2025 ISAKOS Biennial Congress Paper
Injection of Micro-Filtered Adipose Tissue Versus Placebo for Bilateral Knee Osteoarthritis: Results of a Randomized Controlled Trial
Iacopo Romandini, MD, Doha QATAR
Alessandro Di Martino, MD, Bologna, BO ITALY
Luca Andriolo, MD, Bologna ITALY
Angelo Boffa, MD, Bologna ITALY
Simone Silva, MD, Gassino Torinese, Torino ITALY
Lorenzo Zanasi, MD, Bologna ITALY
Giacomo Roveda, MD, Bologna ITALY
Stefano Zaffagnini, MD, Prof., Bologna ITALY
Giuseppe Filardo, MD, PhD, MBA, Prof., Lugano SWITZERLAND
IRCCS Istituto Ortopedico Rizzoli, Bologna, ITALY
FDA Status Cleared
Summary
A single injection of micro-filtered adipose tissue did not show clear superiority over placebo up to 12 months, with both treatments yielding comparable results in clinical scores and treatment failures.
Abstract
Objective
Knee osteoarthritis (OA) represents a very common problem with a high social impact, and a significant number of patients complain of bilateral symptomatic OA. The aim of this double-blind randomized self-placebo-controlled trial is to compare the clinical and imaging results offered by an intra-articular injection of micro-filtered adipose tissue (MF-AT) versus placebo for bilateral knee OA.
Methods
The study design includes 100 patients with bilateral symptomatic knee OA. Each patient receives an MF-AT injection (treatment group, n=100 knees) in one knee and a saline injection (control group, n=100 knees) in the other knee. The side of the treatment is randomly assigned. Patients are prospectively followed at 1-3-6-12-24 months of follow-up using WOMAC, IKDC subjective and objective, EQ-VAS, and Tegner scores. Magnetic resonance imaging is performed at 12 months, and radiographs are performed with James-Duo assistance at 24 months. Up to date, 84 patients (84 knees for each group) have been evaluated up to 12 months of follow-up and are included in the current analysis.
Results
No adverse events were reported in both groups. Nineteen knees failed, requiring a new treatment, eleven in the treatment group and eight in the control group. At the 12-month follow-up, a significant improvement in all clinical scores was found compared to the baseline evaluation in both groups. The WOMAC score in the treatment and placebo groups improved from 40.9±12.0 and 42.1±11.7 to 24.9±17.6 and 27.5±18.3 (both p < 0.0005), respectively. Similar trends were found for all the WOMAC subscales, IKDC, VAS scores. No differences were observed between the two groups in terms of absolute values and improvement of the clinical scores.
Conclusions
The preliminary results of this study suggest that a single injection of MF-AT did not demonstrate a clear superiority compared to placebo injection up to 12 months of follow-up, reporting overall comparable results in terms of clinical scores and failures.