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Recruiting

NCT Number: NCT07400692

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

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

Recruiting

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Key information

Conditions

Olecranon Fracture Arm Injuries Elbow Fractures Elbow Injuries Forearm Injuries Fractures, Bone Ulna Fractures Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EOC - Orthopaedics and Traumatology Service

Lugano, 6900, Switzerland

Location status: Recruiting

Location contact

Christian Candrian, Prof.Dr.med

CONTACT

[email protected]

+41 (0) 91 811 61 23

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological

    Time frame: 6 months after injury

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Davide Previtali, MD

CONTACT

[email protected]

0041918117029

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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