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Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

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ClinicalTrials.gov Identifier: NCT02539030
Recruitment Status : Unknown
Verified August 2015 by Sewon Cellontech Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Sewon Cellontech Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Defect of Articular Cartilage Osteoarthritis Traumatic Arthritis Procedure: Microfracture Device: CartiFill Phase 4

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.)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: microfracture
simple microfracture for cartilage defect of knee
Procedure: Microfracture
simple microfracture

Experimental: modified microfracture using collagen
modified microfracture using collagen (CartiFill) for cartilage defect of knee
Procedure: Microfracture
simple microfracture

Device: CartiFill
add collagen when doing microfracture




Primary Outcome Measures :
  1. 100mmVAS(Visual Analogue Scale) [ Time Frame: 12 month after surgery ]
    It will be evaluated by the VAS score 12 months after surgery of the affected knee of the investigational group and the control group.


Secondary Outcome Measures :
  1. change of 100 mmVAS (Visual Analogue Scale) [ Time Frame: screening, 3, 6, 12 and 24 months after surgery ]
    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.

  2. change of Knee injury and osteoarthritis outcome (KOOS) [ Time Frame: screening, 6, 12 and 24 months after surgery ]
    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.

  3. change of International Knee Documentation Committee (IKDC) [ Time Frame: screening, 6, 12 and 24 months after surgery ]
    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.

  4. the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART [ Time Frame: 12 months after surgery ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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.)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539030


Locations
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Korea, Republic of
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon, Gyeonggi, Korea, Republic of
The Catholic University of Korea Vincent's Hospital
Suwon, Gyeonggi, Korea, Republic of
Wonkwang University Hospital
Iksan, Jeollabuk-do, Korea, Republic of
Daejeon Sun hospital
Daejeon, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Inje University Seoul Paik Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of
The Catholic University of Korea St. Paul's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Sewon Cellontech Co., Ltd.
Investigators
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Principal Investigator: Nam Yong Choi, MD Catholic University of Korea Saint Paul's Hospital
Principal Investigator: Yong In, MD The Catholic University of Korea
Principal Investigator: Chan Woong Moon, MD The Catholic University of Korea Bucheon St.Mary's Hospital
Principal Investigator: Hae Seock Ko, MD The Catholic University of Korea Vincent's Hospital
Principal Investigator: Cheol Hong Jeon, MD Wonkwang University Hospital
Principal Investigator: Seung Back Kang, MD SMG-SNU Boramae Medical Center
Principal Investigator: Ja Young Choi, MD Seoul National University Hospital
Principal Investigator: Myung Koo Kim, MD Inha University Hospital
Principal Investigator: Jae Kyun Jun, MD Daejeon Sun hospital
Principal Investigator: Jae Doo Yoo, MD Ewha Womans University Mokdong Hospital
Principal Investigator: Jung Koo Ha, MD Inje University
Principal Investigator: Jun Ho Wang, MD Samsung Medical Center

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Responsible Party: Sewon Cellontech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02539030     History of Changes
Other Study ID Numbers: 03CAR
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Keywords provided by Sewon Cellontech Co., Ltd.:
Cartilage defect of knee
microfracture
modified microfracture
collagen
Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries