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Recruiting 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

No phase Interventional Olecranon Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Open reduction and plate osteosynthesis, Conservative treatment with early mobilisation.
Who it may be relevant to
Registry conditions: Olecranon Fracture. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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. Rec
  • 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.

Primary outcome measures

  • between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological [Time frame: 6 months after injury]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • EOC - Orthopaedics and Traumatology Service — Lugano

Identifiers

NCT: NCT07400692 · ORL-ORT-049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