NUsurface Implant Registry

Last updated: July 1, 2024
Sponsor: Active Implants
Overall Status: Terminated

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

N/A

Clinical Study ID

NCT03953846
01003
  • Ages 18-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • New or current treatment with the NUsurface® meniscus implant

  • Evidence of a personally signed and dated informed consent document indicating thatthe subject (or a legally acceptable representative) has been informed of allpertinent aspects of the Registry.

Exclusion

Exclusion Criteria:

  • There are no protocol exclusion criteria; all subjects who meet the inclusioncriteria are eligible for enrollment.

Study Design

Total Participants: 36
Study Start date:
June 01, 2019
Estimated Completion Date:
November 01, 2023

Study 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.

Connect with a study center

  • AZ Monica vzw

    Deurne, BE-2100
    Belgium

    Site Not Available

  • Sporthopaedicum

    Berlin, 10627
    Germany

    Site Not Available

  • University of Brandenburg

    Brandenburg an der Havel, 14770
    Germany

    Site Not Available

  • DIAKO Bremen

    Bremen, 28239
    Germany

    Site Not Available

  • St. Elisabeth Krankenhaus

    Damme, 49401
    Germany

    Site Not Available

  • Klinikum der Universität München

    München, 81377
    Germany

    Site Not Available

  • Caritas-Krankenhaus St. Josef

    Regensburg, 93053
    Germany

    Site Not Available

  • Assuta MC

    Tel Aviv, 6971028
    Israel

    Site Not Available

  • Assuta Medical Center

    Tel Aviv, 6971028
    Israel

    Site Not Available

  • Shamir Medical Center

    Zerifin, 70300
    Israel

    Site Not Available

  • Maastricht UMC

    Maastricht, 6229HX
    Netherlands

    Site Not Available

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