Knee Osteoarthritis
Conditions
Interventions
Treatment Group:Intra-articular injection of medical modified chitosan joint injection fluid (biomimetic synovial fluid)
Control Group:Intra-articular injection of sodium hyaluronate injection solution
Sponsors
Zhongshan Hospital of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients who were diagnosed with knee osteoarthritis accompanied by cartilage defects through MRI examination. Here is the English translation of your text for the research project application: 2. No other autoimmune or systemic diseases. 3. Agree not to participate in other related studies, and do not accept other osteoarthritis treatment plans during the participation in this study. 4. No use of other drugs that may affect the effect of osteoarthritis during the treatment period. 5. Signed an informed consent form and can cooperate with the treatment plan of this project.
Exclusion criteria
Exclusion criteria: 1. Suffering from severe systemic diseases other than osteoarthritis. 2. Having clinically significant urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine, or other systemic diseases. 3. Concurrent rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, relapsing polychondritis, or other autoimmune diseases. 4. Having malignant tumors or a history of malignant tumors. 5. Having contraindications for MRI examinations. 6. Suffering from diseases that the research team believes may interfere with the subject's treatment or compliance. 7. Participating in other related studies and receiving other osteoarthritis treatment regimens during this study. 8. Taking other medications that may affect the efficacy of osteoarthritis treatment during the treatment period. 9. Having a history of alcoholism or intravenous drug addiction within one year prior to enrollment. 10. Refusing to join the research team or refusing to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC Index;K-L Grade;WORMS Index;Cartilage Defect Area;Time up to go;Noyes Grade; | — |
Secondary
| Measure | Time frame |
|---|---|
| C-Reactive Protein(CRP);Erythrocyte Sedimentation Rate(ESR);Tumor Necrosis Factor-alpha(TNF-a);Tartrate-Resistant Acid Phosphatase Isomer(TRACP5b);Bone Specific Alkaline Phosphatase(BALP);Bone Gla-containing Protein(BGP);Interleukin-6(IL-6);Interleukin-1 beta(IL-1ß);Type II Collagen(COL2);Matrix Metalloproteinase 13(MMP13); | — |
Countries
China
Contacts
Public ContactChenxiao Zheng
Zhongshan Hospital of Traditional Chinese Medicine
Outcome results
None listed