Knee osteoarthritis
Conditions
Interventions
Control group:Sodium hyaluronate Injection (Alzhi)
Experimental Group:BDDE-crosslinked sodium hyaluronate Injection
Sponsors
Zhejiang Provincial Hospital of TCM
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 not limited. 2. Meet the diagnostic criteria for knee osteoarthritis set by the American College of Rheumatology. The diagnostic criteria are: having knee pain and X-ray of the knee showing osteophytes, and at least one of them: ? Age >=50 years old;? Morning stiffness of the affected knee for less than 30 minutes;? There is a bone friction sound when the joint moves. 3. The VAS score of the knee joint on the study side was 4 to 9 points, while that of the knee joint on the non-study side was less than 4 points. 4. The Kellgren&Lawrence grade of the upright X-ray examination of the knee joint on the study side was I-III. 5. Be able to communicate well with researchers and comply with research requirements; 6. Patients who are willing to sign a written informed consent form, or patients whose guardians can sign a written informed consent form. 7. Oral corticosteroids (prednisolone or equivalent drugs, <=10mg/ day and used for more than 4 weeks), acetaminophen.
Exclusion criteria
Exclusion criteria: 1. There may be systemic infections near the injection site; 2. Those with infectious arthritis; 3. Patients with acute or chronic hemorrhagic arthritis; 4. Patients with multiple joint pain; 5. Patients with a large amount of effusion in the joint cavity or positive floating patellar test; 6. Patients with gout, rheumatic or rheumatoid knee arthritis, knee tuberculosis and tumors; 7. BMI >= 32 kg/m^2; 8. There is a history of hypersensitivity reaction (allergy) to sodium hyaluronate; 9. Those with severe cardiovascular and cerebrovascular diseases (such as stroke, active stage of acute myocardial infarction), severe lung diseases (such as severe asthma, respiratory failure), liver dysfunction, and kidney dysfunction; 10. Diabetic patients with poor blood glucose control (fasting blood glucose >= 8.5mmol/L or postprandial blood glucose >= 13.9mmol/L); 11. Individuals with coagulation disorders (Activated partial thromboplastin time (APTT) or prothrombin time (PT) indicators > 1.5 times the upper limit of normal); 12. Pregnancy, lactation, planning to get pregnant, etc. 13. Those who received intra-articular injection for knee osteoarthritis treatment within 6 months prior to signing the informed consent form; 14. Patients who have received hormone or immunotherapy for knee osteoarthritis within 3 months prior to signing the informed consent form; 15. Those who have participated in other clinical studies within 3 months prior to signing the informed consent form; 16. Patients who have undergone replacement surgery on the target joint ; 17. Patients who have undergone other surgeries (including arthroscopy) on the target knee joint within the past year; 18. Strong painkillers, including opioids and oral corticosteroids, were used within 4 weeks before participating in the trial, but prednisolone or equivalent drugs with a stable dose of =10mg/ day were not included.; 19. Other circumstances that the researcher deems unsuitable for participation in the study, such as having a history of severe mental disorders or having compliance issues, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC pain subscale score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC function/stiffness subscores at each follow-up visit after treatment; | — |
Countries
China
Contacts
Public ContactZhong Ying
Zhejiang Provincial Hospital of TCM
Outcome results
None listed