the highly statistically significant heterogeneity, analyses using the random effects model modified these findings to non-statistically significant differences. There was no statistically significant difference in ankle sprain recurrence, the other primary outcome measure. Though there was a statistically significantly higher incidence of objective instability in conservatively treated patients, the functional implications of this are uncertain. There was some evidence for a lower incidence of long-term ankle swelling in surgically treated patients. However, as well as tending to take longer to resume normal activities, including work, there was some limited evidence from a few trials for a higher incidence of ankle stiffness, impaired ankle mobility and complications in the surgical treatment group. Subgroup analyses by type of conservative treatment (plaster cast or functional treatment) revealed no statistically significant differences in effect for any of the six outcomes examined. REVIEWER'S CONCLUSIONS: There is insufficient evidence available from randomised controlled trials to determine the relative effectiveness of surgical and conservative treatment for acute injuries of the lateral ligament complex of the ankle. Sufficiently powered, good quality and adequately reported randomised trials of primary surgical repair versus the best available conservative treatment for well-defined injuries are required.
背景:踝关节内翻损伤(主要为扭伤)是最常接受治疗的损伤之一。急性外侧踝关节韧带损伤的三种主要治疗方式为用石膏或夹板固定、“功能治疗”(包括早期活动及使用外部支撑物,如踝关节支具或绷带)以及手术修复或重建。 目的:我们旨在比较手术治疗与保守治疗对成人急性外侧踝关节韧带复合体损伤的效果。 检索策略:我们检索了Cochrane肌肉骨骼损伤组专业注册库(2001年12月)、Cochrane对照试验注册库(《Cochrane图书馆》,2001年第4期)、MEDLINE(1966年至2000年5月)、EMBASE(1980年至2000年5月)、《现刊目次》(1993年至1999年)、BIOSIS(至1999年)、文章参考文献列表,并联系了该领域的组织和研究人员。 选择标准:比较手术与保守干预措施治疗成人急性外侧踝关节韧带复合体损伤的随机或半随机对照试验。 数据收集与分析:至少两名,通常为三名,评审员独立评估方法学质量并提取数据。在适当情况下,使用固定效应模型和随机效应模型汇总可比研究的结果,并计算二分结果的相对风险及95%置信区间。使用标准卡方检验检验各试验间的异质性。我们进行了敏感性分析,以探讨纳入半随机试验的影响以及按两种主要保守治疗方法进行的亚组分析。 主要结果:纳入了17项研究,共涉及1950名大多为年轻活跃成年男性的受试者。所有试验均存在方法学缺陷。特别是,仅在一项试验中分配被评为有效隐藏,且在任何试验中均未报告对结果评估者遮蔽干预措施。结局指标定义各异,且最多只有11项研究可获得用于汇总个体结局的数据。虽然使用固定效应模型时,在三个主要结局(未恢复至伤前运动水平;未明确的疼痛或活动时疼痛;主观或功能不稳定)方面手术治疗组有统计学显著差异,但这些结果在敏感性分析中未显示出稳健性。排除明确半随机试验的数据,或者鉴于统计学上高度显著的异质性,使用随机效应模型进行分析后,这些结果变为无统计学显著差异。踝关节扭伤复发这一其他主要结局指标无统计学显著差异。虽然保守治疗患者中客观不稳定的发生率在统计学上显著更高,但其功能影响尚不确定。有一些证据表明手术治疗患者长期踝关节肿胀的发生率较低。然而,手术治疗组不仅恢复正常活动(包括工作)往往需要更长时间,而且少数试验有一些有限证据表明踝关节僵硬、踝关节活动度受损及并发症的发生率更高。按保守治疗类型(石膏固定或功能治疗)进行的亚组分析显示,在所检查的六个结局中,任何一个结局的效果均无统计学显著差异。 评审员结论:随机对照试验中没有足够证据来确定手术和保守治疗对急性外侧踝关节韧带复合体损伤的相对有效性。需要进行足够样本量、高质量且报告充分的随机试验,以比较初次手术修复与针对明确损伤的最佳可用保守治疗。
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