Osteoarthritis, Knee
Conditions
Keywords
Knee Cartilage Defects, Microfracture, HTO, High Tibia Osteotomy, MegaCarti, Cartilage regeneration
Brief summary
Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied.
Detailed description
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. To evaluate cartilage regeneration, the study group is compared with the microfracture group alone through MOCART evaluation at 48 weeks after treatment for cartilage regeneration. In addition, a biopsy is performed to evaluate the formation of hyaline cartilage and the area ratio of regenerated cartilage is measured.
Interventions
DEVICEMegaCarti®
MegaCarti® application after microfracture through athroscopic or incision surgery
PROCEDUREMicrofracture
Microfracture through athroscopic or incision surgery
Sponsors
L&C Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 50 years to 65 years 2. After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate in the clinical trial and sign the consent form 3. Subjects with localized full-thickness cartilage defects in the knee joint, International Cartilage Repair Society(ICRS) Grade III or IV 4. Subjects whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms 5. knee cartilage defect size :1.5cm\^2 to 10cm\^2
Exclusion criteria
1. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis) 2. When screening, Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (However, arthroscopy for diagnostic purposes is possible. Additionally, it is possible if hightibial osteotomy (HTO) has been performed in advance or is scheduled) 3. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month 4. When screening, Patients who took oral steroid within 2 weeks 5. Patients who can't take MRI scan 6. BMI index : 30kg/m\^2 or over 7. Patients who have gout or gout history in the knee 8. Women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception. 9. Patients with risk factor for bleeding 10. Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MOCART score | From 48 weeks after surgery | The independent evaluator measure the MOCART score based on the MRI images taken at 48 weeks after surgery. The MOCART score is an index for evaluating the degree of restoration of cartilage tissue and consists of a total of 9 items. Each item is scored from 0 to a maximum of 20 points and added up. The MOCART score is 0 when the cartilage is in the worst condition, and 100 when it is in the best condition. In other words, when the clinical effect of tissue repair appears, it is evaluated as a score greater than 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IKDC score | Baseline and 12, 24, 48 weeks after surgery | Subjects underwent a self-assessment of knee function using the International Knee Documentation Committee Assessment (IKDC). The outcome was presented with the post-operative change amount from the baseline. |
| VAS | Baseline and 12, 24, 48 weeks after surgery | Subjects underwent a self-assessment of knee joint pain using the 100-mm Visual Analogue Scale (VAS). Use of NSAIDs and acetaminophen have to be discontinued for 24 hours, respectively, prior to the VAS evaluation. The outcome was presented with the post-operative change amount from the baseline. |
| KOOS | Baseline and 12, 24, 48 weeks after surgery | Subjects underwent a self-assessment of knee joint pain using the Knee Injury and Osteoarthritis Outcome score (KOOS) survey. The outcome was presented with the post-operative change amount from the baseline. |
| ICRS-CRA score | From 48 weeks after surgery | Investigator uses the International Cartilage Repair Society (ICRS) - cartilage repair assessment grading (CRA) system to evaluate the degree of cartilage regeneration. |
| OAS | From 48 weeks after surgery | Investigator uses the Oswestry Arthroscopic Score (OAS) system to evaluate the degree of cartilage regeneration. |
| Cartilage Coverage Ratio | From 48 weeks after surgery | Using arthroscopy, the investigator calculates the area of repaired cartilage that is greater than 75% defect depth. |
| Histological Evaluation | From 48 weeks after surgery | Cartilage tissue is collected from the center of the repaired knee cartilage using a needle punch. After the collected tissue is stained, an independent evaluator evaluates it using the ICRS-II Parameters evaluation sheet. |
Countries
South Korea
Contacts
STUDY_DIRECTORSunghwan kim
Yonsei University College of Medicine, Severance Hospital
Outcome results
None listed