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©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Mid-term outcomes of microfragmented adipose tissue plus arthroscopic surgery for knee osteoarthritis: A randomized, active-control, multicenter clinical trial
Cong-Zi Wu, Zhen-Yu Shi, Zhen Wu, Wen-Jun Lin, Wei-Bo Chen, Xue-Wen Jia, Si-Cheng Xiang, Hui-Hui Xu, Qin-Wen Ge, Kai-Ao Zou, Xu Wang, Jia-Li Chen, Ping-Er Wang, Wen-Hua Yuan, Hong-Ting Jin, Pei-Jian Tong
Cong-Zi Wu, Institute of Orthopaedics and Traumatology of Zhejiang Province, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310053, Zhejiang Province, China
Zhen-Yu Shi, Jia-Li Chen, Ping-Er Wang, Wen-Hua Yuan, Hong-Ting Jin, Pei-Jian Tong, Department of Orthopedic Surgery, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310006, Zhejiang Province, China
Zhen Wu, Department of Orthopaedic Surgery, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China
Wen-Jun Lin, Department of Orthopaedic Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325015, Zhejiang Province, China
Wei-Bo Chen, Department of Orthopaedic Surgery, Ruian Hospital of Traditional Chinese Medicine, Wenzhou 325299, Zhejiang Province, China
Xue-Wen Jia, Department of Orthopaedics, Ningbo First Hospital, Ningbo 315010, Zhejiang Province, China
Si-Cheng Xiang, Hui-Hui Xu, Qin-Wen Ge, Kai-Ao Zou, Xu Wang, The First College of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou 310053, Zhejiang Province, China
Co-first authors: Cong-Zi Wu and Zhen-Yu Shi.
Co-corresponding authors: Pei-Jian Tong and Hong-Ting Jin.
Author contributions: Wu CZ, Shi ZY, and Wu Z contributed to the collection and assembly of data, and manuscript writing, and contributed equally to this work; Xiang SC, Xu HH, Ge QW, Zou KA, and Wang X contributed to data analysis and interpretation; Lin WJ, Chen WB, and Jia XW contributed to imaging assessment; Chen JL, Wang PE, and Yuan WH contributed to data analysis and manuscript preparation; Jin HT and Tong PJ contributed to conception and design, imaging assessment, manuscript writing, final approval, and share corresponding authors; and all authors have read and approved the manuscript.
Supported by the National Natural Science Foundation of China, No. 82274547; the Major Program of the National Natural Science Foundation of Zhejiang Province, No. LD22C060002; the State Administration of Traditional Chinese Medicine of Zhejiang Province, No. GZY-ZJ-KJ-23064; and the Zhejiang Provincial Research Foundation for Basic Public Welfare Research, No. LGF20H270005.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 22-KL-048).
Clinical trial registration statement: The trial was registered at chictr.org.cn (registration number ChiCTR2200055124).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The original contributions presented in the study are included in the article, further inquiries can be directed to the corresponding authors.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Pei-Jian Tong, MD, PhD, Professor, Department of Orthopedics and Traumatology, The First Affiliated Hospital of Zhejiang Chinese Medical University, No. 54 Youdian Street, Hangzhou 310006, Zhejiang Province, China.
tongpeijian@163.com
Received: October 5, 2023
Peer-review started: October 5, 2023
First decision: November 22, 2023
Revised: December 4, 2023
Accepted: December 20, 2023
Article in press: December 20, 2023
Published online: December 26, 2023
Processing time: 81 Days and 11 Hours
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.
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.
