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OpenTrials
Completed

NCT Number: NCT05668117

RFN-Advanced Retrograde Femoral Nailing System

This study is a retrospective chart review of the safety and performance Standard of Care data on individuals that have previously been implanted with the femur nail of the RFNA System for the internal fixation of the femur. Demographics, medical history, primary diagnosis, mechanism of injury, type of injury, clinical and radiographic evaluation of bone consolidation, and device-related adverse events were collected. Descriptive statistics were applied to the data collected.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects 18 years or older at the time of index procedure
  • Subjects who received the Depuy Synthes Advanced Retrograde Nail in accordance with the indications for use.
  • Subjects who have at least 6 months of follow-up.

Exclusion criteria

  • Subject with less than 6 months of follow up, pathologic fractures, and patients < 18 years of age will be excluded from the study.

Treatment and study plan

Depuy Synthes Advanced Retrograde femoral nail

Device

The Advanced Retrograde Femoral Nailing System (RFNA) is designed to improve fixation and stabilization of distal femur and femoral shaft fractures by reducing toggle and loss of reduction.

Primary outcomes

  1. Union

    Time frame: 6 months

    Rate of fracture union

Secondary outcomes

  1. Infection

    Time frame: 6 months

    Rate of infection

  2. Implant breakage

    Time frame: 6 months

    Rate of implant breakage

  3. Implant removal

    Time frame: 6 months

    Rate of symptomatic implant removal

  4. Malunion

    Time frame: 6 months

    Rate of malunion

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

RFN-Advanced Retrograde Femoral Nailing System (RFNA) - Early Usage Case-Series Utilizing the Retrograde Femoral Nail-Advanced for Fixation and Stabilization of the Distal Femur and Femoral Shaft

Acronym: RFNA

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 29, 2022
Registry last updated
May 1, 2023

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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