NCT03953846

NUsurface Implant Registry

A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Active Implants · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Meniscus; Degeneration
• Knee Osteoarthritis
• Knee Pain Chronic

Timeline

• Start date: 2019-06-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2019-05-17
• Last updated: 2024-07-03

Locations

6 sites across 4 countries: Belgium, Germany, Israel, Netherlands