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ACTIVE NOT RECRUITING

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

NCT04015154 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

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

Study Locations (4)

Minnesota

  • St. Cloud Orthopedic Associates, Ltd — Sartell

New York

  • NYU Langone Medical Center — New York

Ohio

  • UC Health — Cincinnati

Virginia

  • Inova Fairfax Medical Campus — Falls Church

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2019-09-12
Est. Completion 2026-05

Sponsor

Stryker Trauma and Extremities

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04015154

The ClinicalTrials.gov registry entry for NCT04015154 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stryker Trauma and Extremities, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Femoral Fracture appearing as the primary indexed condition, and to 1 intervention — of which Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04015154 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Minnesota, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04015154 about?

NCT04015154 is a clinical study titled "A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF". 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 incl...

What is the current status of trial NCT04015154?

This trial is currently active not recruiting. The enrollment target is 53 participants. The study started on 2019-09-12. Estimated completion is 2026-05.

What conditions does trial NCT04015154 study?

This clinical trial studies the following conditions: Femoral Fracture. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04015154?

The interventions under investigation include: Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04015154?

This trial is sponsored by Stryker Trauma and Extremities, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04015154 being conducted?

This trial has 4 study locations across Minnesota, New York, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial