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NOVOCART®3D for Treatment of Articular Cartilage of the Knee (N3D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01957722
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Aesculap Biologics, LLC

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.

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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 : August 2023
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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.

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: Alyse Borelli, MPH, CCRP 610-984-9426 alyse.borelli@aesculapbiologics.com
Contact: Sarah Collins 310-948-8400 sarah.collins@aesculapbiologics.com

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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: Ankush Sachdeva       asachdeva@mednet.ucla.edu   
Contact: Sara Rodriguez    310-794-2877    SaraRodriguez@mednet.ucla.edu   
Principal Investigator: Kristofer Jones, MD         
University of California Davis Recruiting
Sacramento, California, United States, 95816
Contact: Julia Martin    916-734-8175    jyhmartin@ucdavis.edu   
Principal Investigator: Cassandra Lee, 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: Jeffrey Wilson    720-848-8200    Jeffrey.Wilson@ucdenver.edu   
Contact: Alexandra Schumacher    720-848-8200    Alexandra.Schumacher@ucdenver.edu   
Principal Investigator: Armando Vidal, 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
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   
Contact: Sarah Rexford    208-866-5522    Sarah@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: Jyoti Gole    847-570-1727    jgole@northshore.org   
Contact: Nancy Goldman    (847) 570-1727    ngoodman@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: Laura Martinez    504-842-0263    laura.martinez@ochsner.org   
Principal Investigator: Deryk Jones, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Jordyn Sessel    734-930-7432    jsessel@med.umich.edu   
Contact: Elizabeth Enselman       esibilsk@med.umich.edu   
Principal Investigator: John Grant, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Krogman    507-538-3562    krogman.jennifer@mayo.edu   
Principal Investigator: Aaron Krych, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Gwendolyn Azar    505-272-1223    alcunningham@salud.unm.edu   
Contact    505-272-6511    cgkurnik@salud.unm.edu   
Principal Investigator: Dustin Richter, MD         
United States, New York
Mount Sinai Faculty Practice Associates Recruiting
New York, New York, United States, 10029
Contact: Nicole Buchenholz    212-241-1678    nicole.buchenholz@mountsinai.org   
Contact: Komal Srivastava       komal.srivastava@mountsinai.org   
Principal Investigator: James Gladstone, MD         
Long Island Bone and Joint Llp Recruiting
Port Jefferson, New York, United States, 11777
Contact: Mike Suzzi Valli    631-747-0008    msuzzivalli@libones.com   
Principal Investigator: Michael Fracchia, MD         
United States, Ohio
Ohio State University Sports Medicine Recruiting
Columbus, Ohio, United States, 43221
Contact: Courtney Webb    614-293-3600    Courtney.Webb@osumc.edu   
Contact: Arielle Smith    614-293-7952    arielle.smith@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. Recruiting
Allentown, Pennsylvania, United States, 18104
Contact: Alicia Wendling    610-973-6227    awendling@oaainstitute.com   
Principal Investigator: Robert Palumbo, MD         
University Orthopedics Center Withdrawn
Altoona, Pennsylvania, United States, 16602
St. Luke'S University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Thomas Wohda    484-526-7825    Thomas.Wojda@sluhn.org   
Contact: Thomas Parsons    484-526-6076    Thomas.Parsons@sluhn.org   
Principal Investigator: Gregory F Carolan, MD         
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: Paul Owens    731-431-5027    powens@crssites.com   
Principal Investigator: Jason Hutchison, MD         
United States, Texas
Mercury Clinical Research Recruiting
Houston, Texas, United States, 77036
Contact: Michelle Washburn    713-777-5343    mewashburn@mercurycr.us.com   
Principal Investigator: Robert Burke, MD         
United States, Utah
Alpine Orthopaedics Recruiting
North Logan, Utah, United States, 84341
Contact    435-774-8512      
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. Recruiting
Lynchburg, Virginia, United States, 24501
Contact: April Page    434-485-8529    april.page@orthovirginia.com   
Contact: Kimberly Rogers    434-485-8529    kimberly.rogers@orthovirginia.com   
Principal Investigator: Gautham Gondo, MD         
Sub-Investigator: Michael Diminick, MD         
Sub-Investigator: Peter Caprise, MD         
Advanced Orthopedics Recruiting
Richmond, Virginia, United States, 23294
Contact: Lisa Thorpe    804-527-6836    lisa.thorpe@orthovirginia.com   
Principal Investigator: Kenneth R Zaslav, MD         
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Lauren Beaupre, PhD    780-492-8626    lauren.beaupre@albertahealthservices.ca   
Principal Investigator: Mark Sommerfeldt, MD         
Canada, British Columbia
Simon Fraser Health Authority Recruiting
Surrey, British Columbia, Canada, V3T 0H1
Contact: Bindu Mohan    604-520-4855    bindu.mohan@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: Nazanin Barkhordari    416-627-9367    barkhorn@mcmaster.ca   
Principal Investigator: Moin Khan, MD         
Queens University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Fiona Howells    613-548-2517    fiona.howells@queensu.ca   
Principal Investigator: Davide Bardana, MD         
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

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Responsible Party: Aesculap Biologics, LLC
ClinicalTrials.gov Identifier: NCT01957722     History of Changes
Other Study ID Numbers: AAG-G-H-1220
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No