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

Active Implants6 sites in 4 countries36 target enrollmentJune 1, 2019

ConditionsMeniscus; Degeneration Knee Osteoarthritis Knee Pain Chronic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Meniscus; Degeneration
Sponsor: Active Implants
Enrollment: 36
Locations: 6
Primary Endpoint: KOOS (Knee Osteoarthritis Outcome Score) Pain improvement
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 1, 2019

End Date

November 1, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Active Implants

Responsible Party

Sponsor

Eligibility Criteria

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.