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Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)
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Griffin, Damian R., Dickenson, Edward J., Wall, Peter D. H., Donovan, J. L., Foster, N. E., Hutchinson, Charles E., Parsons, Nicholas R., Petrou, Stavros, Realpe, Alba, Achten, Juul, Achana, Felix A., Adams, A. C., Costa, Matthew L., Griffin, James M., Hobson, R. and Smith, J. (2016) Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN). BMJ Open, 6 (8). e012453. doi:10.1136/bmjopen-2016-012453 ISSN 2044-6055.
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Official URL: http://dx.doi.org/10.1136/bmjopen-2016-012453
Abstract
Introduction Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome.
Methods We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02).
Ethics and dissemination Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology Assessment, and presented at relevant conferences.
Trial registration number ISRCTN64081839; Pre-results.
| Item Type: | Journal Article | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Subjects: | R Medicine > RD Surgery | ||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
| Library of Congress Subject Headings (LCSH): | Hip joint -- Diseases -- Treatment -- Evaluation, Joints -- Endoscopic surgery | ||||||||
| Journal or Publication Title: | BMJ Open | ||||||||
| Publisher: | BMJ | ||||||||
| ISSN: | 2044-6055 | ||||||||
| Official Date: | 31 August 2016 | ||||||||
| Dates: |
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| Volume: | 6 | ||||||||
| Number: | 8 | ||||||||
| Article Number: | e012453 | ||||||||
| DOI: | 10.1136/bmjopen-2016-012453 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||
| Date of first compliant deposit: | 16 September 2016 | ||||||||
| Date of first compliant Open Access: | 16 September 2016 | ||||||||
| Funder: | National Institute for Health Research (Great Britain) (NIHR), Birmingham Science City, Advantage West Midlands (AWM), Wolfson Foundation (WF), Medical Research Council (Great Britain) (MRC), Collaborations for Leadership in Applied Health Research and Care (CLAHRC) | ||||||||
| Grant number: | Grant number 13/103/02 (NIHR), MR/K025643/1 (MRC) |
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