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

使用图像引导、经皮输送新型骨粘合剂改善桡骨远端骨折的治疗

• 批准号: 10380629
• 负责人: Brian Hess
• 金额: $ 62.45万
• 依托单位: REVBIO, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10380629
• 关键词: Address; Adhesives; Animal Model; Animals; