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Recruiting NCT04929951

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

Phase I Interventional Osteoarthritis Shoulder Shoulder Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Micro Fragmented Adipose Tissue, Corticosteroid injection.
Who it may be relevant to
Registry conditions: Osteoarthritis Shoulder, Shoulder Pain. Basic parameters: 25 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

  • Biological Micro Fragmented Adipose Tissue
    Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
  • Biological Corticosteroid injection
    Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Primary outcome measures

  • ASES Shoulder Score [Time frame: 24 Months]
Secondary outcome measures (2)
  • DASH Outcome Measure [Time frame: 24 Months]
  • Veterans RAND 12 (VR-12) score [Time frame: 24 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT04929951 · 59461

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