van den Heuvel Stein, Penning Diederick, Sanders Fay, van Veen Ruben, Sosef Nico, van Dijkman Bart, Schepers Tim
Trauma Unit, Department of Surgery. Amsterdam Movement Sciences, Amsterdam UMC, Amsterdam, the Netherlands.
Department of Trauma Surgery, OLVG, Amsterdam, the Netherlands.
Bone Jt Open. 2023 Dec 18;4(12):957-963. doi: 10.1302/2633-1462.412.BJO-2023-0061.
The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS).
All patients included in the 'ROutine vs on DEmand removal Of the syndesmotic screw' (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups.
The median OMAS score was 85.0 for patients treated with RR, and 90.0 for patients treated with ODR (p = 0.384), indicating no significant difference between ODR and RR. The secondary outcome measures included the AOFAS (88.0 in the RR group and 90.0 for ODR; p = 0.722), FAOS (87.5 in the RR group and 92.9 for ODR; p = 0.399), and EQ-5D (0.87 in the RR group and 0.96 for ODR; p = 0.092).
This study demonstrated no functional difference comparing ODR to RR in syndesmotic injuries at a four year follow-up period, which supports the results of the primary RODEO trial. ODR should be the standard practice after syndesmotic screw fixation.
本研究的主要目的是展示一项多中心随机对照试验（RCT）的中期随访结果，该试验比较了下胫腓螺钉（SS）常规取出（RR）与按需取出（ODR）后的功能结局。
“下胫腓螺钉常规与按需取出”（RODEO）试验纳入的所有患者均接受了奥勒鲁德 - 莫兰德踝关节评分（OMAS）、美国矫形足踝协会后足评分（AOFAS）、足踝结局评分（FAOS）以及欧洲五维健康量表问卷（EQ - 5D）评估。152例患者中，109例（71.7%）完成了中期随访问卷并纳入本研究（53例接受RR治疗，56例接受ODR治疗）。自急性下胫腓损伤初次手术治疗以来，中位随访时间为50个月（四分位间距43.0至56.0）。本研究的主要结局为由两组的OMAS评分组成。
接受RR治疗的患者中位OMAS评分为85.0，接受ODR治疗的患者为90.0（p = 0.384），表明ODR与RR之间无显著差异。次要结局指标包括AOFAS（RR组为88.0，ODR组为90.0；p = 0.722）、FAOS（RR组为87.5，ODR组为92.9；p = 0.399）以及EQ - 5D（RR组为0.87，ODR组为0.96；p = 0.092）。
本研究表明，在四年随访期内，下胫腓损伤中ODR与RR相比无功能差异，这支持了RODEO初步试验的结果。ODR应成为下胫腓螺钉固定后的标准做法。
