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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT05680987
Status
Recruiting
Apply to this trial

Conditions

  • Femoral Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Jun 23, 2021
Status verified
Feb 2026
Primary completion
Jun 23, 2026
Completion
Jun 23, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Retrograde Femoral Nail-Advanced

Primary Outcome Measure

Healing Rates [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093
Dominic Baun, MS
[email protected]
858-534-8268
William Kent, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Diego· San Diego, CA

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