Last updated: April 21, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Knee Injuries
Osteoarthritis
Treatment
N/AClinical Study ID
NCT04739592
Peking UMCH
Ages 50-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with significant knee pain (pain score≥40mm on the 100mmVAS scale);
- Male or female patients, between 50-75 years old;
- MRI suggests bone marrow edema-like lesions;
- Knee osteoarthritis (in accordance with the diagnostic criteria of American College ofRheumatology (ACR) and Chinese Orthopaedic Association);
- Kellgren-Lawrence gradingⅠorⅡin X-ray;
Exclusion
Exclusion Criteria:
- Other forms of active arthritis (such as rheumatoid arthritis or other inflammatoryarthritis);
- Taken non-steroidal anti-inflammatory drugs and central analgesics (such as opioids)within two weeks;
- Liver function ALT or AST is 1.5 times the upper limit of normal; creatinine clearance <35ml/min;
- Pregnancy or suckling;
- Serious heart disease, endocrine, digestive, mental, nervous system diseases orcancer;
- Active ulcers and a history of upper gastrointestinal bleeding;
- Esophageal motility disorders, such as esophageal tardiness or stenosis;
- Renal dysfunction or osteomalacia;
- Tobacco addiction (mean 10 cigarettes per day or more) or/and alcohol addiction (mean 50ml per day or more);
- Fresh fracture in the last six months;
- Serious illnesses and life expectancy<2 years;
- Allergic to study drugs;
- Used any study drug or device within 30 days before randomization or within the drughalf-life (whichever is longer);
- Failure to take medication as required;
- Replacement surgery in the near future;
- Contraindications to MRI scans (e.g. implanted pacemakers, metal sutures, shrapnel oriron filings in the eyes, claustrophobia, knees too large to use coils);
- Sensitive to or unsuitable for X-ray exposure (e.g. aplastic anemia, etc);
- Poor dental health or dental surgery in the near future.
Study Design
Total Participants: 60
Study Start date:
July 07, 2021
Estimated Completion Date:
July 31, 2024
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing,
ChinaActive - Recruiting
The Third Affiliated Hospital of Southern Medical University
Guangzhou,
ChinaActive - Recruiting
Zhongshan Hospital
Shanghai,
ChinaActive - Recruiting
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