Overview
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.
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.
Eligibility
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,
- Follow-up visits (at least the last two) must be prospective,
- Patient must have complete information available for each completed visit
Exclusion Criteria:
- 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…)