Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

Orthopedics Clinical Trial

— HaWPYC  

Official title:

Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137237
• Other study ID #: 1803-W-HAPYC-RM
• Secondary ID: 2019-A00536-51
• Status: Recruiting
• Start date: November 14, 2019
• Est. completion date: January 2033

Study information

• Verified date: April 2024
• Source: Stryker Trauma GmbH
• Contact: Amjad Uneisi
• Phone: +33638213703
• Email: amjad.uneisi[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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…)

Related Conditions & MeSH terms

• Orthopedics

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

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