SOLUBLE CALCIUM ORGANIC SALTS IN RESORBABLE BONE CEMENT

可吸收骨水泥中的可溶性钙有机盐

• 批准号: 6292746
• 负责人: DAVID D HILE
• 金额: $ 42.52万
• 依托单位: CAMBRIDGE SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-06-01 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6292746
• 关键词: biodegradable product; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; bone prosthesis; calcium; gluconate; histology; laboratory rat; orthopedics; physiologic bone resorption; polymers; sheep; tissue support frame

Trauma, oncologic surgery, and congenital disorders often leave patients with large bony defects that require reconstruction. Autografts and allografts are used in current bone graft procedures to repair defects. However, each has clinical drawbacks. The proposed bioresorbable bone graft substitute is made from the unsaturated polyester, poly(propylene glycol-co-fumaric acid), which can be cross-linked in the presence of soluble and insoluble calcium filler salts and grouted directly into a bony void. This graft substitute provides an osteoconductive pathway for bone ingrowth. In Phase I the technical objective was to demonstrate the feasibility of a degradable grout to encourage bony ingrowth and void filling by the use of soluble fillers. Following this demonstration of a relationship between salt-promoted porosity of the bone graft substitute and cell ingrowth in Phase I, the investigators now propose in Phase II the in vivo evaluation of grouts which encourage optimal ingrowth of bone cells and organized deposition of new bone. It is projected that the work will result in a grout formulation using a mixture of calcium salts that will leach from the graft substitute at a rate supportive of the overall structural integrity of the repairing site, while optimum rates of bone ingrowth and polymer degradation are maintained. PROPOSED COMMERCIAL APPLICATION: There are over 450,000 bone graft procedures annually in the U.S. (2.2 million worldwide) with a market potential of $400 to $600 million. The approved synthetic grafts are considered to be inferior to the use of autograft or allograft materials. Bioresorbable bone void fillers could provide a viable alternative to autografts and allografts used in current bone graft procedures to repair defects caused by surgery, tumors, trauma, implant revisions and infecctions and also for joint fusion.

外伤、肿瘤手术和先天性疾病常常会给患者带来巨大的痛苦。 需要重建的骨缺损。 目前常用的有自体移植物和同种异体移植物。 修复缺损的骨移植手术。然而，每种方法都有临床缺点。 所提出的生物可吸收骨移植替代品由不饱和骨制成 聚酯，聚（丙二醇-富马酸），可以交联 存在可溶性和不溶性钙填料盐并直接灌浆 进入骨头虚空。这种移植物替代品提供了骨传导途径 骨向内生长。在第一阶段，技术目标是证明 可降解灌浆促进骨向内生长和空隙填充的可行性 通过使用可溶性填料。在展示这种关系之后 盐促进骨移植替代物的孔隙率与细胞向内生长之间的关系 在第一阶段，研究人员现在建议在第二阶段进行体内评估 促进骨细胞最佳向内生长和有组织沉积的灌浆 新骨。预计这项工作将产生一种灌浆配方 使用钙盐混合物，该混合物会在一定温度下从移植替代物中浸出 对修复现场整体结构完整性的支持率， 同时保持骨向内生长和聚合物降解的最佳速率。 拟议的商业应用： 美国每年有超过 450,000 例骨移植手术（全球有 220 万例） 市场潜力为400至6亿美元。 批准的合成移植物是 被认为不如使用自体移植或同种异体移植材料。 生物可吸收骨 空隙填充剂可以为当前使用的自体移植物和同种异体移植物提供可行的替代品 骨移植手术修复因手术、肿瘤、创伤、植入物引起的缺陷 修正和感染以及关节融合。