Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures

医学 破折号 内固定 随机对照试验 外科 支撑 握力 物理疗法 撑杆 机械工程 计算机科学 工程类 操作系统
作者
Lasse Rämö,Bakir O. Sumrein,Vesa Lepola,Tuomas Lähdeoja,Jonas Ranstam,Mika Paavola,Teppo L. N. Järvinen,Simo Taimela
出处
期刊:JAMA [American Medical Association]
卷期号:323 (18): 1792-1792 被引量:89
标识
DOI:10.1001/jama.2020.3182
摘要

Importance

Humeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend.

Objective

To compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures.

Design, Setting, and Participants

Randomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma.

Interventions

Patients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n = 38) or to nonsurgical treatment with functional bracing (n = 44).

Main Outcome and Measure

The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points).

Results

Among 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, −3.1 points; 95% CI, −9.6 to 3.3;P = .34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy.

Conclusions and Relevance

Among patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results.

Trial Registration

ClinicalTrials.gov Identifier:NCT01719887
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