Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
This trial is active, not recruiting.
|Conditions||meniscus; degeneration, osteoarthritis, knee|
|Treatment||nusurface meniscus implant|
|Start date||January 2011|
|End date||June 2017|
|Trial size||150 participants|
|Trial identifier||NCT01712191, 00017|
This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Antwerpen, Belgium||AZ Monica||no longer recruiting|
|Ghent, Belgium||Ghent University Hospital||no longer recruiting|
|Berlin, Germany||Sporthopaedicum Berlin||no longer recruiting|
|Regensburg, Germany||UniKlinikum Regensburg||no longer recruiting|
|Afula, Israel||Emek Medical Center||no longer recruiting|
|Beer Yaakoav, Israel||Assaf Harofeh Medical Center||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky Medical Center- Ichilov||no longer recruiting|
|Negar, Italy||Sacro Cuore- Don Calabria Hospital||no longer recruiting|
|Maastricht, Netherlands||Maastricht University Medical Centre||no longer recruiting|
|Göteborg, Sweden||Sahlgrenska universitetssjukhuset||no longer recruiting|
|Intervention model||single group assignment|
Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: 24 Months
All participants from 35 years up to 75 years old.
- 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.
- 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
|Official title||Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant|
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