Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
ConditionOrthopedics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStryker Trauma and Extremities
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
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…)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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).
Time frame
24 monthsSecondary outcomes
1
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".
Time frame
up to 10 years2
Safety evaluation
Number of device associated and procedure associated adverse events
Time frame
up to 10 years3
Implant Survivorship
Rates of revision surgeries; assessed using the Kaplan-Meyer analysis
Time frame
up to 10 years4
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).
Time frame
up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov