Department of Trauma, Hand and Reconstructive Surgery, University of Giessen and Marburg, Baldingerstraße, 35033, Marburg, Germany,
Clin Orthop Relat Res. 2014 May;472(5):1576-85. doi: 10.1007/s11999-013-3415-7. Epub 2013 Dec 11.
Proximal humeral fractures are mainly associated with osteoporosis and are becoming more common with the aging of our society. The best surgical approach for internal fixation of displaced proximal humeral fractures is still being debated.
QUESTIONS/PURPOSES: In this prospective randomized study, we aimed to investigate whether the deltoid-split approach is superior to the deltopectoral approach with regard to (1) complication rate; (2) shoulder function (Constant score); and (3) pain (visual analog scale [VAS]) for internal fixation of displaced humeral fractures with a polyaxial locking plate.
We randomized 120 patients with proximal humeral fractures to receive one of these two approaches (60 patients for each approach). We prospectively documented demographic and perioperative data (sex, age, fracture type, hospital stay, operation time, and fluoroscopy time) as well as complications. Followup examinations were conducted at 6 weeks, 6 months, and 12 months postoperatively, including radiological and clinical evaluations (Constant score, activities of daily living, and pain [VAS]). Baseline and perioperative data were comparable for both approaches. The sample size was chosen to provide 80% power, but it reached only 68% as a result of the loss of followups to detect a 10-point difference on the Constant score, which we considered the minimum clinically important difference.
Complications or reoperations between the approaches were not different. Eight patients in the deltoid-split group (14%) needed surgical revisions compared with seven patients in the deltopectoral group (13%; p = 1.00). Deltoid-split and deltopectoral approaches showed similar Constant scores 12 months postoperatively (Deltoid-split 81; 95% confidence interval [CI], 74-87 versus deltopectoral 73; 95% CI, 64-81; p = 0.13), and there were no differences between the groups in terms of pain at 1 year (deltoid-split 1.8; 95% CI, 1.2-1.4 versus deltopectoral 2.5; 95% CI, 1.7-3.2; p = 0.14). No learning-curve effects were noted; fluoroscopy use during surgery and function and pain scores during followups were similar among the first 30 patients and the next 30 patients treated in each group.
The treatment of proximal humeral fractures with a polyaxial locking plate is reliable using both approaches. For a definitive recommendation for one of these approaches, further studies with appropriate sample size are necessary.
Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
肱骨近端骨折主要与骨质疏松症有关，随着社会老龄化，其发病率越来越高。对于移位的肱骨近端骨折，哪种内固定手术入路最好仍存在争议。
问题/目的：在这项前瞻性随机研究中，我们旨在比较三角肌劈开入路与三角肌胸大肌间入路治疗肱骨近端骨折的内固定术，（1）并发症发生率；（2）肩关节功能（Constant 评分）；（3）疼痛（视觉模拟评分[VAS]）。
我们将 120 例肱骨近端骨折患者随机分为这两种入路（每组 60 例）。前瞻性记录人口统计学和围手术期数据（性别、年龄、骨折类型、住院时间、手术时间和透视时间）以及并发症。术后 6 周、6 个月和 12 个月进行随访检查，包括影像学和临床评估（Constant 评分、日常生活活动和疼痛[VAS]）。两种方法的基线和围手术期数据具有可比性。我们选择了能够提供 80%功效的样本量，但由于随访丢失，导致检测到 Constant 评分相差 10 分（我们认为这是最小的临床重要差异），因此实际功效仅为 68%。
两种入路之间的并发症或再次手术无差异。三角肌劈开组有 8 例（14%）需要手术修正，而三角肌胸大肌间组有 7 例（13%）（p = 1.00）。术后 12 个月，三角肌劈开组和三角肌胸大肌间组的 Constant 评分相似（三角肌劈开组 81；95%置信区间[CI]，74-87 与三角肌胸大肌间组 73；95% CI，64-81；p = 0.13），两组之间的疼痛在 1 年时也无差异（三角肌劈开组 1.8；95% CI，1.2-1.4 与三角肌胸大肌间组 2.5；95% CI，1.7-3.2；p = 0.14）。未发现学习曲线效应；每组前 30 例和后 30 例患者的手术透视使用以及术后功能和疼痛评分相似。
使用多轴锁定钢板治疗肱骨近端骨折，两种入路均可靠。为了对其中一种方法进行明确推荐，需要进行具有适当样本量的进一步研究。
Ⅱ级，治疗性研究。有关证据水平的完整描述，请参见作者指南。
