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NOVOCART®3D for Treatment of Articular Cartilage of the Knee
Sponsor: Aesculap Biologics, LLC
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.
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
233
Start Date
2013-12
Completion Date
2027-12
Last Updated
2025-03-21
Healthy Volunteers
No
Interventions
Microfracture
Surgical procedure which creates a marrow clot in the prepare cartilage defect.
NOVOCART 3D
combination product- biologic (autologous chondrocytes) /device (scaffold) implant
Locations (35)
Grossmont Orthopaedic Medical Group
La Mesa, California, United States
UCLA
Los Angeles, California, United States
Stanford Medicine
Redwood City, California, United States
Cu Sports Medicine
Denver, Colorado, United States
Yampa Valley Medical Center
Steamboat Springs, Colorado, United States
Tenet Florida Physician Services
Boca Raton, Florida, United States
Paley Orthopedic and Spine Institute
West Palm Beach, Florida, United States
Saint Alphonsus Medical Group
Meridian, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Northshore University Health System
Evanston, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Health System
New Orleans, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Tria Orthopaedic Center
Bloomington, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri Healthcare
Columbia, Missouri, United States
Mount Sinai Faculty Practice Associates
New York, New York, United States
Plancher Orthopaedics & Sports Medicine
New York, New York, United States
Long Island Bone and Joint Llp
Port Jefferson, New York, United States
Ohio State University Sports Medicine
Columbus, Ohio, United States
Tulsa Bone and Joint Associates
Tulsa, Oklahoma, United States
St. Luke'S University Health Network
Bethlehem, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny - Singer Research Institute
Pittsburgh, Pennsylvania, United States
Clinical Research Solutions
Jackson, Tennessee, United States
Alpine Orthopaedics
North Logan, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
The Orthopaedic Center of Central Virginia Inc
Lynchburg, Virginia, United States
Advanced Orthopaedics
Richmond, Virginia, United States
University of Alberta
Edmonton, Alberta, Canada
Simon Fraser Orthopaedic Fund
Surrey, British Columbia, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
St. Josephs Healthcare Hamilton
Hamilton, Ontario, Canada
Lawson Health Research Institute
London, Ontario, Canada