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

基本信息

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
项目类别：
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

项目摘要

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。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善螺钉功能的尝试是有限的。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，其基本重点是设计：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 通过抵抗克服了支撑螺钉的许多局限性。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来在我们早期的成功基础上进行测试；大型动物模型；以及优化 BITG 线制造方法，这将使 OsteoCentric 成为可能。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 具体目标 3：针对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。