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Completed

NCT Number: NCT07621172

Long-term Safety and Efficacy of CartiFill After Microfracture Surgery in Knee Cartilage Defects

The purpose of this clinical trial is to evaluate the safety and efficacy of CartiFill implanted at the site of knee joint cartilage defect in a 6-year, long-term, follow-up investigation.

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Key information

Conditions

Cartilage Defects of the Knee Fractures, Bone Fractures, Stress Wounds and Injuries

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Who can participate

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

Inclusion criteria

  • Patients who have undergone microfracture surgery or microfracture surgery using collagen 6 years (±1 year) ago as part of the previously conducted post-marketing clinical trial (Protocol No. 03CAR).
  • Males or females aged 19 to 70 years.
  • Patients or patients whose legal representatives have agreed to participate in the clinical trial and signed the written consent.

Exclusion criteria

  • Patients who have undergone microfracture surgery or microfracture surgery using collagen as part of previously conducted post-marketing clinical trial (Protocol No. 03CAR) but have since then received cartilage surgery, such as high tibial osteotomy (HTO), partial/full implant arthroplasty, etc., at the same site. (Does not include biopsy for diagnosis, a simple arthroscopic examination, or HTO plate removal procedure, etc.)

※ Does not include non-invasive treatment or medication such as exercise therapy, physical therapy, manual therapy, extracorporeal shock wave, joint cavity injection, etc.

  • Patients who are deemed by the clinical trial manager to be unfit to participate due to psychiatric conditions, etc.

Treatment and study plan

CartiFill

Device

add collagen when doing microfracture

Microfracture

Procedure

simple microfracture of ankle

Primary outcomes

  1. 100mm VAS (visual analogue scale) score

    Time frame: From screening to 6 years (±1 year) after surgery

    100 mm VAS values of the experimental and control groups 6 years (±1 year) after the surgery were analyzed using unpaired T-test or Wilcoxon rank-sum test. The difference between the values from the previously conducted post-marketing clinical trial (Protocol No. 03CAR) and values 6 years (±1 year) after the procedure was also analyzed using unpaired T-test.

Secondary outcomes

  1. KOOS (Knee injury and Osteoarthritis Outcome Score)

    Time frame: From screening to 6 years (±1 year) after surgery

  2. IKDC (International Knee Documentation Committee)

    Time frame: From screening to 6 years (±1 year) after surgery

  3. EQ-5D (EuroQol 5 Dimension Scale)

    Time frame: From screening to 6 years (±1 year) after surgery

  4. WPAI (Work Productivity and Activity Impairment Questionnaire)

    Time frame: From screening to 6 years (±1 year) after surgery

  5. Post-surgical Satisfaction (Subject)

    Time frame: 6 years (±1 year) after surgery

    Satisfaction survey based on a questionnaire

  6. Post-surgical Satisfaction (Investigator)

    Time frame: 6 years (±1 year) after surgery

    Satisfaction survey based on a questionnaire

  7. mMOCART (modified Magnetic resonance Observation of Cartilage Repair Tissue)

    Time frame: 6 years (±1 year) after the surgery

  8. MRI cartilage imaging

    Time frame: 6 years (±1 year) after surgery

Sponsors and collaborators

Lead sponsor

Cellontech Co., Ltd.

Industry

Registry information

Official study title

Observational Study to Evaluate the Long-term Safety and Efficacy of CartiFill in Subjects With Cartilage Defect of the Knee Joints Who Have Undergone Microfracture Surgery or Microfracture Surgery Using Collagen

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

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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