COMPLAINT POLYMER LUMBAR ARTIFICIAL DISC PRECLINICAL STUDY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 脊椎疾病是当今社会最常见、最昂贵的疾病之一。仅在美国，每年就有300亿美元用于腰痛的外科治疗。每年大约有40万例这样的手术。直到最近，“黄金标准”一直是进行脊柱融合术。2005年，FDA首次批准在美国免费销售的机械式全盘置换(TDR)设备(预计2006年将有更多设备)。 然而，专家们担心，与传统的脊柱融合术相比，机械式TDR设备没有希望的(并得到赞扬的)长期优势。相邻节段退变，已知是融合的结果，仍然可能作为椎间盘置换手术的不良后果而持续存在。此外，新的并发症，如椎体之间引导不良的运动导致疼痛或来自种植体表面的微小磨损颗粒导致炎症，最终种植体松动，可能会困扰患者。一种新的人工椎间盘概念，即所谓的“顺应性椎间盘”，可能不会有上述缺点，应在狒狒研究中对其临床适用性进行测试。 盘状植入物由三种不同硬度的聚碳酸酯聚氨酯配方组成，分别用于环、核和终板。端板上有一层薄薄的磷酸钙涂层。2006年5月，在一个单独的受试者体内植入了一个临床前装置，进行了一项“先导性”的狒狒研究。每周的X线片记录了一个稳定的植入位置。尸检显示，随着时间的推移，伤口愈合取得了进展。 聚碳酸酯聚氨酯广泛应用于心脏病学，包括左心室起搏器、起搏器和导管。几种商业化的骨科植入物产品使用聚碳酸酯聚氨酯。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Spine ailments are among the most common and costly illnesses of society today. In the US alone, 30 billion dollars annually are spent on the surgical treatment of low back pain. About 400,000 such surgeries are performed every year. Until recently the 'gold standard' has been to perform a spine fusion. In 2005 FDA cleared for the first time a mechanical total disc replacement (TDR) device to be freely sold in the US (more devices are expected in 2006). Mechanical TDR devices, however, are feared by experts not to have the hoped (and praised) long-term advantages when compared with traditional spinal fusion. Adjacent level degeneration, known to exist as a result of fusion, may still persist as an adverse outcome of disc replacement surgery. In addition, new complications such as poorly guided movements between vertebral bodies causing pain or small wear particles originating from the implant surfaces causing inflammation and ultimately implant loosening may plague the patient. A new artificial disc concept, a so-called "compliant disc", that would potentially not have the above shortcomings, shall be tested in a baboon study for its clinical suitability. The disc implant is comprised of three polycarbonate polyurethane formulations of different hardness for annulus, nucleus and end plate. The end plates have a thin coating of calcium phosphate. A 'pilot' baboon study was performed in May 2006 when a preclinical device was implanted in a single subject. Weekly radiographs documented a stable implant position. Necropsy showed progress in wound healing concomitant with the time frame. Polycarbonate polyurethanes are used in a wide variety of cardiology applications, including LVADs, pacemakers and catheters. Several commercialized orthopedic implant products employ polycarbonate polyurethane.