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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jan 9, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on studying a new type of implant called the RFN-advanced Retrograde Femoral Nailing System, which is used to fix fractures in the thigh bone (femur). The goal is to evaluate how well this new system works compared to existing methods, especially since some current designs can lead to complications like misalignment. The study will include patients 18 years and older who have a specific type of fracture and are being treated at UCSD.

If you or a loved one are eligible to participate, you will undergo surgery using this new implant. Throughout the study, researchers will collect information on how well you heal, your level of pain, and any complications that may arise over a period of three years. Participants will need to give their consent to join the study and will be asked to understand the information provided about it. This trial is important because it aims to improve the treatment of femoral fractures and reduce complications associated with current fixation methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Any not medically managed severe systemic disease
• • their doctor has decided that it is in the patient's best interest to receive a different method of fixation
• • Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study
• • Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it
• • Prisoner
• • Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study