Outcomes of Pyrocarbon Implants for Hand and Wrist Surgery

Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

This study is trying to see how safe and effective Pyrocarbon implants are for people undergoing hand and wrist surgeries by collecting information over the next 10 years.

Quick facts

• Study type: Observational
• Enrollment: 417 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stryker Trauma and Extremities (Industry-sponsored)
• Locations: 4 sites (Lyon and 3 other locations)
• Trial ID: NCT04137237 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are undergoing primary or revision surgery with Pyrocarbon hand or wrist implants.

Not a fit: Patients who are part of vulnerable populations as defined by French law may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of Pyrocarbon implants, potentially improving patient outcomes in hand and wrist surgeries.

How similar studies have performed: Other studies on post-market surveillance of orthopedic implants have shown success in demonstrating safety and performance, indicating that this approach is validated.

Eligibility criteria

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 this trial is running

Lyon and 3 other locations

• 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

Conditions Orthopedics; Hand; Wrist; Surgery