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Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
NCT03726554 · View on ClinicalTrials.gov ↗
Study Summary
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.
Conditions Studied
Interventions
- DEVICE Comprehensive Reverse Porous Augmented Glenoid
- DEVICE Comprehensive Mini Humeral Tray
Study Locations (6)
Florida
- Andrews Research and Education Foundation — Gulf Breeze
Kentucky
- Norton Orthopedic Specialists — Louisville
Michigan
- William Beaumont Hospital — Royal Oak
New York
- The Research Foundation for the State University of New York — Buffalo
Tennessee
- Campbell Foundation — Germantown
Virginia
- The Rector and Visitors of the University of Virginia — Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2018-08-28 |
| Est. Completion | 2030-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03726554
The ClinicalTrials.gov registry entry for NCT03726554 describes a study currently listed as active not recruiting. It is categorized as NA, 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 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zimmer Biomet, which has 102 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Post-Traumatic Arthritis appearing as the primary indexed condition, and to 2 interventions — of which Comprehensive Reverse Porous Augmented Glenoid 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: NCT03726554 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Florida, Kentucky, Michigan. 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 NCT03726554 about?
NCT03726554 is a clinical study titled "Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty". This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Ba...
What is the current status of trial NCT03726554?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 99 participants. The study started on 2018-08-28. Estimated completion is 2030-02.
What conditions does trial NCT03726554 study?
This clinical trial studies the following conditions: Post-Traumatic Arthritis, Osteoarthritis of the Shoulder, Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Rheumatoid Arthritis Without Humeral Metaphyseal Defects. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03726554?
The interventions under investigation include: Comprehensive Reverse Porous Augmented Glenoid (DEVICE), Comprehensive Mini Humeral Tray (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03726554?
This trial is sponsored by Zimmer Biomet, which has 102 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03726554 being conducted?
This trial has 6 study locations across Florida, Kentucky, Michigan, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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