Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application

NCT06278480 | Completed

• 1 other identifier: LNC-MECA-003
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment

  Primary Endpoint \[experimental group / control group\]

  When removing fixtures after HTO (an average of 1 year after surgery)

• Comparison of macroscopic status of regenerated cartilage

  Primary Endpoint \[experimental group / control group\]

  When removing fixtures after HTO (an average of 1 year after surgery)

Secondary Outcomes (6)

• Comparison of IKDC score

  At last visit (an average of two years after surgery)

• Comparison of VAS score

  At last visit (an average of two years after surgery)

• Comparison of KOOS score

  At last visit (an average of two years after surgery)

• Comparison of WOMAC score

  At last visit (an average of two years after surgery)

• Comparison of Kellgren-Lawrence grade

  At last visit (an average of two years after surgery)

Study Arms (2)

MegaCarti®

Experimental: MegaCarti® application after microfracture The experimental group is applied with MegaCarti® and underwent high tibial osteotomy(HTO) after microfracture.

Device: MegaCarti®; Procedure: microfracture

Microfracture only

The control group underwent microfracture and high tibial osteotomy(HTO)

Procedure: microfracture

Interventions

MegaCarti® DEVICE

Medical devices containing allogeneic cartilage

MegaCarti®

microfracture PROCEDURE

microfracture

MegaCarti®; Microfracture only

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent HTO were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.

You may qualify if:

• Patients participating in the "Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study"
• Patients who simultaneously underwent HTO during knee joint cartilage surgery

You may not qualify if:

• N/A

Sponsors & Collaborators

• L&C Bio: lead

Study Sites (1)

Yonsei University Health System, Gangnam Severance Hospital

Seoul, Seoul, 06273, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 26, 2024
• Study Start: June 23, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)