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This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of 50 subjects will be enrolled at up to 5 sites. Enrollment is estimated to commence in Q4 of 2018. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System.
Total duration of enrollment, 12 month follow-up and analysis is expected to take 29 months. The clinical investigation has been designed to follow the surgeon's standard of care for femur fractured subjects, in addition to a 12 month follow-up visit.
The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System. Efficacy/performance of the procedure will be measured by an equal or greater (non-inferior) Lower Extremity Measure (LEM) score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature at 12 months.
In addition, demonstration of bone consolidation in correct alignment will be measured by Investigator assessment by 12 months. Safety of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2 Alpha Femoral Nail PF | Subjects in the clinical investigation will undergo placement of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System which allows for insertion through the piriformis fossa, according to the Instructions for Use and Operative Technique Manual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System | Device | The T2 Alpha Femur Antegrade GT / PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Extremity Measure (LEM) | The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be measured by capturing the incidence rate of device-related adverse events | Incidence of device-related adverse events will be monitored by 12 months through data collection and analyses. | 12 months |
| Efficacy/Performance will be measured by demonstration of bone consolidation |
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Inclusion Criteria:
Indications for Use:
Exclusion Criteria:
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Approximately 50 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for treatment of femoral fractures will be evaluated for clinical investigation participation based on the eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma and Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Cloud Orthopedic Associates, Ltd | Sartell | Minnesota | 56377 | United States | ||
| NYU Langone Medical Center |
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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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Bone consolidation will be assessed by 12 months as measured by Investigator assessment. |
| 12 months |
| New York |
| New York |
| 10016 |
| United States |
| UC Health | Cincinnati | Ohio | 45229 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |