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Defect of Articular CartilageNCT02519881

the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle

A study testing Microfracture and CartiFill in people with Defect of Articular Cartilage, run by Cellontech Co., Ltd. at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was designed to evaluate the efficacy and safety of a modified microfracture using collagen, and to compare them with those of a simple microfracture in patients with cartilage defects in their ankles. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Defect of Articular Cartilage
What is being tested?
Microfracture and CartiFill
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesSouth Korea
Study dates
17 Feb 2014to 23 Jan 2018
Phase
Interventional
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 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patients who were 15 years old or older
  • Patients with cartilage defects in their ankle
  • Patients with misalignment of their tibia and talus, unstable ligament in their ankle, or bony defects in the lesions of their ankle, and/or who had been treated for alignment
  • Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form

Who cannot join

  • If patients or their families suffer from or have ever suffered from an autoimmune disease.
  • Patients who have ever suffered an anaphylactic reaction.
  • Patients who have ever suffered hypersensitivity to an implant.
  • Patients with a history of allergy to porcine or bovine protein.
  • Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis.
  • Subjects with autoimmune disease related arthritis.
Show all 14Show fewer
  • Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy.
  • Subjects with tumors.
  • Subjects who have undergone radiotherapy or chemotherapy within the last 2 years (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
  • Subjects who are diabetic. (Exception: if the possibility of CartiFill™ treatment is confirmed with doctor's clinical decision, and/or patient's blood glucose level remains within the normal range and/or no other complications by diabetes mellitus.)
  • Subjects with infections, currently on treatment with antibiotics or antimicrobials (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
  • Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
  • Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.
  • Patients who have ever suffered contraindications of the used Fibrin sealant. (The major contraindications are as follows: patients with hypersensitivity to aprotinin and those treatments for severe brisk arterial or venous bleeding.)

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggi-do

  • Eulji general Hospital

    Seoul, Seoul

  • Hallym University Medical Center-Kangnam Sacred Heart Hospital

    Seoul, Seoul

Other trials in South Korea

About this study

Official title: This Clinical Trial Evaluated the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Patients With Cartilage Defects in Their Ankles.

This study was designed to evaluate the efficacy and safety of a modified microfracture using collagen, and to compare them with those of a simple microfracture in patients with cartilage defects in their ankles.

Read the detailed description

This study was an open-trial study. Sixty subjects participated in it. The study was explained to the subjects and they voluntarily agreed to participate in it. Their eligibility to participate in the study was checked, and they were randomized either into the simple microfracture group or the modified microfracture group using collagen based on a randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects underwent an examination with doctors and MRI to evaluate the efficacy of the procedure. (*If the subject began the first visit on the screening date, the total number of his or her visits was four.)

Being tested
Microfracture, CartiFill
Keywords
cartilage defect in ankle, 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.

  • MicrofractureProcedure or surgery

    simple microfracture of ankle

  • CartiFillDevice

    add collagen when doing microfracture

Study groups in NCT02519881
Study groupRoleWhat they receive
modified microfracture using collagenExperimentalmodified microfracture using collagen (CartiFill) for cartilage defect of ankle
Receives: Procedure: Microfracture; Device: CartiFill
microfractureActive comparatorsimple microfracture for cartilage defect of ankle
Receives: Procedure: Microfracture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 100mmVAS(visual analogue scale) score

    The VAS's were evaluated 12 months after the surgery on the affected ankle in the study and control groups.

    Measured: 12 months after the surgery

Secondary outcomes (7)

  1. Change score of 100mmVAS(visual analogue scale)

    The difference in the 100mmVAS on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the 100mmVAS after 6, and 24 months.

    Measured: Screening, 6, 12, and 24months after surgery

  2. Change of Satisfaction evaluation by patients

    The improvements in the affected ankle before and 12 months after the surgery (and six and 24 months after the surgery) were compared in the study and control group.

    Measured: Screening, 6, 12, and 24months after surgery

  3. Change of AOFAS(American orthopaedic foot & ankle society) Score

    The difference in the AOFAS on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the AOFAS after 6, and 24 months.

    Measured: Screening, 6, 12, and 24months after surgery

  4. Change of Hannover Score

    The difference in the Hannover Score on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the Hannover Score after 6, and 24 months.

    Measured: Screening, 6, 12, and 24months after surgery

  5. Change of Satisfaction evaluation by physician in charge

    The improvements in the affected ankle before and 12 months after the surgery (and six and 24 months after the surgery) were compared in the study and control group.

    Measured: Screening, 6, 12, and 24months after surgery

  6. Change results of Arthroscopy (ICRS(International Cartilage Repair Society))

    The conditions of the affected ankle before and 24 months after the surgery were recorded and the ICRS's were evaluated in the study and control group.

    • Arthroscopy was performed in up to 10 subjects who signed the consent form.

    Measured: before and 24 months after the surgery

  7. the result of MRI(mMOCART)

    The conditions of the affected ankle 24 months after the surgery were recorded and the mMOCART were evaluated in the study and control group.

    Measured: 24 months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2015 (estimated)
  2. Study start17 Feb 2014
  3. Primary completion23 Jan 2018
  4. Study completion23 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02519881
Sponsor's protocol ID
04CAR
Status last verified
Nov 2016
First submitted
6 Aug 2015
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee YK, Young KW, Kim JS, Lee HS, Cho WJ, Kim HN. Arthroscopic microfracture with atelocollagen augmentation for osteochondral lesion of the talus: a multicenter randomized controlled trial. BMC Musculoskelet Disord. 2020 Nov 3;21(1):716. doi: 10.1186/s12891-020-03730-3.

    PubMed 33143647

Questions about this trial

What is this clinical trial studying?

A study testing Microfracture and CartiFill in people with Defect of Articular Cartilage, run by Cellontech Co., Ltd. at 3 sites 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 4 inclusion and 14 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

100mmVAS(visual analogue scale) score (time frame: 12 months after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02519881, which also lists 1 linked publication.

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 7 Apr 2026.

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