MedTrace Logo

RFN-Advanced Retrograde Femoral Nailing System

NCT05668117 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2023-05-01

No results posted yet for this study

Summary

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.

Conditions

  • Femur Fracture

Interventions

DEVICE

Depuy Synthes Advanced Retrograde femoral nail

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.

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Clay Spitler, MD · University of Alabama at Birmingham

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-07-31
Completion
2023-04-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05668117 on ClinicalTrials.gov