Nubac disc arthroplasty: preclinical studies and preliminary safety and efficacy evaluations.
Nubac disc arthroplasty: preclinical studies and preliminary safety and efficacy evaluations.
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DOI：
10.1016/sasj-2006-0007-rr
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发表时间：
2007
期刊：
影响因子：
--
通讯作者：
Yuan, Hansen
中科院分区：
文献类型：
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作者：
Bao, Qi-Bin;Songer, Matthew;Pimenta, Luis;Werner, Dieter;Reyes-Sanchez, Alejandro;Balsano, Massimo;Agrillo, Umberto;Coric, Domagoj;Davenport, Kenneth;Yuan, Hansen
椎间盘成形术越来越受欢迎，用于治疗退行性椎间盘疾病（DDD）引起的腰痛。它可以涉及全椎间盘置换或部分椎间盘或髓核置换（或增强）。与全椎间盘置换术相比，髓核置换术创伤小，手术风险小，术后恢复快，不需要再行手术。然而，髓核置换术具有植入物脱出的高风险，因为该器械未固定到椎骨上。Nubac是第一种聚醚醚酮（PEEK）对PEEK关节盘关节置换器械，设计用于最佳恢复腰椎解剖结构和生物力学。使用ISO 10993标准评价PEEK材料的生物相容性。化学和热机械测试以及体内研究评估了PEEK暴露于高g辐照和苛刻氧化条件后的生物稳定性。使用人体尸体模型进行生物力学测试，以评价植入腰椎运动节段的运动学特性和解剖学恢复，并进行植入物脱出风险评估。由于PEEK对PEEK作为自匹配关节材料的新奇，因此在单向和耦合运动下进行了广泛的磨损试验。还测试了静态和疲劳强度。在术后6个月和12个月，对狒狒模型进行了动物研究，并进行了大体、影像学、生物力学和组织学评价。通过前瞻性多中心队列研究收集初步临床数据。PEEK表现出卓越的生物相容性和生物耐久性。Nubac恢复了椎间盘高度和运动节段活动范围。Nubac独特的关节面设计证明了在人体尸体模型中植入物脱出的风险较低。磨损试验表明，Nubac的磨损最小，与其他椎间盘置换术材料相比更有利。Nubac还具有出色的静态和疲劳性能，适用于预期应用。动物研究表明，Nubac未引起局部或全身不良组织反应，也未检测到磨损碎屑。初步临床数据显示，无重大术中血管和神经系统并发症。视觉模拟量表和奥斯韦斯特里残疾指数评分显著改善。临床前数据支持设计原理，关于安全性和有效性的初步临床数据（II级证据）令人鼓舞。Nubac可能是DDD引起的背痛患者的可行的首选手术选择。
Disc arthroplasty is gaining popularity for treatment of low-back pain caused by degenerative disc disease (DDD). It can involve total disc replacement or partial disc or nucleus replacement (or augmentation). Compared with total disc replacement, nucleus replacement is less invasive, has less surgical risk, has faster postoperative recovery, and doesn't “burn bridges” should further surgery be required. However, nucleus replacement has a high risk of implant expulsion because the device is not fixed to the vertebrae. Nubac is the first polyetheretherketone (PEEK)-on-PEEK articulated disc arthroplasty device designed to optimally restore the lumbar anatomy and biomechanics. ISO 10993 standards were used to evaluate the biocompatibility of the PEEK material. Chemical and thermal–mechanical tests and in vivo study assessed PEEK's biostability after exposure to high g irradiation and harsh oxidative conditions. Biomechanical tests to evaluate kinematic properties and anatomical restoration of the implanted lumbar motion segments and implant expulsion risk assessments were performed with a human cadaveric model. Because of the novelty of PEEK-on-PEEK as a self-mating articulating material, extensive wear tests were conducted with unidirectional and coupled motions. Static and fatigue strength also were tested. Animal study with a baboon model was conducted with gross, radiographic, biomechanical, and histological evaluations at 6 and 12 months postoperatively. Preliminary clinical data were collected through a prospective multicenter cohort study. PEEK demonstrated exceptional biocompatibility and biodurability. Nubac restored disc height and motion segment range of motion. The unique articulating design of the Nubac demonstrated low risk of implant expulsion in a human cadaveric model. Wear tests showed that the Nubac has minimal wear and compares favorably to other disc arthroplasty materials. The Nubac also had excellent static and fatigue properties for the intended application. The animal study showed that the Nubac caused no adverse local or systematic tissue reaction and there was no detectable wear debris. The preliminary clinical data showed no major intraoperative vascular and neurological complications. There was significant Visual Analog Scale and Oswestry Disability Index score improvement. The preclinical data supported the design rationale, and the preliminary clinical data (level II evidence) on safety and efficacy were encouraging. The Nubac could be a viable first surgical option for patients with back pain caused by DDD.