Identifying Non-Union Rates Using Carbo-fix Lateral Plate Devices and Standard Plate-Nail Construct in Distal Femur Fractures
University of Missouri-Columbia
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.
Description
Distal femur fractures are quite common, accounting for 3-6% of all femur fractures. In young adults, high energy trauma is most likely the cause, whereas in the elderly population, a low energy trauma due to osteoporosis is likely. Mortality for elderly patients with distal femur fractures is \<20% at 1 year and approximately 50% at 5 years. Standard of care treatment for distal femur fractures is open reduction and internal fixation with locking plates, condylar screws, blade plates, or intramedullary nails, depending on the fracture characteristics. Non-union is a known complication of dist…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
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.
Location
- University of Missouri-ColumbiaColumbia, Missouri