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

Recruiting now · Not applicable

Conditions studied: Proximal Humeral Fracture, Shoulder Fractures

In brief

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.

Key facts

Study ID

NCT06416618

Run by

Zealand University Hospital

People needed

60

Starts

2024-05-15

Expected to finish

2028-12-31

Last updated by the study team

2025-09-18

Who can join

Age: 50 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Centre for Evidence-Based Orthopaedics, Zealand University Hospital — Køge, Region Sjælland, Denmark (enrolling)
• Tampere University Hospital — Tampere, Finland

Full record on ClinicalTrials.gov

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