Tailored physiotherapy rehabilitation after revision total hip replacement: a feasibility randomised controlled trial
Musculoskeletal and orthopaedics; elective orthopaedic surgery; arthrosis
Study design: A multicentre, parallel two-arm feasibility RCT with an embedded qualitative study to explore acceptability. Timeframe: The study duration will be 24 months. This will include site set-up, recruitment, intervention and follow-ups (final at 8 months post-surgery), participant and clinician qualitative interviews, data analysis, interpretation and report of findings, and preparation for a full, definitive trial if indicated. The study will start recruiting from Oxford University Hospitals Trust first, then a staged set-up of 3 other NHS sites. Randomisation: Following the collection of baseline data and reconfirmation of eligibility and consent after total hip arthroplasty (THA) operation, eligible patients will be randomised in a 1:1 ratio between the intervention and usual care groups using a web-based centralised randomisation database (SealedEnvelope™), which will be managed by the trial manager. Stratified permuted blocks will be used, with the following stratification criteria: sex and site. The blocks will be of random sizes. Setting: Secondary care NHS hospitals. Study participants: The study aims to recruit at least 60 participants (30 in each arm), which is the recommended sample size for a feasibility trial. The target population is adults undergoing a single-stage or final-stage revision of THA. Participant involvement duration: Participants will be involved in the trial for approximately 9 months. This includes a pre-operative screening and recruitment, pre-operative baseline assessment, 4-month and 8-month post-operative assessments for all participants. Participants in the THRIVE intervention arm will receive an initial physiotherapy evaluation and 5-8 visits over 12 weeks, plus 2 follow-up phone calls. The Usual Care arm will receive an initial physiotherapy evaluation and up to 2 visits over 12 weeks. A subset of participants from both arms will be asked to take part in a qualitative interview. In addition, a subset of physiotherapi
1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Undergoing a single-stage rTHA or the final stage of a multi-stage rTHA 4. Independently mobile (with or without an assistive device)
1. Planned lower limb surgery within 8 months 2. Conditions or comorbidities that make participation in an exercise programme unsafe (e.g. severe acute or unstable cardiovascular or pulmonary disease,or undergoing radiotherapy or chemotherapy for cancer treatment) 3. Other neurological or medical conditions that would prevent physical measures from being collected