RFN-Advanced Retrograde Femoral Nailing System

University of Alabama at Birmingham53 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Femur Fracture

Interventions

Depuy Synthes Advanced Retrograde femoral nailDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Union

Rate of fracture union

Time frame: 6 months

Secondary Outcomes

Infection

Rate of infection

Time frame: 6 months

Implant breakage

Rate of implant breakage

Time frame: 6 months

Implant removal

Rate of symptomatic implant removal

Time frame: 6 months

Malunion

Rate of malunion

Time frame: 6 months

Data from ClinicalTrials.gov

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