Cartilage Defects of the Knee
Conditions
Keywords
Cartilage Defects of the knee joint, microfracture, modified microfracture using collagen, collagen
Brief summary
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.
Interventions
DEVICECartiFill
add collagen when doing microfracture
PROCEDUREMicrofracture
simple microfracture of ankle
Sponsors
Cellontech Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Inclusion criteria
1. Patients who have undergone microfracture surgery or microfracture surgery using collagen 6 years (±1 year) ago as part of the previously conducted post-marketing clinical trial (Protocol No. 03CAR). 2. Males or females aged 19 to 70 years. 3. Patients or patients whose legal representatives have agreed to participate in the clinical trial and signed the written consent.
Exclusion criteria
1. 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. 2. Patients who are deemed by the clinical trial manager to be unfit to participate due to psychiatric conditions, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 100mm VAS (visual analogue scale) score | From screening to 6 years (±1 year) after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) | 6 years (±1 year) after surgery | Satisfaction survey based on a questionnaire |
| Post-surgical Satisfaction (Investigator) | 6 years (±1 year) after surgery | Satisfaction survey based on a questionnaire |
| 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 | — |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYong In, MD
The Catholic University of Korea
PRINCIPAL_INVESTIGATORJongSeok Baek, MD
Wonkwang University Hospital
PRINCIPAL_INVESTIGATORSeungBaek Kang
SMG-SNU Boramae Medical Center
PRINCIPAL_INVESTIGATORJunHo Hwang
Samsung Seoul Hospital
PRINCIPAL_INVESTIGATORJaYoung Choi, MD
Seoul National University Hospital
Outcome results
None listed