RFN-Advanced Retrograde Femoral Nailing System (RFNA)

The University of Alabama at Birmingham

Status: Completed

Conditions: Femur Fracture

Treatments: Device: Depuy Synthes Advanced Retrograde femoral nail

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05668117

IRB-300008523

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

53 participants in 2 patient groups

Control

Description:

Historical patient data from other published studies in the literature

Study participants

Description:

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.

Treatment:

Device: Depuy Synthes Advanced Retrograde femoral nail