NL-OMON41631
Completed
Not Applicable
Treatment of the Medial Meniscus with the NUsurface® Meniscus Implant. A Prospective, Multi-Center, Open Label, Non-randomized Study of the NUsurface® Meniscus Implant - NUsurface Meniscus Implant
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- medial meniscus deficiency
- Sponsor
- Active Implants Corporation
- Enrollment
- 3
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be included in the NUsurface study the patient must have medial compartment knee pain and ALL of the following conditions:
- •1\.Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
- •2\.Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
- •3\.Be in neutral alignment \+/\- 5 degrees of the mechanical axis.
- •4\.Be between age 35 and 75 at the time of the planned surgery.
- •5\.Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
- •6\.Have a normal mental status.
- •7\.Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X\-ray and MRI schedule.
- •8\.Be able and willing to understand and sign the informed consent form.
Exclusion Criteria
- •The patient is excluded from the study if ANY of the following conditions are met for the involved knee:
- •1\.Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
- •2\.Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
- •3\.Have a varus or valgus knee deformity \> 5 degrees.
- •4\.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).
- •5\.Have patella instability or non\-anatomically positioned patella
- •6\.Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
- •7\.Need a tibial osteotomy at the time of surgery.
- •8\.Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device
- •9\.Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic.
Outcomes
Primary Outcomes
Not specified
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