knee osteoarthritis
Conditions
Interventions
Test group:Injection of high molecular weight sodium hyaluronate (for orthopedic use)
Control group:Injection of Sodium Hyaluronate Injection (ARTZ)
Sponsors
Zhejiang Provincial Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Zhejiang Chinese Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years old (including 18 and 75 years old), gender unrestricted; 2. Meeting the diagnostic criteria for knee osteoarthritis set by the American College of Rheumatology, with the criteria being: knee pain and osteophytes shown on X-ray of the knee, and at least one of the following: (1) age >= 50 years old; (2) morning stiffness of the affected knee < 30 minutes; (3) crepitus during joint movement. 3. VAS score of the study knee 4-9 points, VAS score of the non-study knee < 4 points; 4. Kellgren & Lawrence grade of the study knee on standing X-ray is I-III; 5. Able to communicate well with the researcher and follow the requirements of the study; 6. Patients willing to provide written informed consent, or patients whose guardians are able to sign the written informed consent. 7. Oral corticosteroids (prednisolone or equivalent, <= 10mg/day), acetaminophen and other non-steroidal anti-inflammatory drugs are allowed, but the dosage must have been stable for at least one week before enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients with local or systemic infection near the injection site; 2. Patients with infectious arthritis; 3. Patients with acute or chronic hemorrhagic arthritis; 4. Patients with multiple joint pain; 5. Patients with large amounts of joint effusion or positive patellar float test; 6. Patients with gouty, rheumatic or rheumatoid knee arthritis, knee tuberculosis or tumors; 7. BMI >= 32 kg/m^2; 8. Patients with a history of hypersensitivity (allergy) to sodium hyaluronate; 9. Patients with severe cardiovascular and cerebrovascular diseases (such as stroke, acute myocardial infarction in the active stage), severe pulmonary diseases (such as severe asthma, respiratory failure), liver dysfunction, or kidney dysfunction; 10. Patients with poor blood sugar control (fasting blood glucose >= 8.5 mmol/L or postprandial blood glucose >= 13.9 mmol/L); 11. Patients with coagulation disorders (activated partial thromboplastin time (APTT) or prothrombin time (PT) indicators > 1.5 times the upper limit of normal); 12. Pregnant, lactating, planning to become pregnant, or unwilling to take medically recognized contraceptive measures (such as oral contraceptives, condoms, intrauterine devices, etc.) during the trial; 13. Patients who have received intra-articular injections for knee osteoarthritis treatment within 6 months before signing the informed consent form; 14. Patients who have received hormone or immunotherapy for knee osteoarthritis within 3 months before signing the informed consent form; 15. Patients who have participated in other clinical studies within 3 months before signing the informed consent form; 16. Patients who have undergone joint replacement surgery on the target joint; 17. Patients who have undergone other surgeries (including arthroscopic examination) on the target knee joint within the past year; 18. Patients who have used strong analgesics, including opioids, oral corticosteroids for treatment within one month before participating in the clinical study, but excluding stable doses of = 10 mg/day of prednisolone or equivalent drugs; 19. Patients with other conditions deemed unsuitable for participation in the study by the investigator, such as a history of severe mental disorders or compliance issues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical overall response rate at 13 weeks post-treatment completion; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in WOMAC scores before and after treatment;The difference in VAS scores before and after treatment; | — |
Countries
China
Contacts
Public ContactTong Peijian
Zhejiang Provincial Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Zhejiang Chinese Medical University)
Outcome results
None listed