Bone and Joint Health, Blizard Institute, Queen Mary University of London, London, UK.
School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Cochrane Database Syst Rev. 2024 Sep 23;9(9):CD005595. doi: 10.1002/14651858.CD005595.pub4.
BACKGROUND: Ankle fracture is one of the most common lower limb fractures. Whilst immobilisation of the ankle can support and protect the fracture site during early healing, this also increases the risk of ankle weakness, stiffness, and residual pain. Rehabilitation aims to address the after-effects of this injury, to improve ankle function and quality of life. Approaches are wide-ranging and include strategies to improve ankle joint movement, muscle strength, or both. This is an update of a Cochrane review last published in 2012. OBJECTIVES: To assess the effects of rehabilitation interventions following surgical or non-surgical management of ankle fractures in adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, three other databases, and two clinical trials registers in May 2022, and conducted additional searches of CENTRAL, MEDLINE, and Embase in March 2023. We also searched reference lists of included studies and relevant systematic reviews. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing any rehabilitation intervention delivered to adults with ankle fracture. Interventions could have been given during or after the initial fracture management period (typically the first six weeks after injury), which may or may not have included surgical fixation. We excluded participants with multi-trauma, pathological fracture, or with established complications secondary to ankle fracture. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We collected data for five outcomes: activity limitation (ankle function), health-related quality of life (HRQoL), participant satisfaction with treatment, pain, and adverse events (we focused on re-operation, defined as unplanned return to theatre). We report the findings up to six months after injury. MAIN RESULTS: We included 53 studies (45 RCTs, 8 quasi-RCTs) with 4489 adults with ankle fracture. In most studies, orthopaedic management included surgical fixation but was non-surgical in five studies, and either surgical or non-surgical in six studies. Here, we summarise the findings for three common rehabilitation comparisons; these included the most data and were the most clinically relevant. Because of different intervention approaches, we sometimes included a study in more than one comparison. Data for other less common comparisons were also available but often included few participants and were imprecise. All studies were unavoidably at high risk of performance and detection bias. We downgraded the certainty of all evidence for this reason. We also downgraded for imprecision and when we noted inconsistencies between studies that precluded meta-analysis of data. Early (within 3 weeks of surgery) versus delayed weight-bearing (12 studies, 1403 participants) Early weight-bearing probably leads to better ankle function (mean difference (MD) 3.56, 95% confidence interval (CI) 1.35 to 5.78; 5 studies, 890 participants; moderate-certainty evidence); however, this does not include a clinically meaningful difference. Early weight-bearing may offer little or no