Optimization of a Novel Thread Geometry for Various Orthopedic Surgery Applications

适用于各种骨科手术应用的新型螺纹几何形状的优化

• 批准号: 10324164
• 负责人: Andrew Ray Fauth
• 金额: $ 110.44万
• 依托单位: OSTEOCENTRIC TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324164
• 关键词: Activities of Daily Living; Anatomy; Animal Model; Animals; Architecture; Area; Bone Screws; Businesses; Case Series; Clinical; Clinical Research; Data; Data Element; Defect; Development; Education; Elements; Equipment; Face; Failure; Fatigue; Finite Element Analysis; Fracture; Future; Geometry; Goals; Healthcare Systems; Histology; Human; Image; Implant; Israel; Lead; Life; Manufacturer Name; Mechanics; Medical center; Methodology; Methods; Modeling; Orthopedic Surgery; Orthopedics; Osseointegration; Osteoporotic; Outcome; Outsourcing; Patient Care; Patients; Performance; Phase; Postoperative Complications; Process; Production; Radial; Resistance; Resolution; Risk; Sheep; Small Business Innovation Research Grant; Source; Stress; Study models; Surface; Technology; Testing; Time; Torque; Translating; Trauma patient; Weight-Bearing state; Width; X-Ray Computed Tomography; austin; base; bone; bone geometry; bone preservation; bone quality; clinical application; commercialization; cost; cost effective; cost effectiveness; design; efficacy evaluation; healing; improved; innovation; long bone; novel; osteoporotic bone; prevent; prototype; research and development; safety and feasibility; sample fixation; success; tool

PROJECT SUMMARY/ABSTRACT The majority of threaded interfaces (screws) used in orthopaedics utilize a buttress thread design which has limitations in clinical application. Clinically, orthopaedic screws must resist the dynamic forces generated during common activities of daily living, yet buttress screws are not designed to resist multidirectional force, leading to increased risk of postoperative complications including screw loosening and failure of fixation. Since the modifiable variables of buttress screw designs—including thread pitch, depth, width and face angle—are interrelated, attempts to improve screw functionality by altering these variables is limited. The challenge in bone threaded surface interface is in the optimization of threaded surfaces that meet the loading scenarios at different anatomic sites with varying bone stock, more often than not, one of poor bone quality. The development of innovative bone-screw-fastener technologies for the field of orthopaedic surgery is the underlying focus of OsteoCentric, Inc., a small business based in Austin, TX. The company has designed, manufactured and implemented a new bone-screw-fastener design, the Bone Interlocking Thread Geometry (BITG), based on a technology that creates a circumferential interlocking interface that maximizes bone volume and preserves bone architecture. The BITG overcomes many of the limitations of buttress screws by resisting multidirectional forces and bending moments, minimizing radial forces, and allowing for higher finishing torques. These enhancements can prevent fixation construct failure especially with cases with inadequate bone quality. We have successfully developed and validated bone-thread-interface Finite Element (FE) models for three loading conditions and have conducted a parametric FE analysis to optimize the BITG thread pitch geometry. The SBIR Phase II proposal seeks to build on our early success by optimizing the thread geometry; testing it in a large animal model; and optimizing the BITG thread manufacturing methodology. This will enable OsteoCentric to market a clinically superior product that reduces the overall cost of implants to the healthcare system by utilizing more cost-effective non-locking screws and plates. The specific aims of the Phase II are: Specific Aim 1: Conduct a comprehensive parametric analysis of the BITG using validated FE analysis to optimize cortical and cancellous thread geometry for normal and osteoporotic bones. Specific Aim 2: Optimize methods of BITG manufacturing to enhance cost-effectiveness and efficiency; build internal prototyping and manufacturing expertise; and build an education package for outsource production manufacturers to streamline BITG technology production. Specific Aim 3: Test the optimized BITG thread design against traditional buttress screw using an ovine fracture model in both normal and osteoporotic conditions.

项目概要/摘要 骨科中使用的大多数螺纹接口（螺钉）均采用偏梯形螺纹设计，具有 临床应用的局限性。临床上，矫形螺钉必须能够抵抗手术过程中产生的动态力。 日常生活中常见的活动，但偏梯形螺钉的设计不能抵抗多向力，导致 术后并发症的风险增加，包括螺钉松动和固定失败。自从 偏梯形螺钉设计的可修改变量——包括螺距、深度、宽度和面角—— 相互关联，通过改变这些变量来改进螺杆功能的尝试是有限的。骨骼的挑战 螺纹面接口正在对满足不同负载场景的螺纹面进行优化 具有不同骨量的解剖部位，通常是骨质量较差的部位之一。 骨科手术领域创新骨螺钉紧固件技术的发展是 OsteoCentric, Inc. 是一家位于德克萨斯州奥斯汀的小型企业，其主要业务重点是。公司设计、 制造并实施了一种新的骨螺钉紧固件设计，即骨互锁螺纹几何形状 (BITG)，基于一种可创建周向互锁界面的技术，可最大限度地增加骨量 并保留骨骼结构。 BITG 克服了偏梯形螺钉的许多限制 多向力和弯矩，最大限度地减少径向力，并允许更高的精加工扭矩。 这些增强功能可以防止固定结构失败，尤其是在骨质量不足的情况下。 我们已成功开发并验证了三种骨螺纹界面有限元 (FE) 模型 负载条件并进行了参数有限元分析，以优化 BITG 螺纹螺距几何形状。 SBIR 第二阶段提案旨在通过优化螺纹几何形状，在我们早期成功的基础上再接再厉；测试它在 大型动物模型；并优化 BITG 螺纹制造方法。这将使 OsteoCentric 营销临床上卓越的产品，通过以下方式降低医疗保健系统植入物的总体成本 使用更具成本效益的非锁定螺钉和板。第二阶段的具体目标是： 具体目标 1：使用经过验证的 FE 分析对 BITG 进行全面的参数分析，以优化皮质 以及用于正常和骨质疏松骨骼的松质螺纹几何形状。具体目标2：优化BITG方法 制造以提高成本效益和效率；建立内部原型和制造 专业知识;并为外包生产制造商构建教育包以简化 BITG 技术生产。具体目标 3：对照传统偏梯形螺钉测试优化的 BITG 螺纹设计 在正常和骨质疏松条件下使用绵羊骨折模型。