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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MegaCarti® application after Microfracture Surgery | Experimental | The study group is applied with MegaCarti® after microfracture. Afterwards, they visit at 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. |
|
| Microfracture Surgery without Medical Devices | Active Comparator | The control group undergoes microfracture and they visit at 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MegaCarti® | Device | MegaCarti® application after microfracture through athroscopic or incision surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 48 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12, 24, 48 weeks after surgery |
| VAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunghwan kim | Yonsei University College of Medicine, Severance Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Gwangmyeong Hospital | Gyeonggi-do | 14353 | South Korea | |||
| Ajou University Medical Center |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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| Microfracture | Procedure | Microfracture through athroscopic or incision surgery |
|
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. |
| 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. | 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. | From 48 weeks after surgery |
| OAS | Investigator uses the Oswestry Arthroscopic Score (OAS) system to evaluate the degree of cartilage regeneration. | 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. | 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. | From 48 weeks after surgery |
| Gyeonggi-do |
| 16499 |
| South Korea |
| Catholic Kwandong University International St.Mary's Hospital | Incheon | South Korea |
| Yonsei University Health System, Severance Hospital | Seoul | 03722 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Yonsei University College of Medicine, Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Yonsei Sarang Hospital | Seoul | 06702 | South Korea |
| D012216 |
| Rheumatic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |