Fixing a broken elbow with a metal plate versus non-surgical care in older adults
Treatment of Olecranon Fractures in the Elderly, a Randomised Controlled Trial Comparing Surgical and Conservative Treatment
This test sees if using a metal plate to fix a displaced olecranon fracture helps older adults with low arm demands recover better and regain arm function than non-surgical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT07400692 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized study enrolls 84 patients aged over 65 with an acute displaced (Mayo type 2A or 2B) olecranon fracture and reduced functional demand. Participants are randomly assigned 1:1 to open reduction with plate osteosynthesis or to conservative treatment with early mobilization. The trial compares recovery and arm function between the two groups over scheduled follow-up visits. The aim is to identify which treatment provides better functional outcomes for this specific older, low-demand population.
Who should consider this trial
Good fit: Ideal candidates are adults older than 65 with an acute (seen within 2 weeks) displaced Mayo type 2A or 2B olecranon fracture, reduced functional demand (Clinical Frailty Scale >2 and <7), and the ability to give informed consent and attend follow-up.
Not a fit: Patients under 65, those with very low or very high frailty (CFS ≤2 or >7), open or pathological fractures, old nonunions, severe prior elbow impairment, other acute ipsilateral limb injuries, severe comorbidities preventing surgery, or inability to consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the results could show whether surgical plate fixation improves recovery and arm function in older adults, helping doctors choose the best treatment.
How similar studies have performed: Previous studies comparing surgical and non-surgical care for olecranon fractures in older adults have shown mixed results, so randomized evidence in this population remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Patients with an acute (\< 2 weeks) Mayo type 2A or 2B olecranon fracture * Patients aged \> 65 years • Patients with reduced functional demand, with a score \> 2 and \< 7 on the Clinical Frailty Scale * Patients able to provide informed consent and follow all study procedures as indicated in the protocol * Signed informed consent for study participation Exclusion criteria: * Patients aged \< 65 years or with a Clinical Frailty Scale score \> 7 or \< 2 * Patients with a Mayo type 2A or 2B fracture seen more than 2 weeks after injury * Old fracture (\> 6 months), pseudoarthrosis, or unhealed nerve injury of the ipsilateral upper limb * Open (Gustilo-Anderson type 2 or 3) or pathological fracture * Previous injury to, or other condition of, the elbow with severe functional impairment * Patients with severe comorbidities preventing safe surgical treatment * Other acute fracture or nerve damage of the ipsilateral upper limb * Known drug or alcohol abuse * Inability to follow study procedures (e.g., due to language barriers or severe comorbidities)
Where this trial is running
Lugano
- EOC - Orthopaedics and Traumatology Service — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Davide Previtali, MD — Eoc
- Study coordinator: Davide Previtali, MD
- Email: RicercaOrtopedia.ORL@eoc.ch
- Phone: 0041918117029
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.