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COMPLETED

A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System

NCT04015167 · View on ClinicalTrials.gov ↗

Study Summary

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 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 T2 Alpha Tibia Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 31 months. The clinical investigation has been designed to follow the surgeon's standard of care for tibia 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 SF-36 Physical Component Summary (PCS). Confirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the benchmark literature.

Conditions Studied

Interventions

  • DEVICE T2 Alpha Tibia Nailing System

Study Locations (4)

Minnesota

  • St. Cloud Orthopedic Associates, Ltd — Sartell

New York

  • New York University — New York

Ohio

  • UC Health — Cincinnati

Virginia

  • Inova Fairfax Medical Campus — Falls Church

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2019-09-12
Est. Completion 2023-08-08

Sponsor

Stryker Trauma and Extremities

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04015167

The ClinicalTrials.gov registry entry for NCT04015167 describes a study currently listed as completed. 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 103 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 Tibial Fractures appearing as the primary indexed condition, and to 1 intervention — of which T2 Alpha Tibia 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: NCT04015167 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 NCT04015167 about?

NCT04015167 is a clinical study titled "A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System". This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 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 T2 Alpha Ti...

What is the current status of trial NCT04015167?

This trial is currently completed. The enrollment target is 103 participants. The study started on 2019-09-12. Estimated completion is 2023-08-08.

What conditions does trial NCT04015167 study?

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

What interventions are being tested in trial NCT04015167?

The interventions under investigation include: T2 Alpha Tibia Nailing System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04015167?

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 NCT04015167 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