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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MegaCarti® application after microfracture | Experimental | The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years. |
|
| Microfracture only | Active Comparator | The control group undergoes microfracture and they visit at 6 weeks, 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 | Primary Endpoint [experimental group / control group] | 48 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of IKDC score | Secondary Endpoint [experimental group / control group] | Baseline and 12, 24, 48 weeks after surgery |
| Comparison of VAS score | Secondary Endpoint [experimental group / control group] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seong Hwan Kim, Professor | Yonsei University Health System, Gangnam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Health Insurance Service Ilsan Hospital | Goyang-si | Gyeonggi-do | 10444 | South Korea | ||
| Korea University Anam Hospital |
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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 |
|
| Baseline and 6, 12, 24, 48 weeks after surgery |
| Comparison of KOOS score | Secondary Endpoint [experimental group / control group] | Baseline and 12, 24, 48 weeks after surgery |
| Comparison of WOMAC score | Secondary Endpoint [experimental group / control group] | Baseline and 12, 24, 48 weeks after surgery |
| Comparison of Kellgren-Lawrence grade | Secondary Endpoint [experimental group / control group] | Baseline and 12, 24, 48 weeks after surgery |
| Frequency of rescue medication | Secondary Endpoint [experimental group / control group] | For 48 weeks after surgery |
| Seoul |
| 02841 |
| South Korea |
| Yonsei University Health System, Severance Hospital | Seoul | 03722 | South Korea |
| Yonsei University Health System, Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| D012216 |
| Rheumatic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |