NUsurface Implant Registry

NCT ID: NCT03953846

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-11-01

Brief Summary

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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

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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.

Conditions

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Meniscus; Degeneration Knee Osteoarthritis Knee Pain Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Active Implants

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard W Threharne, PhD

Role: STUDY_DIRECTOR

Active Implants LLC

Locations

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AZ Monica vzw

Deurne, , Belgium

Site Status

Sporthopaedicum

Berlin, , Germany

Site Status

University of Brandenburg

Brandenburg, , Germany

Site Status

Klinikum der Universität München

München, , Germany

Site Status

Shamir Medical Center

Ẕerifin, , Israel

Site Status

Maastricht UMC

Maastricht, , Netherlands

Site Status

Countries

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Belgium Germany Israel Netherlands

Other Identifiers

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01003

Identifier Type: -

Identifier Source: org_study_id

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