Condition: Proximal Humeral Fracture · Shoulder Fractures · Sponsor: Zealand University Hospital
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.
This description comes directly from the study's public registry record.
Line Løjbert Houkjær, M.D., ph.d.-student · 61711681 · lihol@regionsjaelland.dk
Stig Brorson, Prof. · sbror@regionsjaelland.dk
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| Centre for Evidence-Based Orthopaedics, Zealand University Hospital | Køge, Region Sjælland, Denmark | Recruiting |
| Tampere University Hospital | Tampere, Finland | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06416618