Title: UK Full Randomised Controlled Trial of Arthroscopic Surgery for Hip Impingement versus best coNventional Care (UK FASHIoN)
Funder: Department of Health and Social Care

Abstract: This is a pragmatic multi-centre randomised controlled trial of hip arthroscopy versus best conventional care for femoro-acetabular impingement (FAI). In patients with symptomatic FAI, aged at least 16 years, we will determine whether hip arthroscopy provides a beneficial effect in patient-reported quality of life compared with personalised hip therapy (PHT, a protocol for best conservative care). We will also compare patient satisfaction, need for further procedures, risk of complications and cost-effectiveness for the two treatment strategies. We have performed a feasibility study which demonstrated satisfactory recruitment rates and enabled us to develop inclusion criteria, outcome measures and trial procedures. As part of this feasibility study, an internal pilot trial has already recruited 42 patients. A further 302 patients (344 including pilot patients) will be recruited from 25 hospitals throughout the UK over 20 months. Patients will be randomly allocated to one of the two trial treatments and followed up at three, six and 12 months. The primary outcome is the International Hip Outcome Tool-33 (IHOT-33) score at 12 months. iHOT-33 is a patient reported quality of life tool specifically designed for young adults experiencing pre-arthritic hip pain. Secondary outcome measures include number and type of adverse events, need for further procedures, health related quality of life and patients satisfaction. The incremental cost and cost-effectiveness of hip arthroscopy and PHT will be evaluated from the NHS and societal perspectives; with cost-effectiveness being calculated using both within trial and lifetime horizons. An integrated programme of qualitative research will ensure successful recruitment and exploration of fidelity to treatment interventions, and provide detailed understanding about patients’ trial experiences and outcomes

Lay abstract: The hip joint has two bones that fit together like a ball in a socket. In some people these bones press against each other and can cause pain. The medical term for this is femoroacetabular impingement (FAI for short). Parts of the hip called the “labrum” and “cartilage” cushion the hip joint and allows smooth friction free movement. FAI can injure both the labrum and cartilage and also cause pain. There is now good evidence to suggest a link between FAI and the development of premature osteoarthritis (wear and tear) of the hip. But we do not know how best to treat FAI. There has been a rapid growth around the world and in the NHS to use keyhole surgery to treat this condition. This operation is called “hip arthroscopy”. During hip arthroscopy the patient is put to sleep, the surgeon passes a small telescope and tools into the hip joint through small cuts in the skin. The tools are used to reshape bone around the hip to prevent further impingement. Many patients have already undergone surgery and had improvements in pain and hip function in the short to medium term. However, this research was not compared to conventional care and it is possible that they may have similar levels of improvement without an operation. An alternative treatment option for patients is a course of best conventional care (a structured programme of exercised based care supervised by a physiotherapist - this has been called personalised hip therapy), aimed at improving the muscle strength and control around the hip joint. There are fewer risks associated with this type of treatment and it is less expensive. We therefore propose a randomised controlled trial (RCT) to determine which of these two treatments is most effective for treating patients with FAI upto 12 months after treatment. We have already performed a pilot version of this study and recruited 42 patients. A further 302 patients will need to be recruited to complete a full RCT. Patients who agree to take part will be allocated to one of the two treatments and complete follow up questinnaires about their hip, general health, any complications and any out of pocket expenses as a result of treatment at 6 and 12 months. We plan to recruit patients from 25 hospitals throughout the UK over 20 months and the proposed study will take 50 months to complete. A dedicated research team who are experienced in managing recruitment problems and offering solutions will help the centres to recruit patients. We will report the results of our study widely, through both public channels such as social media and routine professional medical journals and conferences. The aim will be to ensure that in just less than five years both patients with FAI and healthcare professionals managing FAI will know what the best treatment is.

Research activity codes: 6.4 SURGERY;6.7 PHYSICAL
Health categories: MUSCULOSKELETAL