Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
ConditionOrthopedics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStryker Trauma and Extremities
About this trial
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 criteria
Qualifiers
18 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,
For prospective inclusion: considered for treatment with one of PyC Hand/Wrist study implants (primary or revision surgery),
Disqualifiers
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…)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov