Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years: a Pragmatic Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Centre for Evidence-Based Orthopaedics, Zealand University Hospital
RECRUITING
Køge
Finland
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Contact Information
Primary
Line Løjbert Houkjær, M.D., ph.d.-student
lihol@regionsjaelland.dk
61711681
Backup
Stig Brorson, Prof.
sbror@regionsjaelland.dk
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Non-surgical treatment
Patients in the non-surgical group will be offered an optional sling for comfort for an additional 1-2 weeks at their first visit,
Active_comparator: Procedure: Surgical treatment
The surgical group will receive osteosynthesis with a locking plate or an intramedullary locking nail, according to the surgeon's choice
Related Therapeutic Areas
Sponsors
Collaborators: Tampere University Hospital
Leads: Zealand University Hospital

This content was sourced from clinicaltrials.gov