Faculty of Medicine and Health Technology, University of Tampere and Tampere University Hospital, Tampere, Finland.
Department of Orthopaedics, Central Finland Central Hospital, Jyväskylä, Finland.
PLoS Med. 2019 Jul 18;16(7):e1002855. doi: 10.1371/journal.pmed.1002855. eCollection 2019 Jul.
Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures.
The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded.
This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial.
ClinicalTrials.gov NCT01246167.
尽管越来越多地应用，但手术治疗移位的 2 部分肱骨近端骨折的益处尚未得到证实。本试验评估了锁定钢板手术与非手术治疗这些骨折的临床效果。
NITEP 组在芬兰、爱沙尼亚、瑞典和丹麦的 6 家医院进行了一项优势、评估者盲法、多中心随机试验。88 名年龄在 60 岁或以上、有移位（超过 1 厘米或 45 度）的 2 部分外科或解剖颈肱骨近端骨折的患者，按照 1:1 的比例随机分配，接受锁定钢板手术或非手术治疗。非手术组患者的平均年龄为 72 岁，手术组为 73 岁，女性分别占 95%和 87%。患者于 2011 年 2 月至 2016 年 4 月间招募。主要结局测量指标为 2 年随访时的上肢功能障碍（DASH）评分。次要结局包括 Constant-Murley 评分、疼痛视觉模拟评分、生活质量问卷 15D、欧洲五维健康量表自我报告问卷 EQ-5D、牛津肩肘评分和并发症。手术组的平均 DASH 评分（0 分最佳，100 分最差）为 18.5 分，非手术组为 17.4 分（平均差值 1.1[95%CI-7.8 至 9.4]，p=0.81）。在 2 年时，在任何结局测量指标中，两组之间均无统计学或临床显著差异。所有 3 例导致二次手术的并发症均发生在手术组。患者报告结局评估的缺乏盲法是该研究的一个局限性。然而，我们的评估物理治疗师是盲法的。
本试验发现，在 60 岁及以上的肱骨近端 2 部分移位骨折患者中，与非手术治疗相比，手术治疗在 2 年时的临床结局无显著差异。这些结果表明，目前对大多数老年移位的肱骨近端 2 部分骨折进行手术治疗可能没有益处。
ClinicalTrials.gov NCT01246167。
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