Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

Last updated: November 26, 2024
Sponsor: Stryker Trauma and Extremities
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedics

Treatment

N/A

Clinical Study ID

NCT04137237
1803-W-HAPYC-RM
2019-A00536-51
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older at the time he/she receives the information and signs the informedconsent (when applicable as per local regulatory requirements),

  • Informed on the study and willing to sign an informed consent form approved byInstitutional 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 studyimplants (primary or revision surgery),

  • For "ambispective" inclusion: must have undergone a Hand or Wrist arthroplasty witha 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

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 HealthCode), 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 - HumanResearch Act, HRA),

  • Patient unable to comply with the study procedures based on the judgment of theinvestigator (e.g. cannot comprehend study questions, inability to keep scheduledassessment times),

  • Any medical condition that could impact on the study outcomes functionalsignification at the investigator's discretion (e.g., neuropathy, allergy...)

Study Design

Total Participants: 417
Study Start date:
November 14, 2019
Estimated Completion Date:
January 31, 2033

Study 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 related clinical complications and clinical outcomes on the Sponsors market-approved hand and wrist Pyrocarbon implants, to demonstrate safety and performance of these implants in a real-world setting.

Connect with a study center

  • Clinique du Parc

    Lyon, 69006
    France

    Active - Recruiting

  • Espace Médical Vauban

    Paris, 75007
    France

    Active - Recruiting

  • Clinique de la Main

    Saint-Herblain, 44800
    France

    Active - Recruiting

  • Orthopedic Surgeon (Dr. med. Dietmar Bignion)

    Bern, 3011
    Switzerland

    Active - Recruiting

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