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: 6523842
• 负责人: DAVID D HILE
• 金额: $ 32.48万
• 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 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6523842
• 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.

创伤，肿瘤手术和先天性疾病通常会使患者患有较大的患者 需要重建的骨缺陷。 自体移植和同种异体移植物用于电流 修复缺陷的骨移植程序。但是，每个都有临床缺点。 提出的生物吸收性骨移植替代品由不饱和 聚酯，聚丙烯甘油 - 二酸 - 富马酸），可以交联 可溶性和不溶性钙填充盐的存在并直接灌浆 进入骨空隙。这种移植物替代品为 骨向内生长。在第一阶段，技术目标是证明 可降解的灌浆的可行性，以鼓励骨质内部和无效填充 通过使用可溶性填充剂。遵循这种关系的演示 骨移植替代盐和细胞向内生长的盐孔隙率之间 在第一阶段，研究人员现在在第二阶段提出了体内评估 鼓励骨细胞和有组织沉积的灌浆 新骨。预计该工作将导致灌浆配方 使用钙盐的混合物 利率支持维修站点的整体结构完整性， 虽然保持了最佳的骨向内生长和聚合物降解速率。 拟议的商业应用： 在美国，每年有超过450,000个骨移植手术（全球220万个） 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物质。 可生物可吸收的骨头 空隙填充剂可以为当前使用的自体移植和同种异体提供可行的替代方案 修复手术，肿瘤，创伤，植入物引起的缺陷的骨移植手术 修订和不替代以及联合融合。