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Pyrocarbon Clinical Follow-up Study
NCT05049993 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
Conditions Studied
Interventions
- DEVICE Aequalis Pyrocarbon Humeral Head
Study Locations (8)
Colorado
- HCA HealthONE, LLC — Denver
Florida
- Holy Cross Hospital — Fort Lauderdale
Louisiana
- Tulane University — New Orleans
Maryland
- Southern Maryland Orthopedics — Waldorf
Minnesota
- Allina Health Orthopedics — Minneapolis
Missouri
- Missouri Orthopaedic Institute — Columbia
North Carolina
- Duke University — Durham
Oregon
- Southern Oregon Orthopedics — Medford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-10-27 |
| Est. Completion | 2027-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05049993
The ClinicalTrials.gov registry entry for NCT05049993 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 76 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 3 conditions, with Avascular Necrosis appearing as the primary indexed condition, and to 1 intervention — of which Aequalis Pyrocarbon Humeral Head 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: NCT05049993 reports 8 study locations spanning 8 distinct geographic areas — top geographies include Colorado, Florida, Louisiana. 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 NCT05049993 about?
NCT05049993 is a clinical study titled "Pyrocarbon Clinical Follow-up Study". The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will ...
What is the current status of trial NCT05049993?
This trial is currently active not recruiting. The enrollment target is 76 participants. The study started on 2021-10-27. Estimated completion is 2027-12-31.
What conditions does trial NCT05049993 study?
This clinical trial studies the following conditions: Avascular Necrosis, Traumatic Arthritis, Osteoarthritis of the Shoulder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05049993?
The interventions under investigation include: Aequalis Pyrocarbon Humeral Head (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05049993?
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 NCT05049993 being conducted?
This trial has 8 study locations across Colorado, Florida, Louisiana, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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