difference to HRQoL compared to delayed weight-bearing (standardised mean difference (SMD) 0.15, 95% CI -0.01 to 0.30; 5 studies, 739 participants; low-certainty evidence); when translated to the EQ-5D scale (a commonly-used HRQoL questionnaire), any small difference was not clinically important. We were unsure whether there were any differences in participant satisfaction or pain because these outcomes had very low-certainty evidence. For adverse events, there may be little or no difference in re-operation (risk ratio (RR) 0.50, 95% CI 0.09 to 2.68; 7 studies, 1007 participants; low-certainty evidence). Removable versus non-removable ankle support (25 studies, 2206 participants) Following surgery, using a removable ankle support may lead to better ankle function (MD 6.39, 95% CI 1.69 to 11.09; 6 studies, 677 participants; low-certainty evidence). This effect included both a clinically important and unimportant difference. There is probably an improvement in HRQoL with a removable ankle support, although this difference included both a clinically important and unimportant difference when translated to the EQ-5D scale (SMD 0.30, 95% CI 0.11 to 0.50; 3 studies, 477 participants; moderate-certainty evidence). No studies reported participant satisfaction. We were unsure of the effects on pain because of very low-certainty evidence (1 study, 29 participants). There may be little or no difference in re-operations (RR 1.20, 95% CI 0.39 to 3.71; 6 studies, 624 participants; low-certainty evidence). Following non-surgical management, there may be little or no difference between removable and non-removable ankle supports in ankle function (MD 1.08, 95% CI -3.18 to 5.34; 3 studies, 399 participants), and HRQoL (SMD -0.04, 95% CI -0.24 to 0.15; 3 studies, 397 participants); low-certainty evidence. No studies reported participant satisfaction. We were unsure of the effects on pain (2 studies, 167 participants), or re-operation because of very low-certainty evidence (1 study, 305 participants). Physical therapy interventions versus usual care or other physical therapy interventions (9 studies, 857 participants) Types of interventions included the use of active controlled motion, a spring-loaded ankle trainer, an antigravity treadmill, and variations of enhanced physiotherapy (e.g. additional stretching, joint mobilisation, neuromuscular exercises), delivered during or after the initial fracture management period. We were unable to pool data because of the differences in the design of interventions and their usual care comparators. Studies often included very few participants. The certainty of the evidence for all outcomes in this comparison was very low, and therefore we were unsure of the effectiveness of these therapies. No studies in this comparison reported re-operation. AUTHORS' CONCLUSIONS: Early weight-bearing may improve outcomes in the first six months after surgery for ankle fracture, but the difference is likely to be small and may not always be clinically important. A removable ankle support may also provide a better outcome, but again, the difference may not always be clinically important. It is likely that neither approach increases the re-operation risk. We assume that the findings for these comparisons are applicable to people with closed