This study is a retrospective chart review of the safety and performance Standard of Care data on individuals that have previously been implanted with the femur nail of the RFNA System for the internal fixation of the femur. Demographics, medical history, primary diagnosis, mechanism of injury, type of injury, clinical and radiographic evaluation of bone consolidation, and device-related adverse events were collected. Descriptive statistics were applied to the data collected.
Study Type
OBSERVATIONAL
Enrollment
53
The Advanced Retrograde Femoral Nailing System (RFNA) is designed to improve fixation and stabilization of distal femur and femoral shaft fractures by reducing toggle and loss of reduction.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Union
Rate of fracture union
Time frame: 6 months
Infection
Rate of infection
Time frame: 6 months
Implant breakage
Rate of implant breakage
Time frame: 6 months
Implant removal
Rate of symptomatic implant removal
Time frame: 6 months
Malunion
Rate of malunion
Time frame: 6 months
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