NCT04163172

Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized control trial comparing the outcome of ORIF (open reduction and internal fixation) with EHA (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 years or above.

Detailed description

Intraarticular distal humeral fractures AO/OTA type C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results are varying, and sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semiconstrained TEA. There are no studies comparing the results of EHA to that of TEA or ORIF, but case series have reported promising results. In this study, forty-four patients with AO/OTA type C2 or C3 fractures of distal humerus will be randomized to either ORIF or EHA. The patients will be examined after the operation and at 3 months and 1, 2, 5 and 10 years after the surgery. The main objective of this study is to investigate the best treatment option for distal humeral fractures in patients aged 50 years or above. This can be of value to future patients sustaining these complicated fractures.

Conditions

• Distal Humerus Fracture
• Comminuted Fracture
• Intra-Articular Fractures

Interventions

Type	Name	Description
PROCEDURE	Surgical treatment of distal humeral fracture with elbow hemiarthroplasty	Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)
PROCEDURE	Surgical treatment of distal humeral fracture with double plating.	Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)

Timeline

• Start date: 2020-02-01
• Primary completion: 2026-12-31
• Completion: 2032-12-31
• First posted: 2019-11-14
• Last updated: 2023-10-06

Locations

1 site across 1 country: Denmark