Patients with knee osteoarthritis aged between 40-80 years with knee osteoarthritis. Osteoarthritis, Platelet-Rich Plasma, Silk Fibroin, Tissue Regeneration, Controlled Drug Release
Conditions
Interventions
Patients are scheduled for knee joint injection within 7-28 days after screening. The preparation of the investigational products and the knee joint injection takes approximately 35 minutes. The proce
s knee joint by Principial investigator using a 1% lidocaine without adrenaline to anesthetize the skin around the suprapatellar pouch. A 21-gauge needle is used to inject into the anesthetized area w
Experimental Drug,Placebo Comparator Biological/Vaccine
PRP Injection Alone,PRP Injection Alone
Sponsors
ENGINELIFE CO., LTD.
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with one-leg standing of knee osteoarthritis based on the American College of Rheumatology criteria, classified as Grade II or III according to the Kellgren and Lawrence (KL) classification of knee osteoarthritis from the weight bearing knee antero-posterior (AP) radiograph, 2. Patients experiencing osteoarthritis symptoms in only one knee, 3) Patients with a Visual Analog Scale (VAS) pain score higher than 4 in the past month, 4)Patients aged between 40-80 years, 5. Patients must fully understand the details of the research project.
Exclusion criteria
Exclusion criteria: 1. Patients with history thrombocytopenia (Platelet count less than 150000 per microliter) or history of abnormal blood coagulation (activated partial thromboplastin time (aPTT) more than 40 second or the international normalized ratio (INR) more than 1.2), 2. Patients taking medications that affect platelet function, such as aspirin, 3. Patients with active infections, 4. Patients with anemia. (Hemoglobin value of less than 12.0 gm per dl.), 5. Patients who cannot communicate or have cognitive impairments, 6. Patients who have received knee injections within 6 months before the start of the study, 7. Patients with osteoarthritis due to inflammatory joint disease, 8. Patients with a history of protein allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional score at 4, 12, 26 weeks after end of the intervention WOMAC,Functional score at 4, 12, 26 weeks after end of the intervention Lysholm Tegner Knee Scale,Functional score at 4, 12, 26 weeks after end of the intervention SF-12 ,Functional score at 4, 12, 26 weeks after end of the intervention Visual Analog Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional score at 4, 12, 26 weeks after end of the intervention range of motion.,adverse events and reactions after recieved the intervention adverse events and reactions | — |
Countries
Thailand
Contacts
Public ContactThun Itthipanichpong
Faculty of Medicine at Chulalongkorn University
Outcome results
None listed