Pyrocarbon Clinical Follow-up Study
Key facts
- Where
- Columbia, Denver, Durham, Fort Lauderdale, Medford, Minneapolis, New Orleans, and Waldorf, United StatesSee the 8 sites
Where in United States
- Missouri Orthopaedic InstituteColumbia, United StatesNo longer taking part
- HCA HealthONE, LLCDenver, United StatesNo longer taking part
- Duke UniversityDurham, United StatesNo longer taking part
- Holy Cross HospitalFort Lauderdale, United StatesNo longer taking part
- Southern Oregon OrthopedicsMedford, United StatesNo longer taking part
- Allina Health OrthopedicsMinneapolis, United StatesNo longer taking part
- Tulane UniversityNew Orleans, United StatesNo longer taking part
- Southern Maryland OrthopedicsWaldorf, United StatesNo longer taking part
Trial details
- Who runs it
- Stryker Trauma and Extremities
- Trial code
- NCT05049993
- Record updated
- 1 September 2026
- Original description
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.Read full original descriptionShow less
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).
Inclusion: 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: 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).