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

Last updated: October 16, 2024
Sponsor: Stryker Trauma and Extremities
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System

Clinical Study ID

NCT04015128
T2 Alpha Femur Antegrade GT
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is a male or non-pregnant female age 18 years or older at the time ofsurgery;

  • Subject is willing and able to give written informed consent and comply with therequirements of this Clinical Investigation Plan;

  • Subject is intended to be treated with the Femoral Nail GT of the T2 Alpha FemurAntegrade GT/PF Nailing System in accordance with the following legally cleared/approved Indications for Use:

Indications for Use approved Outside of Europe include:

  • Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminutedproximal femoral shaft fractures

  • Femoral fixation required as a result of pathological disease

  • Temporary stabilization of fractures of the femoral shaft ranging from the femoralneck to the supracondylar regions of the femur

  • Open and closed femoral fractures

  • Pseudoarthrosis and correction osteotomy

  • Pathologic fractures, impending pathologic fractures and tumor resections

  • Ipsilateral femur fractures

  • Fractures proximal to a total knee arthroplasty

  • Nonunions and malunions

  • Fractures involving osteopenic and osteoporotic bone

Exclusion

Exclusion Criteria:

  • Subject is currently enrolled in or plans to enroll in any concurrent drug and/ordevice clinical investigation that, in the opinion of the Investigator, may confoundresults;

  • Per the Investigator, the subject is in poor general health or undergoing anyconcurrent disease that would place the subject in excessive risk to surgery (i.e.significant circulatory problems, cardiac disease).

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System
Phase:
Study Start date:
September 12, 2019
Estimated Completion Date:
December 31, 2024

Study Description

The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Femoral Nail GT 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 GT 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 GT 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.

Connect with a study center

  • St. Cloud Orthopedic Associates, Ltd

    Sartell, Minnesota 56377
    United States

    Completed

  • Reno Orthopedic Clinic

    Reno, Nevada 89503
    United States

    Active - Recruiting

  • New York University

    New York, New York 10016
    United States

    Active - Recruiting

  • UC Health

    Cincinnati, Ohio 45229
    United States

    Completed

  • Regional One Health

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • Inova Fairfax Medical Campus

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

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