EICHOR
● Completed
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
Condition: Femoral Fracture · Sponsor: Stryker Trauma and Extremities
About this study
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 25 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 GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (6)
| St. Cloud Orthopedic Associates, Ltd | Sartell, Minnesota, United States | — |
| Reno Orthopedic Clinic | Reno, Nevada, United States | — |
| NYU Langone Medical Center | New York, New York, United States | — |
| UC Health | Cincinnati, Ohio, United States | — |
| Regional One Health | Memphis, Tennessee, United States | — |
| Inova Fairfax Medical Campus | Falls Church, Virginia, United States | — |
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Source record: clinicaltrials.gov/study/NCT04015128