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Defect of Articular CartilagePhase 4NCT02539030

Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

A Phase 4 study testing Microfracture and CartiFill in people with Defect of Articular Cartilage and Osteoarthritis, run by Cellontech Co., Ltd. at 12 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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 to prove the non-inferiority of the modified microfracture using collagen in patients with cartilage defects in their knees. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
What is being tested?
Microfracture and CartiFill
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
12 sitesSouth Korea
Study dates
Feb 2013to Jun 2017
Phase
Phase 4
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

  • 1. Patients with cartilage defects in their knee (Including Knee OA and Knee TA) 2. Knee osteoarthritis patients whose Kellgren-Lawrence Grading Scale score is lower than 3 (patients who received simultaneous or previous correction will be excluded).
  • 3. Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment 4. Patients who were 15 years old or older 5. 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

  • 1. If patients or their families suffer from or have ever suffered from an autoimmune disease.
  • 2. Patients who have ever suffered an anaphylactic reaction. 3. Patients who have ever suffered hypersensitivity to an implant. 4. Patients with a history of allergy to porcine or bovine protein. 5. Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis.
  • 6. Subjects with autoimmune disease related arthritis. 7. Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy. 8. Subjects with tumors. 9. 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).
  • 10. 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.) 11. Subjects with infections, currently on treatment with antibiotics or antimicrobials (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
  • 12. Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
  • 13. Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.
  • 14. 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

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • The Catholic University of Korea Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-do

  • Daejeon Sun hospital

    Daejeon, Daejeon

  • Wonkwang University Hospital

    Iksan, Jeollabuk-do

  • Inha University Hospital

    Incheon, Incheon

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul

  • Inje University Seoul Paik Hospital

    Seoul, Seoul

  • Samsung Medical Center

    Seoul, Seoul

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, Seoul

  • Seoul National University Hospital

    Seoul, Seoul

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

    Seoul, Seoul

  • The Catholic University of Korea St. Paul's Hospital

    Seoul, Seoul

  • The Catholic University of Korea Vincent's Hospital

    Suwon, Gyeonggi-do

Other trials in South Korea

About this study

Official title: Random Clinical Trial for Comparison of Efficacy and Safety of Simple Microfracture and Modified Microfracture Using Collagen in the Patients With Knee Cartilage Defects

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 to prove the non-inferiority of the modified microfracture using collagen in patients with cartilage defects in their knees.

Read the detailed description

This study was an open-trial study. One hundred 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 centrally controlled randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital six times*, including for screening. At each visit, the subjects underwent an examination with doctors, a blood test, an X-ray procedure, an MRI, an observation with the naked eyes, and arthroscopy to evaluate the safety and efficacy of the procedure. (*If the screening date overlaps with the procedure date, the number of his or her visits would be five.)

Being tested
Microfracture, CartiFill
Keywords
Cartilage defect of knee, microfracture, modified microfracture, collagen
Medical subject headings
Osteoarthritis, 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

  • CartiFillDevice

    add collagen when doing microfracture

Study groups in NCT02539030
Study groupRoleWhat they receive
microfractureActive comparatorsimple microfracture for cartilage defect of knee
Receives: Procedure: Microfracture
modified microfracture using collagenExperimentalmodified microfracture using collagen (CartiFill) for cartilage defect of knee
Receives: Procedure: Microfracture; Device: CartiFill

What is being measured

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

  1. 100mmVAS(Visual Analogue Scale)

    It will be evaluated by the VAS score 12 months after surgery of the affected knee of the investigational group and the control group.

    Measured: 12 month after surgery

Secondary outcomes (4)

  1. change of 100 mmVAS (Visual Analogue Scale)

    The difference between the VAS scores of the affected knee at the screening and 12 months after surgery in the investigational group will be compared to that in the control group. The differences in the VAS scores obtained at the follow-ups (3, 6, and 24 months after surgery) will be compared.

    Measured: screening, 3, 6, 12 and 24 months after surgery

  2. change of Knee injury and osteoarthritis outcome (KOOS)

    The difference between the KOOS scores of the affected knee at the screening and 12 months after surgery in the investigational group will be compared to that in the control group. The differences in the KOOS scores obtained at the follow-ups (6 and 24 months after surgery) will be compared.

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

  3. change of International Knee Documentation Committee (IKDC)

    The difference between the IKDC scores of the affected knee at the screening and 12 months after the surgery in the investigation group will be compared to that in the control group. The differences in the IKDC scores obtained at the follow-ups (6 and 24 months after surgery) will be compared.

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

  4. the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART

    The results obtained 12 months after the surgery on the affected knee in the investigational and control groups will be described. mMOCART will be obtained, and the difference will be assessed.

    • Depending on the MRI equipment, if in-house imaging is not possible, it may be done at the other hospitals conducting the research.

    Measured: 12 months after surgery

Timeline

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

  1. First posted2 Sep 2015 (estimated)
  2. Study startFeb 2013
  3. Primary completionJan 2016 (estimated)
  4. Study completionJun 2017 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539030
Sponsor's protocol ID
03CAR
Status last verified
Aug 2015
First submitted
28 Aug 2015
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim MS, Chun CH, Wang JH, Kang SB, Chang MJ, In Y. Microfracture Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: Results at Midterm Follow-up. Orthop J Sports Med. 2024 Nov 7;12(11):23259671241292093. doi: 10.1177/23259671241292093. eCollection 2024 Nov.

    PubMed 39525351

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Microfracture and CartiFill in people with Defect of Articular Cartilage and Osteoarthritis, run by Cellontech Co., Ltd. at 12 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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) (time frame: 12 month after 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 NCT02539030, 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 2 Sep 2015.

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