Health Condition 1: null- OSTEOARTHRITIS OF THE KNEE
Conditions
Interventions
Intervention1: Platelet Rich Plasma Therapy for grade 1 and 2 osteoarthritis of knee
Controls: Joint saline injection
: This will be a single-blinded (patient is blinded), randomized, placebo-contro
2. Group 2-LP-PRP).Both groups of patients will receive either IA saline (Group 1)or IA LP-PRP (Group 2) on day 1. The patients will remain blinded for the first 3 months of study. The patient health
Sponsors
Department Of Orthopaedics SVRR Government General Hospital Tirupati
Dr Sreenivasa Reddy
Dr Charan Ganta
Eligibility
Inclusion criteria
Inclusion criteria: Informed consent obtained Grade 1 and 2 Kellegren and Lawrence classification Walking ability with or with out external support Vas score in the range of 40 to 80
Exclusion criteria
Exclusion criteria: Inability to obtain informed consent Received intra-articular injections of steroids or hyaluronic acid Underwent arthroscopic surgery in the past 3 months Generalised osteoarthritis due to autoimmune diseases Advanced Osteoarthritis Compromised bone metabolism except for osteoporosis Fibromyalgia Chronic fatigue syndrome Liver disease Clotting deficiency Thrombocytopenia Treated with anticoagulants Active or recently recovery from infection Cancer Neuromuscular disease Severe cardiovascular disease Immunosuppressed patients Pregnancy Severe damage of ipsilateral hip or ankle Inflammatory diseases of connective tissue Involved in proceedings for legal incapacitation or financial compensation Documented history of allergy to steroids, bupivacaine or blood products Valgus deformity > 15 degrees or varus deformity > 20 degrees Severe ligamentous instability of the knee joint Limitation of knee range of movement: flexion 20 degrees HIV, Hepatitis serology positive Post- chikungunya induced osteoarthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients treated with PRP are expected to have significant decrease in pain scale scores compared to saline treated patients after 91 days. In addition, patients evaluated at 181 days with two doses of PRP are expected to show more significant decrease in pain scale scores compared to single dose of PRP patients.Timepoint: Patients enrolled in the study will be evaluated before the start of the study (day 0) followed by a 4-week follow-up to assess Western Ontario and McMaster Universities (WOMAC), Rupee Scale (RS) and Visual Analog Score (VAS) pain scales along with a questionnaire to assesses the quality of life. The final pain scale scores will be collected on day 91 and 181 and compared to day 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect the inflammatory cytokines will be significantly decreased in the synovial fluid on day 181 compared to day 0 in patients treated with two doses of PRP therapy. According to Knopet. al. PRP contain soluble TNF-a and IL-1 receptors that cause competitive inhibition of these cytokines and prevents chondrolysisvia decreased production of matrix metalloproteinases.Timepoint: A significant decrease in the inflammatory cytokine levels of TNF-a and IL-1 is expected at the end of 6 months (181 days) within the synovial fluid and increase cartilage regeneration (Knop et. al. 2016). | — |
Countries
India
Contacts
Public ContactDr D L Venkatesh
Sri Venkateswara Medical College, Tirupati
Outcome results
None listed