Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study (HaWPYC)

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedics

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.

• Study Type: Observational
• Enrollment (Estimated): 417

Contacts and Locations

• Study Contact: Name: Amjad Uneisi; Phone Number: +33638213703; Email: amjad.uneisi@stryker.com
• Study Contact Backup: Name: Caryn Thompson; Email: caryn.thompson@stryker.com

Study Locations

• France
  • Lyon, France, 69006
    • Recruiting
    • Clinique du Parc
    • Contact: Christophe RIZZO, MD
  • Paris, France, 75007
    • Recruiting
    • Espace Médical Vauban
    • Contact: Christian COUTURIER, MD
  • Saint-Herblain, France, 44800
    • Recruiting
    • Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique
    • Contact: Philippe BELLEMERE, MD
• Switzerland
  • Bern, Switzerland, 3011
    • Recruiting
    • Orthopedic Surgeon (Dr. med. Dietmar Bignion)
    • Contact: BIGNION Dietmar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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…)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID)	Demonstrate a superior (lower) total QuickDASH average by 24 months postoperatively compared to the predefined Minimal Clinically Important Difference (MCID) upper threshold of 36 points. QuickDash = Disabilities of the Arm, Shoulder and Hand), self-report questionnaire; 11 items to measure physical function and symptoms; items scored on a 1-5-point scale which is then transformed resulting in a score from 0 (least disability) to 100 (most disability).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Patient Satisfaction scores	Single, subjective question measuring patient satisfaction; assessed through 4 levels satisfaction: "Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied".	up to 10 years
Safety evaluation	Number of device associated and procedure associated adverse events	up to 10 years
Implant Survivorship	Rates of revision surgeries; assessed using the Kaplan-Meyer analysis	up to 10 years
Clinical assessment: change from baseline in QuickDash score	QuickDash = Disabilities of the Arm, Shoulder and Hand), self-report questionnaire; 11 items to measure physical function and symptoms; items scored on a 1-5-point scale which is then transformed resulting in a score from 0 (least disability) to 100 (most disability).	up to 10 years
Clinical assessment: change from baseline in PRWE score	PRWE = Patient-rated Wrist Evaluation; patient reported outcome developed to assess pain in the wrist joint and functional difficulties in activities of daily living resulting from injuries affecting wrist joint area. 15-item questionnaire made of two subscales (pain and function), resulting in a score from 0 to 100; Less score = better outcome.	up to 10 years
Clinical assessment: change from baseline in Strength score	Grip/grasp, tip and key pinch strength will be evaluated using a dynamometer.	up to 10 years
Clinical assessment: change from baseline in Mobility score	Evaluation of mobility (movement amplitude and functionality) will be assessed through angle measurement, using a goniometer. Measured movements will be flexion/extension, radial deviation/ulnar deviation, pronation/supination, adduction/abduction, opposition.	up to 10 years

Collaborators and Investigators

• Sponsor: Stryker Trauma and Extremities
• Investigators: Study Director: Rebecca Gibson, Stryker Trauma

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2033

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Surgery; Hand; Wrist
• Other Study ID Numbers: 1803-W-HAPYC-RM; 2019-A00536-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No