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Pyrocarbon Clinical Follow-up Study

NCT05049993 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2026-09-01

No results posted yet for this study

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

DEVICE

Aequalis Pyrocarbon Humeral Head

Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma & Extremities

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2027-05-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05049993 on ClinicalTrials.gov