Predicting Skeletal Stability of Endoprostheses for Above Elbow Amputees

描述(由申请人提供)： 项目摘要截肢是一种毁灭性的事件，伴随着日常功能的丧失和生活的戏剧性变化。仅在美国，就有160万人失去了肢体--几乎每200人中就有1人失去肢体。在这些病例中，84.6万条肢体(54%)因血管障碍(糖尿病)失去，70.5万条肢体(45%)因创伤失去，1.8万条肢体(1%)因癌症失去。不幸的是，在下一代，这些数字只会增加。预测预计，到2030年，美国的糖尿病患病率将几乎翻一番，到2050年将翻两番。此外，在美国国内，高能机动车碰撞和全地形车辆事故是因创伤而截肢的人数的最大贡献者。在国外，战场药物和防弹衣等技术的进步拯救了比以往任何时候都更多的战斗人员。不幸的是，四肢没有得到足够的保护，许多美国退伍军人从战斗中回来时带着创伤性截肢，需要后续护理、广泛的康复和退伍军人管理局医疗保健计划昂贵的假肢服务。根据陆军医务长办公室的数据，从2001年9月到2009年1月12日，在伊拉克自由行动、持久自由行动和无关联的冲突中，有1,286人被截肢，其中近70%的人遭受了重大截肢。许多患者可以使用体外假肢(体外假肢装置)来部分替换他们缺失的肢体。这些患者目前有能力将外假肢连接或对接到其残肢的软组织上。然而，在27万名上肢截肢患者中，近60%的人反对使用外假体，原因是配合性差、训练困难、实用性有限、残肢长度较短等。对于这些患者来说，需要一种新的方法来设计经皮、骨整合的内假体，以满足这些应得的患者的需求。本项目的目的是开发一种方法来预测为上述肘部截肢者建议的经皮骨整合假体的机械稳定性。我们将设计一系列直柄假体和解剖柄假体，以适应具有不同剩余肢体长度的人类肱骨样本，比较(A)植入前宿主骨的皮质厚度，(B)植入前宿主骨的矿物质含量，(C)植入后内假体与宿主骨之间的接触百分比，以及(D)植入导致的骨丢失百分比的初始骨形态。接下来，我们将对原位植入的直柄和解剖柄内假体进行机械测试，分析(A)种植体松动量，(B)失败的循环次数，以及(C)拉伸/压缩和前后弯曲所需的失败载荷。然后，我们将能够利用初始骨形态和植入后的机械稳定性之间的相关性来建立方程来预测肘部截肢患者内假体的骨骼稳定性。从该项目开发的基本原理将允许将该战略全面、通用地扩展到未来用于膝下、膝上、肘上、肘下截肢者和指端截肢者的假体。 公共卫生相关性： 项目简介本项目的目的是开发一种方法来预测为肘部截肢者提出的经皮骨整合假体的机械稳定性。我们将设计一系列直柄假体和解剖柄假体，以适应具有不同剩余肢体长度的人类肱骨样本，比较(A)植入前宿主骨的皮质厚度，(B)植入前宿主骨的矿物质含量，(C)植入后内假体与宿主骨之间的接触百分比，以及(D)植入导致的骨丢失百分比的初始骨形态。接下来，我们将对原位植入的假体进行机械测试，分析(A)种植体松动量，(B)失败周期数，以及(C)拉伸/压缩和前后弯曲所需的载荷。利用初始骨形态与植入后的力学稳定性之间的相关性，将建立预测骨骼稳定性的方程。这个项目的基本原理将允许该战略彻底扩展到未来的内假体。))

DESCRIPTION (provided by applicant): Project Summary Limb amputation is a devastating event with an associated loss of every day function coupled with a dramatic change of life. In the United States alone, 1.6 million people have lost a limb -- nearly 1 in every 200 people. Of these cases, 846,000 limbs (54%) were lost due to dysvascular diseases (diabetes), 705,000 limbs (45%) were lost due to traumas, and 18,000 (1%) limbs were lost due to cancer. Unfortunately, over the next generation, these numbers will only increase. Projections anticipate by the year 2030, the prevalence of diabetes in the United States will nearly double, and will triple by the year 2050. Furthermore, locally within the United States, high-energy motor vehicle collisions and all-terrain vehicle accidents are the top contributors to the number of limbs amputated due to traumas. Abroad, the advancements in battlefield medicines and technologies such as body-armor have saved more combatants than ever before. Unfortunately, there is not adequate protection for the extremities and many US veterans are returning from combat with traumatic amputations that require follow-up care, extensive rehabilitation, and expensive prosthetic services from the Veterans Administration healthcare programs. According to the Army Office of the Surgeon General, between September 2001 and January 12, 2009, there were 1,286 limbs amputated in Operation Iraqi Freedom, Operation Enduring Freedom, and unaffiliated conflicts, of whom nearly 70% have suffered major limb amputations. Many patients can use an exoprosthesis (prosthetic device outside the body) to partially replace their missing extremity. These patients currently have the ability to attach, or to dock, the exoprosthetic limbs to the soft-tissues of their residual limb. However, nearly 60% of the 270,000 patients with amputations of the upper extremity reject the use of exoprostheses because of issues such as poor fit, difficulties with training, limited usefulness, and short residual limb-lengths. It is for these patients that a new approach to designing percutaneous, osseointegrated endoprostheses is needed to meet the needs of these deserving patients. The purpose of this project is to develop a method to predict the mechanical stability of osseointegrated, percutaneous endoprostheses proposed for above elbow amputees. We will design a series of straight-stemmed endoprostheses and anatomical-stemmed endoprostheses to fit a sampling of human humeri with varying residual limb- lengths, comparing the initial bone morphology of (a) the cortical thickness of the host bone prior to implantation, (b) the mineral content of the host bone prior to implantation, (c) the percent contact between the endoprostheses and the host bone following implantation, and (d) the percent bone loss resulting from implantation. Next, we will mechanically test the straight-stemmed and anatomical-stemmed endoprostheses implanted in-situ in the humeri, analyzing (a) the amount of implant loosening, (b) the number of cycles to failure, and (c) the load to failure required in both tension/compression and anteroposterior bending. Then, we will be able to develop equations to predict the skeletal stability of endoprostheses for above elbow amputees using correlations between the initial bone morphology with the mechanical stability following implantation. Fundamentals developed from this project will allow for a thorough versatile extension of the strategy to future endoprostheses used for below-knee, above-knee, above-elbow, below-elbow amputees, and digit amputees. PUBLIC HEALTH RELEVANCE: Project Narrative The purpose of this project is to develop a method to predict the mechanical stability of osseointegrated, percutaneous endoprostheses proposed for above elbow amputees. We will design a series of straight-stemmed endoprostheses and anatomical-stemmed endoprostheses to fit a sampling of human humeri with varying residual limb-lengths, comparing the initial bone morphology of (a) the cortical thickness of the host bone prior to implantation, (b) the mineral content of the host bone prior to implantation, (c) the percent contact between the endoprostheses and the host bone following implantation, and (d) the percent bone loss resulting from implantation. Next, we will mechanically test endoprostheses implanted in-situ, analyzing (a) the amount of implant loosening, (b) the number of cycles to failure, and (c) the load to failure required in both tension/compression and anteroposterior bending. Equations will be developed to predict the skeletal stability of using correlations between the initial bone morphology with the mechanical stability following implantation. Fundamentals from this project will allow for a thorough extension of the strategy to future endoprostheses. ) )