NUsurface Implant Registry

  • STATUS
    Recruiting
  • End date
    Jun 1, 2033
  • participants needed
    500
  • sponsor
    Active Implants
Updated on 31 July 2021

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

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.

Details
Condition Knee Pain Chronic, Meniscus; Degeneration, knee osteoarthritis, Gonarthrosis, Osteoarthritis, Osteoarthritis of knee
Treatment NUsurface meniscus implant
Clinical Study IdentifierNCT03953846
SponsorActive Implants
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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