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NCT Number: NCT04137237

Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Parc, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

Primary outcomes

  1. Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID)

    Time frame: 24 months

    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).

Secondary outcomes

  1. Change from baseline in Patient Satisfaction scores

    Time frame: up to 10 years

    Single, subjective question measuring patient satisfaction; assessed through 4 levels satisfaction: "Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied".

  2. Safety evaluation

    Time frame: up to 10 years

    Number of device associated and procedure associated adverse events

  3. Implant Survivorship

    Time frame: up to 10 years

    Rates of revision surgeries; assessed using the Kaplan-Meyer analysis

  4. Clinical assessment: change from baseline in QuickDash score

    Time frame: up to 10 years

    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).

  5. Clinical assessment: change from baseline in PRWE score

    Time frame: up to 10 years

    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.

  6. Clinical assessment: change from baseline in Strength score

    Time frame: up to 10 years

    Grip/grasp, tip and key pinch strength will be evaluated using a dynamometer.

  7. Clinical assessment: change from baseline in Mobility score

    Time frame: up to 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amjad Uneisi

CONTACT

[email protected]

+33638213703

Caryn Thompson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Acronym: HaWPYC

Important dates

Study start
2019
Primary completion
2029
Study completion
2033
First posted
Oct 23, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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