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Low rate of adverse events in a randomized controlled trial addressing the surgical treatment of femoroacetabular impingement (FAI) syndrome

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Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

The femoroacetabular impingement randomised controlled trial (FIRST) is a multi-center randomized controlled trial (RCT), comparing arthroscopic osteochondroplasty with arthroscopic lavage in adults aged 18–50 years diagnosed with non-arthritic femoroacetabular impingement (FAI) syndrome. The purpose of the present study is to report the prevalence, distribution and severity of adverse events during and within 24-month follow-up period.

Methods

Of the 220 patients included, 6 were adjudicated as ineligible, for a total of 214 patients included in the final analysis. An independent Adjudication Committee evaluated operatively treated and non-operatively treated adverse events that were related to the hip. Adverse events were also reported directly by each participating clinical site. Continuous variables were reported as mean and standard deviation, categorical variables were reported as counts and percentages.

Results

There were a total of 52 (24.2%, 52/214) adverse events in 46 (21.5%) patients (mean age 34.2 ± 7.9 years, 58.7% male) during the 24-month follow-up. There were 12.6% (27/214) operatively treated adverse events for: hip pain, re-injury of labrum and heterotopic ossification. There were 11.7% (25/214) non-operatively treated adverse events for predominantly: hip pain, hip tendinopathy and hip popping/snapping. Approximately, 87% of adverse events resolved within the 24-month follow-up time.

Conclusion

Given the inherent challenges with conducting RCTs, the results of this adverse event study from the FIRST trial demonstrate that it is safe to perform an RCT addressing FAI syndrome.

Level of evidence

Level III.

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Abbreviations

DHAR:

Danish Hip Arthroscopic Registry

FAI:

Femoroacetabular impingement

FIRST:

Femoroacetabular impingement randomised controlled trial

FAIT:

Femoroacetabular impingement trial

UK FASHIoN:

Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome

MRI:

Magnetic resonance imaging

RCT:

Randomised control trial

SD:

Standard deviation

US MHS:

US Military Health System

VAS:

Visual Analog Scale

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Acknowledgements

The Collaborating Group is known as the FIRST investigators. This is constituted of the following authors: Steering Committee: Olufemi R. Ayeni (Chair, McMaster University), Mohit Bhandari (Co-Chair, McMaster University), Asheesh Bedi (University of Michigan), Teppo Järvinen (University of Helsinki), Volker Musahl (University of Pittsburgh), Douglas Naudie (University of Western Ontario), Matti Seppänen MD (Turku University), Gerard Slobogean (University of Maryland, Baltimore), Lehana Thabane (McMaster University). Methods Centre: Olufemi R. Ayeni (Principal Investigator); Nicole Simunovic (Research Manager); Andrew Duong, Matthew Skelly, Ajay Shanmugaraj, Sarah Crouch (Project Management); Sheila Sprague (Research Methodologist); Diane Heels-Ansdell, (Statistical Analysis); Lisa Buckingham (Data Management) (McMaster University). Data and Safety Monitoring Committee: Tim Ramsay (Chair, Ottawa Hospital Research Institute), John Lee (University of Toronto), Petteri Kousa (Sports Clinic Hospital Dextra). Adjudication Committee: Sasha Carsen (Chair, University of Ottawa), Hema Choudur (Hamilton Health Sciences), Yan Sim (McMaster University), Kelly Johnston (University of Calgary). Participating Clinical Sites—Canada: McMaster University Medical Centre (Hamilton, ON)—Olufemi R. Ayeni MD, PhD, FRCSC; Sarah Crouch BSc (Pharm); Andrew Duong MSc; Ajay Shanmugaraj BSc; Nicole Simunovic MSc; Matthew Skelly BSc; Sheila Sprague PhD. Dalhousie University (Halifax, NS)—Ivan Wong MD, FRCSC, Dip. Sports Medicine, MACM; Ryland Murphy BSc; Sara Sparavalo MASc. St. Michael’s Hospital (Toronto, ON)—Daniel Whelan MD, MSc, FRCSC; Ryan Khan BA, CCRP. Kingston Health Sciences Centre (Kingston, ON)—Gavin CA Wood MBChB, FRCS; Fiona Howells BPharm; Heather Grant MSc. London Health Sciences Centre (London, ON)—Douglas Naudie MD, MSc, FRCSC; Bryn Zomar MSc; Michael Pollock MSc. Fowler Kennedy Sport Medicine Clinic (London, ON)—Kevin Willits MD, FRCSC; Andrew Firth MSc; Stacey Wanlin; Alliya Remtulla MSc; Nicole Kaniki PhD. CHU de Québec-Université Laval (Quebec City, QC)—Etienne L. Belzile MD; Sylvie Turmel RN. Participating Clinical Sites -International: Odense University Hospital (Odense, Denmark)—Uffe Jørgensen MD, Dr. Med Sci; Annie Gam-Pedersen RN. Tays Hatanpää (Tampere University Hospital, Tampere, Finland)—Raine Sihvonen MD, PhD; Marko Raivio MD; Pirjo Toivonen PT. Turku University Hospital (Turku, Finland)—Matti Seppänen MD; Mari Pirjetta Routapohja RN. Post-trial statement: The Methods Centre at McMaster University coordinated the trial. The Methods Centre was responsible for programming trial randomization, the maintenance of the database, data validation, data analyses, and study-centre coordination. The Steering Committee designed the trial, some members assisted with developing the statistical analysis plan, and vouch for the completeness and accuracy of the data and analyses.

Funding

Research grants were received from the Canadian Institutes of Health Research (CIHR) (PI: OR Ayeni and M Bhandari), American Orthopaedic Society for Sports Medicine (PI: OR Ayeni), Canadian Orthopaedic Foundation (PI: OR Ayeni and M Bhandari), McMaster Surgical Associates (PI: OR Ayeni and M Bhandari), and Hamilton Health Sciences Department of Surgery (PI: OR Ayeni). Dr. M Bhandari was also funded, in part, by a Canada research chair in musculoskeletal trauma, which is unrelated to the present study (McMaster University, Hamilton, ON, Canada).

Author information

Authors and Affiliations

  1. Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

    Axel Ohlin

  2. Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 1200 Main St W, 4E15, Hamilton, ON, L8N 3Z5, Canada

    Nicole Simunovic, Andrew Duong & Olufemi R. Ayeni

  3. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada

    Olufemi R. Ayeni

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  1. Axel Ohlin
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Consortia

on behalf of the FIRST Investigators

Contributions

The manuscript was conducted and drafted by AO, NS, AD and ORA. The FIRST investigators conducted the research study, and were responsible for the recruitment and follow-up of all patients. All authors have made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data, have been involved in drafting the manuscript and revising it critically for important intellectual content, have given final approval of the version to be published, and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Olufemi R. Ayeni.

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The authors declared that they have no conflict of interest.

Ethical approval

Ethics approval was granted by the Hamilton Integrated Research Ethics Board #12-396.

Informed consent

Informed consent was provided by all patients in the study.

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Ohlin, A., Simunovic, N., Duong, A. et al. Low rate of adverse events in a randomized controlled trial addressing the surgical treatment of femoroacetabular impingement (FAI) syndrome. Knee Surg Sports Traumatol Arthrosc 29, 2015–2020 (2021). https://doi.org/10.1007/s00167-020-06236-6

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