Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
Recruiting now
Conditions studied: Orthopedics
In brief
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.
Key facts
- Study ID
- NCT04137237
- Run by
- Stryker Trauma and Extremities
- People needed
- 417
- Starts
- 2019-11-14
- Expected to finish
- 2033-01-01
- Last updated by the study team
- 2025-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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…)
Where it is running
- Clinique du Parc — Lyon, France (enrolling)
- Espace Médical Vauban — Paris, France (enrolling)
- Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique — Saint-Herblain, France (enrolling)
- Orthopedic Surgeon (Dr. med. Dietmar Bignion) — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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