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

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

Study Overview

• Status: Recruiting
• Conditions: Olecranon Fracture
• Intervention / Treatment: Procedure: Open reduction and plate osteosynthesis; Other: Conservative treatment with early mobilisation

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davide Previtali, MD; Phone Number: 0041918117029; Email: RicercaOrtopedia.ORL@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • EOC - Orthopaedics and Traumatology Service
    • Contact: Christian Candrian, Prof.Dr.med; Phone Number: +41 (0) 91 811 61 23; Email: christian.candrian@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgery; 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; 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.
Other: rehabilitation; Standard rehabilitation with optional upper arm sling for comfort for 2 weeks and progressive mobilization protocol	Other: Conservative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Investigators: Principal Investigator: Davide Previtali, MD, EOC

Study record dates

Study Major Dates

• Study Start (Estimated): February 3, 2026
• Primary Completion (Estimated): February 3, 2030
• Study Completion (Estimated): February 3, 2030

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Elbow Injuries; Elbow Fractures; Wounds and Injuries; Fractures, Bone; Arm Injuries; Forearm Injuries; Ulna Fractures; Olecranon Fracture; Therapeutics; Surgical Procedures, Operative; Orthopedic Procedures; Fracture Fixation; Conservative Treatment; Open Fracture Reduction
• Other Study ID Numbers: ORL-ORT-049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No