NUsurface Implant Registry

Terminated

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

• Registration Number: NCT03953846
• Lead Sponsor: Active Implants

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.

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Study Start: 2019-06-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KOOS (Knee Osteoarthritis Outcome Score) Pain improvement	24 months	a responder is defined as a patient with an increase of at least 20 points on the KOOS pain assessment
WOMET (Western Ontario Meniscus Evaluation Tool) score improvement	24 months	a responder is defined as a patient with an increase of at least 12 points on the WOMET assessment

Trial Locations

Locations (6)

AZ Monica vzw; 🇧🇪 Deurne, Belgium

Sporthopaedicum; 🇩🇪 Berlin, Germany

University of Brandenburg; 🇩🇪 Brandenburg an der Havel, Germany

Klinikum der Universität München; 🇩🇪 München, Germany

Shamir Medical Center; 🇮🇱 Zerifin, Israel

Maastricht UMC; 🇳🇱 Maastricht, Netherlands