title: Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).
abstract: Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome.
  
  
  
  We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02).
  
  
  
  Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology Assessment, and presented at relevant conferences.
  
  
  
  ISRCTN64081839; Pre-results.
authors: University of Warwick, University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.
authors: D R
authors: DR
authors: Griffin
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: E J
authors: EJ
authors: Dickenson
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: P D H
authors: PD
authors: Wall
authors: University of Bristol, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors: J L
authors: JL
authors: Donovan
authors: Arthritis Research UK Primary Care Centre, Research Institute of Primary Care and Health Sciences NIHR, Keele University, Keele, UK.
authors: N E
authors: NE
authors: Foster
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: C E
authors: CE
authors: Hutchinson
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: N
authors: N
authors: Parsons
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: S
authors: S
authors: Petrou
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: A
authors: A
authors: Realpe
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: J
authors: J
authors: Achten
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: F
authors: F
authors: Achana
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: A
authors: A
authors: Adams
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: M L
authors: ML
authors: Costa
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: J
authors: J
authors: Griffin
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: R
authors: R
authors: Hobson
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: J
authors: J
authors: Smith
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001182:Arthroscopy / Q000379:methods*; D003362:Cost-Benefit Analysis; D005260:Female; D057925:Femoracetabular Impingement / Q000601:surgery*; D006621:Hip Joint / Q000503:physiopathology*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D026741:Physical Therapy Modalities; D011788:Quality of Life; D012107:Research Design; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
keywords: femoroacetabular impingement; hip arthroscopy; hip impingement; physiotherapy