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成人移位型单纯内踝骨折的经皮与切开空心螺钉固定:一项随机对照临床试验

Percutaneous versus open cannulated screws fixation for displaced isolated medial malleolar fractures in adults: a randomized controlled clinical trial.

作者信息

Ahmed Khalaf Fathy Elsayed

机构信息

Sohag University, Sohag, Egypt.

出版信息

Arch Orthop Trauma Surg. 2025 Jul 25;145(1):385. doi: 10.1007/s00402-025-06000-w.

Abstract

INTRODUCTION

Isolated medial malleolar (MM) fractures are infrequent injuries. Studies focused on their treatment are scarce. The aim of this study was to compare functional and radiographic outcomes of two surgical techniques for treatment of displaced isolated MM fractures in adults: closed reduction and percutaneous fixation (CRPF), and open reduction and internal fixation (ORIF) by using same implant; two partially-threaded cannulated cancellous screws.

MATERIALS AND METHODS

A prospective randomized controlled clinical trial (RCT) was conducted on 50 patients with isolated displaced MM fractures, treated with CRPF (group A) or ORIF (group B), at orthopaedics department of university hospital, from April 2021 to April 2023. Fractures were classified by Herscovici classification. The primary outcomes were incidence of complications and time to union based on radiographic assessment by plain radiographs of ankle. The secondary outcomes were functional assessment by Foot and Ankle Ability Measure (FAAM) for activities of daily living (ADLs) and sports, American Orthopaedic Foot and Ankle Society (AOFAS) score, and VAS.

RESULTS

No significant differences were noticed among two groups regarding age, sex, side affected, mechanism of injury, smoking, Herscovici classification, or follow-up duration. Mean final FAAM-ADLs was 97.6 ± 2 in group A, and 95 ± 3.4 in group B, (P = 0.155). Mean final FAAM-sports was 87 ± 11.4 in group A, and 73.4 ± 15.6 in group B, (P = 0.312). Mean final AOFAS score was 95.9 ± 8.4 in group A, and 94.6 ± 9.5 in group B, (P = 0.237). Mean final VAS for pain was 0.9 ± 0.5in group A, and 1.5 ± 0.9 in group B, (P = 0.453). Mean time of solid radiographic union was 9.5 ± 2 weeks in group A, and 10.4 ± 3 weeks in group B, (P = 0.026).

CONCLUSION

CRPF of displaced isolated MM fractures is an efficient method with comparable radiographic and functional outcomes to ORIF. Based on these results, percutaneous fixation could be a good alternative for managing displaced isolated MM fractures.

LEVEL OF EVIDENCE

Level II therapeutic: Prospective randomized controlled clinical trial.

TRIAL REGISTRATION

The trial was registered at www.

CLINICALTRIALS

gov (Trial Registration Number: NCT06883435).

摘要

引言

单纯内踝骨折是一种少见的损伤。针对其治疗的研究较少。本研究的目的是比较两种手术技术治疗成人移位型单纯内踝骨折的功能和影像学结果:闭合复位经皮固定(CRPF)和切开复位内固定(ORIF),使用相同的植入物;两枚半螺纹空心松质骨螺钉。

材料与方法

2021年4月至2023年4月,在大学医院骨科对50例单纯移位型内踝骨折患者进行了一项前瞻性随机对照临床试验(RCT),分别采用CRPF(A组)或ORIF(B组)治疗。骨折采用Herscovici分类法进行分类。主要结局是基于踝关节X线平片影像学评估的并发症发生率和骨折愈合时间。次要结局是通过足踝功能测量(FAAM)对日常生活活动(ADL)和运动进行功能评估、美国矫形足踝协会(AOFAS)评分和视觉模拟评分(VAS)。

结果

两组在年龄、性别、患侧、损伤机制、吸烟情况、Herscovici分类或随访时间方面均未发现显著差异。A组最终FAAM-ADL的平均得分为97.6±2,B组为95±3.4,(P = 0.155)。A组最终FAAM-运动的平均得分为87±11.4,B组为73.4±15.6,(P = 0.312)。A组最终AOFAS评分的平均得分为95.9±8.4,B组为94.6±9.5,(P = 0.237)。A组最终疼痛VAS的平均得分为0.9±0.5,B组为1.5±0.9,(P = 0.453)。A组影像学上牢固愈合的平均时间为9.5±2周,B组为10.4±3周,(P = 0.026)。

结论

移位型单纯内踝骨折的CRPF是一种有效的方法,其影像学和功能结果与ORIF相当。基于这些结果,经皮固定可能是治疗移位型单纯内踝骨折的一个良好选择。

证据水平

II级治疗性:前瞻性随机对照临床试验。

试验注册

该试验在www.CLINICALTRIALS.gov上注册(试验注册号:NCT06883435)。

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