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NCT05523635 · ClinicalTrials.gov registry record
Post Market Clinical Evaluation of Gamma 4
A clinical trial of Femoral Fracture, sponsored by Stryker Trauma and Extremities.
- Active
- Registry status
- 100
- Enrollment target
- 5
- Study locations
NCT05523635 is a study of Femoral Fracture that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 100 participants, above the 48-participant average among 6 other Femoral Fracture trials with a reported enrollment target (108% higher). The trial reports 5 study locations across 5 states.
The verdict
NCT05523635, a study of Femoral Fracture, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment. It is anticipated that a total of 100 subjects will be enrolled at five sites. Total duration of enrollment, 12 month follow-up and analysis is expected to take approximately 30 months. The clinical investigation has been designed to follow the surgeon's standard of care for subjects treated with a cephalomedullary nail for femoral fractures or and deformities, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is demonstration of bone consolidation by 12 months.
Conditions Studied
Interventions
- DEVICE Gamma4 Nailing System
Study Locations (5)
Michigan
- William Beaumont Hospital - Royal Oak
Ohio
- MetroHealth - Cleveland
Texas
- UT Health - San Antonio
Virginia
- Inova Health Care Services - Falls Church
Wisconsin
- SSM Health - Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2025-10-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05523635
The ClinicalTrials.gov registry entry for NCT05523635 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 48-participant average among 6 other Femoral Fracture trials with a reported enrollment target (108% 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 Gamma4 Nailing System is the first listed.
NCT05523635 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Michigan, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT05523635 about?
NCT05523635 is a clinical study titled "Post Market Clinical Evaluation of Gamma 4". This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment. It is anticipated that a total of 100 subjects will be enrolled at five sites. Total duration of enrollment, 12 month follow-up...
What is the current status of trial NCT05523635?
This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2023-03-06. Estimated completion is 2025-10-31.
What conditions does trial NCT05523635 study?
This clinical trial studies the following conditions: Femoral Fracture.
What interventions are being tested in trial NCT05523635?
The interventions under investigation include: Gamma4 Nailing System (DEVICE).
Who is sponsoring clinical trial NCT05523635?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05523635 being conducted?
This trial has 5 study locations across Michigan, Ohio, Texas, Virginia, Wisconsin. 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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