Orthopedics
Conditions
Keywords
Hand, Wrist, Surgery
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.
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.
Interventions
None listed
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID) | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | up to 10 years | Number of device associated and procedure associated adverse events |
| Implant Survivorship | up to 10 years | Rates of revision surgeries; assessed using the Kaplan-Meyer analysis |
| Clinical assessment: change from baseline in QuickDash score | 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). |
| Change from baseline in Patient Satisfaction scores | up to 10 years | Single, subjective question measuring patient satisfaction; assessed through 4 levels satisfaction: Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. |
| Clinical assessment: change from baseline in Strength score | up to 10 years | Grip/grasp, tip and key pinch strength will be evaluated using a dynamometer. |
| Clinical assessment: change from baseline in Mobility score | 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. |
| Clinical assessment: change from baseline in PRWE score | 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. |
Countries
France, Switzerland
Contacts
Primary ContactAmjad Uneisi
Backup ContactCaryn Thompson
Outcome results
None listed