Clinical Trial

Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years

Study acronym: PHF50-65
Recruiting
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-05-14; most recent amendment 2025-09-11.
Status change: Not Yet Recruiting → Recruiting 2024-07-29
Trial Details
NCT Number NCT06416618
Lead Sponsor Zealand University Hospital
Collaborators: Tampere University Hospital
Conditions Proximal Humeral Fracture, Shoulder Fractures
Enrollment 60 participants
Start Date 2024-05-15
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-18