NUsurface Implant Registry

Knee Osteoarthritis Clinical Trial

— NIR  

Official title:

A Long-term Non-interventional Registry Study to Assess the Effectiveness and Safety of the NUsurface® Meniscus Implant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03953846
• Other study ID #: 01003
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: June 1, 2033

Study information

• Verified date: September 2022
• Source: Active Implants
• Contact: Rita Molenaar
• Phone: +31.343.200.140
• Email: r.molenaar[@]activeimplants.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2033
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Knee Pain Chronic
• Meniscus; Degeneration
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Belgium	AZ Monica vzw	Deurne
Germany	Sporthopaedicum	Berlin
Germany	University of Brandenburg	Brandenburg an der Havel
Germany	St. Elisabeth Krankenhaus	Damme
Germany	Klinikum der Universität München	München
Israel	Assuta Medical Center	Tel Aviv
Israel	Shamir Medical Center	Zerifin
Netherlands	Maastricht UMC	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Active Implants

Countries where clinical trial is conducted

Belgium,  Germany,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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