Actively Recruiting
Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series
Led by University of California, San Diego · Updated on 2026-02-09
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
D
DePuy Synthes
Collaborating Sponsor
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Distal femur or femoral shaft fracture requiring surgery
- Evaluation and treatment at UCSD
- Age 18 years or older
- Ability to understand the content of the patient information/Informed Consent Form
- Signed and dated IRB-approved written informed consent
You will not qualify if you...
- Any not medically managed severe systemic disease
- Doctor has decided a different fixation method is best
- Doctor determined patient unsuitable for study participation
- Pregnancy or planning pregnancy within 1 year (self-reported)
- Prisoner
- Participation in another medicinal product study within the previous month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to hospital discharge period
Participants undergo surgery with the Retrograde Femoral Nail-Advanced system followed by immediate post-operative care.
Duration - Up to 1 year
Participants attend follow-up visits to monitor healing and assess pain and complications.
Multiple follow-up visits during the year
Trial Site Locations
Total: 1 location
1
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
Research Team
D
Dominic Baun, MS
W
William Kent, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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