DeNovo NT Natural Tissue Graft Stratified Knee Study

Exclusion Criteria

• •1. Clinical disease diagnosis of the indexed affected joint that includes
• •* Osteoarthritis or avascular necrosis,
• •* Rheumatoid arthritis, or history of septic or reactive arthritis,
• •* Gout or a history of gout or pseudogout in the affected knee,
• •* Bipolar articular cartilage involvement (or kissing lesions)
• •* Has more than two clinically relevant chondral lesion(s) on the index knee,
• •* Osteochondritis dissecans of the knee with significant bone loss
• •* Associated damage to the underlying subchondral bone requiring bone graft,
• •* Has well-defined subchondral cyst(s),
• •* Has current or impending subchondral avascular necrosis,
• •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
• •6. Is at substantial risk for the need of organ transplantation
• •7. Is pregnant or breast-feeding,
• •8. Body Mass Index \>35 (BMI=kg/m2),
• •9. Is participating concurrently in another clinical trial
• •10. 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,
• •11. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
• •12. Active joint infection or history of chronic joint infection at the surgical site,
• •13. Prior total meniscectomy of either knee,
• •14. Has severe patellofemoral malalignment/maltracking or patellar instability
• •15. Radiographically has \>5 degrees of malalignment
• •16. Has received, within the past 3 months HA or cortisone injections in knee,
• •17. Has undergone prior tendon repair, meniscus repair, ligament repair or distal realignment/osteotomy surgery in the index knee, \< 6 months prior to surgery,
• •18. Failed marrow stimulation or ACI treatment performed \< 12-mo before baseline,
• •19. Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or osteochondral allograft,
• •20. Involves concomitant procedures in the affected knee with the exception of incidental loose body removal, debridement, synovectomy, retinacular release, and/or partial meniscectomy
• •21. Has contraindications for Magnetic Resonance Imaging (MRI),
• •22. Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,
• •23. Is receiving workman's compensation or currently involved in litigation relating to the index knee