Study Summary

66 patients with unilateral knee osteoarthritis (KOA) were enrolled in a double-blind, randomized controlled trial and were randomized in a 1:1:1 ratio to conventional rehabilitation (control) alone, stromal vascular fraction (SVF) injection alone, or stromal vascular fraction injection combined with conventional rehabilitation (SVF + control). During follow-up, 1 patient in the control group discontinued treatment, 2 patients in the SVF group were lost to follow-up, and 1 patient in the combination group was lost to follow-up, resulting in 62 patients included in the final analysis. The primary outcomes of interest were pain assessed by visual analog scale (VAS) and knee symptoms assessed by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain, stiffness, and function subscales. Secondary outcomes included knee range of motion (ROM) and treatment-related complications. Outcomes were assessed at baseline, 7 days, 1 month, 6 months, and 12 months. Overall, the results of the study demonstrated that both SVF-treated groups had significantly greater and sustained improvements in pain, stiffness, function, and ROM compared with conventional rehabilitation alone, with benefits continuing to increase through 12 months and no significant safety concerns.