Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Diagnosed with knee osteoarthritis (Kellgren-Lawrence [K-L] grade II-III); (2) Recurrent joint swelling, joint pain or pain on movement, and varying degrees of functional limitation; (3) Aged 18 to 80 years; (4) Voluntarily signed the written informed consent form (ICF) and able to comply with the treatment and follow-up procedures.
Exclusion criteria
Exclusion criteria: (1) Diagnosis other than osteoarthritis (including rheumatic arthritis, traumatic arthritis, and infectious arthritis); (2) Allergy to the drugs involved in the trial or occurrence of adverse reactions after previous treatment with hyaluronidase; (3) History of knee surgery (arthroscopic surgery and open surgery); (4) History of knee infection; (5) Patients with active tuberculosis, heart failure, or shock; (6) Patients with malignant tumors; (7) Pregnant women; (8) Mental illness; (9) Cognitive impairment; (10) Neuromuscular dysfunction affecting lower limb function; (11) Complicated with thrombotic events (myocardial infarction, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism); (12) Unable to communicate verbally; (13) Participated in other clinical trials within 30 days prior to the screening visit of this study; (14) Other than the above, reasons judged by the investigator to be unsuitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) score;Osteoarthritis index (WOMAC) pain score;Osteoarthritis index (WOMAC) functional score;Hospital for Special Surgery (HSS) knee score;Effective Rate;Physician Global Assessment(PGA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging examinations (X-ray, MRI, and ultrasound);Incidence of adverse events; | — |
Countries
China
Contacts
West China Hospital, Sichuan University