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NUsurface Implant Registry (NIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953846
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : January 29, 2020
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
Actual 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 (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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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: Rita Molenaar +31.343.200.140 r.molenaar@activeimplants.com
Contact: Cathy Newbill 901-762-0352 cathy.newbill@activeimplants.com

Locations
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Belgium
AZ Monica vzw Recruiting
Deurne, Belgium, BE-2100
Contact: Kristien Vuylsteke    +32 (0)3 320 58 42    morefoundation@azmonica.be   
Principal Investigator: Peter Verdonk, MD PhD         
Germany
Charité Universitätsmedizin Recruiting
Berlin, Germany, 10117
Contact: Tobias Jung    +49 (0)30 450652137    tobias.jung@charite.de   
Principal Investigator: Tobias Jung, MD         
Sporthopaedicum Recruiting
Berlin, Germany, 10627
Contact: Nina Bauer    +49 (0)30 92105993    bauer@arthroskopie.de   
Principal Investigator: Sven Scheffler, MD PhD         
University of Brandenburg Recruiting
Brandenburg an der Havel, Germany, 14770
Contact: Frau Lehman    +49 3381-41-1900    orthopaedie@klinikum-brandenburg.de   
Principal Investigator: Roland Becker, MD PhD         
Sub-Investigator: Sebastian Kopf, MD         
St. Elisabeth Krankenhaus Recruiting
Damme, Germany, 49401
Contact: Rianne Berg    +49 05491 955232    rianne.berg@orthop-damme.de   
Principal Investigator: Berg Tom, MD         
Klinikum der Universität München Recruiting
München, Germany, 81377
Contact: Monika Baylacher    0049-(0)89-4400-57670    monika.baylacher@med.uni-muenchen.de   
Principal Investigator: Peter Müller, MD PhD         
Sub-Investigator: Matthias Pietschmann, MD PhD         
Sub-Investigator: Thomas Niethammer, MD         
Caritas-Krankenhaus St. Josef Recruiting
Regensburg, Germany, 93053
Contact: Sandra Frestl    +941 782 3810    sferstl@caritasstjosef.de   
Contact       sferstl@caritasstjosef.de   
Principal Investigator: Johannes Zellner, MD         
Israel
Shamir Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Karni Barak    +00972 8977 9432    karnib@shamir.gov.il   
Principal Investigator: Gabriel Agar, MD         
Sub-Investigator: Yiftah Beer, MD         
Sponsors and Collaborators
Active Implants
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Responsible Party: Active Implants
ClinicalTrials.gov Identifier: NCT03953846    
Other Study ID Numbers: 01003
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
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
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases