Pyrocarbon Clinical Follow-up Study (PYC CFS)

Stryker Trauma and Extremities

Status: Active, not recruiting

Conditions: Traumatic Arthritis; Osteoarthritis of the Shoulder; Avascular Necrosis

Treatments: Device: Aequalis Pyrocarbon Humeral Head

Study type: Observational

Funder types: Industry

Identifiers

NCT05049993

20A-W-PYC-RM

Details and patient eligibility

About

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).

Enrollment: 76 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)