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NCT04015128 · ClinicalTrials.gov registry record

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

A clinical trial of Femoral Fracture, sponsored by Stryker Trauma and Extremities.

Active
Registry status
66
Enrollment target
6
Study locations

NCT04015128 is a study of Femoral Fracture that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 66 participants, above the 54-participant average among 6 other Femoral Fracture trials with a reported enrollment target (22% higher). The trial reports 6 study locations across 6 states.

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The verdict

NCT04015128, a study of Femoral Fracture, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.

ACTIVE NOT RECRUITING
Registry status
66 participants
Enrollment target
6
Study locations

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.

Conditions Studied

Femoral Fracture

Interventions

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

Study Locations (6)

Minnesota

  • St. Cloud Orthopedic Associates, Ltd - Sartell

Nevada

  • Reno Orthopedic Clinic - Reno

New York

  • NYU Langone Medical Center - New York

Ohio

  • UC Health - Cincinnati

Tennessee

  • Regional One Health - Memphis

Virginia

  • Inova Fairfax Medical Campus - Falls Church

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2019-09-12
Est. Completion 2026-05

Sponsor

Stryker Trauma and Extremities

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04015128

The ClinicalTrials.gov registry entry for NCT04015128 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 54-participant average among 6 other Femoral Fracture trials with a reported enrollment target (22% higher). The listed sponsor is Stryker Trauma and Extremities, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Femoral Fracture appearing as the primary indexed condition, and to 1 intervention - of which Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System is the first listed.

NCT04015128 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Minnesota, Nevada, New York.

Frequently Asked Questions

What is clinical trial NCT04015128 about?

NCT04015128 is a clinical study titled "A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT". 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 Nai...

What is the current status of trial NCT04015128?

This trial is currently active not recruiting. The enrollment target is 66 participants. The study started on 2019-09-12. Estimated completion is 2026-05.

What conditions does trial NCT04015128 study?

This clinical trial studies the following conditions: Femoral Fracture.

What interventions are being tested in trial NCT04015128?

The interventions under investigation include: Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System (DEVICE).

Who is sponsoring clinical trial NCT04015128?

This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04015128 being conducted?

This trial has 6 study locations across Minnesota, Nevada, New York, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.