Actively Recruiting

Phase 1
Age: 25Years - 75Years
All Genders
NCT04929951

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

Led by Stanford University · Updated on 2025-10-30

48

Participants Needed

1

Research Sites

283 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 25Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Age less than 25 or greater than 75 years old
  • Radiographs demonstrating either no, little osteoarthritis, or 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 rheumatologic conditions or inflammatory arthritis
  • Currently undergoing immunomodulatory therapy
  • Uncontrolled endocrine disorder
  • BMI greater than 40 or joint space not visible by ultrasound
  • Current diagnosis of osteomyelitis, HIV-1 or HIV-2, hepatitis C, infection, or poorly controlled diabetes (HgA1C greater than 7.0)
  • Pregnancy or planned pregnancy
  • Previous stem cell injection into treatment joint
  • Patient scheduled for any concomitant shoulder surgical procedures or other surgeries affecting 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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