NUsurface Implant Registry (NIR)

Active Implants

Status: Terminated

Conditions: Knee Pain Chronic; Meniscus; Degeneration; Knee Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT03953846

01003

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.