A STUDY COMPARING THE PAIN AND RANGE OF MOVEMENTS FOLLOWING THE INJECTIONS OF PLATELET RICH PLASMA DERIVED FROM BLOOD AND BONE MARROW ASPIRATION CELLS FROM THE ILIAC BONE INTO THE KNEE JOINT SUFFERING FROM ARTHRITIS

Not Applicable

• Conditions: Health Condition 1: M171- Unilateral primary osteoarthritisof knee

• Registration Number: CTRI/2021/11/038075
• Lead Sponsor: Department Of Orthopaedics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Age < 35 or > 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 <150,000 platelets per mm3.

Currently undergoing immunomodulatory therapy or otherwise immunosuppressedUncontrolled 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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