METHODS: 95 patients with isolated proximal humerus fractures were enrolled in a prospective, randomized study. Patients were assigned to a treatment group with (n = 48, CPM) or without CPM therapy (n = 47, CG). Four patients (2 of each cohort) violated the study protocol and were excluded. CPM therapy was used for 6 weeks after surgery 2-3 times daily. Functional (range of motion) and patient reported outcomes (PROM, Constant Score [CSS], QuickDASH, subjective shoulder value [SSV], pain on visual analogue scale [VAS]) were evaluated at 6 weeks, 3 and 12months. 60 patients completed the 1-year follow-up.
RESULTS: The average patient age was 65.3 years (min: 27, max: 88, SD: ± 14.7). Seventy-two patients were female (79%). There was no difference regarding injury severity (2/3/4 part-fracture: 6/32/7 vs. 9/26/11, p = 0.867) and sex (p = 0.08). However, patients in the CPM group were significantly younger (CPM: 67 [min: 34, max: 82], CG: 74 [min: 27, max: 88], p = 0.032). After 6 weeks we observed a better range of motion for forward flexion (CPM: 90° [min: 50°, max: 180°] vs. CG: 80° [min: 20°, max: 170°] p = 0.035) and abduction (CPM: 80° [min: 40°, max: 180°] vs. CG: 70° [min: 20°, max: 180°], p = 0.048) in the CPM group. There was no difference regarding the further planes of motion or the assessed PROMs at 6 weeks. At 3 and 12 months the results between the treatment groups equalized with no further significant differences.
CONCLUSIONS: The treatment with CPM increases the range of motion after plate osteosynthesis of proximal humerus fractures in the first 6 weeks after surgery. This effect is not sustained after 3 and 12months. The evaluated PROMs are not being influenced by CPM therapy. Hence the results of this prospective randomized study suggest that CPM can be a beneficial asset in the early period of rehabilitation after proximal humerus plate osteosynthesis.
BACKGROUND: The study protocol was registered in the US National Institutes of Health\'s database ( http://www.
RESULTS: gov ) registry under NCT05952622.
方法:95例孤立性肱骨近端骨折患者纳入前瞻性研究,随机研究。患者被分配到接受(n=48,CPM)或不接受CPM治疗(n=47,CG)的治疗组。4名患者(每组2名)违反研究方案并被排除。手术后使用CPM治疗6周,每天2-3次。功能(活动范围)和患者报告的结果(PROM,恒定分数[CSS],QuickDASH,主观肩值[SSV],疼痛视觉模拟评分[VAS])在6周时进行评估,3和12个月。60例患者完成1年随访。
结果:患者平均年龄为65.3岁(min:27,max:88,SD:±14.7)。72例患者为女性(79%)。损伤严重程度没有差异(2/3/4部分骨折:6/32/7与9/26/11,p=0.867)和性别(p=0.08)。然而,CPM组患者明显年轻(CPM:67[min:34,max:82],CG:74[min:27,max:88],p=0.032)。6周后,我们观察到向前屈曲的运动范围更好(CPM:90°[min:50°,max:180°]vs.CG:80°[min:20°,max:170°]p=0.035)和外展(CPM:80°[min:40°,max:180°]vs.CG:70°[min:20°,max:180°],CPM组p=0.048)。在第6周时,进一步的运动平面或评估的PROM没有差异。在3个月和12个月时,治疗组之间的结果相等,没有进一步的显着差异。
结论:CPM治疗增加了肱骨近端骨折术后前6周的钢板固定后的活动范围。这种效果在3个月和12个月后不会持续。评估的PROM不受CPM治疗的影响。因此,这项前瞻性随机研究的结果表明,在肱骨近端钢板接骨术后的早期康复中,CPM可能是一项有益的资产。
背景:研究方案已在美国国立卫生研究院的数据库中注册(http://www.
结果:gov)NCT05952622下的注册表。