Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.

Methods

Randomised, pragmatic, non-inferiority, clinical trial.

随机、实用、非劣效性临床试验。

One specialist university hospital trauma centre in Finland, 16 January 2013 to 7 July 2021.

芬兰一所专业大学医院创伤中心，研究时间范围为2013年1月16日至2021年7月7日。

840 skeletally mature patients (age ≥16 years) with an isolated Weber B fibula fracture on static radiographs.

840名骨骼成熟的患者（年龄≥16岁），在静态X光片上表现为孤立的Weber B型腓骨骨折。

Fracture instability was assessed by standard external rotation stress test under fluoroscopy. 714 participants were excluded (569 with stable fracture, mortise incongruency, or fracture dislocation) and the remaining 126 patients with a congruent but unstable ankle mortise were randomised.

骨折不稳定性通过透视下的标准外旋应力测试进行评估。排除了714名参与者（569名骨折稳定、踝关节不匹配或骨折脱位），剩余的126名患者踝关节虽匹配但不稳定，被随机分配。

Participants were randomly allocated to receive either conventional cast immobilisation for six weeks (n=62) or surgical treatment with open reduction and internal plate fixation followed by cast immobilisation for six weeks (n=64).

参与者被随机分配接受常规石膏固定六周（n=62）或手术治疗，包括开放性复位和内固定钢板固定，随后进行六周的石膏固定（n=64）。

The primary, non-inferiority outcome was the Olerud-Molander Ankle Score (OMAS; range 0-100 points; higher scores indicating better outcomes and fewer symptoms) at two years.

主要的非劣效性结果是两年时的Olerud-Molander踝关节评分（OMAS；范围0-100分；分数越高表示结果越好，症状越少）

The predefined non-inferiority margin for the primary outcome was set at -8 points.

主要结果的预设非劣效性边界设定为-8分

Secondary outcomes were ankle function, pain, health related quality of life, ankle range of motion, and radiographic outcome.

次要结果包括踝关节功能、疼痛、与健康相关的生活质量、踝关节活动范围以及放射学结果。

Treatment related adverse events were also recorded.

还记录了与治疗相关的不良事件。

Results

121 out of 126 randomised participants (96%) completed the study.

126名随机参与者中有121名（96%）完成了研究。

In the primary intention-to-treatanalysis of 121 participants completing two year follow-up, the mean OMAS was 89 in the cast immobilisation group and 87 in the surgery group (between group mean difference 1.3 points, 95% confidence interval-4.8 to 7.3).

在完成两年随访的121名参与者的意向治疗分析中，石膏固定组的平均OMAS为89，手术组为87（组间平均差异为1.3分，95%置信区间为-4.8至7.3）。

No statistically significant between group differences were observed in any secondary outcomes.

在任何次要结果指标中，两组之间未观察到统计学上显著的差异。

One participant in each group had radiographic evidence of non-union.

每组中各有1名参与者在放射影像学上显示有不愈合的证据。

In the surgery group, one participant had a superficial wound infection, one had delayed wound healing, and nine underwent procedures to remove hardware, two of whom developed postoperative infections (one deep and one superficial).

在手术组中，有一名参与者出现了表浅伤口感染，另一名出现了伤口愈合延迟，九名进行了移除硬件的手术，其中两人术后发生了感染（一人深部感染和一人表浅感染）。

Conclusions

Cast immobilisation proved non-inferior to surgery for the treatment of unimalleolar Weber B ankle fractures with a congruent mortise on initial radiography but deemed unstable by external rotation stress testing.

对于初始放射学检查显示单踝Weber B型踝关节骨折且踝穴对合良好但外旋应力测试显示不稳定的患者，石膏固定被证明与手术治疗效果相当。

Overall, fewer treatment related harms occurred with cast immobilisation compared with surgery.

总体而言，与手术相比，使用石膏固定治疗相关的伤害较少发生。

trial_registration

ClinicalTrials.gov NCT01758796.

ClinicalTrials.gov NCT01758796。