Osteoarthritis Clinical Trial
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
Verified date | August 2015 |
Source | Sewon Cellontech Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Ministry of Food and Drug Safety |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | June 2017 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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 CartiFillâ„¢ 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.) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | The Catholic University of Korea Bucheon St. Mary's Hospital | Bucheon | Gyeonggi |
Korea, Republic of | Daejeon Sun hospital | Daejeon | |
Korea, Republic of | Wonkwang University Hospital | Iksan | Jeollabuk-do |
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 | The Catholic University of Korea Vincent's Hospital | Suwon | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
Sewon Cellontech Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 month after surgery | No |
Secondary | 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. | screening, 3, 6, 12 and 24 months after surgery | No |
Secondary | 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. | screening, 6, 12 and 24 months after surgery | No |
Secondary | 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. | screening, 6, 12 and 24 months after surgery | No |
Secondary | 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. |
12 months after surgery | No |
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