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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 : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Active Implants

Tracking Information
First Submitted Date May 15, 2019
First Posted Date May 17, 2019
Last Update Posted Date May 17, 2019
Estimated Study Start Date June 1, 2019
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2019)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NUsurface Implant Registry
Official Title A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant
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
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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
Condition
  • Meniscus; Degeneration
  • Knee Osteoarthritis
  • Knee Pain Chronic
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 15, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2033
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emanuele Nocco 9017620352 emanuele.nocco@activeimplants.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03953846
Other Study ID Numbers 01003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Active Implants
Study Sponsor Active Implants
Collaborators Not Provided
Investigators Not Provided
PRS Account Active Implants
Verification Date May 2019