Active — Not RecruitingNot Applicable

Pyrocarbon Clinical Follow-up Study

United States76 participantsStarted 2021-10-27

Plain-language 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).

Who can participate

Age range22 Years

SexALL

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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)

What they're measuring

Change from Baseline to last follow-up visit in ASES scores

Timeframe: Follow-up visits through 10 years Post-Op

Trial details

NCT IDNCT05049993

SponsorStryker Trauma and Extremities

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-05-31

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