Femur Fracture
Conditions
Keywords
Intramedullary Nail, Retrograde, Union
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.
Interventions
DEVICEDepuy 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
DePuy Synthes
University of Alabama at Birmingham
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Union | 6 months | Rate of fracture union |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | 6 months | Rate of infection |
| Implant breakage | 6 months | Rate of implant breakage |
| Implant removal | 6 months | Rate of symptomatic implant removal |
| Malunion | 6 months | Rate of malunion |
Countries
United States
Outcome results
None listed