Acetabular Fractures in older patients Intervention Trial - Global (AceFIT-G)

Research Question In adults aged =55 years with a surgically treated acetabular fracture, what is the clinical and cost-effectiveness of surgical fixation alone ("fix") compared with fixation followed by immediate total hip replacement ("fix & replace") Background Acetabular fractures in older adults are increasingly common and devastating. Patients often face prolonged immobility, long hospital stays, and permanent loss of independence. Standard fixation typically prevents weight-bearing for months, contributing to poor recovery and the need for later hip replacement in up to 30% of people. An alternative surgical strategy, "fix & replace", combines fixation with total hip arthroplasty during the same admission. It offers earlier mobility and a potential reduction in some complications but also may pose greater perioperative risk. Use of this strategy is growing in the NHS, despite lack of high-quality comparative evidence. This uncertainty is a James Lind Alliance top-ten priority for complex fracture research. Methods Design: Pragmatic, multinational, parallel-group, individual-randomised controlled superiority trial with integrated UK-focussed health economic evaluation and internal pilot. Settings: 20 UK NHS hospitals and up to 30 international sites with strong track records in orthopaedic trauma trials. Participants: 590 (300 in the UK) adults =55 years with native acetabular fractures, eligible for surgery and for whom the treating surgeon considers that acute hip replacement may be an appropriate treatment. Interventions: Participants will be randomised 1:1 to receive either fixation alone or fixation and total hip replacement during the index admission. Primary Outcome: A hierarchical composite outcome (analysed as a Win Ratio) assessed at six months from randomisation, comprising (1) all-cause mortality, (2) ambulatory status, and (3) EQ-5D-5L utility. Secondary Outcomes: Individual components of the primary composite outcome, adverse events, unplanned surgeries, health-related quality-of-life at 2, 6 and 12 months, and incremental cost-effectiveness over 12 months and modelled over five years. Analysis: Primary analysis will use a stratified Win Ratio. Health resource use will be captured via patient reports, study forms and routine health data linkage and costed using UK reference costs. QALYs will be estimated using EQ-5D-5L utility and mortality data. Decision analytic modelling will inform extrapolation of outcomes and costs and cost-effectiveness over 5 years. Timelines for Delivery Commencing April 2026 with a total duration of 60 months: six months setup, 12 months internal pilot, 24 months definitive trial recruitment, 12 months follow-up and six months for analysis and reporting. An internal pilot at 12 months will assess recruitment and international funding feasibility, with clear stop–go criteria in place. Anticipated Impact and Dissemination This will be the first definitive randomised trial comparing “fix” with “fix & replace” for acetabular fractures in older adults. The results will guide surgical decisions, standardise NHS and global practice, and support the next NICE guideline update (NG37, 2032). If “fix & replace” delivers earlier recovery and avoids costly delayed hip replacements, it could unlock substantial NHS savings. Dissemination will include plain-language materials (leaflets, videos) co-produced with patients, open-access publications, and presentations at professional society conferences.