Abstract
Currently, conservative treatment for knee osteoarthritis (KOA) has limited efficacy, and autologous adipose-derived stromal vascular fraction (SVF) knee injections, a novel treatment approach, are receiving widespread attention. Our study aimed to explore the efficacy and safety of SVF treatment for KOA patients. This randomized controlled trial sought to assess the efficacy and safety of intra-articular SVF injections for the treatment of KOA, both as an independent intervention and in conjunction with conventional rehabilitation. Sixty-six KOA subjects were randomly divided into three groups: (1) the SVF group received a single SVF intra-articular knee injection; (2) the control group received conventional rehabilitation treatment (muscle strength training, interferential therapy, and manual therapy, 5 times a week for a total of 4 weeks); and (3) the combination therapy group received a single SVF intra-articular knee injection followed by conventional rehabilitation treatment. Outcomes were assessed during a 12-month follow-up period, with outcome measures including the visual analog scale for pain; the Western Ontario and McMaster Universities Osteoarthritis Index for pain, stiffness, and function; range of motion (ROM); and the occurrence of complications. A total of 62 patients completed the follow-up. There were no significant baseline differences among the groups. The results after treatment revealed that the SVF group and the combination therapy group significantly outperformed the control group in terms of pain relief, improvement in knee function, and increased mobility (P < 0.05). Throughout the treatment and follow-up periods, no severe adverse events were reported in any of the three groups (P > 0.05). The results of this study indicate that SVF intra-articular injection alone or in combination with conventional rehabilitation methods can significantly improve pain, knee function, and stiffness in KOA patients, with the therapeutic effects continuing to increase over a 12-month period. SVF treatment provides an effective and safe therapeutic option for KOA patients and has important implications for future clinical practice and research.