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. The MegaCarti® is applied after Microfracture treatment on patients with Knee Cartilage Defects. The cartilage regeneration, which is a primary endpoint, is compared to the Microfracture group through MOCART evaluation. In addition, the improvement of pain and the recovery of Normal Range of motion are compared to the Microfracture group through secondary endpoints. Then, long-term follow-up study for 5 years is conducted to the experimental group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
MegaCarti® application after microfracture through athroscopic or incision surgery
Microfracture through athroscopic or incision surgery
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Yonsei University Health System, Gangnam Severance Hospital
Seoul, South Korea
MOCART score
Primary Endpoint \[experimental group / control group\]
Time frame: 48 weeks after surgery
Comparison of IKDC score
Secondary Endpoint \[experimental group / control group\]
Time frame: Baseline and 12, 24, 48 weeks after surgery
Comparison of VAS score
Secondary Endpoint \[experimental group / control group\]
Time frame: Baseline and 6, 12, 24, 48 weeks after surgery
Comparison of KOOS score
Secondary Endpoint \[experimental group / control group\]
Time frame: Baseline and 12, 24, 48 weeks after surgery
Comparison of WOMAC score
Secondary Endpoint \[experimental group / control group\]
Time frame: Baseline and 12, 24, 48 weeks after surgery
Comparison of Kellgren-Lawrence grade
Secondary Endpoint \[experimental group / control group\]
Time frame: Baseline and 12, 24, 48 weeks after surgery
Frequency of rescue medication
Secondary Endpoint \[experimental group / control group\]
Time frame: For 48 weeks after surgery
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