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,Jillian Eyles,David G Lloyd,Edward Dickenson,Phong Tran,Stuart M Grieve,John O’Donnell,Michelle Hall,Young Jo Kim,Robert Molnar,James Linklater ,Rachel O’connell ,Kim L Bennell ,Michael E O’sullivan ,Parminder J Singh ,David J Saxby,Alexander Burns,Megan Bohensky,Fraser M Callaghan,Libby Spiers,Stephan Reichenbach,Tim V Wrigley,Damian R Griffin,Rachel Hobson,Sunny Randhawa,Camdon Fary,David J Hunter

doi:10.1186/s12891-017-1767-y

Abstract

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).

Highlights

Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA)
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

Summary

Introduction

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; there is a paucity of clinical trial evidence comparing these approaches. It is unknown whether these management approaches modify the future risk of developing hip OA. Two morphologic patterns of FAI have been described: cam type, where the femoral head is aspheric due to a thickened femoral head-neck junction; and pincer type, where the acetabular rim extends beyond its normal depth to over-cover the femoral head [2] Both cam and pincer type morphology are associated with the repetitive abutment of the proximal femur against the acetabular rim, applying shear forces to the acetabular labrum and/or cartilage, which is believed to lead to hip osteoarthritis (OA) [3,4,5]. It is unknown whether either of these approaches modifies the risk of future hip OA development

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