Clinical Trial to Evaluate the Efficacy and Safety of MegaCartiĀ® in Knee Cartilage Defects (NCT05440370) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Clinical Trial to Evaluate the Efficacy and Safety of MegaCartiĀ® in Knee Cartilage Defects
South Korea90 participantsStarted 2020-04-16
Plain-language summary
The MegaCartiĀ® 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 MegaCartiĀ® 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.
Who can participate
Age range19 Years ā 65 Years
SexALL
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Inclusion criteria
ā. 19 years to 65 years
ā. Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form.
ā. Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
ā. Patients whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms
ā. knee cartilage defect size : Below 10 ć
Exclusion criteria
ā. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
ā. Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery)
ā. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months