Recruiting

RFN-Advanced

Sponsor:

UCLA

Code:

NCT05680987

Conditions

Femoral Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

RFN-Advanced Retrograde Femoral Nailing System

Study Details

Brief 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.

Conditions

Femoral Fracture

Study ID

NCT05680987

Start date

Jun 23, 2021

Status verified date

Feb, 2026

Completion date

Jun 23, 2026

Anticipated

Primary completion date

Jun 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Retrograde Femoral Nail-Advanced

Interventions

RFN-Advanced Retrograde Femoral Nailing System

RFN-Advanced Retrograde Femoral Nailing System for patients with a distal femur or femoral shaft fracture requiring surgery

Primary outcome measure

  • Healing Rates [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Dominic Baun, MS

858-534-8268jbaun@health.ucsd.edu

William Kent, MD

619-543-2694wkent@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Dominic Baun, MS

858-534-8268jbaun@health.ucsd.edu

Principal Investigator:

William Kent, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-09.