The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03467919|
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : May 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Knee Pain||Procedure: Micro Fragmented Adipose Tissue Procedure: Corticosteroid injection||Phase 3|
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 knee. 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 medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: MFAT(Micro Fragmented Adipose Tissue)
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.
Procedure: Micro Fragmented Adipose Tissue
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Active Comparator: Conventional therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
Procedure: Corticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
- Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score [ Time Frame: 24 months ]Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms
- Lysholm score [ Time Frame: 24 months ]Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
- Veterans RAND 12 (VR-12) score [ Time Frame: 24 months ]Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
- MRI Cartilage Scan [ Time Frame: 12 months ]Cartilage thickness on MRI using T2-weighted cartilage mapping
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467919
|Contact: Ma Agnes Ith, MD||(650) email@example.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Eugene Y Roh, MD 650-721-7600 firstname.lastname@example.org|
|Principal Investigator: Eugene Y Roh, MD|
|Principal Investigator:||Eugene Y Roh, MD||Stanford University|
|Principal Investigator:||Jason Dragoo, MD||Stanford University|
|Principal Investigator:||Seth Sherman, MD||Stanford University|