Back to resultsComparison of Efficacy and Safety of Microfracture and Modified Microfracture
Primary Purpose
Defect of Articular Cartilage, Osteoarthritis, Traumatic Arthritis
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Microfracture
CartiFill
Sponsored by
About this trial
This is an interventional treatment trial for Defect of Articular Cartilage focused on measuring Cartilage defect of knee, microfracture, modified microfracture, collagen
Eligibility 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.)
Sites / Locations
- The Catholic University of Korea Bucheon St. Mary's Hospital
- The Catholic University of Korea Vincent's Hospital
- Wonkwang University Hospital
- Daejeon Sun hospital
- Inha University Hospital
- Ewha Womans University Mokdong Hospital
- Inje University Seoul Paik Hospital
- Samsung Medical Center
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
- Seoul National University Hospital
- The Catholic University of Korea Seoul St. Mary's Hospital
- The Catholic University of Korea St. Paul's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
microfracture
modified microfracture using collagen
Arm Description
simple microfracture for cartilage defect of knee
modified microfracture using collagen (CartiFill) for cartilage defect of knee
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT02539030
First Posted
August 28, 2015
Last Updated
August 31, 2015
Sponsor
Sewon Cellontech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02539030
Brief Title
Comparison of Efficacy and Safety of Microfracture and Modified Microfracture
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sewon Cellontech Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defect of Articular Cartilage, Osteoarthritis, Traumatic Arthritis
Keywords
Cartilage defect of knee, microfracture, modified microfracture, collagen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
microfracture
Arm Type
Active Comparator
Arm Description
simple microfracture for cartilage defect of knee
Arm Title
modified microfracture using collagen
Arm Type
Experimental
Arm Description
modified microfracture using collagen (CartiFill) for cartilage defect of knee
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
simple microfracture
Intervention Type
Device
Intervention Name(s)
CartiFill
Intervention Description
add collagen when doing microfracture
Primary Outcome Measure Information:
Title
100mmVAS(Visual Analogue Scale)
Description
It will be evaluated by the VAS score 12 months after surgery of the affected knee of the investigational group and the control group.
Time Frame
12 month after surgery
Secondary Outcome Measure Information:
Title
change of 100 mmVAS (Visual Analogue Scale)
Description
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.
Time Frame
screening, 3, 6, 12 and 24 months after surgery
Title
change of Knee injury and osteoarthritis outcome (KOOS)
Description
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.
Time Frame
screening, 6, 12 and 24 months after surgery
Title
change of International Knee Documentation Committee (IKDC)
Description
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.
Time Frame
screening, 6, 12 and 24 months after surgery
Title
the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART
Description
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.
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam Yong Choi, MD
Organizational Affiliation
Catholic University of Korea Saint Paul's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong In, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chan Woong Moon, MD
Organizational Affiliation
The Catholic University of Korea Bucheon St.Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hae Seock Ko, MD
Organizational Affiliation
The Catholic University of Korea Vincent's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheol Hong Jeon, MD
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seung Back Kang, MD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ja Young Choi, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myung Koo Kim, MD
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Kyun Jun, MD
Organizational Affiliation
Daejeon Sun hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Doo Yoo, MD
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung Koo Ha, MD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Ho Wang, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea Bucheon St. Mary's Hospital
City
Bucheon
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Vincent's Hospital
City
Suwon
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan
State/Province
Jeollabuk-do
Country
Korea, Republic of
Facility Name
Daejeon Sun hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Inje University Seoul Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Paul's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Comparison of Efficacy and Safety of Microfracture and Modified Microfracture
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