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A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
Sponsor: Stryker Trauma and Extremities
Summary
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.
Official title: A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail Piriformis Fossa (PF) of the T2 Alpha Femur Antegrade GT/PF Nailing System
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
53
Start Date
2019-09-12
Completion Date
2026-05
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System
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.
Locations (4)
St. Cloud Orthopedic Associates, Ltd
Sartell, Minnesota, United States
NYU Langone Medical Center
New York, New York, United States
UC Health
Cincinnati, Ohio, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States