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早期活动与单纯肘关节脱位石膏固定的疗效比较:FuncSiE 多中心随机临床试验结果。

Early mobilisation versus plaster immobilisation of simple elbow dislocations: results of the FuncSiE multicentre randomised clinical trial.

机构信息

Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.

Trauma Unit, Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.

出版信息

Br J Sports Med. 2017 Mar;51(6):531-538. doi: 10.1136/bjsports-2015-094704. Epub 2015 Jul 14.

Abstract

BACKGROUND/AIM: To compare outcome of early mobilisation and plaster immobilisation in patients with a simple elbow dislocation. We hypothesised that early mobilisation would result in earlier functional recovery.

METHODS

From August 2009 to September 2012, 100 adult patients with a simple elbow dislocation were enrolled in this multicentre randomised controlled trial. Patients were randomised to early mobilisation (n=48) or 3 weeks plaster immobilisation (n=52). Primary outcome measure was the Disabilities of the Arm, Shoulder, and Hand (-DASH) score. Secondary outcomes were the Oxford Elbow Score, Mayo Elbow Performance Index, pain, range of motion, complications and activity resumption. Patients were followed for 1 year.

RESULTS

-DASH scores at 1 year were 4.0 (95% CI 0.9 to 7.1) points in the early mobilisation group versus 4.2 (95% CI 1.2 to 7.2) in the plaster immobilisation group. At 6 weeks, early mobilised patients reported less disability (-DASH 12 (95% CI 9 to 15) points vs 19 (95% CI 16 to 22); p<0.05) and had a larger arc of flexion and extension (121° (95% CI 115° to 127°) vs 102° (95% CI 96° to 108°); p<0.05). Patients returned to work sooner after early mobilisation (10 vs 18 days; p=0.020). Complications occurred in 12 patients; this was unrelated to treatment. No recurrent dislocations occurred.

CONCLUSIONS

Early active mobilisation is a safe and effective treatment for simple elbow dislocations. Patients recovered faster and returned to work earlier without increasing the complication rate. No evidence was found supporting treatment benefit at 1 year.

TRIAL REGISTRATION NUMBER

NTR 2025.

摘要

背景/目的:比较单纯性肘关节脱位患者早期活动与石膏固定的治疗效果。我们假设早期活动可更早恢复功能。

方法

本多中心随机对照试验纳入 2009 年 8 月至 2012 年 9 月间 100 例成人单纯性肘关节脱位患者。患者被随机分为早期活动组(n=48)或 3 周石膏固定组(n=52)。主要观察指标为残疾程度(Disabilities of the Arm, Shoulder, and Hand,DASH)评分。次要观察指标包括牛津肘关节评分、 Mayo 肘关节功能评分、疼痛、活动范围、并发症及活动恢复情况。所有患者均随访 1 年。

结果

早期活动组 1 年时 DASH 评分为 4.0(95%可信区间 0.9 至 7.1)分,而石膏固定组为 4.2(95%可信区间 1.2 至 7.2)分。治疗后 6 周,早期活动组患者的残疾程度更低(DASH 评分减少 12(95%可信区间 9 至 15)分,而非 19(95%可信区间 16 至 22)分;p<0.05),屈伸活动范围更大(121°(95%可信区间 115°至 127°),而非 102°(95%可信区间 96°至 108°);p<0.05)。早期活动组患者更早恢复工作(10 天 vs 18 天;p=0.020)。12 例患者发生并发症,但与治疗无关。无复发性脱位发生。

结论

早期主动活动是治疗单纯性肘关节脱位的一种安全有效的方法。患者恢复更快,更早重返工作岗位,且并未增加并发症发生率。在 1 年时未发现该治疗方法具有明显优势。

临床试验注册号

NTR 2025。

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