- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01712191
Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
April 4, 2023 updated by: Active Implants
This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerpen, Belgium
- AZ Monica
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Ghent, Belgium
- Ghent University Hospital
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Berlin, Germany
- Sporthopaedicum Berlin
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Regensburg, Germany
- Uniklinikum Regensburg
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Afula, Israel
- Emek Medical Center
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center- Ichilov
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Zerifin, Israel
- Assaf Harofeh Medical Center
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Negrar, Italy
- Sacro Cuore- Don Calabria Hospital
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Maastricht, Netherlands
- Maastricht University Medical Centre
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Göteborg, Sweden, 41345
- Sahlgrenska Universitetssjukhuset
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
- Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
- Be in neutral alignment +/- 5 degrees of the mechanical axis.
- Be between age 35 and 75 at the time of the planned surgery.
- Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
- Have a normal mental status.
- Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule.
- Be able and willing to understand and sign the informed consent form.
Exclusion Criteria:
- Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
- Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
- Have a varus or valgus knee deformity > 5 degrees.
- Have a laxity level of more than II (ICRS), secondary to previous injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL).
- Have patella instability or non-anatomically positioned patella
- Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
- Need a tibial osteotomy at the time of surgery.
- Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device
- Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic.
- Have a knee flexion contracture > 10 degrees
- Be unable to flex the knee to 90 degrees
- Have a leg length discrepancy causing a noticeable limp.
- Have had a previous major knee condyle surgery
- Present with insufficiency fractures or avascular necrosis of the medial compartment.
- Have an active infection or tumor.
- Have any type of knee joint inflammatory disease including Sjogren's syndrome.
- Have neuropathic knee osteoarthropathy, also known as Charcot joint.
- Have any medical condition that does not allow arthroscopy at the point of entry to the knee.
- Be pregnant or is a female intending to become pregnant during the study period.
- Be mentally incapacitated.
- Be a prisoner.
- Be a patient who has economic incentive not to improve (e.g., workman's compensation patient)
- Be morbidly Obese (BMI > 35).
- Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: NUsurface Meniscus Implant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 24 Months
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24 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
October 18, 2012
First Submitted That Met QC Criteria
October 22, 2012
First Posted (Estimate)
October 23, 2012
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00017
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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