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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorEnte Ospedaliero Cantonale, Bellinzona

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Open reduction and plate osteosynthesis

    Procedure/Surgery

    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.

  • Conservative treatment with early mobilisation

    Other intervention

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: surgeryExperimental treatment 1 intervention
Group B: rehabilitationOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months after injury

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.