ISTO Technologies, Inc. is proposing a clinical study with 225 subjects, to establish the safety and efficacy of the Neocartilage Implant for the treatment of ICRS Grade 3 and 4 articular cartilage lesions of the knee compared to microfracture treatment.
In the United States alone, more than 500,000 cartilage lesions per year require some treatment to reduce pain, restore joint mobility, and prevent further damage caused by the progression of osteoarthritis. The lack of effective cartilage repair approaches or products for restoration of defective articular cartilage to its native, hyaline morphology only continues to exacerbate the incidence of osteoarthritis as these initial defects enlarge and degrade over a 10 to 20 year period. The repair of cartilage, especially in the knee, remains a formidable clinical challenge. Regenerative medicine approaches to cartilage repair have only begun to be explored as possible options and there is a clear trend toward biological solutions for the repair and regeneration of damaged or diseased articular cartilage. The study was designed to compare how well the Neocartilage Implant works against the microfracture therapy, a widely used and accepted cartilage repair therapy. Data to be collected include Pain and Function in Daily Living scores, symptoms, Function in Sports and Recreation, and Knee Related Quality of Life. Additionally, MRI and X-rays will be collected to evaluate the cartilage repair progress. These assessments will be used through the five years of post-operative follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
Marrow stimulation using the microfracture technique; performed arthroscopically
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States
Santa Monica Orthopaedic & Sports Medicine Group
Santa Monica, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Knee Injury and Osteoarthritis Outcomes Scores (KOOS)
Knee Injury and Osteoarthritis Outcomes Scores (KOOS) Pain and Function in Daily Living (ADL) subscales.
Time frame: 36 months
IKDC Knee Examination
Time frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
Subject reported questionnaires
Various questionnaires are required to be completed by the subject before and after treatment throughout the study.
Time frame: Baseline, 6 week, 6, 12, 18, 24 months and annually through 5 years
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Hospital for Special Surgery -Sports Medicine and Shoulder Service
New York, New York, United States
Insall Scott Kelly Institute for Orthopaedics & Sports Medicine
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Sports Medicine Center
Columbus, Ohio, United States
The Hawkins Foundation
Greenville, South Carolina, United States
The Methodist Hospital Research Institute
Houston, Texas, United States