ankle fractures, and that satisfactory fracture stabilisation had been achieved with surgery. For people who have non-surgical treatment, there is no evidence that either a removable or non-removable ankle support may be superior. We were uncertain whether any physical therapy interventions were more effective than usual care or other physical therapy interventions. We encourage investigators of future studies on rehabilitation interventions for ankle fracture to use a core outcome set.
背景:踝关节骨折是最常见的下肢骨折之一。虽然在早期愈合过程中对踝关节进行固定可以支撑和保护骨折部位,但这也会增加踝关节无力、僵硬和残留疼痛的风险。康复的目的是解决这种损伤的后遗症,以改善踝关节功能和生活质量。方法多种多样,包括改善踝关节活动度、肌肉力量或两者的策略。这是对 2012 年发表的 Cochrane 综述的更新。
目的:评估成人踝关节骨折手术后或非手术后康复干预的效果。
检索方法:我们于 2022 年 5 月在 Cochrane 图书馆、MEDLINE、Embase 以及其他三个数据库中检索文献,并于 2023 年 3 月在 Cochrane 图书馆、MEDLINE 和 Embase 中进行了额外的检索。我们还检索了纳入研究和相关系统综述的参考文献列表。
纳入标准:我们纳入了比较成人踝关节骨折手术或非手术管理后任何康复干预的随机对照试验(RCT)和准随机对照试验。干预措施可以在骨折管理初期(通常为受伤后 6 周内)进行,也可以在该期间之后进行,这些干预措施可能包括手术固定,也可能不包括。我们排除了有多发伤、病理性骨折或踝关节骨折继发并发症的参与者。
数据收集和分析:我们使用 Cochrane 预期的标准方法学程序。我们收集了五个结局的数据:活动受限(踝关节功能)、健康相关生活质量(HRQoL)、患者对治疗的满意度、疼痛和不良事件(我们主要关注的是再手术,定义为无计划返回手术室)。我们报告了受伤后 6 个月内的发现。
主要结果:我们纳入了 53 项研究(45 项 RCT,8 项准 RCT),涉及 4489 名踝关节骨折患者。在大多数研究中,骨科管理包括手术固定,但有 5 项研究为非手术治疗,6 项研究为手术或非手术治疗。在这里,我们总结了三种常见康复比较的发现;这些研究包含了最多的数据,并且最具临床相关性。由于干预措施的不同,我们有时会将一项研究纳入多个比较。其他不太常见的比较也有数据,但通常参与者较少,且结果不精确。由于不同研究的干预方法不同,我们无法对这些数据进行荟萃分析。所有研究都不可避免地存在高偏倚风险,因此我们降低了所有证据的确定性。我们还降低了证据的确定性,因为我们注意到研究之间存在不一致,这排除了对数据进行荟萃分析的可能性。早期(手术后 3 周内)与延迟负重(12 项研究,1403 名参与者)早期负重可能会改善踝关节功能(平均差异(MD)3.56,95%置信区间(CI)1.35 至 5.78;5 项研究,890 名参与者;中等确定性证据);然而,这并不包括有临床意义的差异。与延迟负重相比,早期负重可能对 HRQoL 几乎没有或没有差异(标准化平均差异(SMD)0.15,95%CI-0.01 至 0.30;5 项研究,739 名参与者;低确定性证据);当转换为 EQ-5D 量表(一种常用的 HRQoL 问卷)时,任何小的差异都没有临床意义。我们不确定患者满意度或疼痛是否存在差异,因为这些结局的证据确定性非常低。对于不良事件,再手术的差异可能很小或没有(风险比(RR)0.50,95%CI 0.09 至 2.68;7 项研究,1007 名参与者;低确定性证据)。可移除与不可移除的踝关节支具(25 项研究,2206 名参与者)手术后,使用可移除的踝关节支具可能会改善踝关节功能(MD 6.39,95%CI 1.69 至 11.09;6 项研究,677 名参与者;低确定性证据)。这种效果包括临床重要和不重要的差异。使用可移除的踝关节支具可能会改善 HRQoL,尽管当转换为 EQ-5D 量表时,这种差异包括有临床意义和无意义的差异(SMD 0.30,95%CI 0.11 至 0.50;3 项研究,477 名参与者;中等确定性证据)。没有研究报告患者满意度。由于证据确定性非常低,我们不确定疼痛的影响(1 项研究,29 名参与者)。可移除与不可移除的踝关节支具在再手术方面可能差异很小或没有(RR 1.20,95%CI 0.39 至 3.71;6 项研究,624 名参与者;低确定性证据)。在非手术治疗后,可移除和不可移除的踝关节支具在踝关节功能(MD 1.08,95%CI-3.18 至 5.34;3 项研究,399 名参与者)和 HRQoL(SMD-0.04,95%CI-0.24 至 0.15;3 项研究,397 名参与者)方面可能差异很小或没有;低确定性证据。没有研究报告患者满意度。由于证据确定性非常低,我们不确定疼痛(2 项研究,167 名参与者)或再手术(1 项研究,305 名参与者)的影响。物理治疗干预与常规护理或其他物理治疗干预(9 项研究,857 名参与者)干预类型包括主动控制运动、弹簧加载踝关节训练器、抗重力跑步机,以及增强型物理治疗的变化(例如额外的伸展、关节松动术、神经肌肉锻炼),在骨折管理初期(通常为受伤后 6 周内)进行。由于干预措施的设计及其常规护理对照存在差异,我们无法对数据进行汇总。研究通常包括很少的参与者。由于所有结局的证据确定性都非常低,因此我们不确定这些疗法的有效性。没有研究报告再手术。
作者结论:踝关节骨折手术后早期负重可能会改善术后 6 个月的结局,但差异可能很小,且可能并不总是具有临床意义。可移除的踝关节支具也可能提供更好的结果,但同样,差异可能并不总是具有临床意义。两种方法都不太可能增加再手术的风险。我们假设这些比较的发现适用于闭合性踝关节骨折患者,并且已经通过手术实现了令人满意的骨折稳定。对于接受非手术治疗的患者,没有证据表明可移除或不可移除的踝关节支具具有优势。我们不确定任何物理治疗干预是否比常规护理或其他物理治疗干预更有效。我们鼓励踝关节骨折康复干预研究的研究人员使用核心结局集。
Cochrane Database Syst Rev. 2024-9-23
Cochrane Database Syst Rev. 2023-11-7
Cochrane Database Syst Rev. 2023-3-3
Cochrane Database Syst Rev. 2022-6-21
Cochrane Database Syst Rev. 2022-2-10
Cochrane Database Syst Rev. 2024-10-29
Cochrane Database Syst Rev. 2022-2-14
Cochrane Database Syst Rev. 2022-2-14
Cochrane Database Syst Rev. 2012-11-14
Cochrane Database Syst Rev. 2021-4-19
Clin Orthop Relat Res. 2025-2-1
J Orthop Surg Res. 2023-1-31