Elbow Hemiarthroplasty Versus Open Reduction and Internal Fixation for AO/OTA Type C2 and C3 Fractures of Distal Humerus in Patients Aged 50 Years or Above; a Randomized Controlled Trial

What this Trial Is About

This research aims to compare two surgical treatments for distal humeral fractures, specifically AO/OTA 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.

Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures