+1 877 705 1914• 24 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID04163172

Randomized Trial Comparing Elbow Hemiarthroplasty and Open Reduction Internal Fixation for Complex Distal Humerus Fractures in Patients 50 Years and Older

Led by Herlev and Gentofte Hospital · Updated on 2023-10-06

44

Participants Needed

1

Research Sites

313 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare two surgical treatments for distal humeral fractures, specifically AOOTA type C2 and C3 fractures, in patients aged 50 years or older. These fractures are challenging to treat, and while open reduction and internal fixation ORIF is often preferred, results can vary. Elbow hemiarthroplasty EHA is a newer option that may avoid some complications seen with total elbow arthroplasty, especially in active patients. This trial investigates which treatment provides better outcomes for these complex fractures. Participants will be randomly assigned to receive either elbow hemiarthroplasty using the Latitude anatomical device or ORIF with double plating implants. The study involves surgical procedures using devices from Wright for EHA and Synthes for ORIF. After surgery, patients will be followed up and evaluated at 3 months and then at 1, 2, 5, and 10 years to assess long-term results. During the study, patients will undergo examinations including functional scoring with the Oxford Elbow Score at 2 years after surgery, along with secondary assessments such as the Mayo Elbow Performance Score, pain severity using a visual scale, range of motion, and patient satisfaction at multiple time points. These evaluations aim to understand the effectiveness and patient experience related to each surgical treatment. The total follow-up period extends up to 10 years to monitor outcomes and safety over time.

CONDITIONS

Brief Title

Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

Research Team

A

Ali Al-Hamdani, MD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here