Clinical trial NCT04137237: Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
Official title: Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthopedics
Keywords: Hand
Wrist
Surgery
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2019-10-23
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 417 patients will be enrolled (About 50 to 80 per implant type). Prospective patients: screening and surgery should occur after the First site initiation visit.

"Ambispective" patients:

* Screening and surgery occurred before the date of the first site initiation visit,
* Follow-up visits (at least the last two) must be prospective (i.e: must occur after the date of the first site initiation visit),
* Inclusions of consecutive patients,
* Minimum available data must be available for each completed visit.

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 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.

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...)

Primary outcomes:
measure: Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID)
timeFrame: 24 months
Secondary outcomes:
measure: Change from baseline in Patient Satisfaction scores
timeFrame: up to 10 years
measure: Safety evaluation
timeFrame: up to 10 years
measure: Implant Survivorship
timeFrame: up to 10 years
measure: Clinical assessment: change from baseline in QuickDash score
timeFrame: up to 10 years
measure: Clinical assessment: change from baseline in PRWE score
timeFrame: up to 10 years
measure: Clinical assessment: change from baseline in Strength score
timeFrame: up to 10 years
measure: Clinical assessment: change from baseline in Mobility score
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique du Parc
city: Paris
country: France
facility: Espace Médical Vauban
city: Saint-Herblain
country: France
facility: Clinique de la Main
city: Bern
country: Switzerland
facility: Orthopedic Surgeon (Dr. med. Dietmar Bignion)
Study officials:
affiliation: Stryker Trauma
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: