Pyrocarbon Clinical Follow-up Study (NCT05049993)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: HCA HealthONE, LLC — Denver, Colorado
Age range: 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- HCA HealthONE, LLC — Denver, Colorado
- Holy Cross Hospital — Fort Lauderdale, Florida
- Tulane University — New Orleans, Louisiana
- Southern Maryland Orthopedics — Waldorf, Maryland
- Allina Health Orthopedics — Minneapolis, Minnesota
- Missouri Orthopaedic Institute — Columbia, Missouri
- Duke University — Durham, North Carolina
- Southern Oregon Orthopedics — Medford, Oregon
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.