Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2016 Aug 31;6(8):e012453.
doi: 10.1136/bmjopen-2016-012453.

Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)

D R Griffin  1 , E J Dickenson  2 , P D H Wall  2 , J L Donovan  3 , N E Foster  4 , C E Hutchinson  2 , N Parsons  2 , S Petrou  2 , A Realpe  2 , J Achten  2 , F Achana  2 , A Adams  2 , M L Costa  2 , J Griffin  2 , R Hobson  2 , J Smith  2 ; FASHIoN Study Group
Collaborators, Affiliations
Multicenter Study

Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)

D R Griffin et al. BMJ Open. .

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.

Keywords: femoroacetabular impingement; hip arthroscopy; hip impingement; physiotherapy.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Participant flow diagram.
See this image and copyright information in PMC

References

    1. Ganz R, Parvizi J, Beck M et al. . Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res 2003;417:112–20. 10.1097/01.blo.0000096804.78689.c2 - DOI - PubMed
    1. Lavigne M, Parvizi J, Beck M et al. . Anterior femoroacetabular impingement: part I. Techniques of joint preserving surgery. Clin Orthop Relat Res 2004;418:61–6. 10.1097/00003086-200401000-00011 - DOI - PubMed
    1. Ganz R, Leunig M, Leunig-Ganz K et al. . The etiology of osteoarthritis of the hip: an integrated mechanical concept. Clin Orthop Relat Res 2008;466:264–72. 10.1007/s11999-007-0060-z - DOI - PMC - PubMed
    1. Beck M, Kalhor M, Leunig M et al. . Hip morphology influences the pattern of damage to the acetabular cartilage femoroacetabular impingement as a cause of early osteoarthritis of the hip. J Bone Joint Surg Br 2005;87:1012–18. 10.1302/0301-620X.87B7.15203 - DOI - PubMed
    1. Hack K, Di Primio G, Rakhra K et al. . Prevalence of cam-type femoroacetabular impingement morphology in asymptomatic volunteers. J Bone Joint Surg Am 2010;92:2436–44. 10.2106/JBJS.J.01280 - DOI - PubMed

Publication types

Associated data

LinkOut - more resources