Knee Osteoarthritis. Osteoarthritis of knee
Conditions
Interventions
Intervention 1: Control group: Patients receiving 3 doses of normal saline + Hyaluronic acid The procedure will be performed in such a way that patients are injected intra-articular injection of 2 cc
Sponsors
Royan Stem Cell Technology Company
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 45-70 years Kellgren and Lawrence grade of both knees between 2 and 3 knee pain for at least 4 months that has not responded to common medical and physical therapies. Visual analogue score = 4 Informed consent
Exclusion criteria
Exclusion criteria: Pregnancy or lactation Presence of any concomitant knee injury that causes pain or swelling (eg, ligament damage or meniscal tear) Intra-articular injection of hyalgan or steroid drugs during the last 2 months Malalignment of the knee joint more than 15 degrees (diagnosis with triple joint view radiography) Documented uncontrolled underlying diseases (including diabetes (HbA1c = 8), heart failure (EF2), liver failure (AST, ALT>100) The existence of blood or cardiovascular diseases, infections and weak immunity, neoplasm, etc., which interfere with the evaluations. History of orthopedic surgery in the spine or lower limbs osteoarthritis of the hip or ankle joint Known allergy to hyaluronic acid products Taking aspirin one week before cell injection History of coagulopathy or use of anticoagulant drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and severe adverse events. Timepoint: 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire.;Western Ontario and McMaster Universities Osteoarthritis Index. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: WOMAC Questionnaire.;Visual analog scale. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Visual Analogue Scale Questionnaire.;Disability index. Timepoint: Baseline and 6, 9, and 12 months after intervention. Method of measurement: Short Form Health-36 Questionnaire.;Articular cartilage thickness. Timepoint: Baseline and 12 months after intervention. Method of measurement: Magnetic resonance imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and severe adverse events. Timepoint: 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMorteza Zarrabi
Royan Institute
Outcome results
None listed