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HIPAA Compliant
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Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05680987

Using the RFN-Advanced Retrograde Femoral Nailing System to Fix Distal Femur and Femoral Shaft Fractures A Prospective Case Series Study

Led by University of California, San Diego · Updated on 2026-02-09

40

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the RFN-Advanced Retrograde Femoral Nailing System for patients aged 18 years or older who have distal femur or femoral shaft fractures requiring surgery. This prospective and retrospective case series study aims to provide insights into this new design of retrograde femoral nails, addressing the relatively high complication rates seen with current femoral nail designs. The study is sponsored by the University of California, San Diego and focuses on improving management of these fractures. Participants who consent will receive the RFN-Advanced implant for fracture fixation during their surgery. The study collects data on functional status, healing rates, complication rates, and pain levels over time. The primary treatment phase involves surgical fixation using this system, and data collection spans up to three years to analyze outcomes and potential benefits of this device. During the study, participants will be monitored with assessments including healing rates measured over two years, pain scores recorded up to one year, and the number of complications tracked for one year. Data on functional outcomes and safety will be gathered through these evaluations. Overall participation includes pre-surgery evaluation, surgery with the implant, and follow-up visits to assess recovery and related outcomes.

CONDITIONS

Brief Title

Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures

Research Team

D

Dominic Baun, MS

W

William Kent, MD

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