Osteosynthesis of 3- or 4- part proximal humeral fractures in the elderly using locking plate with or without synthetic bone graft augmentation: A Randomized Clinical Trial.

Abstract

Osteosynthesis of proximal humeral fractures (PHFs) using locking plates (LPs) is associated with a high complication rate, and graft augmentation aims to reduce it. Our study compared clinical and radiographic outcomes as well as complications in elderly with 3- or 4-part PHFs operated with LP with or without synthetic bone graft. A prospective, randomized controlled trial (RCT) included 70 patients with 3- or 4- part PHFs that were randomly assigned to osteosynthesis using an LP with calcium sulfate paste bone graft (Graft Group) or without graft (Control). The primary outcome was the 12-month Constant-Murley score. The secondary outcomes included the 3- and 6-months Constant-Murley score, the 3-, 6- and 12-months University of California at Los Angeles (UCLA) score, American Shoulder and Elbow Surgeons (ASES) score, visual analogue scale (VAS) for pain, Disabilities of the Arm, Shoulder, and Hand (DASH) score, active range of motion (ROM), the 12-month Individual Relative Constant (IRC), patient satisfaction, and the abduction strength, the head-shaft angle (HSA), and the humeral height (HH), consolidation and complications on the 1^st postoperative day, and at 6 weeks, 3, 6 and 12- months. No differences were evidenced at 12 months between the Graft Group and Control, respectively, on the Constant-Murley score (67.7±13.0 vs. 70.3±9.4 points, p=0.328), IRC (79.3±9.7% and 81.6±6.3%, p=0.227), UCLA, ASES, VAS, DASH scores, active ROM and satisfaction rate (97.2% and 100%, p=0.328). The abduction strength was significantly higher in the Graft group (5.5±1.8 vs. 3.7±0.9 N, p<0.001). No differences were shown between the mean HSA of healthy and operated shoulders in the groups on the first day (p=0.455) and at 12 months (p=0.671), likewise between the groups' mean HH on the first day (p=0.298) and at 12 months (p=0.354). There was a 100% consolidation with a mean of 7.7 and 8.3 weeks, respectively (p=0.347) without any osteonecrosis in the Graft Group. There were no differences in patients with complications (13.9% vs. 29.4%, p=0.111) or who underwent reoperations (5.5% vs. 11.8%, p=0.325). However, the total number of complications was significantly lower in the Graft Group (50.0% vs. 16.7%, p=0.007). Our study confirms that calcium sulfate synthetic bone substitute augmentation did not alter the Constant-Murley score or most secondary clinical and radiographic outcomes in elderly patients with 3- or 4-part PHF. However, overall complications were reduced, and the abduction strength was higher in the Graft Group.