Biopolymeric Strength Augmenation to the Spine

生物聚合物增强脊柱强度

• 批准号: 6787514
• 负责人: DAVID D HILE
• 金额: $ 10万
• 依托单位: CAMBRIDGE SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-01 至 2004-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6787514
• 关键词: biodegradable product; biomaterial development /preparation; biomechanics; biomimetics; biotechnology; bone prosthesis; bone regeneration; bone transplantation; compression; dicarboxylate; intervertebral disk surgery; mechanical pressure; mechanical stress; medical implant science; osteocytes; osteogenesis; polymers; spinal fusion; tissue engineering; tissue support frame; vertebrae

DESCRIPTION (provided by applicant): Spinal fusion is the most common type of bone grafting procedure. Despite the continuing evolution of devices designed to aid in interbody fusion, nonunion remains problematic. Stability of vertebral segments relies on solid bony fusion across the fusion site. In a typical process, autologous bone, the "gold standard," is used to construct the fusion site. However, the sometimes limited supply of autograft and concerns over the safety of allograft have fueled the search for synthetics. It is the hypothesis of this grant application that a biopolymeric scaffold can add dimensional stability to autograft bone while maintaining the osteoinductive properties of the autograft and supporting the volume and shape of the fusion site. The proposed bone graft substitute is based on the biodegradable polymer poly(propylene fumarate-co-fumaric acid), "PPF." PPF, an unsaturated polyester, can be crosslinked in the presence of effervescent and osteoconductive fillers and cured in situ yielding a porous bone-like scaffold in intimate contact with host tissue. The use of a degradable biopolymeric scaffold could, at least, extend the working volume of autograft without compromising its osteoconductive properties and, at best, improve upon the mechanical and bioactive properties of the grafl material as graft consolidation occurs. This Phase I study will determine if it is feasible to develop a PPF biopolymeric-based bone graft substitute suitable for the support of spinal fusion with feasibility defined as mechanics appropriate for immediate stabilization at placement and then continuing stabilization of the polymer-bone construct over the course of the fusion process concomitant with the maintenance of a porosity permissive for cellular ingrowth PPF-based test materials will be evaluated in vitro based upon these initial and temporal morphological and mechanical outcomes in both static and dynamic modes. The formulation that best meets these Phase I in vitro outcomes will be evaluated in vivo in Phase II to evaluate osteointegration and stability using biomechanical histological, and histomorphometric techniques.

描述（由申请人提供）：脊柱融合是最常见的骨移植程序类型。尽管旨在帮助体内融合的设备持续发展，但骨不连仍然有问题。椎段的稳定性取决于整个融合部位的固体骨融合。在典型的过程中，自体骨，“金标准”用于构建融合位点。但是，有时有限的自体移植供应以及对同种异体移植的安全的担忧促进了人们寻找合成剂。这项赠款应用的假设是，生物聚合物支架可以在维持自体移植的骨诱导特性并支撑融合位点的体积和形状的同时，增加自体移植骨的尺寸稳定性。所提出的骨移植替代物基于可生物降解的聚合物聚合物聚合物（富马酸丙烯酸酯 - 富马酸），“ ppf”。 PPF是一种不饱和聚酯纤维，可以在泡腾和骨导导式填充剂的存在下进行交联，并在与宿主组织紧密接触时，可以在原位固化，以产生多孔的骨状支架。使用可降解的生物聚合支架至少可以扩展自体移植的工作体积，而不会损害其骨导导特性，并且充其量最多可以改善GRAFL材料的机械和生物活性特性，因为移植物均匀发生了。 这项I阶段研究将确定开发基于PPF的基于生物聚合物的骨移植替代品是否适用于脊柱融合的支持，其可行性定义为适合于在放置时立即稳定的机制，然后继续稳定聚合物骨构建体的融合过程中的融合过程中的融合过程中，这些构建构建构建的均具有孔隙允许的效果，以使这些允许的效果均具有孔隙率，以使这些允许的效果置于孔隙率的范围内。以及静态和动态模式中的时间形态和机械结果。最能符合这些I期体外结果的公式将在II期中评估，以使用生物力学组织学和组织形态计量技术评估骨整合和稳定性。