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

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Description

This project consists of a prospective and retrospective case series design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have a distal femur or femoral shaft fracture requiring surgical fixation. Patients who consent to study participation will recieve the RFN-advanced Retrograde Femoral Nailing System implant for fracture fixation. Data on functional status, healing rates, complication rates, and pain levels will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight on the utility of this new design of retrograde femoral nails. Given the relatively high rate of complications, such as malalignment, with current femoral nail designs, it is imperative to evaluate novel systems to appropriately manage distal femur or femoral shaft fractures.

Targeted Conditions

Study Overview

Start Date
June 23, 2021
Completion Date
June 23, 2026
Enrollment
40
Date Posted
January 11, 2023
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
University of California, San Diego
San Diego, California 92093, United States

Eligibility

Minimum Age (years)
18
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

Study Contact Info

Study Contact Name
Dominic Baun, MS; William Kent, MD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05680987