The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study.

D.R Griffin,A Realpe,J Achten,M.L Costa,N Parsons,E.J Dickenson,J.L Donovan,P.D.H Wall,C.E Hutchinson,S Petrou,A Adams,N.E Foster,R Hobson

doi:10.1093/jhps/hnw026

Abstract

To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a ‘definitive solution’. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT.

Highlights

Arthroscopic hip surgery for femoroacetabular impingement (FAI) is a rapidly growing and evolving field with increasing number of patients undergoing surgical treatment [1, 2]
In the pilot randomized controlled trial (RCT), we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity
We performed a feasibility study, including an internal pilot trial, to understanding clinician and patient equipoise, and to assess trial procedures, eligibility criteria, recruitment and retention rates in order to determine whether to proceed to a full trial. We conducted this mixed methods feasibility study in two phases: a pre-pilot qualitative research phase that aimed to explore surgeon and patient equipoise followed by a mixed methods internal pilot RCT that aimed to test out the planned trial procedures including eligibility assessment, participant recruitment and retention rates, as well as develop a method of assessing intervention fidelity

Summary

Introduction

Arthroscopic hip surgery for femoroacetabular impingement (FAI) is a rapidly growing and evolving field with increasing number of patients undergoing surgical treatment [1, 2]. A randomised controlled trial comparing arthroscopic hip surgery 305. Conducting RCTs is challenging; clinician and patient equipoise, and the ability to recruit adequate numbers of patients are major obstacles to trials, especially in surgery [7,8,9]. This is made even more difficult if the comparator arm is conservative care [10, 11]

Methods

Results

Conclusion