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
Sponsors and collaborators
University of Missouri-Columbia
Lead sponsor
CarboFix Orthopedics Ltd.
Collaborator