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

Nicholas J Murphy^{1

2}, Jillian Eyles^{1

2}, Kim L Bennell³, Megan Bohensky⁴, Alexander Burns⁵, Fraser M Callaghan^{6

7}, Edward Dickenson⁸, Camdon Fary^{9

10}, Stuart M Grieve^{6

7}, Damian R Griffin⁸, Michelle Hall³, Rachel Hobson⁸, Young Jo Kim¹¹, James M Linklater¹², David G Lloyd^{13

14}, Robert Molnar¹⁵, Rachel L O'Connell^{2

16}, John O'Donnell^{17

18}, Michael O'Sullivan¹⁹, Sunny Randhawa²⁰, Stephan Reichenbach^{21

22}, David J Saxby^{13

14}, Parminder Singh^{17

23}, Libby Spiers³, Phong Tran^{9

10}, Tim V Wrigley³, David J Hunter^{24

25}

Affiliations

¹ Kolling Institute of Medical Research, Institute of Bone and Joint Research, University of Sydney, Camperdown, Australia.
² Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia.
³ Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, Melbourne, Australia.
⁴ Melbourne EpiCentre, University of Melbourne, Melbourne, Australia.
⁵ Orthopaedics ACT, 90 Corinna St., Canberra, 2603, Australia.
⁶ Sydney Translational Imaging Laboratory, Heart Research Institute, Charles Perkins Centre, University of Sydney, Camperdown, Australia.
⁷ Sydney Medical School, University of Sydney, Camperdown, Australia.
⁸ Warwick Medical School, University of Warwick, Coventry, UK and University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.
⁹ Department of Orthopaedic Surgery, Western Health, Melbourne, Australia.
¹⁰ Australian Institute for Musculoskeletal Science (AIMSS), The University of Melbourne and Western Health, St Albans, Melbourne, VIC, Australia.
¹¹ Department of Orthopedic Surgery, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA, 02115, USA.
¹² Department of Musculoskeletal Imaging, Castlereagh Sports Imaging Centre, St Leonards, NSW, Australia.
¹³ Gold Coast Orthopaedic Research and Education Alliance, Menzies Health Institute Queensland, Griffith University, Nathan, Australia.
¹⁴ School of Allied Health Sciences, Griffith University, Nathan, Australia.
¹⁵ Sydney Orthopaedic Trauma & Reconstructive Surgery, Sydney, NSW, Australia.
¹⁶ NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.
¹⁷ Hip Arthroscopy Australia, 21 Erin St, Richmond, VIC, Australia.
¹⁸ St Vincent's Private Hospital, 159 Grey St, East Melbourne, VIC, Australia.
¹⁹ North Sydney Orthopaedic and Sports Medicine Centre, North Sydney, NSW, Australia.
²⁰ Macquarie University Hospital, 3 Technology Pl, Macquarie University, Sydney, NSW, 2109, Australia.
²¹ Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
²² Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Bern, Switzerland.
²³ Maroondah Hospital, Eastern Health, Davey Drive, Ringwood East, Melbourne, VIC, 3135, Australia.
²⁴ Kolling Institute of Medical Research, Institute of Bone and Joint Research, University of Sydney, Camperdown, Australia. david.hunter@sydney.edu.au.
²⁵ Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia. david.hunter@sydney.edu.au.

PMID: 28950859
PMCID: PMC5615805
DOI: 10.1186/s12891-017-1767-y

Randomized Controlled Trial

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

Nicholas J Murphy et al. BMC Musculoskelet Disord. 2017.

. 2017 Sep 26;18(1):406.

doi: 10.1186/s12891-017-1767-y.

Authors

Affiliations

¹ Kolling Institute of Medical Research, Institute of Bone and Joint Research, University of Sydney, Camperdown, Australia.
² Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia.
³ Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, University of Melbourne, Melbourne, Australia.
⁴ Melbourne EpiCentre, University of Melbourne, Melbourne, Australia.
⁵ Orthopaedics ACT, 90 Corinna St., Canberra, 2603, Australia.
⁶ Sydney Translational Imaging Laboratory, Heart Research Institute, Charles Perkins Centre, University of Sydney, Camperdown, Australia.
⁷ Sydney Medical School, University of Sydney, Camperdown, Australia.
⁸ Warwick Medical School, University of Warwick, Coventry, UK and University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.
⁹ Department of Orthopaedic Surgery, Western Health, Melbourne, Australia.
¹⁰ Australian Institute for Musculoskeletal Science (AIMSS), The University of Melbourne and Western Health, St Albans, Melbourne, VIC, Australia.
¹¹ Department of Orthopedic Surgery, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA, 02115, USA.
¹² Department of Musculoskeletal Imaging, Castlereagh Sports Imaging Centre, St Leonards, NSW, Australia.
¹³ Gold Coast Orthopaedic Research and Education Alliance, Menzies Health Institute Queensland, Griffith University, Nathan, Australia.
¹⁴ School of Allied Health Sciences, Griffith University, Nathan, Australia.
¹⁵ Sydney Orthopaedic Trauma & Reconstructive Surgery, Sydney, NSW, Australia.
¹⁶ NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.
¹⁷ Hip Arthroscopy Australia, 21 Erin St, Richmond, VIC, Australia.
¹⁸ St Vincent's Private Hospital, 159 Grey St, East Melbourne, VIC, Australia.
¹⁹ North Sydney Orthopaedic and Sports Medicine Centre, North Sydney, NSW, Australia.
²⁰ Macquarie University Hospital, 3 Technology Pl, Macquarie University, Sydney, NSW, 2109, Australia.
²¹ Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
²² Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Bern, Switzerland.
²³ Maroondah Hospital, Eastern Health, Davey Drive, Ringwood East, Melbourne, VIC, 3135, Australia.
²⁴ Kolling Institute of Medical Research, Institute of Bone and Joint Research, University of Sydney, Camperdown, Australia. david.hunter@sydney.edu.au.
²⁵ Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia. david.hunter@sydney.edu.au.

PMID: 28950859
PMCID: PMC5615805
DOI: 10.1186/s12891-017-1767-y

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).

Keywords: Arthroscopy; Fai; Femoroacetabular impingement syndrome; Hip; Orthopaedic; Osteoarthritis; Physiotherapy; Surgery; dGEMRIC.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

This protocol has been approved by St Vincent’s Hospital Human Research Ethics Committee (HREC/14/SVH/343). Informed consent was obtained from all study participants before participation in the study.

Competing interests

DJH is a consultant to Flexion, TissueGene and Merck Serono and is supported by an NHMRC Practitioner Fellowship. KLB is supported by a NHMRC Principal Research Fellowship. DRG is a consultant for Stryker UK. MH is a member of the Editorial Board of BMC Musculoskeletal Disorders.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 2**
Selection of mid-sagittal plane for dGEMRIC analysis. Selection of the mid-sagittal plane using OsiriX. dGEMRIC analysis will be performed on the three mid-sagittal slices

**Fig. 3**
Hip muscle strength assessment. For hip muscle group strength assessment, participants are instructed to stand upright, look straight ahead and use the rail for light finger-tip support. Following familiarisation participants receive strong verbal encouragement to pull as hard as possible. Two maximal efforts for each hip muscle group are recorded

See this image and copyright information in PMC

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