Osteoarthritis, Knee
Conditions
Keywords
Knee Cartilage Defects, microfracture, MegaCarti, cartilage regeneration
Brief summary
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. The MegaCarti® is applied after Microfracture treatment on patients with Knee Cartilage Defects. The cartilage regeneration, which is a primary endpoint, is compared to the Microfracture group through MOCART evaluation. In addition, the improvement of pain and the recovery of Normal Range of motion are compared to the Microfracture group through secondary endpoints. Then, long-term follow-up study for 5 years is conducted to the experimental group.
Interventions
PROCEDUREMicrofracture
Microfracture through athroscopic or incision surgery
DEVICEMegaCarti®
MegaCarti® application after 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
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 19 years to 65 years 2. Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form. 3. Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage 4. Patients 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 : Below 10 ㎠
Exclusion criteria
1. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis) 2. Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery) 3. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months 4. When screening, Patients who took oral steroid within 1 month 5. When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests 6. Patients taking immunosuppressive drug, or having immune disorder 7. Patients who can't take MRI scan 8. Patients with a history of cancer within the past five years 9. Patients who have chronic renal failure, active hepatitis, or poor blood sugar control 10. BMI index : 30 ㎏/㎡ or over 11. Patients who have gout or gout history in the knee 12. When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception. 13. Drug and alcohol addiction / dependence or mental disorder 14. Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin) 15. Patients who have systemic or localized knee infection 16. Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial 17. Patients who participated in other clinical trials within three months before screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MOCART score | 48 weeks after surgery | Primary Endpoint \[experimental group / control group\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of VAS score | Baseline and 6, 12, 24, 48 weeks after surgery | Secondary Endpoint \[experimental group / control group\] |
| Comparison of KOOS score | Baseline and 12, 24, 48 weeks after surgery | Secondary Endpoint \[experimental group / control group\] |
| Comparison of IKDC score | Baseline and 12, 24, 48 weeks after surgery | Secondary Endpoint \[experimental group / control group\] |
| Comparison of Kellgren-Lawrence grade | Baseline and 12, 24, 48 weeks after surgery | Secondary Endpoint \[experimental group / control group\] |
| Frequency of rescue medication | For 48 weeks after surgery | Secondary Endpoint \[experimental group / control group\] |
| Comparison of WOMAC score | Baseline and 12, 24, 48 weeks after surgery | Secondary Endpoint \[experimental group / control group\] |
Countries
South Korea
Outcome results
None listed