Total hip arthroplasty versus progressive resistance training in patients with severe hip osteoarthritis: protocol for a multicentre, parallel-group, randomised controlled superiority trial

Abstract

IntroductionHip 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.Methods and analysisThis 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.Ethics and disseminationThe 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.Trial registration numberClinicalTrials.gov (NCT04070027).

Patient and public involvement to inform the protocol of a clinical trial comparing total hip arthroplasty with exercise: an exploratory qualitative case study

“…Based on these findings, we included a parallel observational study investigating the generalisability, developed an enrolment procedure using generic guidance and balanced narrative conveyed by an independent clinician to facilitate communication of clinical equipoise, and adopted change in hip pain and function as the primary outcome in the PROHIP trial protocol. 28 Comparison with previous studies and interpretation of findings In line with our findings, a recent qualitative study also found clear and high expectations for surgery among Swedish patients with knee or hip OA. 37 However, several patients reconsidered their treatment options and changed attitudes towards either accepting or declining surgery after participation in a digital non-surgical programme, emphasising the importance of providing sufficient information about management options to facilitate shared-decision-making.…”

“…This study was reported in agreement with the Consolidated Criteria for Reporting Qualitative Research checklist 27 and preceded the Progressive Resistance Training Versus Total Hip Arthroplasty (PROHIP) trial. 28 Written informed consent was obtained from each participant in accordance with the Helsinki Declaration.…”

“…The complete list of inclusion and exclusion criteria has been published previously. 28 Briefly, eligible patients were aged ≥50 years, diagnosed with clinical and radiographic hip OA and considered eligible for THA.…”

Are progressive shoulder exercises feasible in patients with glenohumeral osteoarthritis or rotator cuff tear arthropathy?

“…Adherence to the exercise program was registered by the supervising physiotherapists while adherence to the home-based exercises was registered by the patients in an exercise log. High adherence to the exercise program was a priori defined as participation in > 70% (8 out of 12 sessions) of the supervised exercise sessions; this was similar to other exercise intervention studies [ 18 , 24 , 25 ].…”

“…Similarly, exercise has been shown to potentially postpone or even eliminate the need for arthroplasty in patients with knee OA, exercise has shown to have a significant impact on patient symptoms, physical function, intake of analgesics and sick leave [ 17 ]. Moreover, the effectiveness of exercise therapy is currently under investigation in hip OA [ 18 ].…”