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

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Murphy, N. J., Eyles, J., Bennell, K. L., Bohensky, M., Burns, A., Callaghan, F. M., Dickenson, Edward J., Fary, C., Grieve, S. M., Griffin, Damian R. et al.
(2017) 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, 18 . p. 13. 406. doi:10.1186/s12891-017-1767-y ISSN 1471-2474.

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Official URL: https://doi.org/10.1186/s12891-017-1767-y

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Abstract

Background:
Femoroacetabular 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.

Methods:
This 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.

Discussion:
The 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 registration:
Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549. Trial registered 2/11/2015 (retrospectively registered).

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
R Medicine > RD Surgery
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Arthroscopy, Hip joint -- Surgery, Arthritis -- Surgery
Journal or Publication Title: BMC Musculoskeletal Disorders
Publisher: Biomed central
ISSN: 1471-2474
Official Date: 26 September 2017
Dates:
DateEvent
26 September 2017Published
21 September 2017Accepted
Volume: 18
Page Range: p. 13
Article Number: 406
DOI: 10.1186/s12891-017-1767-y
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 17 July 2018
Date of first compliant Open Access: 30 July 2018
Funder: Australian Hip Arthroscopy Education and Research Foundation
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
APP1069278National Health and Medical Research Councilhttp://dx.doi.org/10.13039/501100000925
UNSPECIFIED[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
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