NCT05049993

Pyrocarbon Clinical Follow-up Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

• Osteoarthritis of the Shoulder
• Avascular Necrosis
• Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	Aequalis Pyrocarbon Humeral Head	Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Timeline

• Start date: 2021-10-27
• Primary completion: 2027-05-31
• Completion: 2027-12-31
• First posted: 2021-09-20
• Last updated: 2026-02-10

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study