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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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…)
Primary outcome measure(s)
Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID) — 24 months Demonstrate a superior (lower) total QuickDASH average by 24 months postoperatively compared to the predefined Minimal Clinically Important Difference (MCID) upper threshold of 36 points.
QuickDash = Disabilities of the Arm, Shoulder and Hand), self-report questionnaire; 11 items to measure physical function and symptoms; items scored on a 1-5-point scale which is then transformed resulting in a score from 0 (least disability) to 100 (most disability).
Trial sites (4)
Facility
City
Region
Status
Clinique du Parc
Lyon
France
Recruiting
Espace Médical Vauban
Paris
France
Recruiting
Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique
Saint-Herblain
France
Recruiting
Orthopedic Surgeon (Dr. med. Dietmar Bignion)
Bern
Switzerland
Recruiting
More Stryker Trauma and Extremities trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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