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

L&C Bio40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

MegaCarti®DEVICE

Medical devices containing allogeneic cartilage

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Primary Endpoint \[experimental group / control group\]

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

Comparison of macroscopic status of regenerated cartilage

Primary Endpoint \[experimental group / control group\]

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