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Recruiting NCT04137237

Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

— Observational Orthopedics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Orthopedics. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 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.

Primary outcome measures

  • Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID) [Time frame: 24 months]
Secondary outcome measures (7)
  • Change from baseline in Patient Satisfaction scores [Time frame: up to 10 years]
  • Safety evaluation [Time frame: up to 10 years]
  • Implant Survivorship [Time frame: up to 10 years]
  • Clinical assessment: change from baseline in QuickDash score [Time frame: up to 10 years]
  • Clinical assessment: change from baseline in PRWE score [Time frame: up to 10 years]
  • Clinical assessment: change from baseline in Strength score [Time frame: up to 10 years]
  • Clinical assessment: change from baseline in Mobility score [Time frame: up to 10 years]

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…)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Clinique du Parc — Lyon
  • Espace Médical Vauban — Paris
  • Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique — Saint-Herblain
Switzerland · 1 center
  • Orthopedic Surgeon (Dr. med. Dietmar Bignion) — Bern

Identifiers

NCT: NCT04137237 · 1803-W-HAPYC-RM · 2019-A00536-51

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