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

NCT07280169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Distal Femur Fracture

Interventions

DEVICE

Carbo-fix Lateral Plate Device

Participants that are randomized to this group will have their distal femur fracture repaired with the Carbofix carbon fiber lateral locking plate

DEVICE

Standard Plate-Nail Construct

Participants who randomize to this group will have their distal femur fracture repaired with the standard lateral plate and intramedullary nail construct.

Sponsors & Collaborators

  • CarboFix Orthopedics Ltd.

    collaborator INDUSTRY

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Kyle M Schweser, MD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2028-12-01
Completion
2029-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280169 on ClinicalTrials.gov