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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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This project consists of a prospective and retrospective case series design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have a distal femur or femoral shaft fracture requiring surgical fixation. Patients who consent to study participation will recieve the RFN-advanced Retrograde Femoral Nailing System implant for fracture fixation. Data on functional status, healing rates, complication rates, and pain levels will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight on the utility of this new design of retrograde femoral nails. Given the relatively high rate of complications, such as malalignment, with current femoral nail designs, it is imperative to evaluate novel systems to appropriately manage distal femur or femoral shaft fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrograde Femoral Nail-Advanced | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFN-Advanced Retrograde Femoral Nailing System | Procedure | RFN-Advanced Retrograde Femoral Nailing System for patients with a distal femur or femoral shaft fracture requiring surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Healing Rates | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (0-10,0=no pain, 10=most severe) | 1 year | |
| Number of Complications | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominic Baun, MS | Contact | 858-534-8268 | jbaun@health.ucsd.edu | |
| William Kent, MD | Contact | 619-543-2694 | wkent@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | San Diego | California | 92093 | United States |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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