NCT Number: NCT01712191
Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.
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Conditions
Age range
35 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
AZ Monica, Antwerp, Belgium
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 Months
Sponsors and collaborators
Lead sponsor
Active Implants
Industry
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2013
- Study completion
- 2016
- First posted
- Oct 23, 2012
- Registry last updated
- Apr 6, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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