RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-28

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04929951

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-28

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-07-28

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Osteoarthritis Shoulder
Shoulder Pain