Comparing surgical and non-surgical treatments for shoulder fractures in middle-aged adults
Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years: a Pragmatic Randomized Controlled Trial
This study is testing whether surgery or non-surgery works better for helping middle-aged adults with shoulder fractures recover and regain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 2 sites (Køge, Region Sjælland and 1 other locations) |
| Trial ID | NCT06416618 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether surgical treatment leads to better functional outcomes compared to non-surgical treatment for displaced proximal humerus fractures in adults aged 50 to 65. Participants will be randomly assigned to receive either surgical intervention or non-surgical care, with their progress monitored through questionnaires at 6 months, 1 year, and 2 years. The primary outcome will be assessed using the Oxford Shoulder Score at the 12-month mark, while secondary outcomes will include additional assessments at various time points. The study also seeks to characterize the patient population regarding fracture morphology and clinical frailty.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 to 65 with a displaced proximal humerus fracture deemed reconstructible by their surgeon.
Not a fit: Patients with fractures that cannot be reconstructed or those with significant comorbidities affecting treatment outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment options for middle-aged adults with shoulder fractures.
How similar studies have performed: Previous studies have shown mixed results regarding surgical versus non-surgical treatment in older populations, but this specific age group has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Køge, Region Sjælland and 1 other locations
- Centre for Evidence-Based Orthopaedics, Zealand University Hospital — Køge, Region Sjælland, Denmark (Recruiting)
- Tampere University Hospital — Tampere, Finland (Not_yet_recruiting)
Study contacts
- Principal investigator: Line Løjbert Houkjær, M.D. — Center for evidensbaseret ortopædkirurgi, Sjællands Universitets Hospital, Køge.
- Study coordinator: Line Løjbert Houkjær, M.D., ph.d.-student
- Email: lihol@regionsjaelland.dk
- Phone: 61711681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.