Actively Recruiting
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
Led by Zealand University Hospital · Updated on 2025-09-18
60
Participants Needed
2
Research Sites
241 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
T
Tampere University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 50 and 65 years with a displaced proximal humerus fracture suitable for reconstruction by the surgeon after low-energy trauma
- Patients must be cognitively able to answer follow-up questionnaires
You will not qualify if you...
- Patients who cannot understand written and spoken Danish, Finnish, or Swedish
- Unable to give informed consent
- Fractures considered unreconstructable by the surgeon
- Isolated tuberosity fractures, fracture dislocations, open fractures, or fractures involving the joint surface
- Less than 25% contact between the head fragment and shaft on X-rays at two weeks
- Pathological fractures or previous fractures in the same shoulder
- Additional fractures that could affect the outcome
- Paralysis in the upper extremity
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centre for Evidence-Based Orthopaedics, Zealand University Hospital
Køge, Region Sjælland, Denmark, 4600
Actively Recruiting
2
Tampere University Hospital
Tampere, Finland, 33520
Not Yet Recruiting
Research Team
L
Line Løjbert Houkjær, M.D., ph.d.-student
CONTACT
S
Stig Brorson, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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