Clinical Trials Logo
  1. Home
  2. Shoulder Pain
  3. NCT04929951
  4. Details
NCT04929951 Clinical Trial

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

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04929951
Other study ID # 59461
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 28, 2022
Est. completion date December 31, 2025

Study information
Verified date September 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary ASES Shoulder Score Patient reported outcome measure that reports shoulder pain and shoulder functionality 24 Months
Secondary DASH Outcome Measure Patient reported questionnaire that measures physical function and symptoms 24 Months
Secondary Veterans RAND 12 (VR-12) score Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy 24 Months
See also
  Status Clinical Trial Phase
Recruiting NCT04930393 - Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients N/A
Completed NCT03717753 - Rotator Cuff Pathway N/A
Active, not recruiting NCT04454671 - Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment N/A
Completed NCT06274827 - Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises N/A
Recruiting NCT06039345 - Shoulder RFA Pilot Study
Not yet recruiting NCT05413213 - Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder N/A
Not yet recruiting NCT05043844 - Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder N/A
Recruiting NCT02903719 - The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection. Phase 4
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Completed NCT02554968 - Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Recruiting NCT02242630 - Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis N/A
Active, not recruiting NCT02843269 - Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM N/A
Completed NCT02631395 - The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball N/A
Completed NCT01885377 - SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain N/A
Completed NCT01733914 - Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain Phase 2
Completed NCT01205542 - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function N/A
Completed NCT01843660 - An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain Phase 4
Completed NCT00743600 - Ultrasound Evaluation of the Rotator Cable and Associated Structures. N/A
Completed NCT00679887 - Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points Phase 1/Phase 2
Completed NCT04058522 - Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection N/A