Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05680987

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

Led by University of California, San Diego · Updated on 2026-02-09

40

Participants Needed

1

Research Sites

260 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Any not medically managed severe systemic disease
  • Doctor has decided a different fixation method is best
  • Doctor has determined the patient is unsuitable for participation
  • Pregnancy or planning to conceive within one year
  • Prisoner
  • Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Diego

San Diego, California, United States, 92093

Actively Recruiting

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Research Team

D

Dominic Baun, MS

CONTACT

W

William Kent, MD

CONTACT

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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