The use of intra-articular injection of autologous micro-fragmented adipose tissue as pain treatment for ankle osteoarthritis: a prospective not randomized clinical study.

PURPOSE: The objective of this study was to evaluate the safety and the efficacy of intra-articular injections of autologous micro-fragmented adipose tissue in patients affected by early or moderate ankle osteoarthritis (AOA). METHODS: A total of 31 symptomatic patients, aged 28-71 years, affected by AOA, were treated with 5 ml of autologous micro-fragmented adipose tissue. Clinical evaluations before the treatment and after six, 12, and 24 months were performed through American Orthopaedic Foot and Ankle Society (AOFAS) scale, the Foot and Ankle Disability Index (FADI), and Visual Analogue Scale (VAS) scores. Adverse events were recorded. RESULTS: No severe complications were noted during the treatment and the follow-up period. A statistically significant improvement from basal evaluation to the six, 12-, and 24-month follow-up visit was observed, whereas a statistically significant worsening from the 12-month to the 24-month follow-up visit was showed. CONCLUSION: The autologous micro-fragmented adipose tissue for the treatment of pain in ankle osteoarthritis seems safe and able to provide positive clinical outcomes, potentially offering a new minimally invasive therapeutic option for patients who are not eligible for more invasive approaches. Further high-quality studies are needed to confirm these findings.