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老年人尺骨鹰嘴骨折手术(SOFIE):SOFIE随机对照试验结果

Surgery for Olecranon Fractures in the Elderly (SOFIE): Results of the SOFIE Randomized Controlled Trial.

作者信息

Joshi Mithun A, Le Michael, Campbell Ryan, Sivakumar Brahman, Limbers John, Harris Ian A, Symes Michael

机构信息

Central Coast Local Health District, Gosford, New South Wales, Australia.

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.

出版信息

J Bone Joint Surg Am. 2025 Mar 5;107(5):452-458. doi: 10.2106/JBJS.24.00655. Epub 2025 Jan 9.

Abstract

BACKGROUND

The financial and resource burden of management of olecranon fractures in the elderly is likely to increase with an aging population. There is limited evidence guiding treatment choice in this cohort. This study aimed to determine whether operative treatment of displaced olecranon fractures in elderly patients provides superior 12-month functional outcomes compared to nonoperative treatment.

METHODS

A multicenter pragmatic randomized controlled trial was conducted across 24 hospitals in Australia and New Zealand. Patients aged ≥75 years presenting with an acute (within 14 days), displaced, closed, isolated olecranon fracture were included. Operative treatment involved reduction and stabilization using tension band wiring or plate fixation. Nonoperative treatment consisted of a sling for comfort and early movement as tolerated. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score at 12 months. Secondary outcomes were the DASH score at 3 months and pain, quality of life, Mayo Elbow Performance Score (MEPS), active elbow range of motion, and complication rate at 3 and 12 months. Data were analyzed based on an intention-to-treat principle, with sensitivity analyses using as-treated groups.

RESULTS

Sixty participants were randomized, 27 to the operative group (mean age and standard deviation [SD], 83 ± 5.8 years; 22 [81%] females) and 33 to the nonoperative group (mean age, 82 ± 4.5 years; 23 [70%] females), with no significant difference in baseline characteristics. There was no significant difference (mean difference, -6.6; 95% confidence interval [CI] = -14.9 to 1.8; p = 0.12) in the mean DASH scores at 12 months (the primary outcome) between the operative (12.3 ± 14) and nonoperative (18.9 ± 18) groups. Although active elbow extension was significantly superior in the operative group at 12 months, no other secondary outcome differed significantly between groups at 12 months.

CONCLUSIONS

The study found no significant difference in DASH scores at 12 months between the operative and nonoperative groups. This supports nonoperative treatment as a reasonable option for displaced stable olecranon fractures in elderly patients.

LEVEL OF EVIDENCE

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

摘要

背景

随着人口老龄化,老年尺骨鹰嘴骨折的管理所带来的经济和资源负担可能会增加。在这一人群中,指导治疗选择的证据有限。本研究旨在确定老年移位性尺骨鹰嘴骨折的手术治疗与非手术治疗相比,在12个月时是否能提供更好的功能结局。

方法

在澳大利亚和新西兰的24家医院进行了一项多中心实用随机对照试验。纳入年龄≥75岁、急性(14天内)、移位、闭合、孤立性尺骨鹰嘴骨折的患者。手术治疗包括使用张力带钢丝或钢板固定进行复位和稳定。非手术治疗包括使用吊带以缓解疼痛,并根据耐受情况尽早活动。主要结局是12个月时的手臂、肩部和手部功能障碍(DASH)评分。次要结局是3个月时的DASH评分以及3个月和12个月时的疼痛、生活质量、梅奥肘关节功能评分(MEPS)、主动肘关节活动范围和并发症发生率。数据基于意向性分析原则进行分析,并对实际治疗组进行敏感性分析。

结果

60名参与者被随机分组,27名进入手术组(平均年龄和标准差[SD],83±5.8岁;22名[81%]为女性),33名进入非手术组(平均年龄,82±4.5岁;23名[70%]为女性),两组基线特征无显著差异。手术组(12.3±14)和非手术组(18.9±18)在12个月时的平均DASH评分(主要结局)无显著差异(平均差,-6.6;95%置信区间[CI]=-14.9至1.8;p=0.12)。虽然手术组在12个月时的主动肘关节伸展明显更优,但两组在12个月时的其他次要结局无显著差异。

结论

该研究发现手术组和非手术组在12个月时的DASH评分无显著差异。这支持非手术治疗作为老年移位性稳定尺骨鹰嘴骨折的合理选择。

证据水平

治疗性I级。有关证据水平的完整描述,请参阅作者指南。

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