Lehman Ronald, Bevevino Adam J, Brewer Devon D, Skelly Andrea C, Anderson Paul A
Walter Reed National Military Medical Center, Bethesda, MD, USA.
Evid Based Spine Care J. 2012 Feb;3(S1):31-8. doi: 10.1055/s-0031-1298606.
Systematic review.Clinical questions: (1) What evidence is available from studies of cervical total disc arthroplasty (C-ADR) failure and retrieval regarding durability, wear, and reasons for failure of C-ADR? (2) What evidence is available from experimental models regarding the durability of C-ADR beyond 5 years?
We searched electronic databases to identify published reports of explanted cervical artificial discs and biomechanical simulations of disc wear.
Nine articles were identified describing 17 devices explanted from human patients and four articles describing 23 devices explanted from non-human subjects. Wear properties were not consistently reported across studies, so summaries for specific variables are based on few cases. No device had been implanted longer than 4 years. In both human and non-human subjects, devices showed evidence of metallic and polymeric (for discs with polymer components) debris. Inflammatory cells were frequently present in surrounding soft tissues. Signs of infection were uncommon.Four patients had reactions interpreted as hypersensitivity to metal. We identified three articles on biomechanical wear simulations. Devices were tested between 10 and 20 million cycles in axial loading, flexion/extension, and lateral bending. No device failures were reported. One study suggests such simulations may represent 50 or more years of wear in actual patients.
Cervical disc implants consistently produced polymeric and metallic debris, which was typically accompanied by inflammation. Hypersensitivity to metal may increase risk for device failure. Biomechanical simulations indicate that cervical disc implants may be durable beyond the currently reported length of clinical follow-up.
系统评价。
(1)关于颈椎全椎间盘置换术(C-ADR)失败及取出的研究,在耐用性、磨损及失败原因方面有哪些证据?(2)实验模型在超过5年的C-ADR耐用性方面有哪些证据?
我们检索了电子数据库,以确定已发表的关于取出的颈椎人工椎间盘的报告以及椎间盘磨损的生物力学模拟研究。
共识别出9篇描述从人类患者体内取出17个器械的文章,以及4篇描述从非人类受试者体内取出23个器械的文章。各研究对磨损特性的报告并不一致,因此特定变量的总结基于少数案例。没有器械的植入时间超过4年。在人类和非人类受试者中,器械均显示出金属和聚合物(对于有聚合物部件的椎间盘)碎片的迹象。周围软组织中经常存在炎症细胞。感染迹象不常见。4名患者出现被解释为对金属过敏的反应。我们识别出3篇关于生物力学磨损模拟的文章。器械在轴向加载、屈伸和侧弯条件下进行了1000万至2000万次循环测试。未报告器械失败情况。一项研究表明,此类模拟可能代表实际患者50年或更长时间的磨损情况。
颈椎间盘植入物持续产生聚合物和金属碎片,通常伴有炎症。对金属过敏可能增加器械失败的风险。生物力学模拟表明,颈椎间盘植入物在目前报告的临床随访时间之外可能具有耐用性。