Randomized Controlled Trial

. 2021 Aug 16;22(1):697.

doi: 10.1186/s12891-021-04576-z.

Multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapist-led care for femoroacetabular impingement (FAI) syndrome on hip cartilage metabolism: the Australian FASHIoN trial

David J Hunter^{1

2}, Jillian Eyles^{3

4}, Nicholas J Murphy^{3

5}, Libby Spiers⁶, Alexander Burns⁷, Emily Davidson⁸, Edward Dickenson^{9

10}, Camdon Fary^{11

12}, Nadine E Foster^{13

14}, Jurgen Fripp¹⁵, Damian R Griffin⁹, Michelle Hall⁶, Young Jo Kim¹⁶, James M Linklater¹⁷, Robert Molnar¹⁸, Ales Neubert¹⁵, Rachel L O'Connell^{3

19}, John O'Donnell^{20

21}, Michael O'Sullivan²², Sunny Randhawa²³, Stephan Reichenbach^{24

25

26}, Florian Schmaranzer²⁶, Parminder Singh^{20

27}, Phong Tran^{11

12}, David Wilson²⁸, Honglin Zhang²⁸, Kim L Bennell⁶

Affiliations

¹ Institute of Bone and Joint Research, Kolling Institute of Medical Research, University of Sydney, Camperdown, Australia. david.hunter@sydney.edu.au.
² Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia. david.hunter@sydney.edu.au.
³ Institute of Bone and Joint Research, Kolling Institute of Medical Research, University of Sydney, Camperdown, Australia.
⁴ Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.
⁵ Department of Orthopaedic Surgery, Gosford and Wyong Hospitals, Gosford, New South Wales, Australia.
⁶ Department of Physiotherapy, Centre for Health, Exercise and Sports Medicine, University of Melbourne, Parkville, Australia.
⁷ Orthopaedics ACT, 90 Corinna St, Canberra, 2603, Australia.
⁸ Department of Radiology, Royal Prince Alfred Hospital, Sydney, New South Wales, 2035, Australia.
⁹ Warwick Medical School, University of Warwick, Coventry, UK.
¹⁰ University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.
¹¹ Department of Orthopaedic Surgery, Western Health, Melbourne, Australia.
¹² Australian Institute for Musculoskeletal Science (AIMSS), The University of Melbourne and Western Health, St. Albans, VIC, Australia.
¹³ STARS Education and Research Alliance, School of Health and Rehabilitation Sciences, University of Queensland, St Lucia, Australia.
¹⁴ Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Newcastle upon Tyne, UK.
¹⁵ The Australian e-Health Research Centre, CSIRO Health and Biosecurity, Brisbane, Australia.
¹⁶ Department of Orthopedic Surgery, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA, 02115, USA.
¹⁷ Department of Musculoskeletal Imaging, Castlereagh Imaging, St Leonards, New South Wales, Australia.
¹⁸ Sydney Orthopaedic Trauma & Reconstructive Surgery, Sydney, New South Wales, Australia.
¹⁹ NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.
²⁰ Hip Arthroscopy Australia, 21 Erin St, Richmond, Victoria, Australia.
²¹ St Vincent's Private Hospital, 159 Grey St, East Melbourne, Victoria, Australia.
²² North Sydney Orthopaedic and Sports Medicine Centre, North Sydney, New South Wales, Australia.
²³ Macquarie University Hospital, 3 Technology Pl, Macquarie University, Macquarie Park, NSW, 2109, Australia.
²⁴ Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
²⁵ Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Bern, Switzerland.
²⁶ Department Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
²⁷ Maroondah Hospital, Eastern Health, Davey Drive, Ringwood East, Melbourne, Victoria, 3135, Australia.
²⁸ Department of Orthopaedics, Center for Hip Health and Mobility, University of British Columbia, Vancouver, BC, Canada.

PMID: 34399702
PMCID: PMC8369620
DOI: 10.1186/s12891-021-04576-z

Randomized Controlled Trial

Multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapist-led care for femoroacetabular impingement (FAI) syndrome on hip cartilage metabolism: the Australian FASHIoN trial

David J Hunter et al. BMC Musculoskelet Disord. 2021.

. 2021 Aug 16;22(1):697.

doi: 10.1186/s12891-021-04576-z.

