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| Name | Class |
|---|---|
| Kyunghee University Medical Center | OTHER |
| Gangnam Severance Hospital | OTHER |
| Severance Hospital | OTHER |
| Ewha Womans University |
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The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CartiLife® | Experimental |
| |
| Microfracture | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CartiLife® | Drug | CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy. |
| Measure | Description | Time Frame |
|---|---|---|
| MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) | Changes in MOCART scores during each visit | Baseline to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lysholm Score | Changes in Lysholm Scores during each visit | Baseline to 48 weeks |
| IKDC (International Knee Documentation Committee Score) | Changes in IKDC scores during each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoung Ho, MD, PhD | Kyunghee University Medical Center | Principal Investigator |
| Jong Hyeok Choi, MD, PhD | Severance Hospital | Principal Investigator |
| Jae-Doo Yoo, MD, PhD | Ewha Womans University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38230875 | Derived | Yoon KH, Lee J, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation Versus Microfracture for the Treatment of Articular Cartilage Defects: A 5-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2024 Feb;52(2):362-367. doi: 10.1177/03635465231222797. Epub 2024 Jan 17. | |
| 32476445 | Derived |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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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| OTHER |
Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection along with a fibrin adhesive through minimal arthrotomy.
Active comparator: Microfracture The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.
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| Microfracture | Procedure | The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate. |
|
| Baseline to 48 weeks |
| KOOS (Knee injury Osteoarthritis Outcome Score) | Changes in KOOS during each visit | Baseline to 48 weeks |
| VAS (100 mm Pain Visual Analogue Scale) | Changes in VAS during each visit | Baseline to 48 weeks |
| ROM (Range Of Motion) | Changes in ROM during each visit | Baseline to 48 weeks |
| Adverse events | Number of adverse events | Baseline to 48 weeks |
| X-ray | Changes in structure during each visit | Baseline to 48 weeks |
| Yoon KH, Yoo JD, Choi CH, Lee J, Lee JY, Kim SG, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2021 Dec;13(1_suppl):1092S-1104S. doi: 10.1177/1947603520921448. Epub 2020 Jun 1. |