Randomized trial on the proximal humerus fracture osteosynthesis with plate or intramedullary nailing

INTRODUCTION: Fractures of the proximal humerus are common, with an increasing incidence in the elderly and with a high impact on quality of life and shoulder function. For displaced fractures, the locking plate is the most used method of osteosynthesis. Studies have shown good clinical results with the use of locking plates, but also with the fixation with locking intramedullary nail. The aim of this study was to compare the clinical outcomes, radiographic results and the complications between these two methods in patients with displaced proximal humerus fractures. METHODS: In this prospective, randomized clinical trial, 72 patients with displaced fractures of the proximal humerus, classified as Neer 2- or 3-part, were randomly assigned to receive osteosynthesis with either locking plate (36 patients - Plate Group) or locking intramedullary nail (36 patients - Nail Group). The clinical outcomes were evaluated at 3, 6 and 12 months and included the Constant and Murley, University of California at Los Angeles (UCLA) and Disability of Arm, Shoulder and Hand (DASH) scores, visual analog scale (VAS) and the passive range of motion. Radiographic findings (consolidation and head shaft angle) and complications, which included the evaluation of rotator cuff by ultrasound, were also evaluated. The primary outcome was the Constant and Murley score at 12 months. RESULTS: Sixty-five patients completed 12 months of follow-up, 32 in the Nail Group and 33 in the Plate Group. The mean Constant score at 12 months was 70.3 points for the Nail Group and 71.5 points for the Plate Group (p = 0.750) and the mean Relative Constant score was 81% for the Nail Group and 85% points for the Plate Group (p = 0.400). There was also no difference at 3 and 6 months for the Constant score. VAS, DASH and radiographic findings also did not differ at 3, 6 and 12 months. Range of motion showed a 2.1 points difference in favor of the Nail Group for medial rotation at 6...