RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-06-23
Study Completion:2026-06-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05680987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Distal femur or femoral shaft fracture requiring surgery
  2. * Evaluation and treatment at UCSD
  3. * Age 18 years or older
  4. * Ability to understand the content of the patient information/Informed Consent Form
  5. * Signed and dated IRB-approved written informed consent
  1. * Any not medically managed severe systemic disease
  2. * their doctor has decided that it is in the patient's best interest to receive a different method of fixation
  3. * Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study
  4. * 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
  5. * Prisoner
  6. * Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Contacts and Locations

Study Contact

Dominic Baun, MS
CONTACT
858-534-8268
jbaun@health.ucsd.edu
William Kent, MD
CONTACT
619-543-2694
wkent@health.ucsd.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-23
Study Completion Date2026-06-23

Study Record Updates

Study Start Date2021-06-23
Study Completion Date2026-06-23

Terms related to this study

Additional Relevant MeSH Terms

  • Femoral Fracture