Perrone Gabriel S, Proffen Benedikt L, Kiapour Ata M, Sieker Jakob T, Fleming Braden C, Murray Martha M
Department of Orthopaedic Surgery, Sports Medicine Research Laboratory, Harvard Medical School/Boston Children's Hospital, Boston, Massachusetts.
Department of Orthopaedics, Bioengineering Labs, Warren Alpert Medical School of Brown University/Rhode Island Hospital, Providence, Rhode Island.
J Orthop Res. 2017 Dec;35(12):2606-2612. doi: 10.1002/jor.23632. Epub 2017 Jul 9.
Anterior cruciate ligament (ACL) injuries are one of the most well-known orthopaedic injuries and are treated with one of the most common orthopaedic procedures performed in the United States. This surgical procedure, ACL reconstruction, is successful at restoring the gross stability of the knee. However, the outcomes of ACL reconstruction can be limited by short and long-term complications, including muscle weakness, graft rupture, and premature osteoarthritis. Thus, new methods of treating this injury are being explored. This review details the pathway of how a tissue engineering strategy can be used to improve the healing of the ACL in preclinical studies and then translated to patients in an FDA-approved clinical study. This review paper will outline the clinical importance of ACL injuries, history of primary repair, the pathology behind failure of the ACL to heal, pre-clinical studies, the FDA approval process for a high risk medical device, and the preliminary results from a first-in-human study. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2606-2612, 2017.
前交叉韧带（ACL）损伤是最广为人知的骨科损伤之一，其治疗采用美国最常见的骨科手术之一。这种外科手术，即ACL重建术，在恢复膝关节的总体稳定性方面是成功的。然而，ACL重建的结果可能会受到短期和长期并发症的限制，包括肌肉无力、移植物破裂和过早出现骨关节炎。因此，正在探索治疗这种损伤的新方法。这篇综述详细阐述了在临床前研究中如何运用组织工程策略来促进ACL愈合，以及随后如何在一项获得美国食品药品监督管理局（FDA）批准的临床研究中应用于患者。这篇综述文章将概述ACL损伤的临床重要性、初次修复的历史、ACL无法愈合背后的病理机制、临床前研究、高风险医疗器械的FDA批准过程以及首例人体研究的初步结果。© 2017骨科研究协会。由威利期刊公司出版。《骨科研究杂志》35:2606 - 2612，2017年。
