Status:
COMPLETED
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Lead Sponsor:
Stanford University
Conditions:
Osteoarthritis, Knee
Knee Pain
Eligibility:
All Genders
35-75 years
Phase:
PHASE3
Brief 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 conventiona...
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 wi...
Eligibility Criteria
Inclusion
- Age between 35 and 75 years-old
- Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3.
- 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
- Age \< 35 or \> 75 years old
- Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )
- Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)
- Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
- Co-morbidity with rheumatologic condition, inflammatory arthritis
- Currently undergoing immunomodulatory therapy
- Uncontrolled endocrine disorder
- BMI \>35
- 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 surgical procedures.
- Coagulopathy or anticoagulant treatment
- Chronic pain involving multiple body parts or opioid medication management
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03467919
Start Date
April 1 2018
End Date
October 29 2024
Last Update
November 22 2024
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305