Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study (HaWPYC)

Stryker Trauma and Extremities

Status: Enrolling

Conditions: Orthopedics

Study type: Observational

Funder types: Industry

Identifiers

NCT04137237

1803-W-HAPYC-RM

2019-A00536-51 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 417 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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...)