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

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the shoulder. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room. To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of the shoulder (glenohumeral joint). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

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

Conditions
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Osteoarthritis Shoulder, Shoulder Pain

Intervention / Treatment
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* Biological: Micro Fragmented Adipose Tissue
* Biological: Corticosteroid injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MFAT (Micro Fragmented Adipose Tissue)<br>Intra-articular shoulder injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's shoulder. | Biological: Micro Fragmented Adipose Tissue<br>* Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection<br>* Other names: MFAT;|
| Active Comparator: Conventional Therapy<br>Intra-articular injection of corticosteroid (Triamcinolone 40mg) | Biological: Corticosteroid injection<br>* Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES Shoulder Score | Patient reported outcome measure that reports shoulder pain and shoulder functionality | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH Outcome Measure | Patient reported questionnaire that measures physical function and symptoms | 24 Months | 
| Veterans RAND 12 (VR-12) score | Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy | 24 Months |