Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects
NCT ID: NCT05440370
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
90 participants
INTERVENTIONAL
2020-04-16
2027-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MegaCarti® application after microfracture
The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years.
MegaCarti®
MegaCarti® application after microfracture through athroscopic or incision surgery
Microfracture
Microfracture through athroscopic or incision surgery
Microfracture only
The control group undergoes microfracture and they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.
Microfracture
Microfracture through athroscopic or incision surgery
Interventions
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MegaCarti®
MegaCarti® application after microfracture through athroscopic or incision surgery
Microfracture
Microfracture through athroscopic or incision surgery
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
65 Years
ALL
No
Sponsors
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L&C Bio
INDUSTRY
Responsible Party
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Principal Investigators
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Seong Hwan Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
Yonsei University Health System, Gangnam Severance Hospital
Locations
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National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Yonsei University Health System, Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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LNC-MECA-001
Identifier Type: -
Identifier Source: org_study_id