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Recruiting

NCT Number: NCT05680987

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

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.

Recruiting

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Key information

Conditions

Femoral Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Location status: Recruiting

Location contact

Dominic Baun, MS

CONTACT

[email protected]

858-534-8268

William Kent, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Healing Rates

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 1 year

  2. Number of Complications

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Dominic Baun, MS

CONTACT

[email protected]

858-534-8268

William Kent, MD

CONTACT

[email protected]

619-543-2694

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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