Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by William Kent, MD (ucsd)
Headshot of William Kent
William Kent

Description

Summary

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.

Official Title

Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series

Keywords

Femoral Fracture, Bone Fractures, Femoral Fractures, RFN-Advanced Retrograde Femoral Nailing System, Retrograde Femoral Nail-Advanced

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join if...

  • 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

Location

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States

Lead Scientist at University of California Health

  • William Kent, MD (ucsd)
    Assistant Clinical Professor, Orthopedic Surgery, Vc-health Sciences-schools. Authored (or co-authored) 25 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05680987
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated