Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures

The purpose of this randomized clinical trial is to decrease non-union rates in distal femur fracture fixation. Carbo-fix lateral femur plate and standard intramedullary nail-plate constructs have been shown to have lower non-union rates. With decreased non-union rates, re-operation rates will decrease, leading to improved patient outcomes and clinical care. This study will randomize patients to one of the two groups. Then investigators will be collecting data on the standard plate and nail combination and compare outcomes with the Carbofix plate to see differences in union rates. All procedures are currently standard of care and no procedures are research only.

NCT Number	NCT07280169
Lead Sponsor	University of Missouri-Columbia Collaborators: CarboFix Orthopedics Ltd.
Conditions	Distal Femur Fracture
Enrollment	100 participants
Start Date	2026-01-29
Primary Completion	2028-12-01 (estimated)
Study Completion	2029-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-17