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

L&C Bio

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Procedure: microfracture; Device: MegaCarti®

Study type: Observational

Funder types: Industry

Identifiers

NCT06278480

LNC-MECA-003

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

MegaCarti®

Description:

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

Treatment:

Device: MegaCarti®

Procedure: microfracture

Microfracture only

Description:

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

Treatment:

Procedure: microfracture