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NCT04015167 · ClinicalTrials.gov registry record
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
A clinical trial of Tibial Fractures, sponsored by Stryker Trauma and Extremities.
- Completed
- Registry status
- 103
- Enrollment target
- 4
- Study locations
NCT04015167 is a study of Tibial Fractures that has completed, run by Stryker Trauma and Extremities. The registered enrollment target is 103 participants, below the 332-participant average among 12 other Tibial Fractures trials with a reported enrollment target (69% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT04015167, a study of Tibial Fractures, has completed, sponsored by Stryker Trauma and Extremities.
- COMPLETED
- Registry status
- 103 participants
- Enrollment target
- 4
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2023-08-08 |
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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, categorized as an unspecified phase. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 12 other Tibial Fractures trials with a reported enrollment target (69% lower). 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 Tibial Fractures appearing as the primary indexed condition, and to 1 intervention - of which T2 Alpha Tibia Nailing System is the first listed.
NCT04015167 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Minnesota, New York, Ohio.
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.
What interventions are being tested in trial NCT04015167?
The interventions under investigation include: T2 Alpha Tibia Nailing System (DEVICE).
Who is sponsoring clinical trial NCT04015167?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.