Low rate of adverse events in a randomized controlled trial addressing the surgical treatment of femoroacetabular imping
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Low rate of adverse events in a randomized controlled trial addressing the surgical treatment of femoroacetabular impingement (FAI) syndrome Axel Ohlin1 · Nicole Simunovic2 · Andrew Duong2 · Olufemi R. Ayeni2,3 · on behalf of the FIRST Investigators Received: 23 July 2020 / Accepted: 10 August 2020 © European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2020
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. Keywords FAI syndrome · Hip arthroscopy · Adverse events Abbreviations DHAR Danish Hip Arthroscopic Registry FAI Femoroacetabular impingement FIRST Femoroacetabular impingement randomised controlled trial FAIT Femoroacetabular impingement trial
* Olufemi R. Ayeni [email protected] 1
Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
2
Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 1200 Main St W, 4E15, Hamilton, ON L8N 3Z5, Canada
3
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada
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
Introduction Femoroacetabular impingement (FAI) syndrome is an important caus
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