Authors

Affiliations

¹ Institute of Bone and Joint Research, Kolling Institute of Medical Research, University of Sydney, Camperdown, Australia. david.hunter@sydney.edu.au.
² Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia. david.hunter@sydney.edu.au.
³ Institute of Bone and Joint Research, Kolling Institute of Medical Research, University of Sydney, Camperdown, Australia.
⁴ Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.
⁵ Department of Orthopaedic Surgery, Gosford and Wyong Hospitals, Gosford, New South Wales, Australia.
⁶ Department of Physiotherapy, Centre for Health, Exercise and Sports Medicine, University of Melbourne, Parkville, Australia.
⁷ Orthopaedics ACT, 90 Corinna St, Canberra, 2603, Australia.
⁸ Department of Radiology, Royal Prince Alfred Hospital, Sydney, New South Wales, 2035, Australia.
⁹ Warwick Medical School, University of Warwick, Coventry, UK.
¹⁰ University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.
¹¹ Department of Orthopaedic Surgery, Western Health, Melbourne, Australia.
¹² Australian Institute for Musculoskeletal Science (AIMSS), The University of Melbourne and Western Health, St. Albans, VIC, Australia.
¹³ STARS Education and Research Alliance, School of Health and Rehabilitation Sciences, University of Queensland, St Lucia, Australia.
¹⁴ Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Newcastle upon Tyne, UK.
¹⁵ The Australian e-Health Research Centre, CSIRO Health and Biosecurity, Brisbane, Australia.
¹⁶ Department of Orthopedic Surgery, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA, 02115, USA.
¹⁷ Department of Musculoskeletal Imaging, Castlereagh Imaging, St Leonards, New South Wales, Australia.
¹⁸ Sydney Orthopaedic Trauma & Reconstructive Surgery, Sydney, New South Wales, Australia.
¹⁹ NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.
²⁰ Hip Arthroscopy Australia, 21 Erin St, Richmond, Victoria, Australia.
²¹ St Vincent's Private Hospital, 159 Grey St, East Melbourne, Victoria, Australia.
²² North Sydney Orthopaedic and Sports Medicine Centre, North Sydney, New South Wales, Australia.
²³ Macquarie University Hospital, 3 Technology Pl, Macquarie University, Macquarie Park, NSW, 2109, Australia.
²⁴ Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
²⁵ Department of Rheumatology, Immunology and Allergology, University Hospital and University of Bern, Bern, Switzerland.
²⁶ Department Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
²⁷ Maroondah Hospital, Eastern Health, Davey Drive, Ringwood East, Melbourne, Victoria, 3135, Australia.
²⁸ Department of Orthopaedics, Center for Hip Health and Mobility, University of British Columbia, Vancouver, BC, Canada.

PMID: 34399702
PMCID: PMC8369620
DOI: 10.1186/s12891-021-04576-z

Abstract

Background: Arthroscopic surgery for femoroacetabular impingement syndrome (FAI) is known to lead to self-reported symptom improvement. In the context of surgical interventions with known contextual effects and no true sham comparator trials, it is important to ascertain outcomes that are less susceptible to placebo effects. The primary aim of this trial was to determine if study participants with FAI who have hip arthroscopy demonstrate greater improvements in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to participants who undergo physiotherapist-led management.

Methods: Multi-centre, pragmatic, two-arm superiority randomised controlled trial comparing physiotherapist-led management to hip arthroscopy for FAI. FAI participants were recruited from participating orthopaedic surgeons clinics, and randomly allocated to receive either physiotherapist-led conservative care or surgery. The surgical intervention was arthroscopic FAI surgery. The physiotherapist-led conservative management was an individualised physiotherapy program, named Personalised Hip Therapy (PHT). The primary outcome measure was change in dGEMRIC score between baseline and 12 months. Secondary outcomes included a range of patient-reported outcomes and structural measures relevant to FAI pathoanatomy and hip osteoarthritis development. Interventions were compared by intention-to-treat analysis.

Results: Ninety-nine participants were recruited, of mean age 33 years and 58% male. Primary outcome data were available for 53 participants (27 in surgical group, 26 in PHT). The adjusted group difference in change at 12 months in dGEMRIC was -59 ms (95%CI - 137.9 to - 19.6) (p = 0.14) favouring PHT. Hip-related quality of life (iHOT-33) showed improvements in both groups with the adjusted between-group difference at 12 months showing a statistically and clinically important improvement in arthroscopy of 14 units (95% CI 5.6 to 23.9) (p = 0.003).

Conclusion: The primary outcome of dGEMRIC showed no statistically significant difference between PHT and arthroscopic hip surgery at 12 months of follow-up. Patients treated with surgery reported greater benefits in symptoms at 12 months compared to PHT, but these benefits are not explained by better hip cartilage metabolism.

Trial registration details: Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015.

Keywords: Arthroscopy; FAI; Femoroacetabular impingement syndrome; Hip; Physiotherapy; Surgery; dGEMRIC.

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Conflict of interest statement

DJH is a consultant to Pfizer, Lilly, TLCBio and Merck Serono and is supported by an NHMRC Practitioner Fellowship. KLB was supported by an NHMRC Principal Research Fellowship (APP1058440). SMG acknowledges the support of the Parker-Hughes endowment and the Frecker Family bequest. NEF is an NIHR Senior Investigator in the UK and was supported through an NIHR Research Professorship (NIHR-RP-011-015). MH was supported by a Sir Randal Heymanson Research Fellowship from The University of Melbourne. The rest of the authors do not have any competing interest.

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References

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Multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapist-led care for femoroacetabular impingement (FAI) syndrome on hip cartilage metabolism: the Australian FASHIoN trial

Affiliations

Multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapist-led care for femoroacetabular impingement (FAI) syndrome on hip cartilage metabolism: the Australian FASHIoN trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources