Clinical trial NCT01670617: DeNovo NT Natural Tissue Graft Stratified Knee Study
Official title: A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Defect of Articular Cartilage
Knee Injuries
Lead sponsor: Zimmer Orthobiologics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.


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

Primary outcomes:
measure: Improvement in KOOS scores
timeFrame: Between baseline and 24 months post surgery
Secondary outcomes:
measure: X-ray Evaluation
timeFrame: Preop, 12 months and 24 months post surgery
measure: Incidence and time to reoperation/revision
timeFrame: 5 years
measure: Mean IKDC Knee Examination grades
timeFrame: Annually to 5 years post surgery
measure: MRI Evaluation
timeFrame: Preop, 12 Months and 24 Months post surgery
measure: Incidence of adverse events
timeFrame: Annually to 5 years post surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kerlan Jobe Orthopaedics
state: California
city: San Deigo
country: United States
facility: Naval Medical Center San Deigo
state: California
city: Aurora
country: United States
facility: Colorado Orthopedic Consultants
state: Colorado
city: Gulf Breeze
country: United States
facility: Andrews Institute for Orthopaedics & Sports Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory Spine & Sports Medicine Center
state: Georgia
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
city: Edina
country: United States
facility: Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics
state: Minnesota
city: Kirksville
country: United States
facility: A.T. Still University of Health Sciences
state: Missouri
city: Somerset
country: United States
facility: University Orthopaedic Associates
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Orthopaedic Consultants
state: New Mexico
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronoto
country: Canada
facility: Women's College Hospital
Study officials:
References:
citation: Farr J, Cole BJ, Sherman S, Karas V. Particulated articular cartilage: CAIS and DeNovo NT. J Knee Surg. 2012 Mar;25(1):23-9. doi: 10.1055/s-0031-1299652.