Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial

BMC Musculoskeletal Disorders

Study Protocol

Libby Spiers¹  Tim V. Wrigley¹  Kim L. Bennell¹  Michelle Hall¹  James M. Linklater²  Phong Tran³  Camdon Fary³  Young Jo Kim⁴  Rachel L. O’Connell⁵  David G. Lloyd⁶  David J. Saxby⁶  Parminder Singh⁷  John O’Donnell⁸  Stephan Reichenbach⁹  Nicholas J. Murphy^1,10  Jillian Eyles^1,10  David J. Hunter^1,10  Sunny Randhawa^1,11  Megan Bohensky^1,12  Michael O’Sullivan^1,13  Alexander Burns^1,14  Robert Molnar^1,15  Fraser M. Callaghan^1,16  Stuart M. Grieve^1,16  Rachel Hobson^1,17  Edward Dickenson^1,17  Damian R. Griffin^1,17 

[1] Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, Melbourne, Australia;Department of Musculoskeletal Imaging, Castlereagh Sports Imaging Centre, St Leonards, NSW, Australia;Department of Orthopaedic Surgery, Western Health, Melbourne, Australia;Australian Institute for Musculoskeletal Science (AIMSS), The University of Melbourne and Western Health, St Albans, Melbourne, VIC, Australia;Department of Orthopedic Surgery, Boston Children’s Hospital, 300 Longwood Avenue, 02115, Boston, MA, USA;Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia;NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia;Gold Coast Orthopaedic Research and Education Alliance, Menzies Health Institute Queensland, Griffith University, Nathan, Australia;School of Allied Health Sciences, Griffith University, Nathan, Australia;Hip Arthroscopy Australia, 21 Erin St, Richmond, VIC, Australia;Maroondah Hospital, Eastern Health, Davey Drive, Ringwood East, 3135, Melbourne, VIC, Australia;Hip Arthroscopy Australia, 21 Erin St, Richmond, VIC, Australia;St Vincent’s Private Hospital, 159 Grey St, East Melbourne, VIC, Australia;Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland;Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Bern, Switzerland;Kolling Institute of Medical Research, Institute of Bone and Joint Research, University of Sydney, Camperdown, Australia;Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia;Macquarie University Hospital, 3 Technology Pl, Macquarie University, 2109, Sydney, NSW, Australia;Melbourne EpiCentre, University of Melbourne, Melbourne, Australia;North Sydney Orthopaedic and Sports Medicine Centre, North Sydney, NSW, Australia;Orthopaedics ACT, 90 Corinna St., 2603, Canberra, Australia;Sydney Orthopaedic Trauma & Reconstructive Surgery, Sydney, NSW, Australia;Sydney Translational Imaging Laboratory, Heart Research Institute, Charles Perkins Centre, University of Sydney, Camperdown, Australia;Sydney Medical School, University of Sydney, Camperdown, Australia;Warwick Medical School, University of Warwick, Coventry, UK and University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK;

关键词: Arthroscopy;    dGEMRIC;    Femoroacetabular impingement syndrome;    Fai;    Hip;    Orthopaedic;    Osteoarthritis;    Physiotherapy;    Surgery;   

DOI  :  10.1186/s12891-017-1767-y

 received in 2017-08-15, accepted in 2017-09-21,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundFemoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management.MethodsThis is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and 12 months. Secondary outcomes include patient-reported outcomes and several structural and biomechanical measures relevant to the pathogenesis of FAI and development of hip OA. Interventions will be compared by intention-to-treat analysis.DiscussionThe findings will help determine whether hip arthroscopy or an individualised physiotherapy program is superior for the management of FAI, including for the prevention of hip OA.Trial registrationAustralia New Zealand Clinical Trials Registry reference: ACTRN12615001177549. Trial registered 2/11/2015 (retrospectively registered).

【 授权许可】

CC BY   
© The Author(s). 2017