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

May 27, 2026 updated by: Cellontech Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. 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).
  2. Males or females aged 19 to 70 years.
  3. Patients or patients whose legal representatives have agreed to participate in the clinical trial and signed the written consent.

Exclusion Criteria:

  1. 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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Microfracture
simple microfracture of ankle
Device: CartiFill
add collagen when doing microfracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From screening to 6 years (±1 year) after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS (Knee injury and Osteoarthritis Outcome Score)
Time Frame: From screening to 6 years (±1 year) after surgery
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
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
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
From screening to 6 years (±1 year) after surgery
Post-surgical Satisfaction (Subject)
Time Frame: 6 years (±1 year) after surgery
Satisfaction survey based on a questionnaire
6 years (±1 year) after surgery
Post-surgical Satisfaction (Investigator)
Time Frame: 6 years (±1 year) after surgery
Satisfaction survey based on a questionnaire
6 years (±1 year) after surgery
mMOCART (modified Magnetic resonance Observation of Cartilage Repair Tissue)
Time Frame: 6 years (±1 year) after the surgery
6 years (±1 year) after the surgery
MRI cartilage imaging
Time Frame: 6 years (±1 year) after surgery
6 years (±1 year) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellontech Co., Ltd.

Investigators

  • Principal Investigator: Yong In, MD, The Catholic University of Korea
  • Principal Investigator: JongSeok Baek, MD, Wonkwang University Hospital
  • Principal Investigator: SeungBaek Kang, SMG-SNU Boramae Medical Center
  • Principal Investigator: JunHo Hwang, Samsung Seoul Hospital
  • Principal Investigator: JaYoung Choi, MD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Actual)

April 27, 2021

Study Completion (Actual)

April 27, 2021

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06CAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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