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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * Age under 18 years * Currently pregnant or breastfeeding (patient will simply be asked pregnancy status) * Unable to give consent * Prisoner * Mentally disabled
About the study
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.
What is being tested
- Carbo-fix Lateral Plate Device (device)
- Standard Plate-Nail Construct (device)
Sponsor: University of Missouri-Columbia · Participants: 100 · Started: Jan 29, 2026
Contact the study team
- Vicki L Jones, MEd · Phone: 573-882-7583
- Nash Kolb · Phone: 573-884-8428
Official record on ClinicalTrials.gov — NCT07280169
Locations in the U.S.
| Missouri | University of Missouri-Columbia, Columbia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.