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

Primary Purpose

Femoral Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RFN-Advanced Retrograde Femoral Nailing System
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Femoral Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Retrograde Femoral Nail-Advanced

Arm Description

Outcomes

Primary Outcome Measures

Healing Rates

Secondary Outcome Measures

Pain Score (0-10,0=no pain, 10=most severe)
Number of Complications

Full Information

First Posted
December 19, 2022
Last Updated
January 9, 2023
Sponsor
University of California, San Diego
Collaborators
DePuy Synthes
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1. Study Identification

Unique Protocol Identification Number
NCT05680987
Brief Title
Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
Official Title
Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
June 23, 2024 (Anticipated)
Study Completion Date
June 23, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
DePuy Synthes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fracture

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retrograde Femoral Nail-Advanced
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
RFN-Advanced Retrograde Femoral Nailing System
Intervention Description
RFN-Advanced Retrograde Femoral Nailing System for patients with a distal femur or femoral shaft fracture requiring surgery
Primary Outcome Measure Information:
Title
Healing Rates
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pain Score (0-10,0=no pain, 10=most severe)
Time Frame
1 year
Title
Number of Complications
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominic Baun, MS
Phone
858-534-8268
Email
jbaun@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
William Kent, MD
Phone
619-543-2694
Email
wkent@health.ucsd.edu
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Baun, MS
Phone
858-534-8268
Email
jbaun@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
William Kent, MD

12. IPD Sharing Statement

Learn more about this trial

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

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