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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
ARTICLE HIGHLIGHTS
Research background
The most common kind of degenerative whole-joint disease is osteoarthritis (OA). Before the ultimate choice of knee replacement, the most common joint-preserving surgical procedure was arthroscopic surgery. Mesenchymal stem cells, platelet-rich plasma, and microfragmented adipose tissue (MFAT) are examples of emerging regenerative medicines that have been thrust into the forefront of treatment to stop the progression of OA. MFAT is now being used to treat various orthopedic diseases with effectiveness.
Research motivation
Current mainstream medicine mainly focuses on relieving symptoms and cannot prevent the disease from progressing to the late stages of arthritis that require knee replacement. MFAT as a novel way of treatment may be of great significance in alleviating knee OA (KOA).
Research objectives
The present study aimed to assess the efficacy and safety of MFAT with arthroscopic surgery in patients with KOA.
Research methods
Patients diagnosed with KOA (Kellgren-Lawrence grades 2-3) were included in a multicenter, prospective, single-blind randomized trial. In this trial, 302 patients were randomized into 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 included 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, from baseline to 24 mo.
Research results
The changes in the WOMAC score (including the 3 subscale scores), VAS pain score, and Lequesne index score at 24 mo showed significant differences in both groups between the posttreatment visit and baseline (P < 0.001). The MFAT group exhibited significant decreases in the WOMAC pain scores and VAS scores at all follow-ups, suggesting the pain-relieving potential of MFAT combined with arthroscopy compared to arthroscopy alone HA treatment (P < 0.05). The significant differences in the WOMAC stiffness score, WOMAC function score, and Lequesne index score at 12 and 24 mo after MFAT administration and surgery suggested the potential of MFAT combined with arthroscopy compared to arthroscopy alone control group to improve function and quality of life (P < 0.05). There were no significant between-group differences in the WORMS at 24 mo (P = 0.367). No serious adverse events occurred in the two groups.
Research conclusions
In summary, our study demonstrates that MFAT injection combined with arthroscopic surgery is a safe and effective approach for improving function and alleviating pain in patients with KOA. Based on these results, MFAT injection combined with arthroscopic surgery may be considered a potential therapeutic option for KOA.
Research perspectives
We demonstrated that MFAT injection combined with arthroscopic surgery had better clinical efficacy than control group for treating KOA at a mid-term follow-up and could be a potential therapeutic approach for patients with KOA.
