Knee Osteoarthritis Clinical Trial
— NIROfficial title:
A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant
NCT number | NCT03953846 |
Other study ID # | 01003 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | June 1, 2033 |
The purpose of this active post-market surveillance clinical registry study is to further characterize the therapeutic effect, the long-term safety and effectiveness of the NUsurface® meniscus implant in the real-world post-marketing setting
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 1, 2033 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - New or current treatment with the NUsurface® meniscus implant - Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry. Exclusion Criteria: - There are no protocol exclusion criteria; all subjects who meet the inclusion criteria are eligible for enrollment. |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Monica vzw | Deurne | |
Germany | Sporthopaedicum | Berlin | |
Germany | University of Brandenburg | Brandenburg an der Havel | |
Germany | St. Elisabeth Krankenhaus | Damme | |
Germany | Klinikum der Universität München | München | |
Israel | Assuta Medical Center | Tel Aviv | |
Israel | Shamir Medical Center | Zerifin | |
Netherlands | Maastricht UMC | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Active Implants |
Belgium, Germany, Israel, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | KOOS (Knee Osteoarthritis Outcome Score) Pain improvement | a responder is defined as a patient with an increase of at least 20 points on the KOOS pain assessment | 24 months | |
Primary | WOMET (Western Ontario Meniscus Evaluation Tool) score improvement | a responder is defined as a patient with an increase of at least 12 points on the WOMET assessment | 24 months |
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