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.
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
Age under 18 years
Currently pregnant or breastfeeding (patient will simply be asked pregnancy status)
Unable to give consent
Prisoner
Parallel
Carbo-fix Lateral Plate Device
DeviceParticipants that are randomized to this group will have their distal femur fracture repaired with the Carbofix carbon fiber lateral locking plate
Standard Plate-Nail Construct
DeviceParticipants who randomize to this group will have their distal femur fracture repaired with the standard lateral plate and intramedullary nail construct.
The total number of participants that have non-union of their distal femur fractures when utilizing a carbon fiber lateral plate only or a standard nail/plate combination as assessed by standard of care radiographs.
The average scores of the patient reported outcomes for pain scores in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care with VAS Pain scores.
Visual Analogue Scale (VAS) pain scores will be collected through standard of care at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year and the average for both treatment groups will be reported.
The average scores of the patient reported outcomes for the PROMIS PF in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care patient reported outcome measures.
Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores will be collected through standard of care at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year and the average for both treatment groups will be reported.
The average scores of the patient reported outcomes for the PROMIS PI in distal femur fractures with the carbon fiber lateral plate or the nail plate combination as assessed by standard of care patient reported outcome measures.
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) scores will be collected through standard of care at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year and the average for both treatment groups will be reported.
The total number of patients with infection in the lateral plate versus the nail plate combination cohorts as assessed by standard of care wound check at follow up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year.
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University of Missouri-Columbia
Lead sponsor
CarboFix Orthopedics Ltd.
Collaborator
