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.

中文翻译：

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在一项针对股骨髋臼撞击（FAI）综合征的外科治疗的随机对照试验中，不良事件发生率低。

目的

股骨髋臼撞击随机对照试验（FIRST）是一项多中心随机对照试验（RCT），比较了18-50岁被诊断为非关节炎性股骨髋臼撞击（FAI）综合征的成人，在关节镜下进行软骨碎裂术与关节镜灌洗。本研究的目的是报告在24个月的随访期间和之内的不良事件的发生率，分布和严重程度。

方法

在纳入的220名患者中，有6名被判定为不合格，最终分析中总共包括214名患者。一个独立的裁决委员会评估了与髋部相关的手术治疗和非手术治疗的不良事件。每个参与的临床站点也直接报告了不良事件。连续变量报告为均值和标准差，类别变量报告为计数和百分比。

结果

在24个月的随访期间，共有46例（21.5％）患者（平均年龄34.2±7.9岁，男性58.7％）发生了52例（24.2％，52/214）不良事件。接受手术治疗的不良事件有12.6％（27/214），这些不良事件包括：髋部疼痛，唇唇再损伤和异位骨化。有11.7％（25/214）的非手术治疗不良事件主要为：髋部疼痛，髋部肌腱病和髋部爆裂/ s啪声。约有87％的不良事件在24个月的随访时间内得以解决。

结论

考虑到进行RCT的固有挑战，FIRST试验的不良事件研究结果表明，进行针对FAI综合征的RCT是安全的。

证据水平

第三级。