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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. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MegaCarti® | Experimental: MegaCarti® application after microfracture The experimental group is applied with MegaCarti® and underwent high tibial osteotomy(HTO) after microfracture. |
| |
| Microfracture only | The control group underwent microfracture and high tibial osteotomy(HTO) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MegaCarti® | Device | Medical devices containing allogeneic cartilage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment | Primary Endpoint [experimental group / control group] | When removing fixtures after HTO (an average of 1 year after surgery) |
| Comparison of macroscopic status of regenerated cartilage | Primary Endpoint [experimental group / control group] | When removing fixtures after HTO (an average of 1 year after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of IKDC score | Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome | At last visit (an average of two years after surgery) |
| Comparison of VAS score |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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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. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent HTO were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Gangnam Severance Hospital | Seoul | Seoul | 06273 | South Korea |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| 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 |
|
Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome
| At last visit (an average of two years after surgery) |
| Comparison of KOOS score | Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome | At last visit (an average of two years after surgery) |
| Comparison of WOMAC score | Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome | At last visit (an average of two years after surgery) |
| Comparison of Kellgren-Lawrence grade | Secondary Endpoint [experimental group / control group] | At last visit (an average of two years after surgery) |
| Comparison of HKA angle, Posterior Tibial slope | Secondary Endpoint [experimental group / control group] | At last visit (an average of two years after surgery) |
| D012216 |
| Rheumatic Diseases |