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

BackgroundProximal 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 1- and 2-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.MethodA 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 the between-group difference in Oxford Shoulder Score at 12 months. Sample size was calculated assuming a clinically relevant difference of 9.6 points on the OSS (SD 12), corresponding to 80% power at a 5% significance level. In case of treatment failure (persistent pain or a failed osteosynthesis), a salvage procedure will be offered. Patients not consenting to randomization will be asked to participate in a non-randomized cohort. They will have baseline data and preferences recorded, and they will receive the same follow-up and outcome assessments.DiscussionYoung 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 registrationClinicaltrials.gov, NCT06416618, registered 14 May 2024.