Comparing Surgical and Non-Surgical Treatments for Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years A Randomized Controlled Study of Shoulder Fracture Outcomes

What this Trial Is About

This research aims to determine whether surgery leads to better functional outcomes than non-surgical treatment in patients aged 50 to 65 with displaced proximal humerus fractures. The study focuses on comparing osteosynthesis using either plate or intramedullary nail fixation to non-surgical care, while also examining factors like fracture type, osteoporosis status, and clinical frailty in this age group. Current knowledge mainly comes from older populations, so this trial fills an important gap for younger adults. Participants will be randomly assigned to receive either surgical treatment with osteosynthesis or non-surgical management. The surgical group will have follow-up visits at 2, 12, and 24 weeks with clinical and radiological assessments, while the non-surgical group will have visits at 6, 12, and 24 weeks. Both groups are referred to rehabilitation services. Surgical patients use a sling post-operation, while non-surgical patients may be offered an optional sling for comfort. During the study, participants will complete questionnaires including the Oxford Shoulder Score and EQ-5D-3L at 6 months, 12 months, and 24 months to assess function and quality of life. Researchers will monitor adverse events, any need for additional surgery, and rehabilitation adherence. The primary outcome is the Oxford Shoulder Score at 12 months, with additional evaluations at 6 and 24 months. Safety and treatment failures will also be tracked throughout the two-year follow-up.

Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years