A Phase 3 interventional study of Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft) and Microfracture in Articular Cartilage Disorder, Degeneration; Articular Cartilage and Chronic Cartilage Injury, sponsored by ISTO Technologies, Inc.. Terminated at 9 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-31.
Sponsored by ISTO Technologies, Inc. · Phase 3, Interventional, and Treatment
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.
73 studies on the registry are indexed under Cartilage Diseases; 5 are open to participants now.
This study's enrollment of 14 is below the median of 47 across 49 interventional studies indexed under Cartilage Diseases.
Browse Cartilage Diseases studies →ISTO Technologies, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Generally, the following inclusion criteria must be met, however, this is not a complete list.
Exclusion Criteria:
Generally, if a potential participant meets any of the following criterions, they will not be eligible for this study. Additionally, more criteria will be evaluated to confirm eligibility as this list is not a complete list of criteria.
Neocartilage Implant surgically implanted and affixed to subchondral bone using commercial fibrin during mini-open knee arthrotomy.
Biological: Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)
Standard of care cartilage repair technique.
Other: Microfracture
The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
Also known as: RevaFlex
Marrow stimulation using the microfracture technique; performed arthroscopically
Also known as: marrow stimulation
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
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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ISTO Technologies, Inc.