Trials / Recruiting
RecruitingNCT04137237
Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 417 (estimated)
- Sponsor
- Stryker Trauma and Extremities · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2019-11-14
- Primary completion
- 2029-01-01
- Completion
- 2033-01-01
- First posted
- 2019-10-23
- Last updated
- 2025-09-16
Locations
4 sites across 2 countries: France, Switzerland
Source: ClinicalTrials.gov record NCT04137237. Inclusion in this directory is not an endorsement.