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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Aesculap Biologics, LLC
Sponsor:
Information provided by (Responsible Party):
Aesculap Biologics, LLC
ClinicalTrials.gov Identifier:
NCT01957722
First received: September 17, 2013
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

This study is to 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 Intervention Phase
Articular Cartilage of the Femoral Condyle Between 2-6cm2
Procedure: microfracture
Biological: NOVOCART 3D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Aesculap Biologics, LLC:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 months post treatment ] [ Designated as safety issue: Yes ]
    As measured by change in score from Baseline in KOOS score

  • Function [ Time Frame: 24 months post treatment ] [ Designated as safety issue: No ]
    As measured by change in score from Baseline in KOOS score


Estimated Enrollment: 233
Study Start Date: January 2014
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOVOCART 3D
Scaffold assisted autologous chondrocyte Implant
Biological: NOVOCART 3D
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957722

Locations
United States, Arizona
The Core Institute Recruiting
Phoenix, Arizona, United States, 85023
Contact: Beth Gleason    623-537-5695    'elizabeth.gleason@thecoreinstitute.com   
Principal Investigator: John Brown         
United States, California
CORE Orthopedic Recruiting
Encinitas, California, United States, 92024
Contact: Farouk Awad    760-943-6710 ext 162    fawad@coreorthopaedic.com   
Principal Investigator: Gregory Loren, MD         
United States, Colorado
Yampa Valley Medical Center Recruiting
Steamboat Spring,, Colorado, United States, 80487
Contact: Laurel Martin    970.879.4612    lmartin@steamboatortho.com   
Principal Investigator: Alexander Meininger, MD         
United States, District of Columbia
The George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Stacy Tam    202-741-2602    stam@mfa.gwu.edu   
Principal Investigator: Rajeev Padrinath         
United States, Florida
Tenet Florida Physician Services Recruiting
Boca Raton, Florida, United States, 33433
Contact: Beck Pamela    561-844-5255    'pamela.beck@tenethealth.com   
Principal Investigator: Johnathan Hersch         
Florida Orthopaedic Institute 13020 N. Telecom Pkwy Tampa, FL 33637 Recruiting
Tampa, Florida, United States, 33637
Contact: Rachel Clark       rclark@foreonline.org   
Principal Investigator: Seth Gasser         
United States, Georgia
Glynn Brunswick Memorial Authority/ SE Georgia Health System Recruiting
Brunswick, Georgia, United States, 31525
Contact: Gwen Gratto-Cox    912-262-9961 ext 122    ggratto@sghs.org   
Principal Investigator: Melvin Deese         
United States, Idaho
Saint Alphonsus Medical Group Not yet recruiting
Meridian, Idaho, United States, 83642
Contact: Jackie Atkinson    208-866-5522    Jackie@nauticalclinical.com   
Principal Investigator: Andrew Curran         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Kavita Ahuja    312-432-2381    kahuja_md@yahoo.com   
Principal Investigator: Brian Cole         
Northshore University Healthsystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Alana Burns    847-570-1727    ABurns@northshore.org   
Principal Investigator: Jason Koh, MD         
SIU School of Medicine Recruiting
Springfield, Illinois, United States, 62794
Contact: Terri Wislson    217-545-6711    twilson@siumed.edu   
Principal Investigator: Saadiq El-Amin, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Dorothy Ross    859-323-2737    dross3@email.uky.edu   
Principal Investigator: Christian Lattermann         
United States, New York
Mount Sinai Medical Practice Associates Recruiting
New York, New York, United States, 10029
Contact: Chris Moll    212-241-1645    christina.moll@mountsinai.org   
Principal Investigator: James Gladstone, MD         
United States, Ohio
Ohio State University Sports Medicine Recruiting
Columbus, Ohio, United States, 43221
Contact: Isac Kunnath    614-293-2410    Isac.kunnath@osumc.edu   
Principal Investigator: David Flanigan, MD         
United States, Pennsylvania
University Orthopedics Center Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Robin Stern    814-949-4050    rstern@uoc.com   
Principal Investigator: William Tyndall         
St Luke's Health System Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Denise Tarsi    484-526-7825    Denise.Tarsi@sluhn.org   
Principal Investigator: Gregory Carolan, MD         
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Susan Hassenbein    717-531-0003 ext 284214    ahorne@hmc.psu.edu   
Principal Investigator: Robert Gallo, MD         
Temple University Hospital, Dept. of Orthopaedic Surgery Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Joanne Donnelly    215-707-9221    Joanne.Donnelly@tuhs.temple.edu   
Principal Investigator: J. Milo Sewards         
United States, Tennessee
Clinical Research Solutions Recruiting
Jackson, Tennessee, United States, 38305
Contact: Amy Arnold    731-431-5027    aarnold@crssites.com   
Principal Investigator: Jason Hutchison, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Joe Hart    434-924-6187      
Principal Investigator: David Diduch         
Advanced Orthopedics Recruiting
Richmond, Virginia, United States, 23294
Contact: Lisa Thorpe    804-527-6803    lthorp@advancedortho.me   
Principal Investigator: Kenneth Zaslav         
Sponsors and Collaborators
Aesculap Biologics, LLC
  More Information

No publications provided

Responsible Party: Aesculap Biologics, LLC
ClinicalTrials.gov Identifier: NCT01957722     History of Changes
Other Study ID Numbers: AAG-G-H-1220
Study First Received: September 17, 2013
Last Updated: April 21, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 28, 2015