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MFAT for Knee Osteoarthritis

Phase 3

Waitlist Available

Led By Eugene Y Roh, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 35 and 75 years-old

Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial compares the outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus intra-articular injection of corticosteroid.

Who is the study for?

This trial is for adults aged 35-75 with moderate knee osteoarthritis who've tried physical therapy and anti-inflammatories without success. They must understand English, be able to complete surveys, follow instructions, and walk on their own. Excluded are those outside the age range, severe or minimal arthritis, recent joint injections, high BMI (>35), pregnancy plans, certain medical conditions like uncontrolled diabetes or coagulopathy.Check my eligibility

What is being tested?

The study compares two treatments for knee pain due to osteoarthritis: an injection of Micro Fragmented Adipose Tissue (MFAT) versus a standard corticosteroid injection. The goal is to see which treatment better improves clinical outcomes and function in patients.See study design

What are the potential side effects?

Potential side effects may include pain at the injection site, swelling, infection risk increase from injections generally. Corticosteroids can also cause skin discoloration or thinning around the injection area and temporary flare-ups of joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 35 and 75 years old.

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I have moderate osteoarthritis according to the Kellgren-Lawrence scale.

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I am able to understand and agree to the study's procedures and risks.

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I can walk by myself without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score

Secondary outcome measures

Lysholm score

Veterans RAND 12 (VR-12) score

Other outcome measures

MRI Cartilage Scan

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MFAT(Micro Fragmented Adipose Tissue)Experimental Treatment1 Intervention

Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's knee.

Group II: Conventional therapyActive Control1 Intervention

Intra-articular injection of corticosteroid (Triamcinolone 40mg).

0 / 4Eligibility criteria met