Resumen del estudio

One hundred twenty patients with symptomatic tibiofemoral knee osteoarthritis (Kellgren–Lawrence grade 2–3) were randomised to receive a single intra-articular injection of autologous micro-fragmented adipose tissue (n=60) or placebo isotonic saline (n=60) following abdominal liposuction. The primary outcome of interest was KOOS4 at 6 months. Secondary outcomes included KOOS subscales (Pain, Symptoms, ADL, Sports/Recreation, QoL), Tegner activity score, proportion achieving the KOOS4 MCID, treatment failure, return to work and sport, adverse events, and treatment-related discomfort, assessed at 3, 6, 12, and 24 months. Overall, the results of the study revealed no statistically significant or clinically important between-group differences in KOOS4 at any time point (6-month between-group difference in change 1.7, 95% CI −3.6 to 7.1; p=0.52), nor in Tegner scores or other secondary outcomes, although both groups showed substantial and sustained improvements from baseline over 2 years. These findings suggest that a single point-of-care injection of micro-fragmented adipose tissue offers no meaningful advantage over saline for knee osteoarthritis despite the presence of viable stem cells in the injected product.