Pyrocarbon Clinical Follow-up Study

Running, not enrolling

Conditions studied: Osteoarthritis of the Shoulder, Avascular Necrosis, Traumatic Arthritis

In brief

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).

Key facts

Study ID

NCT05049993

Run by

Stryker Trauma and Extremities

People needed

76

Starts

2021-10-27

Expected to finish

2027-12-31

Last updated by the study team

2026-02-10

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject in the Pyrocarbon IDE Study and has not had the device explanted.
• Patient informed, willing, and able to sign an informed consent form approved by IRB or EC
• Willing and able to comply with the requirements of the study protocol

You may not qualify if…

• Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)

Where it is running

• HCA HealthONE, LLC — Denver, Colorado, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Tulane University — New Orleans, Louisiana, United States
• Southern Maryland Orthopedics — Waldorf, Maryland, United States
• Allina Health Orthopedics — Minneapolis, Minnesota, United States
• Missouri Orthopaedic Institute — Columbia, Missouri, United States
• Duke University — Durham, North Carolina, United States
• Southern Oregon Orthopedics — Medford, Oregon, United States

Full record on ClinicalTrials.gov

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