COMPLAINT POLYMER LUMBAR ARTIFICIAL DISC PRECLINICAL STUDY

投诉聚合物腰椎人工椎间盘临床前研究

• 批准号: 7716089
• 负责人: KAREN S RICE
• 金额: $ 0.11万
• 依托单位: TEXAS BIOMEDICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716089
• 关键词: Autopsy; Cardiology; Catheters; Cell Nucleus; Clinical; Computer Retrieval of Information on Scientific Projects Database; Devices; Drug Formulations; Fright; Funding; Gold; Grant; Hardness; Implant; Inflammation; Institution; Low Back Pain; Mechanics; Movement; Operative Surgical Procedures; Orthopedics; Outcome; Pacemakers; Pain; Papio; Patients; Plague; Polymers; Polyurethanes; Positioning Attribute; Research; Research Personnel; Resources; Societies; Source; Spinal Fusion; Standards of Weights and Measures; Surface; Testing; Time; Today; United States Food and Drug Administration; United States National Institutes of Health; Vertebral column; Wound Healing; calcium phosphate coating; concept; particle; polycarbonate; pre-clinical; preclinical 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 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.

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300亿美元用于下背痛的手术治疗。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首次批准了机械全椎间盘置换（TDR）器械在美国自由销售（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TDR器械不会有所希望的（和赞扬的）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，应在狒狒研究中对其临床适用性进行测试。 椎间盘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。在2006年5月进行了一项“试点”狒狒研究，当时将临床前器械植入单个受试者体内。每周X线片记录了稳定的植入物位置。尸检显示随着时间的推移，伤口愈合有所进展。 聚碳酸酯聚氨酯用于各种心脏病学应用，包括LVAD、起搏器和导管。几种商业化的骨科植入物产品采用聚碳酸酯聚氨酯。