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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
Stanford University
Stanford, California, United States
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Time frame: Baseline, 3, 6, 12, and 24 months
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Time frame: Baseline, 3, 6, 12, and 24 months
Lysholm Score
Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
Time frame: Baseline, 3, 6, 12, and 24 months
Veterans RAND 12 (VR-12) Score - Physical
Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better physical outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD).
Time frame: Baseline, 3, 6, 12, and 24 months
Veterans RAND 12 (VR-12) Score - Mental
Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better mental outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD).
Time frame: Baseline, 3, 6, 12, and 24 months
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