The purpose of this clinical trial is to evaluate the safety and efficacy of CartiFill implanted at the site of knee joint cartilage defect in a 6-year, long-term, follow-up investigation.
Study Type
OBSERVATIONAL
Enrollment
36
add collagen when doing microfracture
simple microfracture of ankle
Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
100mm VAS (visual analogue scale) score
100 mm VAS values of the experimental and control groups 6 years (±1 year) after the surgery were analyzed using unpaired T-test or Wilcoxon rank-sum test. The difference between the values from the previously conducted post-marketing clinical trial (Protocol No. 03CAR) and values 6 years (±1 year) after the procedure was also analyzed using unpaired T-test.
Time frame: From screening to 6 years (±1 year) after surgery
KOOS (Knee injury and Osteoarthritis Outcome Score)
Time frame: From screening to 6 years (±1 year) after surgery
IKDC (International Knee Documentation Committee)
Time frame: From screening to 6 years (±1 year) after surgery
EQ-5D (EuroQol 5 Dimension Scale)
Time frame: From screening to 6 years (±1 year) after surgery
WPAI (Work Productivity and Activity Impairment Questionnaire)
Time frame: From screening to 6 years (±1 year) after surgery
Post-surgical Satisfaction (Subject)
Satisfaction survey based on a questionnaire
Time frame: 6 years (±1 year) after surgery
Post-surgical Satisfaction (Investigator)
Satisfaction survey based on a questionnaire
Time frame: 6 years (±1 year) after surgery
mMOCART (modified Magnetic resonance Observation of Cartilage Repair Tissue)
Time frame: 6 years (±1 year) after the surgery
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MRI cartilage imaging
Time frame: 6 years (±1 year) after surgery