DeNovo NT Natural Tissue Graft Stratified Knee Study



Status:Active, not recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 55
Updated:1/27/2017
Start Date:March 2012
End Date:December 2021

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A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee

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.


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
We found this trial at
17
sites
Albuquerque, New Mexico 87106
Principal Investigator: Samuel Tabet, MD
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Albuquerque, NM
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Dennis Crawford, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Atlanta, Georgia 30329
Principal Investigator: Sameh Labib, MD
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Atlanta, GA
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Aurora, Colorado 80012
Principal Investigator: Stewart Weinerman, MD
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Aurora, CO
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baltimore, MD
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Bloomington, Minnesota 55431
Principal Investigator: Brad Nelson, MD
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Bloomington, MN
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: David Diduch, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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Edina, Minnesota 55435
Principal Investigator: Corey Wulf, MD
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Edina, MN
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Gulf Breeze, Florida 32561
Principal Investigator: Charles Roth, MD
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Gulf Breeze, FL
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Kirksville, Missouri 63501
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Kirksville, MO
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Los Angeles, California 90045
Principal Investigator: Ralph Gambardella, MD
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Los Angeles, CA
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New Orleans, Louisiana 70112
Principal Investigator: Wendell Heard, MD
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New Orleans, LA
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1967 Riverside Drive
Ottawa, Ontario K1H 7W9
Principal Investigator: Geoffrey Dervin, MD
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Ottawa,
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San Antonio, TX
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San Deigo, California 92134
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San Deigo, CA
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Somerset, New Jersey 08873
Principal Investigator: Timothy Hosea, MD
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Somerset, NJ
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9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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Tacoma, WA
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