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手术与非手术干预治疗髌骨脱位。

Surgical versus non-surgical interventions for treating patellar dislocation.

机构信息

Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.

Trauma and Orthopaedics, St George's University Hospital NHS trust, London, UK.

出版信息

Cochrane Database Syst Rev. 2023 Jan 24;1(1):CD008106. doi: 10.1002/14651858.CD008106.pub4.


DOI:10.1002/14651858.CD008106.pub4
PMID:36692346
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9872769/
Abstract

BACKGROUND: Patellar (knee cap) dislocation occurs when the patella disengages completely from the trochlear (femoral) groove. It affects up to 42/100,000 people, and is most prevalent in those aged 20 to 30 years old. It is uncertain whether surgical or non-surgical treatment is the best approach. This is important as recurrent dislocation occurs in up to 40% of people who experience a first time (primary) dislocation. This can reduce quality of life and as a result people have to modify their lifestyle. This review is needed to determine whether surgical or non-surgical treatment should be offered to people after patellar dislocation. OBJECTIVES: To assess the effects (benefits and harms) of surgical versus non-surgical interventions for treating people with primary or recurrent patellar dislocation. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, AMED, CINAHL, Physiotherapy Evidence Database and trial registries in December 2021. We contacted corresponding authors to identify additional studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled clinical trials evaluating surgical versus non-surgical interventions for treating primary or recurrent lateral patellar dislocation in adults or children. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were recurrent patellar dislocation, and patient-rated knee and physical function scores. Our secondary outcomes were health-related quality of life, return to former activities, knee pain during activity or at rest, adverse events, patient-reported satisfaction, patient-reported knee instability symptoms and subsequent requirement for knee surgery. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included 10 studies (eight randomised controlled trials (RCTs) and two quasi-RCTs) of 519 participants with patellar dislocation. The mean ages in the individual studies ranged from 13.0 to 27.2 years. Four studies included children, mainly adolescents, as well as adults; two only recruited children. Study follow-up ranged from one to 14 years. We are unsure of the evidence for all outcomes in this review because we judged the certainty of the evidence to be very low. We downgraded each outcome by three levels. Reasons included imprecision (when fewer than 100 events were reported or the confidence interval (CI) indicated appreciable benefits as well as harms), risk of bias (when studies were at high risk of performance, detection and attrition bias), and inconsistency (in the event that pooled analysis included high levels of statistical heterogeneity). We are uncertain whether surgery lowers the risk of recurrent dislocation following primary patellar dislocation compared with non-surgical management at two to nine year follow-up. Based on an illustrative risk of recurrent dislocation in 348 people per 1000 in the non-surgical group, we found that 157 fewer people per 1000 (95% CI 209 fewer to 87 fewer) had recurrent dislocation between two and nine years after surgery (8 studies, 438 participants). We are uncertain whether surgery improves patient-rated knee and function scores. Studies measured this outcome using different scales (the Tegner activity scale, Knee Injury and Osteoarthritis Outcome Score, Lysholm, Kujala Patellofemoral Disorders score and Hughston visual analogue scale). The most frequently reported score was the Kujala Patellofemoral Disorders score. This indicated people in the surgical group had a mean score of 5.73 points higher at two to nine year follow-up (95% CI 2.91 lower to 14.37 higher; 7 studies, 401 participants). On this 100-point scale, higher scores indicate better function, and a change score of 10 points is considered to be clinically meaningful; therefore, this CI includes a possible meaningful improvement. We are uncertain whether surgery increases the risk of adverse events. Based on an assumed risk of overall incidence of complications during the first two years in 277 people out of 1000 in the non-surgical group, 335 more people per 1000 (95% CI 75 fewer to 723 more) had an adverse event in the surgery group (2 studies, 144 participants). Three studies (176 participants) assessed participant satisfaction at two to nine year follow-up, reporting little difference between groups. Based on an assumed risk of 763 per 1000 non-surgical participants reporting excellent or good outcomes, seven more participants per 1000 (95% CI 199 fewer to 237 more) reported excellent or good satisfaction. Four studies (256 participants) assessed recurrent patellar subluxation at two to nine year follow-up. Based on an assumed risk of patellar subluxation in 292 out of 1000 in the non-surgical group, 73 fewer people per 1000 (95% CI 146 fewer to 35 more) had patellar subluxation as a result of surgery. Slightly more people had subsequent surgery in the non-surgical group. Pooled two to nine year follow-up data from three trials (195 participants) indicated that, based on an assumed risk of subsequent surgery in 215 people per 1000 in the non-surgical group, 118 fewer people per 1000 (95% CI 200 fewer to 372 more) had subsequent surgery after primary surgery. AUTHORS' CONCLUSIONS: We are uncertain whether surgery improves outcome compared to non-surgical management as the certainty of the evidence was very low. No sufficiently powered trial has examined people with recurrent patellar dislocation. Adequately powered, multicentre, randomised trials are needed. To inform the design and conduct of these trials, expert consensus should be achieved on the minimal description of both surgical and non-surgical interventions, and the pathological variations that may be relevant to both choice of these interventions.

