None listed
Conditions
Interventions
Drug, Medical Device, Procedure/Surgery : According to the assigned group, either the Experimental group or the Control group, the investigational medical device or drug is administered.
The Experimen
Sponsors
OV MEDI CO.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 40 or older 2) Negative (-) or within the normal range on rheumatoid factor testing 3) Patients diagnosed with degenerative knee osteoarthritis classified as Kellgren & Lawrence grade I to III 4) Weight-bearing pain (100 mm-VAS) = 40 mm 5) Patients capable of walking without assistive devices 6) Patients who voluntarily agree to participate in the clinical trial and have signed a written consent form
Exclusion criteria
Exclusion criteria: 1) History of knee injection treatment before the screening visit 2) Use of anticoagulants or antiplatelet agents, analgesics, arthritis supplements, and physical therapy or oriental medicine treatment for the knee prior to randomization (participation allowed after washout) 3) Subjects who are continuously taking analgesics or are expected to require analgesic use during the clinical trial period 4) Subjects with hemorrhagic disorders, or those for whom discontinuation of antithrombotic agents is expected to cause significant harm. 5) BMI > 39 kg/m2 6) Pain disorders or secondary arthritis that may affect the evaluation of efficacy 7) Procedures including arthroscopy of the knee joint (within 1 year), severe trauma (within 6 months), surgical surgery history, surgical surgery planned during the clinical trial period, infection, severe inflammation, joint effusion 8) Patients with HbA1c = 9.0% or diabetes requiring insulin treatment 9) Subjects deemed unsuitable for participation in the clinical trial based on clinical laboratory test results. 10) Patients with a history of malignant tumors within 5 years 11) Participation in another clinical trial within 30days prior to participation in this trial 12) Men or women of childbearing age who do not agree to use contraception during the clinical trial 13) Pregnant or lactating women 14) Subjects with a history of hypersensitivity to components of the investigational medical device or drug, or those with hypersensitivity to local anesthetics. 15) Other patients deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 100 mm-VAS(Visual Analog Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in KKS(Korean Knee Score);Change in WOMAC(The Western Ontario and McMaster Universities Osteoarthritis Index) ;Change in SMC(The Samsung Medical Center);Change in muscle volume;Change in thigh circumference;Use of rescue medication;Satisfaction score(Likert scale) | — |
Countries
Korea, Republic of
Contacts
Public ContactSe rang Moon
Korea University Ansan Hospital
Outcome results
None listed