Study rationale
The Nordic DeltaCon Trial is a multicenter, randomized controlled study designed to compare reverse total shoulder arthroplasty (RTSA) with non-operative treatment in older patients (aged 65–85) suffering from displaced proximal humerus fractures (PHFs). PHFs are among the most prevalent fractures in the elderly, often resulting from low-energy trauma – simple fall. While most PHFs are managed non-operatively, surgical interventions like RTSA have gained popularity despite limited high-quality evidence supporting their superiority.
Recent randomized controlled trials and meta-analyses have indicated no significant difference in functional outcomes between non-operative treatment and surgical options such as locking plates or hemiarthroplasty, which has been our research group’s recent study. However, surgical treatments are associated with higher complication and reoperation rates. RTSA, initially developed for cuff-deficient shoulders, has seen increased use for PHFs in the last decade.
By providing high-quality evidence on the efficacy and safety of RTSA compared to non-operative treatment for PHFs in the elderly, the Nordic DeltaCon Trial seeks to inform clinical decision-making and optimize patient outcomes in this growing patient population.
Study design
The Nordic DeltaCon Trial aims to address this gap by enrolling patients with multi-part PHFs, classified according to the AO/OTA 2018 system. Participants are randomized to receive either RTSA or non-operative treatment, with the primary outcome being the QuickDASH score assessed at two years post-treatment. Secondary outcomes include pain levels, grip strength, Oxford Shoulder Score, Constant Score, complication rates, reoperations, and quality of life measures. A cost-effectiveness analysis is also planned as a separate study.
The trial has been conducted across multiple Nordic trauma centers to enhance the generalizability of the findings. We have collaborating parties in Finland, Estonia, Denmark, and Norway. Ethical approval has been obtained, and patient involvement is emphasized through interviews and self-assessments to align the study with patient-centered care principles.
Status
The recruitment has been concluded, and the analysis of the results and the publication are expected to be completed by 2026.
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