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DeNovo NT Natural Tissue Graft Stratified Knee Study

Sponsor
Zimmer Orthobiologics, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01670617
Collaborator
(none)
90
Enrollment
18
Locations
1
Arm
117
Duration (Months)
5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Particulated Juvenile Articular Cartilage
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee
Study Start Date :
Mar 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: DeNovo NT Graft

DeNovo NT Graft stratified by lesion location - femur or patella

Other: Particulated Juvenile Articular Cartilage
Treatment of articular cartilage defects up to 7.5 cm2
Other Names:
  • DeNovo NT Natural Tissue Graft

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in KOOS scores [Between baseline and 24 months post surgery]

      Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores

    Secondary Outcome Measures

    1. X-ray Evaluation [Preop, 12 months and 24 months post surgery]

      X-ray evaluation of joint narrowing, and osteophyte and cyst formation

    2. Incidence and time to reoperation/revision [5 years]

    3. Mean IKDC Knee Examination grades [Annually to 5 years post surgery]

    4. MRI Evaluation [Preop, 12 Months and 24 Months post surgery]

      Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score

    5. Incidence of adverse events [Annually to 5 years post surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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,

    1. History of secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or autoimmune disease),

    2. Uncontrolled diabetes,

    3. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,

    4. Has HIV or other immunodeficient state

    5. Is at substantial risk for the need of organ transplantation

    6. Is pregnant or breast-feeding,

    7. Body Mass Index >35 (BMI=kg/m2),

    8. Is participating concurrently in another clinical trial

    9. 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,

    10. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,

    11. Active joint infection or history of chronic joint infection at the surgical site,

    12. Prior total meniscectomy of either knee,

    13. Has severe patellofemoral malalignment/maltracking or patellar instability

    14. Radiographically has >5 degrees of malalignment

    15. Has received, within the past 3 months HA or cortisone injections in knee,

    16. Has undergone prior tendon repair, meniscus repair, ligament repair or distal realignment/osteotomy surgery in the index knee, < 6 months prior to surgery,

    17. Failed marrow stimulation or ACI treatment performed < 12-mo before baseline,

    18. Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or osteochondral allograft,

    19. Involves concomitant procedures in the affected knee with the exception of incidental loose body removal, debridement, synovectomy, retinacular release, and/or partial meniscectomy

    20. Has contraindications for Magnetic Resonance Imaging (MRI),

    21. Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,

    22. Is receiving workman's compensation or currently involved in litigation relating to the index knee

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kerlan Jobe Orthopaedics Los Angeles California United States 90045
    2 Naval Medical Center San Deigo San Deigo California United States 92134
    3 Colorado Orthopedic Consultants Aurora Colorado United States 80012
    4 Andrews Institute for Orthopaedics & Sports Medicine Gulf Breeze Florida United States 32561
    5 Emory Spine & Sports Medicine Center Atlanta Georgia United States 30329
    6 Tulane University Medical Center New Orleans Louisiana United States
    7 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    8 TRIA Orthopaedic Center Bloomington Minnesota United States 55431
    9 Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics Edina Minnesota United States 55435
    10 A.T. Still University of Health Sciences Kirksville Missouri United States 63501
    11 University Orthopaedic Associates Somerset New Jersey United States 08873
    12 New Mexico Orthopaedic Consultants Albuquerque New Mexico United States 87106
    13 Oregon Health & Science University Portland Oregon United States 97201
    14 San Antonio Military Medical Center San Antonio Texas United States 78234
    15 University of Virginia Charlottesville Virginia United States 22903
    16 Madigan Army Medical Center Tacoma Washington United States 98431
    17 Ottawa Hospital Ottawa Ontario Canada
    18 Women's College Hospital Toronoto Canada M5S 1B1

    Sponsors and Collaborators

    • Zimmer Orthobiologics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zimmer Orthobiologics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01670617
    Other Study ID Numbers:
    • CSU2011-03B
    First Posted:
    Aug 22, 2012
    Last Update Posted:
    Jan 26, 2017
    Last Verified:
    Dec 1, 2016
    Additional relevant MeSH terms:
    Knee Injuries

    Study Results

    No Results Posted as of Jan 26, 2017