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

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).

Arthroscopic surgery versus physiotherapy for femoroacetabular impingement: a meta-analysis study

“…The most relevant limitation of the present study is the reduced number of papers eligible for inclusion and overall procedures. Up to date, the only further registered RCT studies in the International Clinical Trial Register of the WHO comparing arthroscopic versus physiotherapy is the Australian FASHioN trial, but data has not been published yet [ 12 ]. Therefore, only limited high-quality data can be expected in the next years, but hopefully further RCT studies will be designed to improve data pooling.…”

Trajectory of clinical outcomes following hip arthroscopy in female subgroup populations

“…Although our results certainly warrant further investigation into the role of subgroup allocation of patients, it appears doing so may lead to more appropriate surgical candidate selection. The role of conservative management within the FAIS population remains understudied; however, is a growing focus of research [30, 31]. As this continues to be explored it appears subgroup allocation of patients may allow surgeons to identify those that will benefit from surgical intervention and consider alternative non-surgical treatment options for the less optimal surgical candidates.…”

Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: Preliminary Results of Clinical Responsiveness

“…In addition, a patient-reported outcome, that is, the GTO for hip pain, was used to categorize patients as responders vs. non-responders. An objective measure, such as hip cartilage health assessed using MRI arthrography, could be used to avoid subjective bias (32), since treatments for FAIS should aim at reducing pain, but also at decelerating the hip degenerative process (4). However, hip joint degeneration changes were not expected in this study because of the short-term follow-up.…”