A Clinical Trial to Evaluate the Efficacy and Safety of Cartilage Regeneration in the Use of MegaCarti^® in Patients With Knee Joint Cartilage Injury: Multicenter, Independent Evaluator-subject Blinded, Microfracture-comparative, Randomized Clinical Study
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti\^® will be applied.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 65
Healthy Volunteers: f
View:
• 50 years to 65 yaers
• 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
• Subjects with localized full-thickness cartilage defects in the knee joint, International Cartilage Repair Society(ICRS) Grade III or IV
• 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
• knee cartilage defect size :1.5cm\^2 to 10cm\^2
Locations
Other Locations
Republic of Korea
Ajou University Medical Center
RECRUITING
Gyeonggi-do
Chung-Ang University Gwangmyeong Hospital
RECRUITING
Gyeonggi-do
Catholic Kwandong University International St.Mary's Hospital
RECRUITING
Incheon
Konkuk University Medical Center
RECRUITING
Seoul
Yonsei Sarang Hospital
RECRUITING
Seoul
Yonsei University Health System, Gangnam Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
JY Ahn
sarahahn@lncbio.co.kr
822- 070-7791-2290
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 60
Treatments
Experimental: MegaCarti^® application after Microfracture Surgery
The study group is applied with MegaCarti\^® after microfracture. Afterwards, they visit at 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires.
Active_comparator: Microfracture Surgery without Medical Devices
The control group undergoes microfracture and they visit at 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.
Related Therapeutic Areas
Sponsors
Leads: L&C Bio