The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)

Exclusion Criteria

• •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 cm2 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 \< 9 months prior to study treatment
• •11. Has a BMI \> 32.5 at the start 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 \< 90º
• •16. Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
• •17. Has insufficiency fractures or avascular necrosis of the medial compartment
• •18. Has an active infection or tumor (local or systemic)
• •19. Has any type of knee joint inflammatory disease including Sjogren's syndrome
• •20. Has neuropathic knee osteoarthropathy, also known as Charcot joint
• •21. Has any medical condition that does not allow possible arthroscopy of the knee
• •22. Has neurological deficit (sensory, motor, or reflex)
• •23. Is currently involved in another investigation of the lower extremity
• •24. Anticipates having another lower extremity surgery during the study period
• •25. Is contraindicated for hyaluronic acid injections (i.e., patients with known hypersensitivity \[allergy\] to hyaluronan \[sodium hyaluoronate\] preparations); patients having knee joint infections or skin diseases or infections in the site of possible injections
• •26. Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
• •27. Has received any corticosteroid knee injections ≤ 3 months prior to study treatment
• •28. Has chondrocalcinosis
• •29. Is on immunostimulating or immunosuppressing agents
• •30. Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS (e.g. have a leg length discrepancy \> 2.5 cm \[1 inch\], causing a noticeable limp)
• •31. Is a female who is lactating, expecting, or is intending to become pregnant during the study period
• •32. Is an active smoker
• •33. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
• •34. Is a prisoner
• •35. Is a patient who has economic incentive not to improve
• •36. Certain patient populations that are at high risk for poor healing or outcomes such as patients who have a co-morbidity that reduces life expectancy to less than 36 months
• •37. Patients who are contraindicated for MRI (i.e., pacemaker, defibrillator, cochlear implants, etc.)