Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

Conditions
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Orthopedics

Participation Criteria
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Eligibility Criteria
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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…)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand, Wrist, Surgery