Surgical versus non-surgical treatment of proximal humerus fracture in patients aged 50-65 years: Young shoulder CARE (displaCed proximAl humerRus fractueE) trial - a study protocol for a pragmatic randomized controlled trial

Abstract Background: Proximal humerus fractures (PHF) are common in adults above 50 years, often following low-energy trauma and underlying osteoporosis. Randomized trials in patients 60 years and older have found no clinically important difference in one- and two-year outcomes between surgical and non-surgical treatments. There is limited evidence for the 50–65 age group, who may have different functional demands and even a different overall health status. There is limited knowledge to guide treatment decisions for this age group. Method: A multicenter, parallel-group, randomized, superiority trial comparing osteosynthesis with non-surgical treatment in patients aged 50–65 years with displaced PHF. A total of 60 patients will be randomized equally to surgical treatment (primary osteosynthesis) or non-surgical treatment. Follow up visits are arranged at 6 weeks and 6 months for all patients, with an additional 12-week visit mandatory for the surgical group and optional for the non-surgical group. The primary outcome is Oxford Shoulder Score at 12 months. In case of treatment failure (persistent pain or a failed osteosynthesis), a salvage procedure will be offered. Non-randomised cohort will have baseline data and preferences recorded, and they will receive the same follow-up and outcome assessments. Discussion: Young Shoulder CARE trial aims to provide insights into the treatment of displaced proximal humerus fractures in patients aged 50-65 years, and to understand the benefits and harms of both surgical and non-surgical treatment options. The trial results will be published in an open-access peer-reviewed journal. Trial registration: Clinicaltrials.gov, NCT06416618, registered 14 May 2024.