Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

NCT04137237 | Recruiting

• 2 other identifiers: 1803-W-HAPYC-RM2019-A00536-51
• Study Type: observational
• Target: 417
• Locations: 2 countries
• Sites: 4

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.

Conditions

Orthopedics

Keywords

Hand; Wrist; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in Patient Satisfaction scores

  up to 10 years

• Safety evaluation

  up to 10 years

• Implant Survivorship

  up to 10 years

• Clinical assessment: change from baseline in QuickDash score

  up to 10 years

• Clinical assessment: change from baseline in PRWE score

  up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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,
• Follow-up visits (at least the last two) must be prospective,
• Patient must have complete information available for each completed visit

You may not qualify if:

• 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…)

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (4)

Clinique du Parc

Lyon, 69006, France

RECRUITING

Espace Médical Vauban

Paris, 75007, France

RECRUITING

Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique

Saint-Herblain, 44800, France

RECRUITING

Orthopedic Surgeon (Dr. med. Dietmar Bignion)

Bern, 3011, Switzerland

RECRUITING

Study Officials

• Rebecca Gibson

  Stryker Trauma

  STUDY DIRECTOR

Central Study Contacts

Amjad Uneisi

CONTACT

+33638213703; amjad.uneisi@stryker.com

Caryn Thompson

CONTACT

caryn.thompson@stryker.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 23, 2019
• Study Start: November 14, 2019
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2033
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); CH (1)