A clinical study to evaluate the efficacy and safety of MegaCarti® as a treatment for cartilage regeneration in patients with knee joint cartilage injury : multicenter, microfracture control, randomization, superiority clinical trial

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2023
INTERVENTION: Medical Device : Subject who meet the inclusion criteria are assigned according to the randomization table. On the day of surgery, subjects undergo knee cartilage surgery under anesthesia. According to the assigned group, MegaCarti® is applied after microfracture in the study group, and microfracture is performed in the control group. CONDITION: Injury, poisoning and certain other consequences of external causes PRIMARY OUTCOME: Pain score of KOOS(Knee injury and Osteoarthritis Outcome Score) SECONDARY OUTCOME: Evaluation of cartilage regeneration KOOS (Knee injury and Osteoarthritis Outcome Score) VAS (Visual Analogue Scale) WOMAC (Western Ontario & McMaster Universities) INCLUSION CRITERIA: All subjects can participate in the clinical trial only when all of the following criteria are met. ? 51 years to 65 years ? Subject or legal representatives who voluntarily decide to participate in the clinical trial and give written consent after hearing a detailed explanation of this clinical trial and fully understanding it ? Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage ? Subject 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 ? Knee cartilage defect size : below 10cm2 ? Subject who need concurrent Misalignment correction osteotomy(Subject who perform high tibial osteotomy due to varus deformity above ‐5 degrees in Hip‐knee‐ankle angle)
Epistemonikos ID: d68e493988603c93feb75cc96a6cdfd90867b1d6
First added on: Feb 20, 2024