This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap
Mean change from baseline in the KOOS
Time frame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months
Change from Baseline in the Modified Cincinnati Score
Time frame: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport
Time frame: 12mo, 24mo, 36mo, 48mo
Change from Baseline in the SF-36 Health Status Survey
Time frame: 12mo, 24mo, 36mo, 48mo
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