Micro-fragmented adipose tissue provides durable 1-year relief in advanced knee osteoarthritis: a double-blind randomized controlled trial

Objectives The purpose of this randomized controlled trial was to evaluate the comparative clinical effectiveness and safety of a single ultrasound-guided intra-articular injection of microfragmented adipose tissue (MFAT) versus triamcinolone hexacetonide in patients with advanced knee osteoarthritis (OA) who were already indicated for total knee arthroplasty. We hypothesized that MFAT would provide superior and longer-lasting improvements in pain relief and function compared with corticosteroid injection. Methods Sixty patients with symptomatic knee OA (Kellgren–Lawrence grade 2-4) were randomized to receive a single ultrasound-guided intra-articular injection of either MFAT or triamcinolone. To maintain blinding, adipose tissue harvesting was performed in both groups. Outcomes were assessed at baseline, 7 days, 3, 6, and 12 months using WOMAC, KOOS, EQ-5D, VAS, and SSQ-8. The primary outcome was the WOMAC pain subscore (WOMAC-A). Results Both groups improved in pain and function at 7 days and 3 months. At 12 months, the MFAT group maintained significant improvements in WOMAC pain (Δ –15.0 vs +5.0; P < .05) and WOMAC function (Δ –5.9 vs +4.4; P < .05). KOOS subscales (pain, symptoms, ADL, quality of life) also favored MFAT (all P < .05). EQ-5D demonstrated superior improvements in self-care and anxiety/depression for MFAT ( P < .05). VAS pain decreased more in MFAT (–3.0) than control (0.0; P < .001). Patient satisfaction (SSQ-8) was higher in MFAT group. No severe adverse events were reported. Conclusions MFAT provided sustained improvements in pain, function, quality of life, and satisfaction for up to 12 months, outperforming corticosteroid in patients with advanced knee OA awaiting arthroplasty. MFAT represents a safe, minimally invasive option for long-term symptom management in this challenging population.