Cartilage Defects of the KneeNCT07621172
Long-term Safety and Efficacy of CartiFill After Microfracture Surgery in Knee Cartilage Defects
An observational study of Cartilage Defects of the Knee, run by Cellontech Co., Ltd. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Cartilage Defects of the Knee
- What is being tested?
- CartiFill and Microfracture
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2020to 27 Apr 2021
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Adult, Older adult
Study population: The study population consisted of subjects with cartilage defects of the knee joint who had previously participated in a post-marketing clinical trial (Protocol No. 03CAR) and had undergone microfracture surgery with or without collagen implantation. Subjects were enrolled approximately 6 years (±1 year) after surgery and voluntarily agreed to participate in this long-term follow-up study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
About this study
Official 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
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.
- Conditions
- Cartilage Defects of the Knee
- Being tested
- CartiFill, Microfracture
- Keywords
- Cartilage Defects of the knee joint, microfracture, modified microfracture using collagen, collagen
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartiFillDevice
add collagen when doing microfracture
MicrofractureProcedure or surgery
simple microfracture of ankle
| Study group | Role | What they receive |
|---|---|---|
| Experimental: modified microfracture using collagen (CartiFill) | Subjects with knee cartilage defects who previously underwent microfracture surgery with CartiFill (atelocollagen) implantation in a prior clinical study (Protocol No. 03CAR) and were enrolled for long-term follow-up. Participants were observed for up to 6 years to evaluate the long-term safety and efficacy outcomes without additional intervention. Receives: Device: CartiFill; Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
100mm VAS (visual analogue scale) score
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.
Measured: From screening to 6 years (±1 year) after surgery
Secondary outcomes (8)
KOOS (Knee injury and Osteoarthritis Outcome Score)
Measured: From screening to 6 years (±1 year) after surgery
IKDC (International Knee Documentation Committee)
Measured: From screening to 6 years (±1 year) after surgery
EQ-5D (EuroQol 5 Dimension Scale)
Measured: From screening to 6 years (±1 year) after surgery
WPAI (Work Productivity and Activity Impairment Questionnaire)
Measured: From screening to 6 years (±1 year) after surgery
Post-surgical Satisfaction (Subject)
Satisfaction survey based on a questionnaire
Measured: 6 years (±1 year) after surgery
Post-surgical Satisfaction (Investigator)
Satisfaction survey based on a questionnaire
Measured: 6 years (±1 year) after surgery
mMOCART (modified Magnetic resonance Observation of Cartilage Repair Tissue)
Measured: 6 years (±1 year) after the surgery
MRI cartilage imaging
Measured: 6 years (±1 year) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start3 Feb 2020
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage Defects of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong In, MD, Principal investigator, The Catholic University of KoreaJongSeok Baek, MD, Principal investigator, Wonkwang University HospitalSeungBaek Kang, Principal investigator, SMG-SNU Boramae Medical CenterJunHo Hwang, Principal investigator, Samsung Seoul HospitalJaYoung Choi, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621172
- Sponsor's protocol ID
- 06CAR
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No