RecruitingNCT04137237

Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

Sponsor

Stryker Trauma and Extremities

Enrollment

417 participants

Start Date

Nov 14, 2019

Study Type

OBSERVATIONAL

Conditions

Orthopedics

Summary

HaWPYC is an international Post-Market Clinical Follow-up (PMCF) to collect post-market safety and performance data on commercially available Pyrocarbon (PyC) hand and wrist implants used in this study. Data may be used for Post-Market Surveillance, and regulatory requirements.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

years or older at the time he/she receives the information and signs the informed consent (when applicable as per local regulatory requirements),
Informed on the study and willing to sign an informed consent form approved by Institutional Review Board or Ethics Committee,
Willing and able to comply with the requirements of the study protocol,
Follow-up visits (at least the last two) must be prospective,
Patient must have complete information available for each completed visit

Exclusion Criteria3

Patient pertaining to one of the categories referred to as "vulnerable population" in the French Law (articles L. 1121-5 to L. 1121-8 of the French Public Health Code), or as "particularly vulnerable persons" in the Swiss Federal Law (Chapter 3, Sections 1 to 4 of CC 810.30 Federal Act on Research involving Human Beings - Human Research Act, HRA),
Patient unable to comply with the study procedures based on the judgment of the investigator (e.g. cannot comprehend study questions, inability to keep scheduled assessment times),
Any medical condition that could impact on the study outcomes functional signification at the investigator's discretion (e.g., neuropathy, allergy…)

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