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Trial record 1 of 1 for:    NCT01957722
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NOVOCART®3D for Treatment of Articular Cartilage of the Knee (N3D)

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ClinicalTrials.gov Identifier: NCT01957722
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Aesculap Biologics, LLC

Study Description
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Brief Summary:
This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Condition or disease Intervention/treatment Phase
Articular Cartilage of the Femoral Condyle Between 2-6cm2 Procedure: Microfracture Biological: NOVOCART 3D Phase 3

Detailed Description:
Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared ot Microfracture in the Treatment of Articular Cartilage Defects
Actual Study Start Date : December 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NOVOCART 3D
Scaffold assisted autologous chondrocyte Implant
 Biological: NOVOCART 3D
combination product- biologic (autologous chondrocytes) /device (scaffold) implant
Active Comparator: Microfracture
considered a typical treatment for articular cartilage repair
 Procedure: Microfracture
Surgical procedure which creates a marrow clot in the prepare cartilage defect.


Outcome Measures
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Primary Outcome Measures :
  1. Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain [ Time Frame: 24 months post treatment ]
    As measured by a change in KOOS (pain subdomain) score at 24 months from baseline

  2. Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain [ Time Frame: 24 months post treatment ]
    As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 18 years old
  • Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
  • Minimum score on the KOOS questionnaire

Exclusion Criteria:

  • Instability of the knee joint
  • Arthritis
  • Autoimmune disease
  • Immune suppression
  • Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
  • Bone disease
  • Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957722


Contacts
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Contact: Sarah Collins 310-948-8400 sarah.collins@aesculapbiologics.com

