RecruitingPhase 1NCT04929951
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
Sponsor
Stanford University
Enrollment
48 participants
Start Date
Jul 28, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 25 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria16
- 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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Interventions
BIOLOGICALMicro Fragmented Adipose Tissue
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
BIOLOGICALCorticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04929951
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