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Post Market Clinical Evaluation of Gamma 4
NCT05523635 · View on ClinicalTrials.gov ↗
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 |
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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. 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 100 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 Gamma4 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: NCT05523635 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Michigan, Ohio, Texas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05523635?
The interventions under investigation include: Gamma4 Nailing System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05523635?
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 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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