Comparison of locking plates and intramedullary nails in treatment of three-part or four-part proximal humeral neck fractures in elderly population: A randomized trial protocol

BACKGROUND: Locking plate and intramedullary nail are two commonly applied methods to fix proximal humeral fractures. There are limited randomized studies that specifically evaluate the results of proximal humeral neck fractures with three-part or four-part treated by locking plates or intramedullary nails. Our goal was to compare functional outcomes, complications, and imaging features between the two groups. METHODS: This single-center, prospective, randomized controlled test will be conducted in Tengzhou Central People's Hospital. Patients with these conditions will be included: age between 55 and 80 years; are able to communicate normally and agree to participate in our study; with the radiological evidence of proximal humeral fractures with three-part or four-part; surgical treatment was performed within twenty-one days after the acute fracture. Consecutive patients with proximal humeral fractures will be stochastic to be dealt with a locking plate or a bone nail. The informed consent will be acquired in each patients. Two groups will use the same postoperative rehabilitation protocol. Clinical outcomes include Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications. The significance level was defaulted as P < .05. RESULTS: This study will provide a solid theoretical basis for exploring which technique is better in treatment of 3-part or 4-part proximal humeral neck fractures in elderly population. TRIAL REGISTRATION: This study protocol was registered in Research Registry (number: researchregistry6047).