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

Osteoarthritis, Knee Clinical Trial

Official title:

Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application : Multicenter, Comparative, Evaluator-blinded, Retrospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06278480
• Other study ID #: LNC-MECA-003
• Status: Active, not recruiting
• Start date: June 23, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: L&C Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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"

2. Patients who simultaneously underwent HTO during knee joint cartilage surgery

Exclusion Criteria:

N/A

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• MegaCarti®
Medical devices containing allogeneic cartilage

Procedure:
• microfracture
microfracture

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
L&C Bio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Comparison of IKDC score	Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome	At last visit (an average of two years after surgery)
Secondary	Comparison of VAS score	Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome	At last visit (an average of two years after surgery)
Secondary	Comparison of KOOS score	Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome	At last visit (an average of two years after surgery)
Secondary	Comparison of WOMAC score	Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome	At last visit (an average of two years after surgery)
Secondary	Comparison of Kellgren-Lawrence grade	Secondary Endpoint [experimental group / control group]	At last visit (an average of two years after surgery)
Secondary	Comparison of HKA angle, Posterior Tibial slope	Secondary Endpoint [experimental group / control group]	At last visit (an average of two years after surgery)