RecruitingNot ApplicableNCT07280169

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

Identifying Non-Union Rates Using Carbo-fix Lateral Plate Devices and Standard Plate-Nail Construct in Distal Femur Fractures


Sponsor

University of Missouri-Columbia

Enrollment

100 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Adult patients, 18 years or older, with a distal femur fracture requiring surgery
  • Adult patients able to understand and sign the consent and answer PROs

Exclusion Criteria5

  • Age under 18 years
  • Currently pregnant or breastfeeding (patient will simply be asked pregnancy status)
  • Unable to give consent
  • Prisoner
  • Mentally disabled

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Interventions

DEVICECarbo-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

DEVICEStandard 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.


Locations(1)

University of Missouri-Columbia

Columbia, Missouri, United States

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NCT07280169


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