Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK
Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Botnar Research Centre, Oxford OX3 7LD, UK.
BMJ. 2019 Feb 7;364:l185. doi: 10.1136/bmj.l185.
OBJECTIVE: To compare arthroscopic hip surgery with physiotherapy and activity modification for improving patient reported outcome measures in patients with symptomatic femoroacetabular impingement (FAI). DESIGN: Two group parallel, assessor blinded, pragmatic randomised controlled trial. SETTING: Secondary and tertiary care centres across seven NHS England sites. PARTICIPANTS: 222 participants aged 18 to 60 years with symptomatic FAI confirmed clinically and with imaging (radiography or magnetic resonance imaging) were randomised (1:1) to receive arthroscopic hip surgery (n=112) or a programme of physiotherapy and activity modification (n=110). Exclusion criteria included previous surgery, completion of a physiotherapy programme targeting FAI within the preceding 12 months, established osteoarthritis (Kellgren-Lawrence grade ≥2), and hip dysplasia (centre-edge angle <20 degrees). INTERVENTIONS: Participants in the physiotherapy group received a goal based programme tailored to individual patient needs, with emphasis on improving core stability and movement control. A maximum of eight physiotherapy sessions were delivered over five months. Participants in the arthroscopic surgery group received surgery to excise the bone that impinged during hip movements, followed by routine postoperative care. MAIN OUTCOME MEASURES: The primary outcome measure was the hip outcome score activities of daily living subscale (HOS ADL) at eight months post-randomisation, with a minimum clinically important difference between groups of 9 points. Secondary outcome measures included additional patient reported outcome measures and clinical assessment. RESULTS: At eight months post-randomisation, data were available for 100 patients in the arthroscopic hip surgery group (89%) and 88 patients in the physiotherapy programme group (80%). Mean HOS ADL was 78.4 (95% confidence interval 74.4 to 82.3) for patients randomised to arthroscopic hip surgery and 69.2 (65.2 to 73.3) for patients randomised to the physiotherapy programme. After adjusting for baseline HOS ADL, age, sex, and study site, the mean HOS ADL was 10.0 points higher (6.4 to 13.6) in the arthroscopic hip surgery group compared with the physiotherapy programme group (P<0.001)). No serious adverse events were reported in either group. CONCLUSIONS: Patients with symptomatic FAI referred to secondary or tertiary care achieve superior outcomes with arthroscopic hip surgery than with physiotherapy and activity modification. TRIAL REGISTRATION: ClinicalTrials.gov NCT01893034.
目的:比较关节镜髋关节手术与物理治疗和活动方式改变,以改善症状性股骨髋臼撞击症(FAI)患者的患者报告结局测量。
设计:两组平行,评估者设盲,实用随机对照试验。
设置:七个英格兰 NHS 地点的二级和三级保健中心。
参与者:222 名年龄在 18 至 60 岁之间的有症状的 FAI 患者,通过临床和影像学(射线照相或磁共振成像)确诊,他们被随机(1:1)分配接受关节镜髋关节手术(n=112)或物理治疗和活动方式改变方案(n=110)。排除标准包括既往手术、在过去 12 个月内完成针对 FAI 的物理治疗方案、已确诊的骨关节炎(Kellgren-Lawrence 分级≥2)和髋关节发育不良(中心边缘角<20 度)。
干预措施:物理治疗组的参与者接受了基于目标的方案,根据患者的个体需求进行定制,重点是改善核心稳定性和运动控制。在五个月内最多提供八次物理治疗。关节镜手术组的参与者接受了切除髋关节运动时受撞击的骨骼的手术,然后进行常规术后护理。
主要结局测量指标:主要结局测量指标是随机分组后 8 个月的髋关节结局评分日常生活活动量表(HOS ADL),组间最小临床差异为 9 分。次要结局测量指标包括其他患者报告结局测量指标和临床评估。
结果:在随机分组后 8 个月时,关节镜髋关节手术组有 100 名患者(89%)和物理治疗方案组有 88 名患者(80%)的数据可用。随机分配到关节镜髋关节手术组的患者的 HOS ADL 平均为 78.4(95%置信区间 74.4 至 82.3),随机分配到物理治疗方案组的患者为 69.2(65.2 至 73.3)。在调整基线 HOS ADL、年龄、性别和研究地点后,与物理治疗方案组相比,关节镜髋关节手术组的 HOS ADL 平均高 10.0 分(6.4 至 13.6)(P<0.001)。两组均未报告严重不良事件。
结论:在二级或三级保健机构就诊的有症状 FAI 患者,与物理治疗和活动方式改变相比,关节镜髋关节手术可获得更好的结局。
试验注册:ClinicalTrials.gov NCT01893034。
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