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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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 1, 2013
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2027
Last Updated
March 21, 2025
233
ACTUAL participants
Microfracture
PROCEDURE
NOVOCART 3D
BIOLOGICAL
Lead Sponsor
Aesculap Biologics, LLC
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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