NOVOCART®3D for Treatment of Articular Cartilage of the Knee

Last updated: March 19, 2025
Sponsor: Aesculap Biologics, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

NOVOCART 3D

Microfracture

Clinical Study ID

NCT01957722
AAG-G-H-1220
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Instability of the knee joint

  • Arthritis

  • Autoimmune disease

  • Immune suppression

  • Prior surgical treatment using mosaicplasty, autologous chondrocyte implantationand/or microfracture (debridement and lavage are acceptable beyond three months frombaseline)

  • Bone disease

  • Any degenerative muscular, connective tissue or neurological condition or otherdisease process that would interfere with healing or the evaluation of outcomemeasures.

Study Design

Total Participants: 233
Treatment Group(s): 2
Primary Treatment: NOVOCART 3D
Phase: 3
Study Start date:
December 01, 2013
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G 2R3
    Canada

    Site Not Available

  • Simon Fraser Health Authority

    Surrey, British Columbia V3T 0H1
    Canada

    Site Not Available

  • Simon Fraser Orthopaedic Fund

    Surrey, British Columbia V3T 0H1
    Canada

    Site Not Available

  • Dalhousie University

    Halifax, Nova Scotia B3H 2E1
    Canada

    Site Not Available

  • St. Josephs Healthcare

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • St. Josephs Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Queens University

    Kingston, Ontario K7L 3N6
    Canada

    Site Not Available

  • Lawson Health Research Institute

    London, Ontario N6C 2R5
    Canada

    Site Not Available

  • The Core Institute

    Phoenix, Arizona 85023
    United States

    Site Not Available

  • CORE Orthopedic

    Encinitas, California 92024
    United States

    Site Not Available

  • Grossmont Orthopaedic Group

    La Mesa, California 91942
    United States

    Site Not Available

  • Grossmont Orthopaedic Medical Group

    La Mesa, California 91942
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford Medicine

    Redwood, California 94063
    United States

    Site Not Available

  • Stanford Medicine

    Redwood City, California 94063
    United States

    Site Not Available

  • University of California Davis

    Sacramento, California 95816
    United States

    Site Not Available

  • UCSF Orthopaedic Institute

    San Francisco, California 94158
    United States

    Site Not Available

  • Cu Sports Medicine

    Denver, Colorado 80222
    United States

    Site Not Available

  • Va Eastern Colorado Health System

    Denver, Colorado 80220
    United States

    Site Not Available

  • Yampa Valley Medical Center

    Steamboat Spring,, Colorado 80487
    United States

    Site Not Available

  • Yampa Valley Medical Center

    Steamboat Springs, Colorado 80487
    United States

    Site Not Available

  • George Washington University Hospital

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Tenet Florida Physician Services

    Boca Raton, Florida 33433
    United States

    Site Not Available

  • Florida Orthopaedic Institute

    Tampa, Florida 33637
    United States

    Site Not Available

  • Paley Orthopedic and Spine Institute

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Glynn Brunswick Memorial Authority

    Brunswick, Georgia 31525
    United States

    Site Not Available

  • St. Lukes Intermountain Research Center

    Boise, Idaho 83702
    United States

    Site Not Available

  • Saint Alphonsus Medical Group

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Northshore University Health System

    Evanston, Illinois 60201
    United States

    Site Not Available

  • SIU School of Medicine

    Springfield, Illinois 62794
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Ochsner Health System

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Peninsula Orthopaedic Associates

    Salisbury, Maryland 21804
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Chestnut Hill, Massachusetts 02467
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Tria Orthopaedic Center

    Bloomington, Minnesota 55431
    United States

    Site Not Available

  • Tria Orthopedic Center

    Bloomington, Minnesota 55431
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Missouri Healthcare

    Columbia, Missouri 65212
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Mount Sinai Faculty Practice Associates

    New York, New York 10029
    United States

    Site Not Available

  • Plancher Orthopaedics & Sports Medicine

    New York, New York 10128
    United States

    Site Not Available

  • Long Island Bone and Joint Llp

    Port Jefferson, New York 11777
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Ohio State University Sports Medicine

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Tulsa Bone and Joint Associates

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Orthopaedic Associates of Allentown Ltd.

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • University Orthopedics Center

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • St. Luke'S University Health Network

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Rothman Institute

    Newtown Square, Pennsylvania 19073
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • AHN Orthopaedic Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Allegheny - Singer Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Clinical Research Solutions

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Mercury Clinical Research

    Houston, Texas 77036
    United States

    Site Not Available

  • Alpine Orthopaedics

    North Logan, Utah 84341
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • The Orthopaedic Center of Central Virginia Inc

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • The Orthopaedic Center of Central Virginia Inc.

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Advanced Orthopaedics

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Advanced Orthopedics

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Jordan-Young Institute

    Virginia Beach, Virginia 23462
    United States

    Site Not Available

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