University of Warwick, Coventry, UK; University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.
University of Warwick, Coventry, UK; University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.
Lancet. 2018 Jun 2;391(10136):2225-2235. doi: 10.1016/S0140-6736(18)31202-9. Epub 2018 Jun 1.
BACKGROUND: Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery, including reshaping the hip, or with physiotherapist-led conservative care. We aimed to compare the clinical effectiveness of hip arthroscopy with best conservative care. METHODS: UK FASHIoN is a pragmatic, multicentre, assessor-blinded randomised controlled trial, done at 23 National Health Service hospitals in the UK. We enrolled patients with femoroacetabular impingement syndrome who presented at these hospitals. Eligible patients were at least 16 years old, had hip pain with radiographic features of cam or pincer morphology but no osteoarthritis, and were believed to be likely to benefit from hip arthroscopy. Patients with bilateral femoroacetabular impingement syndrome were eligible; only the most symptomatic hip was randomly assigned to treatment and followed-up. Participants were randomly allocated (1:1) to receive hip arthroscopy or personalised hip therapy (an individualised, supervised, and progressive physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre and was done by research staff at each hospital, using a central telephone randomisation service. Patients and treating clinicians were not masked to treatment allocation, but researchers who collected the outcome assessments and analysed the results were masked. The primary outcome was hip-related quality of life, as measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed in all eligible participants who were allocated to treatment (the intention-to-treat population). This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN64081839, and is closed to recruitment. FINDINGS: Between July 20, 2012, and July 15, 2016, we identified 648 eligible patients and recruited 348 participants: 171 participants were allocated to receive hip arthroscopy and 177 to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (319 of 348 participants). At 12 months after randomisation, mean iHOT-33 scores had improved from 39·2 (SD 20·9) to 58·8 (27·2) for participants in the hip arthroscopy group, and from 35·6 (18·2) to 49·7 (25·5) in the personalised hip therapy group. In the primary analysis, the mean difference in iHOT-33 scores, adjusted for impingement type, sex, baseline iHOT-33 score, and centre, was 6·8 (95% CI 1·7-12·0) in favour of hip arthroscopy (p=0·0093). This estimate of treatment effect exceeded the minimum clinically important difference (6·1 points). There were 147 patient-reported adverse events (in 100 [72%] of 138 patients) in the hip arthroscopy group) versus 102 events (in 88 [60%] of 146 patients) in the personalised hip therapy group, with muscle soreness being the most common of these (58 [42%] vs 69 [47%]). There were seven serious adverse events reported by participating hospitals. Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment, and the one in the personalised hip therapy group was not. There were no treatment-related deaths, but one patient in the hip arthroscopy group developed a hip joint infection after surgery. INTERPRETATION: Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement than did personalised hip therapy, and this difference was clinically significant. Further follow-up will reveal whether the clinical benefits of hip arthroscopy are maintained and whether it is cost effective in the long term. FUNDING: The Health Technology Assessment Programme of the National Institute of Health Research.
背景:髋关节撞击综合征是年轻成年人髋关节疼痛的一个重要原因。它可以通过关节镜髋关节手术治疗,包括髋关节整形,也可以通过物理治疗师主导的保守治疗。我们旨在比较髋关节镜手术与最佳保守治疗的临床疗效。
方法:英国 FASHIoN 是一项多中心、评估者盲法、随机对照试验,在英国 23 家国民保健服务医院进行。我们招募了患有髋关节撞击综合征的患者,这些患者在这些医院就诊。符合条件的患者年龄至少 16 岁,有髋关节疼痛,影像学表现为凸轮或钳夹形态,但没有骨关节炎,并且被认为可能受益于髋关节镜手术。患有双侧髋关节撞击综合征的患者符合条件;只有最有症状的髋关节被随机分配到治疗和随访中。参与者被随机分配(1:1)接受髋关节镜手术或个性化髋关节治疗(一种个体化、监督和渐进的物理治疗师主导的保守治疗计划)。随机分组按撞击类型和招募中心分层,由每家医院的研究人员使用中央电话随机服务进行。患者和治疗临床医生对治疗分配没有被蒙蔽,但收集结果和分析结果的研究人员被蒙蔽。主要结局是髋关节相关生活质量,采用患者报告的国际髋关节结局工具(iHOT-33)在随机分组后 12 个月进行评估,并在接受治疗的所有符合条件的参与者(意向治疗人群)中进行分析。该试验作为国际标准随机对照试验进行注册,编号为 ISRCTN64081839,现已关闭招募。
结果:2012 年 7 月 20 日至 2016 年 7 月 15 日,我们确定了 648 名符合条件的患者,并招募了 348 名参与者:171 名参与者被分配接受髋关节镜手术,177 名参与者接受个性化髋关节治疗。在随机分组后,又有 3 名患者因不符合入选标准而被排除在试验之外。主要结局评估的随访率为 92%(319 名参与者中的 348 名)。随机分组后 12 个月时,髋关节镜组参与者的 iHOT-33 评分从 39.2(20.9)改善至 58.8(27.2),个性化髋关节治疗组从 35.6(18.2)改善至 49.7(25.5)。在主要分析中,调整撞击类型、性别、基线 iHOT-33 评分和中心后,髋关节镜组 iHOT-33 评分的平均差值为 6.8(95%CI 1.7-12.0),有利于髋关节镜手术(p=0.0093)。这一治疗效果估计超过了最小临床重要差异(6.1 分)。髋关节镜组有 147 例患者报告不良事件(138 例患者中的 100 例),个性化髋关节治疗组有 102 例(146 例患者中的 88 例),肌肉酸痛是最常见的不良事件(58 例[42%] vs 69 例[47%])。参与医院报告了 7 例严重不良事件。髋关节镜组的 6 例严重不良事件中有 5 例(83%)与治疗有关,个性化髋关节治疗组的 1 例与治疗无关。没有与治疗相关的死亡病例,但髋关节镜组的 1 例患者术后发生髋关节感染。
解释:髋关节镜手术和个性化髋关节治疗均可改善髋关节撞击综合征患者的髋关节相关生活质量。髋关节镜手术的改善程度大于个性化髋关节治疗,且差异具有临床意义。进一步随访将揭示髋关节镜手术的临床获益是否持续,以及从长期来看是否具有成本效益。
资金:英国国家卫生研究院卫生技术评估计划。
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