Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: INTRAARTICULAR INJECTION: UNDER STERILE ASEPTIC PRECAUTIONS 15ML OF PERIPHERAL VENOUS BLOOD ASPIRATED , PROCESSED AND INJECTED INTO THE KNEE JOINT IN THE OPERATION THEATRE
UNDER STERIL
Sponsors
Department Of Orthopaedics
Eligibility
Inclusion criteria
Inclusion criteria: Age between 35 and 75 years-old Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 1, 2 or 3. Vas Score between 40 to 80. Working understanding of the English language and able to fully understand the procedure Capable of providing informed consent Able to complete online, in-person or phone surveys for the purposes of follow-up Capable of understanding pre- and post-procedure care instructions Ambulatory at baseline Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.
Exclusion criteria
Exclusion criteria: Age 75 years old MRI demonstrating either no or severe osteoarthritis (Kellgren-Lawrence Grade 0,4) Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc.) Previous cortisone and/or Hyaluronic acid intra-articular injection or arthroscopic procedure within the last 3 months Co-morbidity with autoimmune disease including rheumatologic condition, inflammatory arthritis Chronic disease or medical condition such as cancer, cardiac conditions including CHF NYHA class 2 or worse, liver failure, renal failure including CKD grade 3 or worse, respiratory disease such as COPD and pulmonary fibrosis, clotting/coagulation disorder or Thrombocytopenia with Currently undergoing immunomodulatory therapy or otherwise immunosuppressed Uncontrolled endocrine disorder BMI >35 Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C >7.0) Pregnancy or planned pregnancy previous stem cell injection into treatment joint Patient scheduled to undergo any concomitant surgical procedures. Coagulopathy or anticoagulant treatment Fibromyalgia, chronic fatigue or chronic pain involving multiple body parts or opioid medication management Active or recent (within 2 weeks) history of infection Neuromuscular disease Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 WOMAC and VAS scores along with a questionnaire to assesses the quality of life.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 WOMAC and VAS scores along with a questionnaire to assesses the quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| The patient health and clinical outcome which include Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analog scale (VAS) score will be monitored after one yearTimepoint: one year | — |
Countries
India
Contacts
Public ContactDR D L VENKATESH
SRI VENKATESWARA MEDICAL COLLEGE, TIRUPATI
Outcome results
None listed