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NCT04015154 · ClinicalTrials.gov registry record
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
A clinical trial of Femoral Fracture, sponsored by Stryker Trauma and Extremities.
- Active
- Registry status
- 53
- Enrollment target
- 4
- Study locations
NCT04015154 is a study of Femoral Fracture that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 53 participants, roughly in line with the 56-participant average among 6 other Femoral Fracture trials with a reported enrollment target. The trial reports 4 study locations across 4 states.
The verdict
NCT04015154, a study of Femoral Fracture, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.
- ACTIVE NOT RECRUITING
- Registry status
- 53 participants
- Enrollment target
- 4
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2026-05 |
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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, categorized as an unspecified phase. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 56-participant average among 6 other Femoral Fracture trials with a reported enrollment target. 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 PF of the T2 Alpha Femur Antegrade GT/PF Nailing System is the first listed.
NCT04015154 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Minnesota, New York, Ohio.
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.
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).
Who is sponsoring clinical trial NCT04015154?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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