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The purpose of this clinical trial is to evaluate the safety and efficacy of CartiFill implanted at the site of knee joint cartilage defect in a 6-year, long-term, follow-up investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: modified microfracture using collagen (CartiFill) | Subjects with knee cartilage defects who previously underwent microfracture surgery with CartiFill (atelocollagen) implantation in a prior clinical study (Protocol No. 03CAR) and were enrolled for long-term follow-up. Participants were observed for up to 6 years to evaluate the long-term safety and efficacy outcomes without additional intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CartiFill | Device | add collagen when doing microfracture |
|
| Measure | Description | Time Frame |
|---|---|---|
| 100mm VAS (visual analogue scale) score | 100 mm VAS values of the experimental and control groups 6 years (±1 year) after the surgery were analyzed using unpaired T-test or Wilcoxon rank-sum test. The difference between the values from the previously conducted post-marketing clinical trial (Protocol No. 03CAR) and values 6 years (±1 year) after the procedure was also analyzed using unpaired T-test. | From screening to 6 years (±1 year) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS (Knee injury and Osteoarthritis Outcome Score) | From screening to 6 years (±1 year) after surgery | |
| IKDC (International Knee Documentation Committee) | From screening to 6 years (±1 year) after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have undergone microfracture surgery or microfracture surgery using collagen as part of previously conducted post-marketing clinical trial (Protocol No. 03CAR) but have since then received cartilage surgery, such as high tibial osteotomy (HTO), partial/full implant arthroplasty, etc., at the same site. (Does not include biopsy for diagnosis, a simple arthroscopic examination, or HTO plate removal procedure, etc.)
※ Does not include non-invasive treatment or medication such as exercise therapy, physical therapy, manual therapy, extracorporeal shock wave, joint cavity injection, etc.
Patients who are deemed by the clinical trial manager to be unfit to participate due to psychiatric conditions, etc.
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The study population consisted of subjects with cartilage defects of the knee joint who had previously participated in a post-marketing clinical trial (Protocol No. 03CAR) and had undergone microfracture surgery with or without collagen implantation. Subjects were enrolled approximately 6 years (±1 year) after surgery and voluntarily agreed to participate in this long-term follow-up study.
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| Name | Affiliation | Role |
|---|---|---|
| Yong In, MD | The Catholic University of Korea | Principal Investigator |
| JongSeok Baek, MD | Wonkwang University Hospital | Principal Investigator |
| SeungBaek Kang | SMG-SNU Boramae Medical Center | Principal Investigator |
| JunHo Hwang | Samsung Seoul Hospital | Principal Investigator |
| JaYoung Choi, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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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 | simple microfracture of ankle |
|
| EQ-5D (EuroQol 5 Dimension Scale) | From screening to 6 years (±1 year) after surgery |
| WPAI (Work Productivity and Activity Impairment Questionnaire) | From screening to 6 years (±1 year) after surgery |
| Post-surgical Satisfaction (Subject) | Satisfaction survey based on a questionnaire | 6 years (±1 year) after surgery |
| Post-surgical Satisfaction (Investigator) | Satisfaction survey based on a questionnaire | 6 years (±1 year) after surgery |
| mMOCART (modified Magnetic resonance Observation of Cartilage Repair Tissue) | 6 years (±1 year) after the surgery |
| MRI cartilage imaging | 6 years (±1 year) after surgery |