摘要

背景:髌骨(膝盖骨)脱位是指髌骨完全从滑车(股骨)槽中脱出。它影响了多达 42/100,000 的人,在 20 至 30 岁的人群中最为常见。目前尚不确定手术治疗还是非手术治疗是最佳方法。这很重要,因为首次(原发性)脱位后,有多达 40%的人会再次发生脱位。这会降低生活质量,因此人们不得不改变生活方式。需要进行这项综述来确定在发生髌骨脱位后,应该向患者提供手术治疗还是非手术治疗。

目的:评估手术与非手术干预治疗原发性或复发性髌骨脱位的效果(益处和危害)。

检索方法:我们于 2021 年 12 月检索了 Cochrane 骨骼、关节和肌肉创伤组的专业注册库、Cochrane 对照试验中心注册库(CENTRAL)、MEDLINE、Embase、AMED、CINAHL、物理治疗证据数据库和试验注册库。我们联系了相应的作者以确定其他研究。

纳入标准:我们纳入了评估手术与非手术干预治疗成人或儿童原发性或复发性外侧髌骨脱位的随机和准随机对照临床试验。

数据收集与分析:我们使用了标准的 Cochrane 方法。我们的主要结局是复发性髌骨脱位,以及患者自评的膝关节和身体功能评分。我们的次要结局是健康相关生活质量、重返以前的活动、活动或休息时的膝关节疼痛、不良事件、患者报告的满意度、患者报告的膝关节不稳定症状以及随后需要进行膝关节手术。我们使用 GRADE 评估每个结局的证据确定性。

主要结果:我们纳入了 10 项研究(8 项随机对照试验(RCT)和 2 项准 RCT),共纳入了 519 名髌骨脱位患者。个体研究中的平均年龄范围为 13.0 至 27.2 岁。四项研究纳入了儿童,主要是青少年,以及成年人;两项研究仅纳入了儿童。研究随访时间从 1 年到 14 年不等。由于我们判断证据确定性为极低,我们对本综述中的所有结局均不确定。我们将每个结局都降低了三个等级。降级的原因包括:结果不精确(报告的事件少于 100 例,或置信区间表明益处和危害并存)、偏倚风险(当研究存在高偏倚风险时,如高检测、偏倚和失访)以及不一致性(当汇总分析包括高水平的统计学异质性时)。我们不确定与非手术治疗相比,手术是否能降低初次髌骨脱位后两年至九年时复发性脱位的风险。基于非手术组每 1000 人中 348 人发生复发性脱位的风险,我们发现手术组每 1000 人中发生复发性脱位的人数减少了 157 人(95% CI 209 人至 87 人)(8 项研究,438 名参与者)。我们不确定手术是否能提高患者自评的膝关节和功能评分。研究使用了不同的评分量表(Tegner 活动量表、膝关节损伤和骨关节炎结果评分、Lysholm 评分、Kujala 髌股关节紊乱评分和 Hughston 视觉模拟量表)来测量这一结局。最常报告的评分是 Kujala 髌股关节紊乱评分。该评分表明,手术组在两年至九年的随访中平均得分高出 5.73 分(95% CI 2.91 分至 14.37 分;7 项研究,401 名参与者)。在这个 100 分的量表中,分数越高表示功能越好,10 分的变化被认为是有临床意义的;因此,这一 CI 包括了可能的有意义的改善。我们不确定手术是否会增加不良事件的风险。基于非手术组在前两年内每 1000 人中发生并发症的总体发生率为 277 人的假设风险,手术组每 1000 人中发生不良事件的人数增加了 335 人(95% CI 75 人至 723 人)(2 项研究,144 名参与者)。三项研究(176 名参与者)在两年至九年的随访中评估了患者的满意度,结果显示两组之间没有差异。基于非手术组每 1000 人中 763 人报告良好或极好结局的假设风险,手术组每 1000 人中报告良好或极好满意度的人数增加了 7 人(95% CI 199 人至 237 人)。四项研究(256 名参与者)在两年至九年的随访中评估了复发性髌骨半脱位。基于非手术组每 1000 人中 292 人发生髌骨半脱位的假设风险,手术组每 1000 人中发生髌骨半脱位的人数减少了 73 人(95% CI 146 人至 35 人)。非手术组中更多的人需要进行后续手术。三项试验(195 名参与者)的两年至九年随访数据表明,基于非手术组每 1000 人中 215 人需要进行后续手术的假设风险,手术组每 1000 人中需要进行后续手术的人数减少了 118 人(95% CI 200 人至 372 人)。

作者结论:我们不确定手术是否能改善与非手术治疗相比的结局,因为证据确定性非常低。目前还没有足够大的试验研究复发性髌骨脱位患者。需要进行设计合理、多中心、随机试验。为了指导这些试验的设计和实施,应该就手术和非手术干预的最小描述以及可能与这两种干预措施都相关的病理变化达成专家共识。

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