Outcomes of Pyrocarbon Implants for Hand and Wrist Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international observational study aims to collect post-market safety and performance data on commercially available Pyrocarbon implants used in hand and wrist surgeries. It will gather data at various stages, including preoperative, intraoperative, and long-term postoperative periods, to assess clinical complications and outcomes associated with these implants. The study is designed to demonstrate the safety and effectiveness of Pyrocarbon implants in real-world clinical settings over a span of up to 10 years.

Why it matters

Who can join: the full rules

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…)

Where it's running

• 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

Study contacts

• Study coordinator: Amjad Uneisi
• Email: amjad.uneisi@stryker.com
• Phone: +33638213703

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.