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

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: microfracture; Device: MegaCarti®

• Registration Number: NCT06278480
• Lead Sponsor: L&C Bio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-23
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-26
• Primary Completion: 2024-03-29
• Study Completion: 2024-03-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Microfracture only	microfracture	The control group underwent microfracture and high tibial osteotomy(HTO)
MegaCarti®	MegaCarti®	Experimental: MegaCarti® application after microfracture The experimental group is applied with MegaCarti® and underwent high tibial osteotomy(HTO) after microfracture.
MegaCarti®	microfracture	Experimental: MegaCarti® application after microfracture The experimental group is applied with MegaCarti® and underwent high tibial osteotomy(HTO) after microfracture.

Primary Outcome Measures

Name	Time	Method
Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment	When removing fixtures after HTO (an average of 1 year after surgery)	Primary Endpoint \[experimental group / control group\]
Comparison of macroscopic status of regenerated cartilage	When removing fixtures after HTO (an average of 1 year after surgery)	Primary Endpoint \[experimental group / control group\]

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonsei University Health System, Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of