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NCT05668117
RFN-Advanced Retrograde Femoral Nailing System
Conditions: Femur Fracture
Sex: All
Ages: 18 Years – N/A
Enrollment: 53
Sponsor: University of Alabama at Birmingham
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Subjects 18 years or older at the time of index procedureSubjects who received the Depuy Synthes Advanced Retrograde Nail in accordance with the indications for use.Subjects who have at least 6 months of follow-up.Exclusion Criteria:Subject with less than 6 months of follow up, pathologic fractures, and patients < 18 years of age will be excluded from the study.
Source: ClinicalTrials.gov (NCT05668117). StuddyBuddy aggregates publicly available trial information.