Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Active Implants Europe closed operations
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Patients eligible for the Registry includes any patient who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria (Evidence of a personally signed and dated informed consent document). The NUsurface Implant Regitstry is about data collection only and under routine standard of care by treating physician. Data collection points are pre-op (i.e. baseline), surgery and multiple times after surgery during the first 6 months to correspond to clinic standard of care schedules, 6 months, 1 year post-operatively and then yearly thereafter out to 10 years.Surveys used are KOOS; Knee injury and Osteoarthritis Outcome Score & WOMET; Western Ontario Meniscal Evaluation Tool.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study population eligible for this protocol includes any subject who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard W Threharne, PhD | Active Implants LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Monica vzw | Deurne | BE-2100 | Belgium | |||
| Sporthopaedicum |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Berlin |
| 10627 |
| Germany |
| University of Brandenburg | Brandenburg an der Havel | 14770 | Germany |
| Klinikum der Universität München | München | 81377 | Germany |
| Shamir Medical Center | Ẕerifin | 70300 | Israel |
| Maastricht UMC | Maastricht | 6229HX | Netherlands |
| D012216 |
| Rheumatic Diseases |