Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05049993

Pyrocarbon Clinical Follow-up Study

Sponsor: Stryker Trauma and Extremities

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).

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

76

Start Date

2021-10-27

Completion Date

2027-12-31

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DEVICE

Aequalis Pyrocarbon Humeral Head

Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Locations (8)

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