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

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.