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
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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 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.
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 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.
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.
