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

RecruitingNAAges 50 Years - 65 YearsAllZealand University Hospital
NCT06416618 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 O

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility. * Patients should be cognitively capable of answering the follow-up questionnaires. Exclusion Criteria: * The patient does not understand written and spoken native language (Danish or Finnish/Swedish) * Inability to give informed consent * Fractures assessed to be unreconstructedly by the treating surgeon * Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface * Less than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks. * Pathological fractures or previous fractures in the same proximal humerus * Concomitant fractures, which could influence the outcome * Paralysis in upper extremity
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What it tests

  • Surgical
  • Non surgical
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Where

2 sites
Centre for Evidence-Based Orthopaedics, Zealand University Hospital
Køge, Denmark
Tampere University Hospital
Tampere, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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