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



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:2/2/2019
Start Date:January 2014
End Date:December 2021
Contact:Jennifer Sisler, BSN, RN
Email:jennifer.sisler@aesculapbiologics.com
Phone:610-984-9066

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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.

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.
We found this trial at
39
sites
University of California-Davis
1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Cassandra Lee, MD
Phone: 916-734-8175
University of California-Davis As we begin our second century, UC Davis is poised to become...
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Florida Orthopaedic Institute
13020 N Telecom Pkwy
Tampa, Florida 33637
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University of New Mexico
Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Dustin Richter, MD
Phone: 505-272-1223
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Orthopaedic Associates of Allentown Ltd.
Allentown, Pennsylvania 18104
Principal Investigator: Robert Palumbo, MD
Phone: 610-973-6227
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University Orthopedics Center
Altoona, Pennsylvania 16602
Principal Investigator: William Tyndall
Phone: 814-949-4050
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: John Grant, MD
Phone: 734-930-7432
University of Michigan The University of Michigan was founded in 1817 as one of the...
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St. Luke's University Health Network
Bethlehem, Pennsylvania
Principal Investigator: Gregory F Carolan, MD
Phone: 484-526-7825
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Tenet Florida Physician Services
Boca Raton, Florida 33433
Principal Investigator: Johnathan Hersch, MD
Phone: 561-513-3699
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St. Luke's Intermountain Research Center
Boise, Idaho 83702
Principal Investigator: James Beckmann, MD
Phone: 208-706-9084
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Glynn Brunswick Memorial Authority
Brunswick, Georgia 31525
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University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: David Diduch, MD
Phone: 434-924-6184
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Rush University Medical Center
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Brian Cole, MD
Phone: 312-563-2216
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Ohio State University Sports Medicine
Columbus, Ohio 43221
Principal Investigator: David Flanigan, MD
Phone: 614-293-3600
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Va Eastern Colorado Health System
Denver, Colorado 80220
Principal Investigator: Lorenzo Silvestri, MD
Phone: 303-399-8020
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Cu Sports Medicine
Denver, Colorado 80222
Principal Investigator: Armando Vidal, MD
Phone: 720-848-8200
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University of Alberta
Edmonton, Alberta T6G 2J2
Principal Investigator: Mark Sommerfeldt, MD
Phone: 780-492-8626
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CORE Orthopedic
Encinitas, California 92024
Principal Investigator: Gregory Loren, MD
Phone: 760-943-6710
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NorthShore University Health System
Evanston, Illinois 60201
Principal Investigator: Jason Koh, MD
Phone: 847-570-1727
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Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
Principal Investigator: Robert Gallo, MD
Phone: 717-531-0003
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Mercury Clinical Research
Houston, Texas 77093
Principal Investigator: Robert Burke, MD
Phone: 713-777-5343
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Clinical Research Solutions
Jackson, Tennessee 38305
Principal Investigator: Jason Hutchison, MD
Phone: 731-431-5027
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Grossmont Orthopaedic Group
La Mesa, California 91942
Principal Investigator: Scott Hacker, MD
Phone: 619-456-6012
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University of Kentucky
Lexington, Kentucky
859) 257-9000
Principal Investigator: Christian Lattermann
Phone: 859-323-2737
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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UCLA
Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Kristofer Jones, MD
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Orthopaedic Center of Central Virginia, Inc
Lynchburg, Virginia 24501
Principal Investigator: Gautham Gondo, MD
Phone: 434-485-8529
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Saint Alphonsus Medical Group
Meridian, Idaho 83642
Principal Investigator: Andrew Curran, CO
Phone: 208-866-5522
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Ochsner Health System
New Orleans, Louisiana 70121
Principal Investigator: Deryk Jones, MD
Phone: 504-842-0263
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New Orleans, LA
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Mount Sinai Faculty Practice Associates
5 East 98th Street
New York, New York 10029
Principal Investigator: James Gladstone, MD
Phone: 212-241-1678
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Rothman Institute
Newtown Square, Pennsylvania 19073
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Alpine Orthopaedics
North Logan, Utah 84341
Principal Investigator: Brad Larson, MD
Phone: 435-774-8512
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Temple University Hospital
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: J. Milo Sewards, MD
Phone: 215-707-9221
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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The CORE Institute
Phoenix, Arizona 85023
Principal Investigator: John Brown
Phone: 623-537-5695
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Long Island Bone and Joint Llp
Port Jefferson, New York 11777
Principal Investigator: Michael Fracchia, MD
Phone: 631-747-0008
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Advanced Orthopedics
Richmond, Virginia 23294
Principal Investigator: Kenneth R Zaslav, MD
Phone: 804-527-6836
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The Mayo Clinic
Rochester, Minnesota 55905
Principal Investigator: Aaron Krych, MD
Phone: 507-538-3562
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SIU School of Medicine
Springfield, Illinois 62702
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Yampa Valley Medical Center
Steamboat Springs, Colorado 80487
Principal Investigator: Alexander Meininger, MD
Phone: 970-879-4612
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Tulsa Bone & Joint Associates
Tulsa, Oklahoma 74146
Principal Investigator: John Balbas, MD
Phone: 918-392-1505
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George Washington University Hospital
Washington, District of Columbia 20037
Principal Investigator: Rajeev Padrinath
Phone: 202-741-2602
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