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锁定钢板与髓内钉治疗胫骨近端骨折:一项多中心 RCT。

Locked Plating versus Nailing for Proximal Tibia Fractures: A Multicenter RCT.

机构信息

Harborview Medical Center/University of Washington, Seattle, WA.

NYU Langone Health, New York, NY.

出版信息

J Orthop Trauma. 2023 Apr 1;37(4):155-160. doi: 10.1097/BOT.0000000000002537.

Abstract

OBJECTIVES

The main 2 forms of treatment for extraarticular proximal tibial fractures are intramedullary nailing (IMN) and locked lateral plating (LLP). The goal of this multicenter, randomized controlled trial was to determine whether there are significant differences in outcomes between these forms of treatment.

DESIGN

Multicenter, randomized controlled trial.

SETTING

16 academic trauma centers.

PATIENTS/PARTICIPANTS: 108 patients were enrolled. 99 patients were followed for 12 months. 52 patients were randomized to IMN, and 47 patients were randomized to LLP.

INTERVENTION

IMN or lateral locked plating.

MAIN OUTCOME MEASUREMENTS

Functional scoring including Short Musculoskeletal Functional Assessment, Bother Index, EQ-5Dindex and EQ-5DVAS. Secondary measures included alignment, operative time, range of motion, union rate, pain, walking ability, ability to manage stairs, need for ambulatory aid and number, and complications.

RESULTS

Functional testing demonstrated no difference between the groups, but both groups were still significantly affected 12 months postinjury. Similarly, there was no difference in time of surgery, alignment, nonunion, pain, walking ability, ability to manage stairs, need for ambulatory support, or complications.

CONCLUSIONS

Both IMN and LLP provide for similar outcomes after these fractures. Patients continue to improve over the course of the year after injury but remain impaired even 1 year later.

LEVEL OF EVIDENCE

Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

摘要

目的

治疗胫骨近端关节外骨折的主要两种方法是髓内钉(IMN)和外侧锁定钢板(LLP)。本多中心随机对照试验的目的是确定这两种治疗方法的结果是否存在显著差异。

设计

多中心随机对照试验。

地点

16 个学术创伤中心。

患者/参与者:共纳入 108 例患者,其中 99 例随访 12 个月,52 例随机分配至 IMN 组,47 例随机分配至 LLP 组。

干预

IMN 或外侧锁定钢板。

主要观察指标

包括短肌肉骨骼功能评估、烦恼指数、EQ-5D 指数和 EQ-5D VAS 的功能评分。次要测量指标包括对线、手术时间、活动范围、愈合率、疼痛、行走能力、上下楼梯能力、对助行器的需求以及并发症。

结果

功能测试显示两组之间没有差异,但两组在受伤后 12 个月仍受到显著影响。同样,手术时间、对线、不愈合、疼痛、行走能力、上下楼梯能力、对助行器的需求或并发症方面也没有差异。

结论

IMN 和 LLP 在这些骨折后都能提供相似的结果。患者在受伤后的一年内持续改善,但即使在 1 年后仍存在功能障碍。

证据水平

治疗性 II 级。请参阅作者指南,以获取完整的证据水平描述。

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