Bone and Joint Health, Blizard Institute, Queen Mary University of London, London, UK.
Warwick Medical School, University of Warwick, Coventry, UK.
Cochrane Database Syst Rev. 2023 Nov 7;11(11):CD008628. doi: 10.1002/14651858.CD008628.pub3.
Fractures of the calcaneus (heel bone) comprise up to 2% of all fractures. These fractures are mostly caused by a fall from a height, and are common in younger adults. Treatment can be surgical or non-surgical; however, there is clinical uncertainty over optimal management. This is an update of a Cochrane Review first published in 2013.
To assess the effects (benefits and harms) of surgical versus conservative treatment of displaced intra-articular calcaneal fractures.
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL, MEDLINE, Embase, and clinical trials registers in November 2022.
We included randomised controlled trials (RCTs) and quasi-RCTs comparing surgical versus non-surgical management of displaced intra-articular calcaneal fractures in skeletally mature adults (older than 14 years of age). For surgical treatment, we included closed manipulation with percutaneous wire fixation, open reduction with internal fixation (ORIF) with or without bone graft, or primary arthrodesis. For non-surgical treatment, we included ice, elevation and rest, or plaster cast or splint immobilisation.
We used standard Cochrane methodological procedures. We collected data for the following outcomes: function in the short term (within three months of injury) or long term (more than three months after injury), chronic pain, health-related quality of life (HRQoL) and ability to return to normal activities, as well as complications which may or may not have led to an unplanned return to theatre.
We included 10 RCTs and two quasi-RCTs with 1097 participants. Sample sizes in studies ranged from 29 to 424 participants. Most participants were male (86%), and the mean age in studies ranged from 28 to 52 years. In the surgical groups, participants were mostly managed with ORIF with plates, screws, or wires; one study used only minimally invasive techniques. Participants in the non-surgical groups were managed with a plaster cast, removable splint or a bandage, or with rest, elevation, and sometimes ice. Risk of performance bias was unavoidably high in all studies as it was not possible to blind participants and personnel to treatment; in addition, some studies were at high or unclear risk of other types of bias (including high risk of selection bias for quasi-RCTs, high risk of attrition bias, and unclear risk of selective reporting bias). We downgraded the certainty of all the evidence for serious risk of bias. We also downgraded the certainty of the evidence for imprecision for all outcomes (except for complications requiring return to theatre for subtalar arthrodesis) because the evidence was derived from few participants. We downgraded the evidence for subtalar arthrodesis for inconsistency because the pooled data included high levels of statistical heterogeneity. We found that surgical management may improve function at six to 24 months after injury when measured using the American Orthopaedic Foot and Ankle Society (AOFAS) score (mean difference (MD) 6.58, 95% confidence interval (CI) 1.04 to 12.12; 5 studies, 319 participants; low-certainty evidence). We are not aware of a published minimal clinically important difference (MCID) for the AOFAS score for this type of fracture. Previously published MCIDs for other foot conditions range from 2.0 to 7.9. No studies reported short-term function within three months of injury. Surgical management may reduce the number of people with chronic pain up to 24 months after injury (risk ratio (RR) 0.56, 95% CI 0.37 to 0.84; 4 studies, 175 participants; low-certainty evidence); this equates to 295 per 1000 fewer people with pain after surgical management (95% CI 107 to 422 per 1000). Surgical management may also lead to improved physical HRQoL (MD 6.49, 95% CI 2.49 to 10.48; 2 studies, 192 participants; low-certainty evidence). This outcome was measured using the physical component score of the 36-Item Short Form Health Survey. We used a change in effect of 5% to indicate a clinically important difference for this scoring system and thus judged that the difference in HRQoL between people treated surgically or non-surgically includes both clinically relevant and not relevant changes for those treated surgically. There may be little or no difference in the number of people who returned to work within 24 months (RR 1.26, 95% CI 0.94 to 1.68; 5 studies, 250 participants; low-certainty evidence) or who require secondary surgery for subtalar arthrodesis (RR 0.38, 95% CI 0.09 to 1.53; 3 studies, 657 participants; low-certainty evidence). For other complications requiring return to theatre in people treated surgically, we found low-certainty evidence for amputation (2.4%; 1 study, 42 participants), implant removal (3.4%; 3 studies, 321 participants), deep infection (5.3%; 1 study, 206 participants), and wound debridement (2.7%; 1 study, 73 participants). We found low-certainty evidence that 14% of participants who were treated surgically (7 studies, 847 participants) had superficial site infection.
AUTHORS' CONCLUSIONS: Our confidence in the evidence is limited. Although pooled evidence indicated that surgical treatment may lead to improved functional outcome but with an increased risk of unplanned second operations, we judged the evidence to be of low certainty as it was often derived from few participants in studies that were not sufficiently robust in design. We found no evidence of a difference between treatment options in the number of people who needed late reconstruction surgery for subtalar arthritis, although the estimate included the possibility of important harms and benefits. Large, well-conducted studies that attempt to minimise detection bias and that measure functional outcomes using calcaneal-specific measurement tools would increase the confidence in these findings. Given that minimally invasive surgical procedures are already becoming more prevalent in practice, research is urgently needed to determine whether these newer surgical techniques offer better outcomes with regard to function, pain, quality of life, and postoperative complications for intra-articular displaced calcaneal fractures.
