NCT06278480Recruitment Completed

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

Name: Clinical Trial NCT06278480
Creator: L&C Bio
Keywords: Osteoarthritis, Knee, MegaCarti®, device, clinical trial, South Korea

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

L&C BioClinicalTrials.govdeviceDevice trial

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Study focus

Disease/Condition: Osteoarthritis, Knee
Drug/Device/Intervention: MegaCarti®
Study type: Observational
Intervention type: device

Sponsor & location

Primary sponsor: L&C Bio
Location: Seoul, South Korea

Timeline & enrollment

Phase: N/A
Start date: Jun 23, 2023
End date: Feb 29, 2024
Enrollment: 40 participants

Primary outcome

Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment,Comparison of macroscopic status of regenerated cartilage

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.

ICD-10 classifications

Chronic instability of kneeInjuries to the knee and lower legGonarthrosis [arthrosis of knee]Dislocation, sprain and strain of joints and ligaments of kneeSprain and strain of other and unspecified parts of knee

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06278480
Type: Device Trial

About this record

Access comprehensive clinical trial information for NCT06278480 through Pure Global AI's free database. This phase not specified trial is sponsored by L&C Bio and is currently Recruitment Completed. The study focuses on Osteoarthritis, Knee. Target enrollment is 40 participants.

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