Improved Treatment of Distal Radius Fractures Using an Image-Guided, Percutaneous Delivery of a Novel Bone Adhesive

项目摘要/摘要 从站立高度的福尔斯跌倒和其他低能量创伤占所有骨科骨折的87%， 老人桡骨远端骨折（DRF）是这些骨折中最常见的类型之一，大约 在美国每年报告的超过675，000例DRF病例中，有40%发生在65岁或以上的人群中。 老了不幸的是，这些损伤导致难以执行最基本的日常任务， 患者，可能导致丧失独立性，生活质量下降，甚至死亡率增加。 目前DRF损伤的护理标准是切开复位内固定（ORIF）手术，包括 放置金属硬件，如掌侧接骨板和/或克氏针。这些开放手术方法的结果 混合;据报道，老年人的并发症发生率高达36%， 腕管综合征的发病，复杂的区域疼痛综合征，并导致肌腱刺激和断裂， 深部感染，需要再次手术取出钢板。 为了解决这个问题，LaunchPad Medical（LPM）开发了一种新型骨粘合剂Tetranite®（TN） 生物材料可以将骨碎片粘合在一起，填充骨空隙，并将骨粘附到金属上。随着时间的推移， 创新的材料作为支架，促进愈合，并允许骨骼通过它生长， 用新的有活力的骨头代替TN的强大的粘结强度，当受到剪切负荷，以各种 已经显示出显著大于市场上的非粘性骨水泥。然而 当适当混合时，TN的流动特性使其成为经皮输送的理想选择。独特的是，TN可以装载 与BaSO 4一起使用，而不会显著降低其机械性能，使外科医生能够 通过荧光透视在真实的时间内监测其在体内的放置，而不需要开放手术。 在该项目的第一阶段，对TN粘合剂化学进行了表征和优化，以产生具有以下特性的产品： 具有足够的机械和微观结构特性，可将上肢骨折固定在独立的 基础（不使用金属固定硬件）。初步的尸体研究表明， 使用优化的制剂进行经皮治疗。在这一成功的第一阶段项目的基础上， 初步研发，TN的翻译为治疗DRF损伤的临床适应症将继续在拟议的 II期研究，通过完成以下内容：目标1：优化经皮给药 TN用于DRF程序和目的2：证明TN在大型动物中的安全有效使用 Study. 该转化动物研究的结果，以及外科医生确认的模拟使用尸体 试验，将用作向FDA提交试验用器械豁免（IDE）的基础， 人类研究从长远来看，LPM的使命是为外科医生提供一种新型产品， 减少与老年人DRF手术相关的并发症和翻修手术。

Project Abstract/Summary Falls from standing height and other low-energy trauma account for 87% of all orthopedic fractures among the elderly. Distal radius fractures (DRF) are one of the most common types of these fractures, with approximately 40% of the more than 675,000 DRF cases reported annually in the U.S. occurring in people aged 65 years or older. Unfortunately, these injuries result in difficulty performing the most basic daily tasks and, for elderly patients, can lead to a loss of independence, a reduction in quality of life, and even increased mortality. The current standard of care for DRF injuries is open reduction internal fixation (ORIF) procedures that involve placement of metal hardware such as volar plates and/or K-wires. Results of these open surgical approaches have been mixed; complication rates have been reported to be as high as 36% in the elderly and involve the onset of carpal tunnel syndrome, complex regional pain syndrome, and have led to tendon irritation and rupture, deep infections, and the need to re-operate to remove the plates. To address this issue LaunchPad Medical (LPM) has developed Tetranite® (TN), a novel bone adhesive biomaterial that can bond bone fragments together, fill bone voids, and adhere bone to metal. Over time this innovative material acts as a scaffold, promoting healing and allowing bone to grow through it to ultimately replace it with new, vital bone. TN’s robust bond strength, when subjected to shear loading to the various substrates, has been shown to be significantly greater than non-adhesive bone cements on the market. Yet when properly mixed, TN’s flow properties make it ideal for percutaneous delivery. Uniquely, TN can be loaded with BaSO4 without significant degradation to its mechanical properties, making it possible for a surgeon to monitor its placement in vivo via fluoroscopy in real time and without the need for open surgery. In Phase I of this project the TN adhesive chemistry was characterized and optimized to yield a product with sufficient mechanical and microstructural properties to fixate upper extremity bone fractures on a stand-alone basis (without the use of metal fixation hardware). Preliminary cadaver studies have demonstrated the effective percutaneous treatment using the optimized formulation. Building on this successful Phase I project, and other preliminary R & D, TN’s translation to a clinical indication for treating DRF injuries will continue in the proposed Phase II study through the completion of the following: Aim 1: Optimization of the Percutaneous Delivery of TN for DRF Procedures and Aim 2: Demonstration of the Safe and Effective Use of TN in a Large Animal Study. The results from this translational animal study, complemented with surgeon validated simulated use cadaver testing, will be used to as the basis for filing an Investigational Device Exemption (IDE) with the FDA to initiate human studies. Long term, LPM’s mission is to provide surgeons with a novel product that will enhance fixation, reduce complications and revision surgeries associated with DRF procedures in the elderly.