DeNovo NT Natural Tissue Graft Stratified Knee Study

Launched by ZIMMER ORTHOBIOLOGICS, INC. · Aug 17, 2012

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • 1. Voluntary signature of the IRB approved Informed Consent,
• • 2. Male or female subjects between the ages of 18 to 55 years,
• • 3. If female: Actively practicing a contraception method and willing to continue for a minimum of 1 year postoperatively, practicing abstinence and willing to continue for a minimum of 1 year postoperatively, or sterile
• • 4. One or two contained lesion(s) of the femur or patella ≥ ICRS Grade 3 or OCD lesions with healed bone base with no loss of bone greater than 6mm
• • 5. Has peripheral cartilage debridement to healthy cartilage that results in at least one lesion with an area of ≥ 2 cm2 and ≤ 7.5 cm2,
• • 6. Lesion(s) to be treated must be contained/shouldered \> 70% of the periphery,
• • 7. Ligaments in the affected knee are stable,
• • 8. Ipsilateral knee compartment has intact menisci
• • 9. The contralateral knee is asymptomatic, stable, and fully functional,
• • 10. Is refractory to conservative non-surgical management or minimal surgical intervention and ≥ 3 months from the start of either treatment,
• • 11. Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P9.
• • 12. Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol
• 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