Elledge R, Mercuri L G, Attard A, Green J, Speculand B
University Hospitals Birmingham NHS Foundation Trust.
Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.
Br J Oral Maxillofac Surg. 2019 Oct;57(8):722-728. doi: 10.1016/j.bjoms.2019.08.009. Epub 2019 Aug 25.
Total temporomandibular joint (TMJ) replacement has been documented as a viable option for the management of end-stage TMJ disease, but data on long-term outcomes have been reported for only two established systems: TMJ Concepts, and Zimmer Biomet. Other devices are now emerging globally, but reports of preclinical laboratory and clinical outcomes are limited. We retrieved information on the design, material composition, preclinical laboratory tests, regulatory status, and clinical outcomes of new TMJ replacement systems from PubMed and Google, and from personal correspondence with surgeons worldwide. Fifteen countries have developed, or are developing, 27 TMJ replacement systems, of which 21 are custom-designed, but to date, only four have been given regulatory approval. All the devices are designed to have both a skull-based glenoid fossa component and a mandibular ramus or condyle, and 22/27 are similar to the designs of the two established systems. Twenty-one devices use an ultra-high-molecular-weight polyethylene (UHMWPE) fossa-bearing surface, and 10 have a titanium alloy condyle. Nineteen manufacturers report that a titanium alloy is used for the ramus portion of the condyle/ramus component. Preclinical laboratory tests on 12 of the systems have been reported but, to our knowledge, no outcomes have yet been reported on nine of the 27 reviewed. Not all systems are equal in terms of design, material composition, preclinical laboratory testing, manufacturing methods, regulatory status, and reports of clinical outcomes.
全颞下颌关节（TMJ）置换已被证明是治疗终末期TMJ疾病的一种可行选择，但关于长期疗效的数据仅报道了两种成熟系统：TMJ Concepts和捷迈邦美（Zimmer Biomet）。现在全球其他设备也在不断涌现，但临床前实验室和临床疗效的报告有限。我们从PubMed和谷歌以及与全球外科医生的个人通信中检索了有关新型TMJ置换系统的设计、材料成分、临床前实验室测试、监管状态和临床疗效的信息。15个国家已经或正在开发27种TMJ置换系统，其中21种是定制设计的，但迄今为止，只有4种获得了监管批准。所有这些设备都设计为既有基于颅骨的关节窝组件，又有下颌支或髁突，并且27种中有22种与两种成熟系统的设计相似。21种设备使用超高分子量聚乙烯（UHMWPE）关节窝承载表面，10种有钛合金髁突。19家制造商报告称，髁突/下颌支组件的下颌支部分使用钛合金。已报告了其中12种系统的临床前实验室测试，但据我们所知，在审查的27种中，有9种尚未报告结果。在设计、材料成分、临床前实验室测试、制造方法、监管状态和临床疗效报告方面，并非所有系统都是相同的。
