Using fat tissue injections to treat shoulder osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is a randomized controlled study comparing the effectiveness of intra-articular injections of Micro Fragmented Adipose Tissue (MFAT) against conventional corticosteroid injections in patients with mild to moderate shoulder osteoarthritis. The MFAT is harvested through lipoaspiration and processed with minimal manipulation in a clinical setting. Participants will be monitored for clinical and functional outcomes to determine the efficacy of MFAT in alleviating shoulder pain and improving joint function.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.