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Clinical Trials in France / NCT04137237
Recruiting Observational

Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

NCT04137237 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-11-14
Last updated
2025-09-16

Condition(s) studied

Orthopedics

Study 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

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)

Trial sites (4)

FacilityCityRegionStatus
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 France

Official registry record

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.

View NCT04137237 on ClinicalTrials.gov ↗ ← All trials in France