NUsurface Implant Registry

Active Implants36 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Meniscus; Degeneration Knee Osteoarthritis Knee Pain Chronic

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (6)

AZ Monica vzw

Deurne, Belgium

Sporthopaedicum

Berlin, Germany

University of Brandenburg

Brandenburg, Germany

Klinikum der Universität München

München, Germany

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 24 months

Data from ClinicalTrials.gov

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