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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Age under 18 years

Currently pregnant or breastfeeding (patient will simply be asked pregnancy status)

Unable to give consent

Prisoner

Trial design

Treatments tested in this trial

  • Carbo-fix Lateral Plate Device
  • Standard Plate-Nail Construct

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Missouri-Columbia

Lead sponsor

CarboFix Orthopedics Ltd.

Collaborator