Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractur
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 impr
| Condition(s) | Distal Femur Fracture |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Missouri-Columbia |
| Locations | Columbia, Missouri, United States |
| Start date | 2026-01-29 |
| NCT ID | NCT07280169 |
| Official listing | https://clinicaltrials.gov/study/NCT07280169 |