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

Trial ID or NCT#

NCT04929951

Status

recruiting iconRECRUITING

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 Shoulder Osteoarthritis

Eligibility Criteria

Ages Eligible for Study: 25 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Age between 25 and 75 years-old - Diagnosis of pre-existing osteoarthritis of the glenohumeral joint - 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 < 25 or > 75 years old - Radiographs demonstrating either no, little osteoarthritis, severe(bone on bone) osteoarthritis - Prior total or partial joint replacement surgery or surgery involving cartilage regeneration - Previous cortisone, PRP or Hyaluronic acid intra-articular injection within the last 3 months - Co-morbidity with the rheumatologic condition, inflammatory arthritis - Currently undergoing immunomodulatory therapy - Uncontrolled endocrine disorder - BMI >40 or joint space not visible by ultrasound - 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 shoulder surgical procedures or other surgery which may affect outcomes. - Coagulopathy or anticoagulant treatment - Chronic pain involving multiple body parts or opioid medication management - Diagnosis of fibromyalgia - Concomitant massive(2 tendons with retraction), complete rotator cuff tendon tear
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Investigator(s)

Eugene Y. Roh, MD
Geoffrey Abrams, MD
Geoffrey Abrams, MD
Sports medicine surgeon, Shoulder surgeon
Associate Professor of Orthopaedic Surgery

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Contact

Shannon Schultz, BA
650-723-2897

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View on ClinicalTrials.gov