PREHAB FAI- Prehabilitation for patients undergoing arthroscopic hip surgery for Femoroacetabular Impingement Syndrome -Protocol for an assessor blinded randomised controlled feasibility study

Abstract

Background The past decade has seen an exponential growth of minimally invasive surgical procedures. Procedures such as hip arthroscopy have rapidly grown and become the standard of care for patients with Femoroacetabular Impingement Syndrome (FAIS). Although, the results of such procedures are encouraging, a large proportion of patients do not achieve optimal outcomes due to chronicity and deconditioning as a result of delay in diagnosis and increased waiting times amongst other factors. In a recent systematic review and meta-analysis of randomised control trials, moderate certainty evidence supported prehabilitation over standard care in optimising several domains including muscle strength, pain and health related quality of life in patients undergoing orthopaedic surgical interventions. However, the role of prehabilitation in patients with FAI syndrome undergoing hip arthroscopy has received little attention. Aim To evaluate the feasibility, suitability, acceptability and safety of a prehabilitation programme for FAI to inform a future definitive randomised control trial to assess effectiveness. Methods A systematically developed prehabilitation intervention based on a literature review and international consensus will be utilised in this study. A mixed methodology encompassing a two-arm randomised parallel study alongside an embedded qualitative component will be used to answer the study objectives. Patients will be recruited from a tertiary referral NHS centre for young adult hip pathology in the UK. Patient reported outcomes such as iHOT-12, Brief Pain Inventory Scale (Short form), Hospital Anxiety and Depression Scale and Patient Global Impression of Change score will be obtained alongside objective measurements such as Muscle Strength and Star Excursion Balance Test at various time points. Outcome measures will be obtained at baseline (prior to prehabilitation intervention), after prehabilitation before surgery, and at 6 weeks+/- 4 weeks and 6 months +/- 4 weeks (planned primary endpoint for definitive RCT) postoperatively when participants attend the research site for clinical care and remotely at 12 months +/- 4 weeks postoperatively. Mean change and 95% CI, and effect size of outcome measures will be used to determine the sample size for a future RCT. For the qualitative component, in depth face-to-face semi-structured interviews with physiotherapists and focus groups with participants will be conducted to assess the feasibility, suitability, and acceptability of the prehabilitation intervention using a predetermined success criteria. All qualitative data will be recorded, transcribed verbatim and thematically analysed. Discussion This study will be first of its kind to evaluate a systematically developed prehabilitation intervention for patients with FAIS undergoing hip arthroscopy. This study will provide important preliminary data to inform feasibility of a definitive RCT in the future to evaluate effectiveness of a prehabilitation intervention. Trial registration ISRCTN 15371248, 09/03/2023. Trial protocol Version 2.3, 26th June 2023.