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Purpose: To evaluate the effectiveness of microfragmented adipose tissue (MFAT) for pain relief and improved joint functionality in osteoarthritis (OA) of the knee in a randomized controlled clinical trial with 1-year follow-up.
Methods: Seventy-five patients were stratified by baseline pain level and randomized to 1 of 3 treatment groups: MFAT, corticosteroid (CS), or saline control (C) injection. Patients 18 years of age or older, diagnosed with symptomatic OA of the knee, with radiographic evidence of OA of the knee and a visual analog pain scale score of 3 of 10 or greater were included. Patients were excluded if they had any previous intra-articular knee injection, current knee ligamentous instability, or an allergy to lidocaine/corticosteroid. The visual analog pain scale, Western Ontario and McMaster Universities Osteoarthritis Index, and the Knee Injury and Osteoarthritis Outcome score (KOOS) were recorded preprocedure and at 2 weeks, 6 weeks, 3 and 6 months, and 1-year follow-up.
Results: MFAT demonstrated consistent and statistically significant improvements across all primary outcome measures for joint pain and functionality compared with C. For MFAT, there was a significant improvement over baseline at each follow-up, with median (95% confidence interval) KOOS Pain score changes of 18.1 (11.1-26.4) at week 2 to 27.8 (19.4-37.5) at 1 year. For CS, the median KOOS pain score reached a maximum of 22.2 (15.3-30.6) at week 2, only to level off to 13.9 (e2.8 to 29.2), a level not statistically different from baseline, at 1 year. The median changes for C hovered around 6 to 11 points, with statistically significant improvements over baseline indicating a placebo effect. Similar trends were seen for the Western Ontario and McMaster Universities Osteoarthritis Index Pain score and VAS Pain score.
Conclusions: In this study, MFAT demonstrated a clinically significant improvement in primary outcome scores compared with the C group, whereas the CS group only showed statistically significant improvement compared with the C group at 2 and 6 weeks. This finding indicates that MFAT may be a viable alternative treatment for patients with OA of the knee who fall into the orthopaedic treatment gap.
Level of Evidence: Level II, partially blinded, randomized controlled clinical trial.
Autori
Dustin L. Richter, M.D., Joshua L. Harrison, M.D., Lauren Faber, M.D., Samuel Schrader, M.D., Yiliang Zhu, Ph.D., Carina Pierce, Leorrie Watson, Anil K. Shetty, M.D., Robert C. Schenck Jr., M.D.
