NCT03953846

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
4 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 3, 2024

Status Verified

April 1, 2024

Enrollment Period

4.4 years

First QC Date

May 15, 2019

Last Update Submit

July 1, 2024

Conditions

Meniscus; DegenerationKnee OsteoarthritisKnee Pain Chronic

Outcome Measures

Primary Outcomes (2)

  • KOOS (Knee Osteoarthritis Outcome Score) Pain improvement

    a responder is defined as a patient with an increase of at least 20 points on the KOOS pain assessment

    24 months

  • WOMET (Western Ontario Meniscus Evaluation Tool) score improvement

    a responder is defined as a patient with an increase of at least 12 points on the WOMET assessment

    24 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AZ Monica vzw

Deurne, BE-2100, Belgium

Location

Sporthopaedicum

Berlin, 10627, Germany

Location

University of Brandenburg

Brandenburg, 14770, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Shamir Medical Center

Ẕerifin, 70300, Israel

Location

Maastricht UMC

Maastricht, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Richard W Threharne, PhD

    Active Implants LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 17, 2019

Study Start

June 1, 2019

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

July 3, 2024

Record last verified: 2024-04

Locations

BE(1)DE(3)NL(1)IL(1)