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

Femoral Fracture Clinical Trial

Official title:

Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680987
• Other study ID #: 210669
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: June 23, 2026

Study information

• Verified date: February 2024
• Source: University of California, San Diego
• Contact: Dominic Baun, MS
• Phone: 858-534-8268
• Email: jbaun[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 23, 2026
• Est. primary completion date: June 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	DePuy Synthes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Rates		2 years
Secondary	Pain Score (0-10,0=no pain, 10=most severe)		1 year
Secondary	Number of Complications		1 year