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NUsurface Implant Registry (NIR)

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ClinicalTrials.gov Identifier: NCT03953846
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Meniscus; Degeneration Knee Osteoarthritis Knee Pain Chronic Device: NUsurface meniscus implant

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2033

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: NUsurface meniscus implant
    The NUsurface® Meniscus Implant is a medical device developed for treating subjects with painful medial knee compartment due to meniscus deficiencies.


Primary Outcome Measures :
  1. KOOS 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 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population eligible for this protocol includes any subject who received or is scheduled to receive the NUsurface® meniscus implant and meets the Registry inclusion criteria
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953846


Contacts
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Contact: Emanuele Nocco 9017620352 emanuele.nocco@activeimplants.com

Sponsors and Collaborators
Active Implants

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Responsible Party: Active Implants
ClinicalTrials.gov Identifier: NCT03953846     History of Changes
Other Study ID Numbers: 01003
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases