The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis

Trial ID or NCT#

NCT03467919

Status

not recruiting iconNOT RECRUITING

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

Ages Eligible for Study: 35 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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.
Exclusion Criteria:
  1. - 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
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Investigator(s)

Eugene Y. Roh, MD
Eugene Y. Roh, MD
Sports medicine doctor
Clinical Associate Professor, Orthopaedic Surgery
Seth Lawrence Sherman, MD
Sports medicine surgeon, Shoulder surgeon, Orthopaedic surgeon
Associate Professor of Orthopaedic Surgery

Contact us to find out if this trial is right for you.

Contact

Eugene Y Roh, MD
650-721-7600

View on ClinicalTrials.gov