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

NCT04015154 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Femoral Fracture

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.

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma and Extremities

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2025-09-15
Completion
2025-09-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04015154 on ClinicalTrials.gov