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

59461

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.

2022-07-28

2025-12-31

2025-12-31

Recruiting

Early phase I

48

Inclusion Criteria: * 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: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

2023-09-21