Protocol for the Femoroacetabular Impingement Trial (FAIT): a multi-centre randomised controlled trial comparing surgical and non-surgical management of femoroacetabular impingement

Bone Joint Res. 2014 Nov;3(11):321-7. doi: 10.1302/2046-3758.311.2000336.

Abstract

Aims: Femoroacetabular Junction Impingement (FAI) describes abnormalities in the shape of the femoral head-neck junction, or abnormalities in the orientation of the acetabulum. In the short term, FAI can give rise to pain and disability, and in the long-term it significantly increases the risk of developing osteoarthritis. The Femoroacetabular Impingement Trial (FAIT) aims to determine whether operative or non-operative intervention is more effective at improving symptoms and preventing the development and progression of osteoarthritis.

Methods: FAIT is a multicentre superiority parallel two-arm randomised controlled trial comparing physiotherapy and activity modification with arthroscopic surgery for the treatment of symptomatic FAI. Patients aged 18 to 60 with clinical and radiological evidence of FAI are eligible. Principal exclusion criteria include previous surgery to the index hip, established osteoarthritis (Kellgren-Lawrence ≥ 2), hip dysplasia (centre-edge angle < 20°), and completion of a physiotherapy programme targeting FAI within the previous 12 months. Recruitment will take place over 24 months and 120 patients will be randomised in a 1:1 ratio and followed up for three years. The two primary outcome measures are change in hip outcome score eight months post-randomisation (approximately six-months post-intervention initiation) and change in radiographic minimum joint space width 38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Bone Joint Res 2014;3:321-7.

Keywords: Femoroacetabular Impingment; Hip Arthroscopy; Osteoarthritis; Physiotherapy; Randomised Controlled Trial.

Associated data

  • ClinicalTrials.gov/NCT01893034

Grants and funding

Support is received from the NIHR Oxford Musculoskeletal Biomedical Research Unit, Thames Valley Clinical Research Network, Arthritis Research UK Centre of Excellence for Sports, Exercise and Osteoarthritis, a Royal College of Surgeons and Dunhill Medical Trust Research Fellowship, and Orthopaedic Research UK. The funding sources have no role in the design, execution, data analysis, or publication of this study. Mr Andrade reports consultancy fees and payment for lectures from Smith & Nephew. Mr Hollinghurst reports consultancy fees from Arthrex Stryker and Mr Taylor reports payment for lectures from Teaching Zimmer/Corin, none of which are related to this article.