COMPLIANT POLYMER LUMBAR ARTIFICIAL DISC (PILOT STUDY)

顺应性聚合物人工腰椎间盘（试点研究）

• 批准号: 7562469
• 负责人: KAREN S RICE
• 金额: $ 0.63万
• 依托单位: TEXAS BIOMEDICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7562469
• 关键词: Carbonates; Cell Nucleus; Class; Clinical; Computer Retrieval of Information on Scientific Projects Database; Devices; Drug Formulations; Elastomers; Femur; Fright; Funding; Gold; Grant; Hardness; Hydrocarbons; Implant; Inflammation; Institution; International; Low Back Pain; Mechanics; Medical; Medical Device; Metals; Movement; Operative Surgical Procedures; Outcome; Pain; Papio; Patients; Pilot Projects; Plague; Polyethylene; Polyethylenes; Polymers; Polyurethanes; Range; Recording of previous events; Research; Research Personnel; Resources; Slide; Societies; Source; Spinal; Spinal Fusion; Standards of Weights and Measures; Stress; Surface; Technology; Testing; Time; Today; United States Food and Drug Administration; United States National Institutes of Health; Vertebral column; Week; calcium phosphate coating; concept; cytotoxicity test; oxidation; particle; polycarbonate; research study; vertebra body

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 amongst the most common and costly illnesses of today's societies. In the US alone, 30 billion dollars are spent annually for 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 disc replacement device to be freely sold in the US (several more devices are expected in 2006). Mechanical disc replacement devices, however, are feared by experts not to have the hoped (and praised) long term advantages when compared to 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 experiment for its clinical suitability. The CAdisc 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. The range of formulations and the coating have been subjected to cytotoxicity testing and have also been used in implants for a 12 week ovine femur study without ill effect. Moreover, polycarbonate polyurethanes are a well understood class of materials, with considerable history in medical devices. They were one of the first classes of polyurethane materials promoted for their biostability. They are thermoplastic elastomers with carbonate linkages adjacent to hydrocarbon groups which give this class of materials oxidative stability, making these polymers attractive for medical device applications where oxidation is a potential mode ofdegradation. In addition, polycarbonate polyurethanes have been shown to minimize surface degradation such as stress induced microfissures. Three commercial grades of polycarbonate urethanes are in use as part of approved medical applications, including Bionate' (the Polymer Technology Group), CarbothaneB (Noveon) and ChronoFlexB C (CardioTech International). Should the CAdisc implant prove to be a valid option to presently used artificial disc implants featuring sliding metal-on-metal or metal-on-polyethylene surfaces, complications or adverse outcomes associated with these types of implant (induced adjacent level degeneration, sudden and painful giveaway episodes for spinal movements known as "clinical instability," lack of axial cushioning, small wear particles causing inflammation, etc.) could be avoided.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 脊柱疾病是当今社会最常见和最昂贵的疾病之一。仅在美国，每年就有300亿美元用于手术治疗腰痛。每年约有40万例此类手术。直到最近，“黄金标准”一直是进行脊柱融合。2005年，FDA首次批准在美国自由销售机械椎间盘置换器械（预计2006年将有更多器械）。 然而，专家们担心，与传统的脊柱融合术相比，机械椎间盘置换器械不具有所希望的（并受到称赞的）长期优势。已知融合导致的相邻节段退变仍可能作为椎间盘置换术的不良结局持续存在。此外，新的并发症，如椎体之间的不良引导运动导致疼痛或植入物表面产生的小磨损颗粒导致炎症并最终导致植入物松动，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”，可能不具有上述缺点，应在狒狒实验中对其临床适用性进行测试。 CAdisc植入物由三种不同硬度的聚碳酸酯聚氨酯配方组成，用于瓣环、髓核和终板。终板上有一层薄薄的磷酸钙涂层。对一系列配方和涂层进行了细胞毒性试验，并将其用于12周绵羊股骨研究的植入物中，未出现不良反应。此外，聚碳酸酯聚氨酯是一种众所周知的材料，在医疗器械中具有相当长的历史。它们是因其生物稳定性而被推广的第一类聚氨酯材料之一。它们是热塑性弹性体，具有与烃基相邻的碳酸酯键，这赋予这类材料氧化稳定性，使得这些聚合物对于氧化是潜在降解模式的医疗器械应用具有吸引力。此外，聚碳酸酯聚氨酯已被证明可以最大限度地减少表面降解，如应力诱导的微裂缝。三种商业等级的聚碳酸酯树脂作为批准的医疗应用的一部分， Bionate'（聚合物技术集团）、CarbothaneB（Noveon）和ChronoFlexB C（CronoTech International）。 如果CAdisc植入物被证明是目前使用的具有滑动金属对金属或金属对聚乙烯表面的人工椎间盘植入物的有效选择，则与这些类型的植入物相关的并发症或不良结局（诱导相邻节段退变，称为“临床不稳定”的脊柱运动的突然和疼痛泄露事件，缺乏轴向缓冲，引起炎症的小磨损颗粒等）。是可以避免的。