ReNu™ Marrow Stimulation Augmentation

Exclusion Criteria

• •1. Clinical and/or radiographic disease diagnosis of the indexed affected joint that Includes:
• •1. Osteoarthritis or avascular necrosis,
• •2. Rheumatoid arthritis, or history of septic or reactive arthritis,
• •3. Gout or history of gout or pseudogout in the affected knee,
• •4. Osteochondritis dissecans of the knee with significant bone loss (greater than 6mm deep from the subchondral plate)
• •5. Associated damage to the underlying subchondral bone requiring a bone graft
• •2. History of secondary arthropathies (i.e. sickle cell disease, hemochromatosis, or autoimmune disease).
• •3. Uncontrolled diabetes.
• •4. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease.
• •5. Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint.
• •6. Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
• •7. Is pregnant or breast-feeding.
• •8. Body mass index \> 35.
• •9. Has bipolar articular cartilage involvement or kissing lesions of the ipsilateral compartment, described as tibial or patellar lesions in the same compartment with greater than ICRS Grade 2 chondrosis.
• •10. Is participating concurrently in another clinical trial, or has participated in a clinical trial within 30 days of surgery.
• •11. Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking corticosteroids.
• •12. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee.
• •13. Active joint infection.
• •14. Prior total meniscectomy of either knee.
• •15. Radiographically has \>5 degrees of malalignment as measured from the hip, knee and ankle mechanical axis.
• •16. Has subchondral bone loss of greater than 6mm
• •17. Has received within the past three months intra-articular platelet rich plasma, hyaluronic acid therapy, steroid, amniotic-derived or stem cell injections in the index knee.
• •18. Prior realignment surgery in the affected knee within the past 6 months.
• •19. Failed microfracture/marrow stimulation treatment performed less than 12-months before baseline.
• •20. Is receiving workman's compensation or currently involved in litigation relating to the index knee.
• •21. Has history of alcoholism, medication, or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder (s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or any combination of variables in the investigator's judgment that should exclude a potential subject.
• •22. Any conditions or implants that might affect having MRIs: had or have an aneurysm clip implanted, intraocular foreign bodies (commonly seen in welders), subcutaneous metal shards (found in sheet metal workers), or some shrapnel; additionally, no cardiac pacemaker, defibrillator, implanted neurostimulater (TENS implants) some prosthetic heart valve (especially mitral valve), cochlear implant or other hearing aide. Subjects should be excluded if they have a tendency of claustrophobia or have tattoos that may contain iron-based dyes.