Knee Osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age>40 yearsr, gender unrestricted; KPS score >70 2.knee osteoarthritis, with joint pain persisting for at least one month 3.Patients must be ambulatory without assistance during screening and efficacy evaluation 4.The target knee joint must have a Kellgren-Lawrence grade of II, III, or IV, and the grade of the contralateral knee must not exceed that of the target knee 5.Prior to randomization, the target knee must meet the following WOMAC pain score criteria: a VAS score >=40 mm (on a 0-100 mm scale) for pain during "walking on a flat surface," and a total WOMAC pain subscale score =225 mm (on a 0-500 mm scale) 6.The subject(s) shall understand and comply with the study procedures, voluntarily participate in the study, and sign the informed consent form (ICF)
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant, lactating, or planning to become pregnant during the study period. 2.Other inflammatory or painful conditions of the knee joint, such as rheumatoid arthritis, psoriatic arthritis, gout, tumors, pigmented villonodular synovitis, traumatic arthritis, septic (pyogenic) arthritis, tuberculous arthritis, etc 3.Patients with osteoarthritis secondary to osteomyelitis, bone tumors, or bone tuberculosis 4.Patients with active skin lesions (e.g., ulceration, infection, rash) overlying the target knee 5.Patients with comorbidities in the target lower limb (e.g., significant bone deformity, advanced meniscal tear, neurovascular disease) that could confound the efficacy assessment 6.Patients with a history of radiation therapy to the target knee joint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC Pain Subscale Score; | — |
Countries
China
Contacts
Jinan Central Hospital