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

NCT ID: NCT05680987

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2026-06-23

Brief Summary

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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.

Detailed Description

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Conditions

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Femoral Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Retrograde Femoral Nail-Advanced

Group Type OTHER

RFN-Advanced Retrograde Femoral Nailing System

Intervention Type PROCEDURE

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

Interventions

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RFN-Advanced Retrograde Femoral Nailing System

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DePuy Synthes

INDUSTRY

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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William Kent

Assistant Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dominic Baun, MS

Role: CONTACT

858-534-8268

William Kent, MD

Role: CONTACT

619-543-2694

Facility Contacts

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Dominic Baun, MS

Role: primary

858-534-8268

Other Identifiers

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210669

Identifier Type: -

Identifier Source: org_study_id

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