Clinical Trial

Pyrocarbon Clinical Follow-up Study

Study acronym: PYC CFS
Active, Not Recruiting
View on ClinicalTrials.gov →
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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-09-09; most recent amendment 2026-02-09.
Status change: Enrolling by Invitation → Active, Not Recruiting 2023-10-20
Status change: Not Yet Recruiting → Enrolling by Invitation 2022-01-06
Status change: Withheld → Not Yet Recruiting 2021-09-17
Trial Details
NCT Number NCT05049993
Lead Sponsor Stryker Trauma and Extremities
Conditions Osteoarthritis of the Shoulder, Avascular Necrosis, Traumatic Arthritis
Enrollment 76 participants
Start Date 2021-10-27
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-10