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This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment

Treatment of Olecranon Fractures in the Elderly, a Randomised Controlled Trial Comparing Surgical and Conservative Treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07400692
Enrollment
84
Registered
2026-02-10
Start date
2026-02-03
Completion date
2030-02-03
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Olecranon Fracture

Brief summary

This study takes place in one hospital and uses a random method to divide patients into groups. It looks at the best way to treat a broken elbow (specifically, a displaced olecranon fracture) in older adults who don't use their arms heavily. There are 84 patients in total, with 42 people in each group

Interventions

A cut is made along the back of the elbow to reach the broken bone. The surgeon carefully moves tissues aside and protects nearby nerves. The broken bone is cleaned, realigned, and held in place with a special metal plate and screws. This helps support the bone, especially in older patients with fragile bones. The surgeon checks the placement using live X-ray and moves the arm to ensure stability. The area is then closed with stitches, bandaged, and sometimes supported with a light splint. Recovery starts early, with gentle exercises to regain movement while protecting the repair.

OTHERConservative treatment with early mobilisation

Conservativel treatment usually involves wearing a sling or light support for about two weeks to manage pain. After that, the patient begins gentle, supervised arm movements to prevent stiffness and muscle loss. As the pain improves, exercises become more active and focused on regaining strength. The goal is to let the bone heal while keeping the elbow working well.

Sponsors

Ente Ospedaliero Cantonale, Bellinzona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological6 months after injurythe Oxford Elbow Score is a patient-reported outcome measure specifically developed to evaluate elbow function. It includes 12 items divided into three domains: elbow pain, elbow function, and social-psychological impact. Each item is scored on a 5-point scale, and domain scores can be summed to obtain an overall score, where higher values indicate better outcomes. It is validated for use in both clinical and research settings and is sensitive to change, making it suitable for assessing treatment effects in patients with elbow disorders

Countries

Switzerland

Contacts

CONTACTDavide Previtali, MD
RicercaOrtopedia.ORL@eoc.ch0041918117029
PRINCIPAL_INVESTIGATORDavide Previtali, MD

EOC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026