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Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
Sponsor: Zealand University Hospital
Summary
The goal of this clinical trial is to study whether surgery results in better functional outcomes than non-surgical treatment among patients aged 50-65 with a displaced proximal humerus fracture. The main questions it aims to answer are: • Does osteosynthesis result in better patient-reported functional outcomes compared to non-surgical treatment at 12 months follow-up? Aim is also to characterize the patient group aged 50-65 regarding fracture morphology, osteoporosis, and clinical frailty scale. The study compare operation with either plate or nail fixation to non-surgical treatment. Participants will: * Receive either surgical treatment or non-surgical treatment. * At 6 months, 1 year, and 2 years, the patient will answer two short questionnaires (Oxford Shoulder Score and Eq-5D-3L). The primary outcome will be Oxford Shoulder Score at 12 months. The secondary outcome will be OSS at 6 and 24 months and EQ-5D-3L score measured at the same time-points. Adverse events and conversion to surgery will be registered. OSS and EQ-5D-3L will be completed just before the 6 months visit.
Official title: Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years: a Pragmatic Randomized Controlled Trial
Key Details
Gender
All
Age Range
50 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-05-15
Completion Date
2028-12-31
Last Updated
2025-09-18
Healthy Volunteers
No
Interventions
Surgical
Surgical group: After osteosynthesis, they will be provided with a sling and swathe immediately after the surgery. From the first postoperative day, only the sling will be used. Two weeks postoperatively, patients will undergo clinical and radiological follow-up in the outpatient clinic. They will be referred to post-operative rehabilitation in the municipalities. At 12 weeks postoperatively, patients will have another clinical and radiological follow-up. This is the current standard care for surgical treatment with a plate or intramedullary nail.
Non surgical
Non-surgical group: Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit, 10-14 days post-injury. Patients will be referred to rehabilitation in the municipalities. At week 6 post-injury, all patients will undergo clinical and radiological follow-up. This represents the current standard care for non-surgical treatment of displaced PHF at the departments.
Locations (2)
Centre for Evidence-Based Orthopaedics, Zealand University Hospital
Køge, Region Sjælland, Denmark
Tampere University Hospital
Tampere, Finland