Effects of COX-2 selective inhibitor and hyaluronan acid to prevent cartilage degeneration in patients with knee osteoarthritis
- Conditions
- knee osteoarthritis
- Registration Number
- JPRN-UMIN000005643
- Lead Sponsor
- Teikyo University Chiba Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Not provided
Patients who meet any of the following exclusion criteria will not be enrolled in this research study. 1)History of hypersensitivity to any components of the investigational products to be used in this research study 2)History of hypersensitivity to any other medicinal products 3)Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. 4)Secondary knee osteoarthritis due to trauma or other diseases 5)History of surgery of the involved knee joint (including arthroscopy) 6)Conservative therapy of the involved knee joint within one month of enrollment in this study 7)Diseases in the involved knee joint other than those associated with osteoarthritis, e.g., injury of semi-lunar disc, ligament injury, and cartilage injury 8)Serious renal, hepatic, and/or cardiovascular disease 9)Significant mental disorder, drug dependence, and/or alcohol abuse 10)Patients who are unable to come to the medical center for all scheduled visits 11)Other patients considered to be ineligible for this research study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MRI examination with T2 mapping
- Secondary Outcome Measures
Name Time Method 1) MRI examination with Modified Outerbridge classification (T1 weighted image, T2 weighted image, etc.), 2) simple X-ray examination with Kellgren-Lawrence classification, 3) assessment of clinical symptoms using JKOM (Japanese Knee Osteoarthritis Measure), Lysholm score, and VAS (visual analogue scale.