medial meniscus deficiency medial meniscus torn
Conditions
Interventions
Patients will be randomized to receive either the NUsurface Meniscus implant,or
be treated with the non-surgical Standard of Care.
Sponsors
Active Implants LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: In the opinion of the investigator, if ALL of the following 8 conditions are applicable for the index knee, then the patient is included if he/she: ;1. Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI 2. Has a KOOS Pain of * 75 (100 being the highest attainable and no pain) 3. Is between age 30 and 75 years (inclusive) at the time of study treatment 4. Has neutral alignment ± 5º of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine to the center of the ankle joint 5. Has * 2 mm intact medial meniscal rim capable of being fitted with a NUsurface® device AND is also recommended for the baseline non-surgical (and, if likely to receive benefit, any injection) therapies to be administered in the study. 6. Is willing to be entered into either arm of the study: implanted with the NUsurface device OR treated with the recommended control arm therapies. 7. Is able to do the study required follow up visits, questionnaires, X-rays, and MRI*s 8. Is able and willing to understand and sign the study Informed Consent Form 9. Is able to read and understand the national language of the country in which the relevant clinical site is located
Exclusion criteria
Exclusion criteria: Exclusion Criteria: If ANY of the following 35 conditions are applicable, then the patient is excluded if he/she:;1) Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy leaving > 4 mm of medial meniscus rim 2) Has evidence of a Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a NUsurface implant (e.g., a focal lesion > 0.5 cm correlating to a circular defect of > 8 mm in diameter) 3) Has complete disruption of the posterior root attachment of the meniscus 4) Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in the lateral compartment 5) Has a varus or valgus knee deformity > 5º requiring a tibial or femoral osteotomy 6) Has a laxity level of more than Grade II (IKDC), primary or secondary to an 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) 7) Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment 8) Has patellar compartment pain and Grade III or Grade IV Outerbridge cartilage score in the patellar compartment. 9) Compared to a normal knee, has obvious radiological evidence of medial femoral squaring, anatomical variance in the medial tibial plateau, or irregularly shaped cartilage surface 10) Had an ACL reconstruction performed 32.5 at the time of study treatment 12) Decides to receive (if eligible and an option) allograft medial meniscus transplantation 13) Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the NUsurface® Meniscus Implant 14) Has a knee flexion contracture > 10º 15) Has flexion 2.5 cm [1 inch], causing a noticeable limp) 31) Is a female who is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint components of the study are as follows: Effectiveness: The KOOS Pain Subscale and KOOS Overall Scale (Average of the 5 KOOS Subscales) relative to baseline * at 24 months Investigational Group Device-Related Secondary Surgical Interventions: The device related secondary surgical interventions of the NUsurface® Meniscus Implant during the 24 month post-operative period. Control Group Post-InterventionTreatment Surgical Procedures: The treatment failures of the control group are defined as any surgery on the index knee medial compartment up to and including 24 months. Each of these components of Overall Success will be analysed separately, but their analyses will not affect the 0.05 type I error rate (threshold p-value of 0.05 for significance) for the test of the primary superiority hypothesis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Data Elements: Safety: Adverse events in either Group occurring at a rate of 5% or more at any post-treatment follow-up period will, if applicable, be statistically compared between study groups. Examples of safety measurements are: 1. Incidence of all adverse events through the 1.5, 3, 6, 12, and 24-month post-treatment period. 2. Incidence of secondary (or primary for the non-surgical control patients) surgical intervention through the 1.5, 3, 6, 12, and 24-month post- treatment period. 3. Device-related complication is defined as a complication found to be caused by the device and device malfunctions (including severity), as assessed at each post-op period. Device malfunctions include dislocation, device fracture, and/or removal (and infection, if related to device). 4. Non-surgical Control Post-Treatment Procedures: Treatment failures of the control group defined as any post-intervention surgical procedure of the index medial knee compartment. | — |
Countries
Netherlands
Outcome results
None listed