近日，芬兰奥卢大学附属医院Tero Kortekangas团队比较了石膏固定与手术治疗不稳定外踝骨折的疗效。2026年1月14日，《英国医学杂志》发表了这一成果。

为了比较石膏固定与切开复位内固定手术治疗单踝Weber B型踝关节骨折的疗效，该类骨折在初始X线片中显示踝穴对合良好，但经外旋应力测试判定为不稳定骨折，2013年1月16日至2021年7月7日，研究组在芬兰一家大学附属专科医院创伤中心进行了一项随机、实用性、非劣效性临床试验。

研究组招募了840例骨骼发育成熟（年龄≥16岁）的孤立性Weber B型腓骨骨折患者，均接受静态X线检查。在透视下通过标准外旋应力测试评估骨折稳定性。排除714例参与者（569例为稳定骨折、踝穴对合不良或骨折脱位），剩余126例踝穴对合良好但存在不稳定的患者被随机分组。随机分配接受传统石膏固定六周（n=62）或接受切开复位内固定钢板手术治疗，术后同样石膏固定六周（n=64）。主要非劣效性结局为两年时的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）。预先设定的主要结局非劣效性界值为-8分。次要结局包括踝关节功能、疼痛、健康相关生活质量、踝关节活动度及影像学结果。同时记录治疗相关不良事件。

126例随机分组的参与者中，121例（96%）完成研究。在对完成两年随访的121例参与者进行的意向性治疗分析中，石膏固定组的平均OMAS为89分，手术组为87分（组间平均差异1.3分，95%置信区间-4.8至7.3）。任何次要结局均未观察到具有统计学意义的组间差异。每组各有一例参与者出现影像学上的骨不连证据。手术组中，一例出现浅表伤口感染，一例伤口延迟愈合，九例接受了内固定取出手术，其中两例出现术后感染（一例深部感染，一例浅表感染）。

研究结果表明，对于初始X线显示踝穴对合良好但经外旋应力测试判定为不稳定的单踝Weber B型踝关节骨折，石膏固定被证明在疗效上不劣于手术治疗。总体而言，与手术相比，石膏固定带来的治疗相关损害更少。

附：英文原文

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

Author: Tero Kortekangas, Ristomatti Lehtola, Hannu-Ville Leskel, Simo Taimela, Pasi Ohtonen, Olli Savola, Teppo L N Jrvinen, Harri Pakarinen

Issue&Volume: 2026/01/14

Abstract:

Objective To compare cast immobilisation with surgery using open reduction and internal plate fixation for unimalleolar Weber B ankle fractures with a congruent mortise on initial radiography but deemed unstable by external rotation stress testing.

Design Randomised, pragmatic, non-inferiority, clinical trial.

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

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

Interventions 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).

Main outcome measures 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. The predefined non-inferiority margin for the primary outcome was set at 8 points. Secondary outcomes were ankle function, pain, health related quality of life, ankle range of motion, and radiographic outcome. Treatment related adverse events were also recorded.

Results 121 out of 126 randomised participants (96%) completed the study. In the primary intention-to-treat analysis 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). No statistically significant between group differences were observed in any secondary outcomes. One participant in each group had radiographic evidence of non-union. 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).

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

DOI: 10.1136/bmj-2025-085295

Source: https://www.bmj.com/content/392/bmj-2025-085295