About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Open reduction and plate osteosynthesis
Procedure/SurgeryA 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.
Conservative treatment with early mobilisation
Other interventionConservativel 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.
Treatment groups
Trial outcomes
Primary outcomes
between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological
the 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
Sponsors and contacts
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