NUsurface Implant Registry

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03953846

Acronym

NIR

Enrollment

Registered

2019-05-17

Start date

2019-06-01

Completion date

2023-11-01

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis, Knee Pain Chronic, Meniscus; Degeneration

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Belgium, Germany, Israel, Netherlands

Contacts

STUDY_DIRECTORRyan Belaney, MSBME

Phoenix Kinetics

Outcome results