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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03953846
Study type Observational [Patient Registry]
Source Active Implants
Contact Rita Molenaar
Phone +31.343.200.140
Email r.molenaar@activeimplants.com
Status Recruiting
Phase
Start date June 1, 2019
Completion date June 1, 2033

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