跟骨骨折(足跟骨)约占所有骨折的 2%。这些骨折主要由高处坠落引起,常见于年轻成年人。治疗方法可以是手术或非手术;然而,对于最佳治疗方法,临床上存在不确定性。这是 2013 年首次发表的 Cochrane 综述的更新。
评估手术与保守治疗移位性关节内跟骨骨折的疗效(益处和危害)。
我们于 2022 年 11 月在 Cochrane 骨骼、关节和肌肉创伤组专业注册库、CENTRAL、MEDLINE、Embase 和临床试验登记处检索了随机对照试验(RCT)和准 RCT。
我们纳入了比较成熟成年人(年龄大于 14 岁)移位性关节内跟骨骨折手术与非手术治疗的 RCT 和准 RCT。对于手术治疗,我们纳入了闭合手法复位经皮钢丝固定、切开复位内固定(ORIF)联合或不联合植骨、或一期关节融合术。对于非手术治疗,我们纳入了冰敷、抬高和休息、石膏或夹板固定。
我们使用了标准的 Cochrane 方法学程序。我们收集了以下结果的数据:伤后三个月内或三个月后短期(伤后三个月内)或长期(伤后三个月以上)功能、慢性疼痛、健康相关生活质量(HRQoL)和恢复正常活动的能力,以及可能或不可能导致计划外再次手术的并发症。
我们纳入了 10 项 RCT 和两项准 RCT,共 1097 名参与者。研究中的样本量范围为 29 至 424 名参与者。大多数参与者为男性(86%),研究中的平均年龄范围为 28 至 52 岁。在手术组中,参与者主要接受 ORIF 联合钢板、螺钉或钢丝治疗;一项研究仅使用微创技术。非手术组的参与者接受石膏、可移动夹板或绷带固定,或接受休息、抬高,有时还接受冰敷。由于无法对参与者和人员进行治疗,因此所有研究中的绩效偏倚风险不可避免地很高;此外,一些研究存在其他类型偏倚的高风险或不确定性(包括准 RCT 选择偏倚高风险、失访偏倚高风险和选择性报告偏倚不确定性)。我们将所有结局的严重偏倚风险的证据质量均降级为非常低。由于证据来源于少数参与者,我们还将所有结局(除了需要行距下关节融合术的并发症)的精确性证据质量降级为非常低。我们将距下关节融合术的证据质量降级为不一致,因为汇总数据包含高水平的统计学异质性。我们发现,手术治疗可能会改善伤后 6 至 24 个月时的功能,使用美国矫形足踝协会(AOFAS)评分测量(平均差值(MD)6.58,95%置信区间(CI)1.04 至 12.12;5 项研究,319 名参与者;低质量证据)。我们不知道这种骨折类型的 AOFAS 评分的最小临床重要差异(MCID)。以前发表的其他足部疾病的 MCID 范围为 2.0 至 7.9。没有研究报告伤后三个月内的短期功能。手术治疗可能会减少 24 个月时慢性疼痛的人数(风险比(RR)0.56,95%CI 0.37 至 0.84;4 项研究,175 名参与者;低质量证据);这相当于手术后每 1000 人中减少 295 人疼痛(95%CI 每 1000 人中 107 至 422 人)。手术治疗也可能改善身体 HRQoL(MD 6.49,95%CI 2.49 至 10.48;2 项研究,192 名参与者;低质量证据)。这一结果是使用 36 项简短健康调查的物理成分评分来衡量的。我们使用 5%的效果变化来表示对评分系统的临床相关差异,因此我们判断接受手术或非手术治疗的患者之间的 HRQoL 差异既包括对接受手术治疗的患者的临床相关变化,也包括不相关变化。在 24 个月内返回工作岗位的人数(RR 1.26,95%CI 0.94 至 1.68;5 项研究,250 名参与者;低质量证据)或需要行距下关节融合术的二次手术的人数(RR 0.38,95%CI 0.09 至 1.53;3 项研究,657 名参与者;低质量证据)可能差异不大或没有差异。对于手术治疗患者需要再次手术的其他并发症,我们发现低质量证据表明截肢(2.4%;1 项研究,42 名参与者)、植入物取出(3.4%;3 项研究,321 名参与者)、深部感染(5.3%;1 项研究,206 名参与者)和伤口清创(2.7%;1 项研究,73 名参与者)。我们发现低质量证据表明,接受手术治疗的 14%(7 项研究,847 名参与者)有浅表部位感染。
我们对证据的信心有限。尽管汇总证据表明手术治疗可能会改善功能结局,但风险是需要进行计划外的二次手术,我们判断证据质量为低,因为它通常来自研究中很少的参与者,而且这些研究在设计上不够稳健。我们没有发现治疗方案之间在需要进行距下关节炎晚期重建手术的人数方面存在差异,尽管估计结果包括重要的获益和危害。进行更大规模、设计良好的研究,尝试最小化检测偏倚并使用跟骨特异性测量工具来测量功能结局,将提高对这些发现的信心。鉴于微创外科手术已经越来越普及,因此迫切需要研究来确定对于关节内移位性跟骨骨折,这些新技术是否在功能、疼痛、生活质量和术后并发症方面提供了更好的结果。