NCT04015154

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Femoral Fracture

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-12
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2019-07-10
• Last updated: 2026-04-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study