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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
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 pau...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5615805/ https://www.ncbi.nlm.nih.gov/pubmed/28950859 http://dx.doi.org/10.1186/s12891-017-1767-y |
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author | Murphy, Nicholas J. Eyles, Jillian Bennell, Kim L. Bohensky, Megan Burns, Alexander Callaghan, Fraser M. Dickenson, Edward Fary, Camdon Grieve, Stuart M. Griffin, Damian R. Hall, Michelle Hobson, Rachel Kim, Young Jo Linklater, James M. Lloyd, David G. Molnar, Robert O’Connell, Rachel L. O’Donnell, John O’Sullivan, Michael Randhawa, Sunny Reichenbach, Stephan Saxby, David J. Singh, Parminder Spiers, Libby Tran, Phong Wrigley, Tim V. Hunter, David J. |
author_facet | Murphy, Nicholas J. Eyles, Jillian Bennell, Kim L. Bohensky, Megan Burns, Alexander Callaghan, Fraser M. Dickenson, Edward Fary, Camdon Grieve, Stuart M. Griffin, Damian R. Hall, Michelle Hobson, Rachel Kim, Young Jo Linklater, James M. Lloyd, David G. Molnar, Robert O’Connell, Rachel L. O’Donnell, John O’Sullivan, Michael Randhawa, Sunny Reichenbach, Stephan Saxby, David J. Singh, Parminder Spiers, Libby Tran, Phong Wrigley, Tim V. Hunter, David J. |
author_sort | Murphy, Nicholas J. |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-5615805 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-56158052017-09-28 Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial Murphy, Nicholas J. Eyles, Jillian Bennell, Kim L. Bohensky, Megan Burns, Alexander Callaghan, Fraser M. Dickenson, Edward Fary, Camdon Grieve, Stuart M. Griffin, Damian R. Hall, Michelle Hobson, Rachel Kim, Young Jo Linklater, James M. Lloyd, David G. Molnar, Robert O’Connell, Rachel L. O’Donnell, John O’Sullivan, Michael Randhawa, Sunny Reichenbach, Stephan Saxby, David J. Singh, Parminder Spiers, Libby Tran, Phong Wrigley, Tim V. Hunter, David J. BMC Musculoskelet Disord Study Protocol 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). BioMed Central 2017-09-26 /pmc/articles/PMC5615805/ /pubmed/28950859 http://dx.doi.org/10.1186/s12891-017-1767-y Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Murphy, Nicholas J. Eyles, Jillian Bennell, Kim L. Bohensky, Megan Burns, Alexander Callaghan, Fraser M. Dickenson, Edward Fary, Camdon Grieve, Stuart M. Griffin, Damian R. Hall, Michelle Hobson, Rachel Kim, Young Jo Linklater, James M. Lloyd, David G. Molnar, Robert O’Connell, Rachel L. O’Donnell, John O’Sullivan, Michael Randhawa, Sunny Reichenbach, Stephan Saxby, David J. Singh, Parminder Spiers, Libby Tran, Phong Wrigley, Tim V. Hunter, David J. Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial |
title | Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial |
title_full | Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial |
title_fullStr | Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial |
title_full_unstemmed | Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial |
title_short | Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial |
title_sort | protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (fai): the australian fashion trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5615805/ https://www.ncbi.nlm.nih.gov/pubmed/28950859 http://dx.doi.org/10.1186/s12891-017-1767-y |
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