Clinical trial NCT06278480: Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application
Official title: Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application : Multicenter, Comparative, Evaluator-blinded, Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Lead sponsor: L&C Bio
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment
timeFrame: When removing fixtures after HTO (an average of 1 year after surgery)
measure: Comparison of macroscopic status of regenerated cartilage
timeFrame: When removing fixtures after HTO (an average of 1 year after surgery)
Secondary outcomes:
measure: Comparison of IKDC score
timeFrame: At last visit (an average of two years after surgery)
measure: Comparison of VAS score
timeFrame: At last visit (an average of two years after surgery)
measure: Comparison of KOOS score
timeFrame: At last visit (an average of two years after surgery)
measure: Comparison of WOMAC score
timeFrame: At last visit (an average of two years after surgery)
measure: Comparison of Kellgren-Lawrence grade
timeFrame: At last visit (an average of two years after surgery)
measure: Comparison of HKA angle, Posterior Tibial slope
timeFrame: At last visit (an average of two years after surgery)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Gangnam Severance Hospital
Study officials:
References: