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

NCT07400692 | Recruiting

• 1 other identifier: ORL-ORT-049
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Olecranon Fracture

Outcome Measures

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

  6 months after injury

Study Arms (2)

surgery

EXPERIMENTAL

Open reduction and plate osteosynthesis. The surgical treatment will be performed with a direct approach to the olecranon using a locking compression plate.

Procedure: Open reduction and plate osteosynthesis

rehabilitation

OTHER

Standard rehabilitation with optional upper arm sling for comfort for 2 weeks and progressive mobilization protocol

Other: Conservative treatment with early mobilisation

Interventions

Open reduction and plate osteosynthesis PROCEDURE

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.

surgery

Conservative treatment with early mobilisation OTHER

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.

rehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

EOC - Orthopaedics and Traumatology Service

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Olecranon Fracture

Interventions

Open Fracture Reduction; Conservative Treatment

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Ulna Fractures; Forearm Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Davide Previtali, MD

  EOC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Previtali, MD

CONTACT

0041918117029; RicercaOrtopedia.ORL@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): February 3, 2030
• Study Completion (Estimated): February 3, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CH (1)