背景:半导体全肘关节成形术(TEA)是一种针对不适合稳定内固定(不可重建)的肱骨远端骨折的老年患者的既定治疗方法。近年来,对肘关节置换术(EHA)的兴趣越来越大,与TEA相比,一种不需要限制负重的治疗方案。这两种治疗方法尚未在随机对照试验(RCT)中进行比较。这项研究的目的是比较EHA和TEA治疗老年患者不可重建的肱骨远端骨折的功能结果。
方法:这是一个多中心RCT。患者在2011年1月至2019年11月期间在3家参与医院之一纳入。纳入标准是不可重建的肱骨远端骨折,年龄≥60岁,独立生活。最终随访时间为≥2年。主要结果指标是手臂的残疾,肩和手(DASH)得分。次要结果指标是梅奥肘部表现评分(MEPS),EQ-5D指数,运动范围(屈曲,扩展,内旋和外旋)和握力。
结果:40例患者随机接受TEA(n=20)和EHA(n=20)。五名病人在完成最后的随访前死亡,留下18名EHA和17名TEA患者进行分析。有31名妇女。平均年龄为74.0(标准差,EHA组的8.5年)和76.9年(SD,7.6)在TEA组中(P=0.30)。EHA组平均DASH评分为21.6分,TEA组为27.2分(P=0.39),差异为-5.6分(95%CI:-18.6-7.5)。EHA和TEA治疗的MEPS平均值没有差异(85.0vs.88.2,P=0.59),EQ-5D指数(0.92与0.86,P=0.13),延伸(29°vs.29°,P=0.98),屈曲(126°vs.136°,P=0.05),屈伸弧(97°vs.107°,P=0.25),旋光(81°vs.75°,P=0.13),内旋(78°vs.74°,P=0.16)或握力(17.5kgvs.17.2kg,P=0.89)。各治疗组共发生6起不良事件。
结论:在此RCT中,肘关节置换术(EHA)和全肘关节置换术(TEA)对于老年患者不可重建的肱骨远端骨折,在至少2年的随访中,均取得了良好且相似的功能结局.
BACKGROUND: Semiconstrained total elbow arthroplasty (TEA) is an established treatment for elderly patients with distal humeral fractures not amenable to stable internal fixation (unreconstructable). In recent years, there has been increasing interest in elbow hemiarthroplasty (EHA), a treatment option which does not entail restrictions on weight-bearing as opposed to TEA. These 2 treatments have not been compared in a randomized controlled trial (RCT). The aim of this study was to compare the functional outcome of EHA and TEA for the treatment of unreconstructable distal humeral fractures in elderly patients.
METHODS: This was a multicenter randomized controlled trial (RCT). Patients were included between January 2011 and November 2019 at one of 3 participating hospitals. The inclusion criteria were an unreconstructable distal humeral fracture, age ≥60 years and independent living. The final follow-up took place after ≥2 years. The primary outcome measure was the Disabilities of the Arm, Shoulder, and Hand (DASH) score. Secondary outcome measures were the Mayo Elbow Performance Score (MEPS), the EQ-5D index, range of motion (flexion, extension, pronation, and supination) and grip strength.
RESULTS: Forty patients were randomized to TEA (n = 20) and EHA (n = 20). Five patients died before completing the final follow-up, leaving 18 EHA and 17 TEA patients for analysis. There were 31 women. The mean age was 74.0 (SD, 8.5) years in the EHA group and 76.9 (SD, 7.6) in the TEA group (P = .30). The mean DASH score was 21.6 points in the EHA group and 27.2 in the TEA group (P = .39), a difference of -5.6 points (95% CI: -18.6 to 7.5). There were no differences between treatment with EHA and TEA for the mean values of the MEPS (85.0 vs. 88.2, P = .59), EQ-5D index (0.92 vs. 0.86, P = .13), extension (29° vs. 29°, P = .98), flexion (126° vs. 136°, P = .05), arc of flexion-extension (97° vs. 107°, P = .25), supination (81° vs. 75°, P = .13), pronation (78° vs. 74°, P = .16) or grip strength (17.5 kg vs. 17.2 kg, P = .89). There were 6 adverse events in each treatment group.
CONCLUSIONS: In this RCT, both elbow hemiarthroplasty (EHA) and total elbow arthroplasty (TEA) resulted in a good and similar functional outcome for unreconstructable distal humeral fractures in elderly patients at a minimum of 2 years of follow-up.