Osteoarthritis, Knee
Conditions
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.
Interventions
DEVICEMegaCarti®
Medical devices containing allogeneic cartilage
PROCEDUREmicrofracture
microfracture
Sponsors
L&C Bio
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 WOMAC 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 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 HKA angle, Posterior Tibial slope | At last visit (an average of two years after surgery) | Secondary Endpoint \[experimental group / control group\] |
| Comparison of Kellgren-Lawrence grade | 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 |
Countries
South Korea
Outcome results
None listed