Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti\^® will be applied.
The MegaCarti\^® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. To evaluate cartilage regeneration, the study group is compared with the microfracture group alone through MOCART evaluation at 48 weeks after treatment for cartilage regeneration. In addition, a biopsy is performed to evaluate the formation of hyaline cartilage and the area ratio of regenerated cartilage is measured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
MegaCarti® application after microfracture through athroscopic or incision surgery
Microfracture through athroscopic or incision surgery
Yonsei Sarang Hospital
Seoul, Seoul, South Korea
Chung-Ang University Gwangmyeong Hospital
Gyeonggi-do, South Korea
Ajou University Medical Center
Gyeonggi-do, South Korea
Catholic Kwandong University International St.Mary's Hospital
Incheon, South Korea
MOCART score
The independent evaluator measure the MOCART score based on the MRI images taken at 48 weeks after surgery. The MOCART score is an index for evaluating the degree of restoration of cartilage tissue and consists of a total of 9 items. Each item is scored from 0 to a maximum of 20 points and added up. The MOCART score is 0 when the cartilage is in the worst condition, and 100 when it is in the best condition. In other words, when the clinical effect of tissue repair appears, it is evaluated as a score greater than 0.
Time frame: From 48 weeks after surgery
IKDC score
Subjects underwent a self-assessment of knee function using the International Knee Documentation Committee Assessment (IKDC). The outcome was presented with the post-operative change amount from the baseline.
Time frame: Baseline and 12, 24, 48 weeks after surgery
VAS
Subjects underwent a self-assessment of knee joint pain using the 100-mm Visual Analogue Scale (VAS). Use of NSAIDs and acetaminophen have to be discontinued for 24 hours, respectively, prior to the VAS evaluation. The outcome was presented with the post-operative change amount from the baseline.
Time frame: Baseline and 12, 24, 48 weeks after surgery
KOOS
Subjects underwent a self-assessment of knee joint pain using the Knee Injury and Osteoarthritis Outcome score (KOOS) survey. The outcome was presented with the post-operative change amount from the baseline.
Time frame: Baseline and 12, 24, 48 weeks after surgery
ICRS-CRA score
Investigator uses the International Cartilage Repair Society (ICRS) - cartilage repair assessment grading (CRA) system to evaluate the degree of cartilage regeneration.
Time frame: From 48 weeks after surgery
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Konkuk University Medical Center
Seoul, South Korea
Yonsei University College of Medicine, Gangnam Severance Hospital
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
OAS
Investigator uses the Oswestry Arthroscopic Score (OAS) system to evaluate the degree of cartilage regeneration.
Time frame: From 48 weeks after surgery
Cartilage Coverage Ratio
Using arthroscopy, the investigator calculates the area of repaired cartilage that is greater than 75% defect depth.
Time frame: From 48 weeks after surgery
Histological Evaluation
Cartilage tissue is collected from the center of the repaired knee cartilage using a needle punch. After the collected tissue is stained, an independent evaluator evaluates it using the ICRS-II Parameters evaluation sheet.
Time frame: From 48 weeks after surgery