Orthopedics Clinical Trial
— HaWPYCOfficial title:
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.
Status | Recruiting |
Enrollment | 417 |
Est. completion date | January 2033 |
Est. primary completion date | January 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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…) |
Country | Name | City | State |
---|---|---|---|
France | Clinique du Parc | Lyon | |
France | Espace Médical Vauban | Paris | |
France | Clinique de la Main | Saint-Herblain | |
Switzerland | Orthopedic Surgeon (Dr. med. Dietmar Bignion) | Bern |
Lead Sponsor | Collaborator |
---|---|
Stryker Trauma GmbH |
France, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Safety evaluation | Number of device associated and procedure associated adverse events | up to 10 years | |
Secondary | Implant Survivorship | Rates of revision surgeries; assessed using the Kaplan-Meyer analysis | up to 10 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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