Abstract
PURPOSE: Micro-fragmented adipose tissue is emerging as a promising option for the treatment of various diseases including knee osteoarthritis (OA), though clinical trials are often limited by short follow-up periods. Our aim was to evaluate the safety and clinical outcomes of an arthroscopic debridement followed by a single injection of micro-fragmented adipose tissue in patients affected by knee OA. METHODS: From 2016 to 2020, patients affected by knee OA were enroled. Micro-fragmented adipose tissue was obtained through the Lipogems® kit and intraarticularly injected after an arthroscopic debridement. Visual analogue scale for pain, Tegner score, Knee Injury and Osteoarthritis Outcome score subscales variations were assessed from baseline to 3, 6, 12, 24 and 48 months of follow-up. RESULTS: Forty-one patients were evaluated up to 6 months of follow-up, 39 patients up to 24 months of follow-up and 38 patients up to 48 months of follow-up. Three underwent knee replacement surgery during the time of the study. All the clinical scores analyzed achieved statistically significant changes up to the last follow-up. CONCLUSIONS: A single intra-articular knee injection of micro-fragmented adipose tissue following arthroscopic debridement is able to provide significant clinical benefits in patients affected by knee OA up to 4 years of follow-up.The present clinical study was registered on clinicaltrials.gov (no. NCT06545266). LEVEL OF EVIDENCE: Level IV case series.