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用于促进前交叉韧带重建后愈合效果的生物材料:临床前动物模型的功效、手术方案和评估。

Biomaterials developed for facilitating healing outcome after anterior cruciate ligament reconstruction: Efficacy, surgical protocols, and assessments using preclinical animal models.

机构信息

Musculoskeletal Research Laboratory of Department of Orthopaedics & Traumatology and Innovative Orthopaedic Biomaterial and Drug Translational Research Laboratory of Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.

Musculoskeletal Research Laboratory of Department of Orthopaedics & Traumatology and Innovative Orthopaedic Biomaterial and Drug Translational Research Laboratory of Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.

出版信息

Biomaterials. 2021 Feb;269:120625. doi: 10.1016/j.biomaterials.2020.120625. Epub 2020 Dec 23.

Abstract

Anterior cruciate ligament (ACL) reconstruction is the recommended treatment for ACL tear in the American Academy of Orthopaedic Surgeons (AAOS) guideline. However, not a small number of cases failed because of the tunnel bone resorption, unsatisfactory bone-tendon integration, and graft degeneration. The biomaterials developed and designed for improving ACL reconstruction have been investigated for decades. According to the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO) regulations, animal studies should be performed to prove the safety and bioeffect of materials before clinical trials. In this review, we first evaluated available biomaterials that can enhance the healing outcome after ACL reconstruction in animals and then discussed the animal models and assessments for testing applied materials. Furthermore, we identified the relevance and knowledge gaps between animal experimental studies and clinical expectations. Critical analyses and suggestions for future research were also provided to design the animal study connecting basic research and requirements for future clinical translation.

摘要

前交叉韧带(ACL)重建是美国骨科医师学会(AAOS)指南中推荐的 ACL 撕裂治疗方法。然而,仍有相当数量的病例因隧道骨吸收、骨-腱结合不良和移植物退变而失败。几十年来,人们一直在研究开发用于改善 ACL 重建的生物材料。根据食品和药物管理局(FDA)和国际标准化组织(ISO)的规定,在进行临床试验之前,应该进行动物研究以证明材料的安全性和生物效应。在这篇综述中,我们首先评估了可用于增强动物 ACL 重建后愈合效果的现有生物材料,然后讨论了用于测试应用材料的动物模型和评估方法。此外,我们还确定了动物实验研究与临床预期之间的相关性和知识差距。我们还提供了对未来研究的批判性分析和建议,以设计连接基础研究和未来临床转化需求的动物研究。

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