Status:
RECRUITING
Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
Lead Sponsor:
Stryker Trauma and Extremities
Conditions:
Orthopedics
Eligibility:
All Genders
18+ years
Brief 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 stud...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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…)
Key Trial Info
Start Date :
November 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2033
Estimated Enrollment :
417 Patients enrolled
Trial Details
Trial ID
NCT04137237
Start Date
November 14 2019
End Date
January 1 2033
Last Update
September 16 2025
Active Locations (4)
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1
Clinique du Parc
Lyon, France, 69006
2
Espace Médical Vauban
Paris, France, 75007
3
Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique
Saint-Herblain, France, 44800
4
Orthopedic Surgeon (Dr. med. Dietmar Bignion)
Bern, Switzerland, 3011