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OpenTrials
Terminated

NCT Number: NCT03953846

NUsurface Implant Registry

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

Why the study stopped: Active Implants Europe closed operations
Terminated

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Key information

Conditions

Meniscus; Degeneration Arthritis Joint Diseases Knee Osteoarthritis Knee Pain Chronic Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Monica vzw, Deurne, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. KOOS (Knee Osteoarthritis Outcome Score) Pain improvement

    Time frame: 24 months

    a responder is defined as a patient with an increase of at least 20 points on the KOOS pain assessment

  2. WOMET (Western Ontario Meniscus Evaluation Tool) score improvement

    Time frame: 24 months

    a responder is defined as a patient with an increase of at least 12 points on the WOMET assessment

Sponsors and collaborators

Lead sponsor

Phoenix Kinetics

Industry

Registry information

Official study title

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

Acronym: NIR

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 17, 2019
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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