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Headline
This trial showed that hip arthroscopy and personalised hip therapy both improved hip-related quality of life, but hip arthroscopy led to greater improvements at 12 months.
Abstract
Background:
Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery or with physiotherapist-led conservative care.
Objective:
To compare the clinical effectiveness and cost-effectiveness of hip arthroscopy with best conservative care.
Design:
The UK FASHIoN (full trial of arthroscopic surgery for hip impingement compared with non-operative care) trial was a pragmatic, multicentre, randomised controlled trial that was carried out at 23 NHS hospitals.
Participants:
Participants were included if they had femoroacetabular impingement, were aged ≥ 16 years old, had hip pain with radiographic features of cam or pincer morphology (but no osteoarthritis) and were believed to be likely to benefit from hip arthroscopy.
Intervention:
Participants were randomly allocated (1 : 1) to receive hip arthroscopy followed by postoperative physiotherapy, or personalised hip therapy (i.e. an individualised physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre using a central telephone randomisation service. Outcome assessment and analysis were masked.
Main outcome measure:
The primary outcome was hip-related quality of life, measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed by intention to treat.
Results:
Between July 2012 and July 2016, 648 eligible patients were identified and 348 participants were recruited. In total, 171 participants were allocated to receive hip arthroscopy and 177 participants were allocated to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (N = 319; hip arthroscopy, n = 157; personalised hip therapy, n = 162). At 12 months, mean International Hip Outcome Tool (iHOT-33) score had improved from 39.2 (standard deviation 20.9) points to 58.8 (standard deviation 27.2) points for participants in the hip arthroscopy group, and from 35.6 (standard deviation 18.2) points to 49.7 (standard deviation 25.5) points for participants in personalised hip therapy group. In the primary analysis, the mean difference in International Hip Outcome Tool scores, adjusted for impingement type, sex, baseline International Hip Outcome Tool score and centre, was 6.8 (95% confidence interval 1.7 to 12.0) points in favour of hip arthroscopy (p = 0.0093). This estimate of treatment effect exceeded the minimum clinically important difference (6.1 points). Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment and one serious adverse event in the personalised hip therapy group was not. Thirty-eight (24%) personalised hip therapy patients chose to have hip arthroscopy between 1 and 3 years after randomisation. Nineteen (12%) hip arthroscopy patients had a revision arthroscopy. Eleven (7%) personalised hip therapy patients and three (2%) hip arthroscopy patients had a hip replacement within 3 years.
Limitations:
Study participants and treating clinicians were not blinded to the intervention arm. Delays were encountered in participants accessing treatment, particularly surgery. Follow-up lasted for 3 years.
Conclusion:
Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement in quality of life than personalised hip therapy, and this difference was clinically significant at 12 months. This study does not demonstrate cost-effectiveness of hip arthroscopy compared with personalised hip therapy within the first 12 months. Further follow-up will reveal whether or not the clinical benefits of hip arthroscopy are maintained and whether or not it is cost-effective in the long term.
Trial registration:
Current Controlled Trials ISRCTN64081839.
Funding:
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 16. See the NIHR Journals Library website for further project information.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Introduction
- Chapter 2. Methods
- Trial design
- Participants
- Screening and recruitment
- Consent
- Qualitative research intervention
- Randomisation
- Sequence generation
- Blinding
- Post randomisation withdrawals
- Interventions
- Arthroscopic surgery
- Personalised hip therapy
- Treatment crossover
- Outcomes
- Follow-up
- Adverse event management
- Risks and benefits
- Statistical analysis
- Sample size
- Analysis plan
- Software
- Data validation
- Missing data
- Interim analyses
- Exploratory analysis
- Economic evaluation
- Research Ethics Committee approval
- Trial Management Group
- Trial Steering Committee
- Data Monitoring Committee
- Patient and public involvement
- Chapter 3. Qualitative research to improve recruitment and to assess outcomes
- Understanding recruitment as it happened
- Mapping of eligibility and recruitment pathways
- Interviewing clinicians and research associates responsible for recruitment
- Analysing audio-recorded recruitment appointments
- Patient questions, concerns and preferences
- Action plans to promote informed consent and improve recruitment
- Evaluation of the qualitative recruitment intervention
- Discussion and conclusions
- Chapter 4. Results
- Chapter 5. Economic evaluation results
- Chapter 6. Discussion
- Chapter 7. Conclusion
- Acknowledgements
- References
- Appendix 1. Case report forms
- Appendix 2. Results
- Appendix 3. Health economics
- List of abbreviations
About the Series
Declared competing interests of authors: Damian R Griffin is a surgeon with a hip preservation practice that includes treating femoroacetabular impingement syndrome and hip arthroscopy, and he reports consulting and teaching fees from Stryker UK (Newbury, UK) and Smith & Nephew UK (Watford, UK), outside the submitted work. Joanna Smith is a physiotherapist who treats patients with femoroacetabular impingement syndrome. Peter DH Wall is a hip surgeon who treats patients with femoroacetabular impingement syndrome. Nadine Foster is a member of Clinical Trial Units that were funded by the National Institute for Health Research until 2021 and was a member of the Health Technology Assessment Primary Care, Community and Preventive Interventions Panel (2010–15). Jenny Donovan reports membership of the Rapid Trials and Add-on Studies Board (2012 to present) and the Health Technology Assessment Commissioning Committee (2006–12).
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 13/103/02. The contractual start date was in April 2014. The draft report began editorial review in November 2019 and was accepted for publication in August 2021. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Last reviewed: November 2019; Accepted: August 2021.
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