The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Trial ID or NCT#
Status
Purpose
This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.
Official Title
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Eligibility Criteria
- - Age between 35 and 75 years-old - Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3. - 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.
- - Age < 35 or > 75 years old - Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 ) - 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 within the last 3 months - Co-morbidity with rheumatologic condition, inflammatory arthritis - Currently undergoing immunomodulatory therapy - 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 - Chronic pain involving multiple body parts or opioid medication management
Investigator(s)
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Contact
Ma Agnes Ith
View on ClinicalTrials.gov