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About
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.
Full description
The objective of this multicenter study is to collect preoperative, intraoperative, intermediate (approx. 2 years), mid-term (approx. 5 years), and long-term (approx. 10 years) postoperative data, on related clinical complications and clinical outcomes on the Sponsors market-approved hand and wrist Pyrocarbon implants, to demonstrate safety and performance of these implants in a real-world setting.
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Inclusion criteria
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),
For "ambispective" inclusion: must have undergone a Hand or Wrist arthroplasty with a PyC Hand/Wrist study implant before the date of first site initiation visit,
Exclusion criteria
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Central trial contact
Amjad Uneisi
Data sourced from clinicaltrials.gov
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