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Completed

NCT Number: NCT06278480

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Health System, Gangnam Severance Hospital

Seoul, 06273, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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"
  • Patients who simultaneously underwent HTO during knee joint cartilage surgery

Exclusion criteria

N/A

Treatment and study plan

MegaCarti®

Device

Medical devices containing allogeneic cartilage

Microfracture

Procedure

microfracture

Primary outcomes

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

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

    Primary Endpoint [experimental group / control group]

  2. Comparison of macroscopic status of regenerated cartilage

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

    Primary Endpoint [experimental group / control group]

Secondary outcomes

  1. Comparison of IKDC score

    Time frame: At last visit (an average of two years after surgery)

    Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome

  2. Comparison of VAS score

    Time frame: At last visit (an average of two years after surgery)

    Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome

  3. Comparison of KOOS score

    Time frame: At last visit (an average of two years after surgery)

    Secondary Endpoint [experimental group / control group], Higher scores mean a better outcome

  4. Comparison of WOMAC score

    Time frame: At last visit (an average of two years after surgery)

    Secondary Endpoint [experimental group / control group], Higher scores mean a worse outcome

  5. Comparison of Kellgren-Lawrence grade

    Time frame: At last visit (an average of two years after surgery)

    Secondary Endpoint [experimental group / control group]

  6. Comparison of HKA angle, Posterior Tibial slope

    Time frame: At last visit (an average of two years after surgery)

    Secondary Endpoint [experimental group / control group]

Sponsors and collaborators

Lead sponsor

L&C Bio

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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