Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects

NCT06249828 | Completed

• 1 other identifier: LNC-MECA-004
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 7

Brief Summary

Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied.

Conditions

Osteoarthritis, Knee

Keywords

Knee Cartilage Defects; Microfracture; HTO; High Tibia Osteotomy; MegaCarti; Cartilage regeneration

Outcome Measures

Primary Outcomes (1)

• MOCART score

  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.

  From 48 weeks after surgery

Secondary Outcomes (7)

• IKDC score

  Baseline and 12, 24, 48 weeks after surgery

• VAS

  Baseline and 12, 24, 48 weeks after surgery

• KOOS

  Baseline and 12, 24, 48 weeks after surgery

• ICRS-CRA score

  From 48 weeks after surgery

• OAS

  From 48 weeks after surgery

Study Arms (2)

MegaCarti® application after Microfracture Surgery

EXPERIMENTAL

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.

Device: MegaCarti®; Procedure: Microfracture

Microfracture Surgery without Medical Devices

ACTIVE COMPARATOR

The control group undergoes microfracture and they visit at 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.

Procedure: Microfracture

Interventions

MegaCarti® DEVICE

MegaCarti® application after microfracture through athroscopic or incision surgery

MegaCarti® application after Microfracture Surgery

Microfracture PROCEDURE

Microfracture through athroscopic or incision surgery

MegaCarti® application after Microfracture Surgery; Microfracture Surgery without Medical Devices

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 65 years
• 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

You may not qualify if:

• Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
• 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)
• When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month
• When screening, Patients who took oral steroid within 2 weeks
• Patients who can't take MRI scan
• BMI index : 30kg/m\^2 or over
• Patients who have gout or gout history in the knee
• Women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
• Patients with risk factor for bleeding
• Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial

Sponsors & Collaborators

• L&C Bio: lead

Study Sites (7)

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, 14353, South Korea

Location

Ajou University Medical Center

Gyeonggi-do, 16499, South Korea

Location

Catholic Kwandong University International St.Mary's Hospital

Incheon, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Yonsei University College of Medicine, Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Yonsei Sarang Hospital

Seoul, 06702, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Sunghwan kim

  Yonsei University College of Medicine, Severance Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 8, 2024
• Study Start: January 22, 2024
• Primary Completion: December 13, 2025
• Study Completion: December 13, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)