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ACTIVE NOT RECRUITING
NCT04015154

A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF

Sponsor: Stryker Trauma and Extremities

View on ClinicalTrials.gov

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

Interventions

DEVICE

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