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A Multicenter, Randomized, Pivotal Study to Evaluate the Safety and Efficacy of the Cartilage Autograft Implantation System (CAIS) for the Surgical Treatment of Articular Cartilage Lesions of the Knee
The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region. CAIS is indicated for the repair of articular cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage regeneration.
The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical procedure. The system is designed as a surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
Tucson Orthopaedic Institute
Tucson, Arizona, United States
MWMC Bentonville Hospital
Bentonville, Arkansas, United States
CORE Orthopaedic Medical Center
Encinitas, California, United States
Santa Monica Orthopaedic Group
Santa Monica, California, United States
Southern California Orthopaedic Group
Van Nuys, California, United States
JDP Medical Research, LLC
Denver, Colorado, United States
Shrock Orthopedic Research
Fort Lauderdale, Florida, United States
Andrews Institute
Gulf Breeze, Florida, United States
Florida Orthopaedics Institute and Research Foundation
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Start Date
July 1, 2010
Primary Completion Date
December 1, 2014
Completion Date
December 1, 2014
Last Updated
August 3, 2016
75
ACTUAL participants
Microfracture
PROCEDURE
Cartilage Autograft Implantation System
DEVICE
Lead Sponsor
DePuy Mitek
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.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02664337