Mid-term outcomes of microfragmented adipose tissue plus arthroscopic surgery for knee osteoarthritis: A randomized, active-control, multicenter clinical trial

BACKGROUND

Osteoarthritis (OA) is the most prevalent form of degenerative whole-joint disease. Before the final option of knee replacement, arthroscopic surgery was the most widely used joint-preserving surgical treatment. Emerging regenerative therapies, such as those involving platelet-rich plasma, mesenchymal stem cells, and microfragmented adipose tissue (MFAT), have been pushed to the forefront of treatment to prevent the progression of OA. Currently, MFAT has been successfully applied to treat different types of orthopedic diseases.

AIM

To assess the efficacy and safety of MFAT with arthroscopic surgery in patients with knee OA (KOA).

METHODS

A randomized, multicenter study was conducted between June 2017 and November 2022 in 10 hospitals in Zhejiang, China. Overall, 302 patients diagnosed with KOA (Kellgren-Lawrence grades 2-3) were randomized to the MFAT group (n = 151, were administered MFAT following arthroscopic surgery), or the control group (n = 151, were administered hyaluronic acid following arthroscopic surgery). The study outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, the visual analog scale (VAS) score, the Lequesne index score, the Whole-Organ Magnetic Resonance Imaging Score (WORMS), and safety over a 24-mo period from baseline.

RESULTS

The changes in the WOMAC score (including the three subscale scores), VAS pain score, and Lequesne index score at the 24-mo mark were significantly different in the MFAT and control groups, as well as when comparing values at the posttreatment visit and those at baseline (P < 0.001). The MFAT group consistently demonstrated significant decreases in the WOMAC pain scores and VAS scores at all follow-ups compared to the control group (P < 0.05). Furthermore, the WOMAC stiffness score, WOMAC function score, and Lequesne index score differed significantly between the groups at 12 and 24 mo (P < 0.05). However, no significant between-group differences were observed in the WORMS at 24 mo (P = 0.367). No serious adverse events occurred in both groups.

CONCLUSION

The MFAT injection combined with arthroscopic surgery treatment group showed better mid-term clinical outcomes compared to the control group, suggesting its efficacy as a therapeutic approach for patients with KOA.

Key Words: Osteoarthritis, Microfragmented adipose tissue, Lipogems, Arthroscopic surgery, Knee

Core Tip: Microfragmented adipose tissue (MFAT) has been successfully applied to treat different types of orthopedic diseases. To assess the efficacy and safety of MFAT with arthroscopic surgery in patients with knee osteoarthritis (OA). In this study, patients’ own MFAT combined with arthroscopic surgery was used to promote recovery from OA. Our findings provide evidence supporting the safety and feasibility of this approach in treating knee OA.

• Citation: Wu CZ, Shi ZY, Wu Z, Lin WJ, Chen WB, Jia XW, Xiang SC, Xu HH, Ge QW, Zou KA, Wang X, Chen JL, Wang PE, Yuan WH, Jin HT, Tong PJ. Mid-term outcomes of microfragmented adipose tissue plus arthroscopic surgery for knee osteoarthritis: A randomized, active-control, multicenter clinical trial. World J Stem Cells 2023; 15(12): 1063-1076
• URL: https://www.wjgnet.com/1948-0210/full/v15/i12/1063.htm
• DOI: https://dx.doi.org/10.4252/wjsc.v15.i12.1063