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| Name | Class |
|---|---|
| Synthes Inc. | INDUSTRY |
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The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation⢠(PFNA)(Investigational Group) and Gamma Nail 3⢠(Gamma3) (Control Group).
Intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. Unstable fractures treated with intramedullary nailing carry the risk of fracture fixation complications. The PFNA (Synthes) has evolved from the original PFN design, featuring a novel antirotation screw. Apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. Empirical information about the fracture fixation complication rates of the PFNA device is not available. The primary objective of this study is to compare the 1-year fracture fixation rates between the PFNA and Gamma Nail 3⢠(Stryker). Secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Proximal Femoral Nail AntirotationTM (PFNA) |
|
| 2 | Other | Gamma Nail 3TM (Gamma3) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proximal Femoral Nail AntirotationTM (PFNA) | Device | intramedullary nailing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Any fracture fixation complication. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beate P. Hanson, MD | AO Clinical Investigation and Documentation, Davos, Switzerland | Study Director |
| Javier Vaquero Martin, MD | Hospital Gregorio MaraƱon, Madrid, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario "MarquƩs de Valdecilla" | Santander | Cantabria | 39008 | Spain | ||
| Hospital Clinic |
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| Gamma Nail 3TM (Gamma3) |
| Device |
intramedullary nailing |
|
| Barcelona |
| Catalonia |
| 08036 |
| Spain |
| Hospital Gregorio MaraƱon | Madrid | Madrid | 28007 | Spain |
| Hospital Puerta de Hierro | Madrid | Madrid | 28035 | Spain |
| H.U. Virgen de la Arrixaca | Murcia | 30071 | Spain |
| Hospital Donostia | San SebastiƔn | 20014 | Spain |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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