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

NCT05680987 | Recruiting

• 1 other identifier: 210669
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Healing Rates

  2 years

Secondary Outcomes (2)

• Pain Score (0-10,0=no pain, 10=most severe)

  1 year

• Number of Complications

  1 year

Study Arms (1)

Retrograde Femoral Nail-Advanced

OTHER

Procedure: RFN-Advanced Retrograde Femoral Nailing System

Interventions

RFN-Advanced Retrograde Femoral Nailing System PROCEDURE

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

Retrograde Femoral Nail-Advanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, San Diego: lead
• DePuy Synthes: collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Dominic Baun, MS

CONTACT

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

William Kent, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 11, 2023
• Study Start: June 23, 2021
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)