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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07621172
- Acronym / sponsor ID
- 06CAR
- Conditions
- Cartilage Defects of the Knee
- Keywords
- Cartilage Defects of the knee joint, microfracture, modified microfracture using collagen, collagen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: modified microfracture using collagen (CartiFill) | – | Device: CartiFill, Procedure: MicrofractureSubjects 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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CartiFilladd collagen when doing microfracture | Device | Experimental: modified microfracture using collagen (CartiFill) |
| Microfracturesimple microfracture of ankle | Procedure or surgery | Experimental: modified microfracture using collagen (CartiFill) |
Primary outcome
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.
8 secondary outcomes
KOOS (Knee injury and Osteoarthritis Outcome Score)
Time frame: From screening to 6 years (±1 year) after surgery
IKDC (International Knee Documentation Committee)
Time frame: From screening to 6 years (±1 year) after surgery
EQ-5D (EuroQol 5 Dimension Scale)
Time frame: From screening to 6 years (±1 year) after surgery
WPAI (Work Productivity and Activity Impairment Questionnaire)
Time frame: From screening to 6 years (±1 year) after surgery
Post-surgical Satisfaction (Subject)
Time frame: 6 years (±1 year) after surgery
Post-surgical Satisfaction (Investigator)
Time frame: 6 years (±1 year) after surgery
mMOCART (modified Magnetic resonance Observation of Cartilage Repair Tissue)
Time frame: 6 years (±1 year) after the surgery
MRI cartilage imaging
Time frame: 6 years (±1 year) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong In, MD principal investigator
The Catholic University of Korea
JongSeok Baek, MD principal investigator
Wonkwang University Hospital
SeungBaek Kang principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Defects of the Knee, run by Cellontech Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100mm VAS (visual analogue scale) score (time frame: From screening to 6 years (±1 year) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.