Locations
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United States, Arizona
The Core Institute Withdrawn
Phoenix, Arizona, United States, 85023
United States, California
Core Orthopedic Withdrawn
Encinitas, California, United States, 92024
Grossmont Orthopaedic Group Recruiting
La Mesa, California, United States, 91942
Contact: Dino Subasic    619-456-6012    dino@horizontrials.com   
Principal Investigator: Scott Hacker, MD         
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Barbara Domermuth       bdomermuth@mednet.ucla.edu   
Principal Investigator: Kristofer Jones, MD         
Stanford Medicine Recruiting
Redwood City, California, United States, 94063
Contact: Elizabeth Jameiro    650-725-5978    ejamerio@standford.edu   
Contact: Taylor Ray       raytay@standford.edu   
Principal Investigator: Seth Sherman, MD         
University of California Davis Withdrawn
Sacramento, California, United States, 95816
UCSF Orthopaedic Institute Recruiting
San Francisco, California, United States, 94158
Contact: Jocelyn Carpio    415-502-7389    jocelyn.carpio@ucsf.edu   
Principal Investigator: C Benjamin Ma, MD         
United States, Colorado
Va Eastern Colorado Health System Withdrawn
Denver, Colorado, United States, 80220
Cu Sports Medicine Recruiting
Denver, Colorado, United States, 80222
Contact: Andres Barandiaran    720-848-8228    andres.barandiaran@ucdenver.edu   
Principal Investigator: Rachel Frank, MD         
Yampa Valley Medical Center Recruiting
Steamboat Springs, Colorado, United States, 80487
Contact: Laurel Martin    970-879-4612    lmartin@steamboatortho.com   
Principal Investigator: Alexander Meininger, MD         
United States, District of Columbia
George Washington University Hospital Withdrawn
Washington, District of Columbia, United States, 20037
United States, Florida
Tenet Florida Physician Services Withdrawn
Boca Raton, Florida, United States, 33433
Florida Orthopaedic Institute Withdrawn
Tampa, Florida, United States, 33637
Paley Orthopedic and Spine Institute Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Liana Leja    561-844-5255    lleja@paleyinstitute.org   
Principal Investigator: Tom Minas, MD         
United States, Georgia
Glynn Brunswick Memorial Authority Withdrawn
Brunswick, Georgia, United States, 31525
United States, Idaho
St. Lukes Intermountain Research Center Recruiting
Boise, Idaho, United States, 83702
Contact: Kailyn Hickey    208-706-9084    hickeyk@slhs.org   
Principal Investigator: James Beckmann, MD         
Saint Alphonsus Medical Group Recruiting
Meridian, Idaho, United States, 83642
Contact: Jackie Atkinson    208-866-5522    Jackie@nauticalclinical.com   
Principal Investigator: Andrew Curran, CO         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Kavita Ahuja    312-563-2216    kavita.ahuja@rushortho.com   
Contact: Mukesh Ahuja    312-563-2214    mukesh.ahuja@rushortho.com   
Principal Investigator: Brian Cole, MD         
Northshore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Meryem Saracoglu    847-570-1727    msaracoglu@northshore.org   
Principal Investigator: Jason Koh, MD         
Siu School of Medicine Withdrawn
Springfield, Illinois, United States, 62794
United States, Kentucky
University of Kentucky Withdrawn
Lexington, Kentucky, United States, 40536
United States, Louisiana
Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: John Maggio    504-842-0263    jmaggio@ochnser.org   
Contact: Graylin Jacobs       graylin.jacobs@ochnser.org   
Principal Investigator: Deryk Jones, MD         
United States, Maryland
Peninsula Orthopaedic Associates Withdrawn
Salisbury, Maryland, United States, 21804
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Chris Ray    734-930-7432    raychri@med.umich.edu   
Principal Investigator: John Grant, MD         
United States, Minnesota
Tria Orthopedic Center Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Lauren Smude    952-806-5603    TriaResearch@tria.com   
Principal Investigator: Marc Tompkins, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ciara Terry    507-538-3562    Terry.Ciara@mayo.edu   
Principal Investigator: Aaron Krych, MD         
United States, Missouri
University of Missouri Healthcare Recruiting
Columbia, Missouri, United States, 65212
Contact: Bryce Fletcher    573-884-1248    brycefletcher@health.missouri.edu   
Principal Investigator: Richard Ma, MD         
United States, New Mexico
University of New Mexico Withdrawn
Albuquerque, New Mexico, United States, 87131
United States, New York
Mount Sinai Faculty Practice Associates Active, not recruiting
New York, New York, United States, 10029
Plancher Orthopaedics & Sports Medicine Recruiting
New York, New York, United States, 10128
Contact: Stephanie Petterson    203-869-2002    spetterson@ofals.org   
Principal Investigator: Kevin Plancher, MD         
Long Island Bone and Joint Llp Withdrawn
Port Jefferson, New York, United States, 11777
United States, North Carolina
Duke University Withdrawn
Durham, North Carolina, United States, 27705
United States, Ohio
Ohio State University Sports Medicine Recruiting
Columbus, Ohio, United States, 43221
Contact: Jenna DeFranco    614-293-7952    Jenna.Defranco@osumc.edu   
Principal Investigator: David Flanigan, MD         
United States, Oklahoma
Tulsa Bone and Joint Associates Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Faye Biggs    918-392-1505    f.biggs@tbja.org   
Principal Investigator: John Balbas, MD         
United States, Pennsylvania
Orthopaedic Associates of Allentown Ltd. Withdrawn
Allentown, Pennsylvania, United States, 18104
University Orthopedics Center Withdrawn
Altoona, Pennsylvania, United States, 16602
St. Luke'S University Health Network Active, not recruiting
Bethlehem, Pennsylvania, United States, 18015
Penn State Hershey Medical Center Withdrawn
Hershey, Pennsylvania, United States, 17033
Rothman Institute Withdrawn
Newtown Square, Pennsylvania, United States, 19073
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Joanne Donnelly    215-707-9221    Joanne.Donnelly@tuhs.temple.edu   
Contact: Bridget Slattery    610-999-1778    Bridget.Slattery@tuhs.temple.edu   
Principal Investigator: J. Milo Sewards, MD         
Sub-Investigator: Pekka Mooar, MD         
United States, Tennessee
Clinical Research Solutions Recruiting
Jackson, Tennessee, United States, 38305
Contact: Amy Arnold    731-431-5027    aarnold@crssites.com   
Contact: Marion Evans    731-431-5027    mevans@crssites.com   
Principal Investigator: Jason Hutchison, MD         
United States, Texas
Mercury Clinical Research Withdrawn
Houston, Texas, United States, 77036
United States, Utah
Alpine Orthopaedics Recruiting
North Logan, Utah, United States, 84341
Contact: Kelly Larson    435-774-8512    kellysue70@gmail.com   
Principal Investigator: Brad Larson, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kaitlyn Shank    434-924-6184    KCG4HF@hscmail.mcc.virginia.edu   
Contact: Stephan Bodkin    484-243-0274    SGB3D@hcsmail.mcc.virginia.edu   
Principal Investigator: David Diduch, MD         
The Orthopaedic Center of Central Virginia Inc. Withdrawn
Lynchburg, Virginia, United States, 24501
Advanced Orthopedics Recruiting
Richmond, Virginia, United States, 23294
Contact: Brendan Baggot       brendan.baggott@orthovirginia.com   
Principal Investigator: Kwadwo Owusu-Akyaw, MD         
Jordan-Young Institute Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Karen Adams       kadams@jyvb.co   
Principal Investigator: Kevin Bonner, MD         
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Jeffrey Narayan    780-222-4491    jnarayan@ualberta.ca   
Principal Investigator: Mark Sommerfeldt, MD         
Canada, British Columbia
Simon Fraser Health Authority Recruiting
Surrey, British Columbia, Canada, V3T 0H1
Contact: Krysten Payne    604-520-4855    kyrsten.payne@fraserhealth.ca   
Principal Investigator: Robert McCormack, MD         
Canada, Nova Scotia
Dalhousie University Recruiting
Halifax, Nova Scotia, Canada, B3H 2E1
Contact: Sarah Sparavalo    902-473-7626    sara@drivanwong.com   
Principal Investigator: Ivan Wong, MD         
Canada, Ontario
St. Josephs Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Breanne Flood    905-870-1382    bflood@stjoes.ca   
Principal Investigator: Moin Khan, MD         
Queens University Withdrawn
Kingston, Ontario, Canada, K7L 3N6
Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6C 2R5
Contact: Stacey Wanlin    519-661-2111    swanlin@uwo.ca   
Principal Investigator: Alan Getgood, MD         
Sponsors and Collaborators
Aesculap Biologics, LLC
Investigators
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Study Director: Robert Spiro, PhD Aesculap Biologics
More Information
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Responsible Party: Aesculap Biologics, LLC
ClinicalTrials.gov Identifier: NCT01957722    
Other Study ID Numbers: AAG-G-H-1220
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No