NCT05668117

RFN-Advanced Retrograde Femoral Nailing System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-07-31
• Completion: 2023-04-27
• First posted: 2022-12-29
• Last updated: 2023-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study