Department of Physio- and Occupational Therapy, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
BMJ Open. 2021 Oct 22;11(10):e051392. doi: 10.1136/bmjopen-2021-051392.
Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain, and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appears to improve multiple outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary aim of this trial is to investigate whether THA followed by standard care is superior to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT for improving hip pain and function in patients with severe hip OA.
This is a protocol for a multicentre, parallel-group, assessor-blinded, randomised controlled superiority trial conducted at four hospitals across three healthcare regions in Denmark. 120 patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA followed by standard care, or 12 weeks of PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score, from baseline to 6 months after initiating the treatment. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40 m fast-paced walk test, 30 s chair stand test and occurrence of serious adverse events. Patients declining participation in the trial will be invited into a prospective observational cohort study.
The trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158). All results will be presented in peer-reviewed scientific journals and international conferences.
ClinicalTrials.gov (NCT04070027).
髋骨关节炎（OA）是全髋关节置换术（THA）的主要原因。尽管 THA 被认为是本世纪的手术，但仍有 23%的患者报告长期疼痛，并且 THA 后身体功能和肌肉力量的缺陷可能仍然存在。渐进式抗阻训练（PRT）似乎可以适度改善髋 OA 患者的多种结局。目前的治疗选择是基于低水平的证据，因为没有随机对照试验比较过 THA 与非手术治疗。本试验的主要目的是研究 THA 加标准护理是否优于 12 周监督 PRT 加 12 周可选非监督 PRT，以改善严重髋 OA 患者的髋痛和功能。
这是一项在丹麦三个医疗保健区的四家医院进行的多中心、平行组、评估者盲法、随机对照优效性试验的方案。将有 120 名年龄≥50 岁、经骨科医生评估适合 THA 的临床和影像学髋 OA 患者随机分为 THA 加标准护理组或 12 周 PRT 组（1:1 分配）。主要结局是从治疗开始到 6 个月时，使用牛津髋关节评分（Oxford Hip Score）测量的患者报告的髋痛和功能的变化。次要结局包括髋关节残疾和骨关节炎结局评分亚量表、加利福尼亚大学洛杉矶活动评分、40 米快速步伐行走测试、30 秒坐站测试和严重不良事件的变化。拒绝参与试验的患者将被邀请参加前瞻性观察队列研究。
该试验已获得南丹麦地区健康研究伦理委员会的批准（项目编号：S-20180158）。所有结果将在同行评议的科学期刊和国际会议上公布。
ClinicalTrials.gov（NCT04070027）。
