The therapeutic effect of platelet enriched blood plasma for treating knee osteoarthritis
- Conditions
- Health Condition 1: null- OSTEOARTHRITIS OF THE KNEE
- Registration Number
- CTRI/2018/03/012293
- Lead Sponsor
- Department Of Orthopaedics SVRR Government General Hospital Tirupati
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
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 <90 degrees, extension deficit > 20 degrees
HIV, Hepatitis serology positive
Post- chikungunya induced osteoarthritis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).