RFN-Advanced Retrograde Femoral Nailing System

Completed

• Conditions: Femur Fracture
• Interventions: Device: Depuy Synthes Advanced Retrograde femoral nail

• Registration Number: NCT05668117
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-07-31
• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-29
• Status Verified: 2023-01
• Study Completion: 2023-04-27
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Subjects 18 years or older at the time of index procedure
2. Subjects who received the Depuy Synthes Advanced Retrograde Nail in accordance with the indications for use.
3. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study participants	Depuy Synthes Advanced Retrograde femoral nail	Adult patients with non-pathologic distal femur and femoral shaft fractures treated with the Depuy Synthes Advanced Retrograde femoral nail who had at least 6 months of follow up.

Primary Outcome Measures

Name	Time	Method
Union	6 months	Rate of fracture union

Secondary Outcome Measures

Name	Time	Method
Infection	6 months	Rate of infection
Implant breakage	6 months	Rate of implant breakage
Malunion	6 months	Rate of malunion
Implant removal	6 months	Rate of symptomatic implant removal

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States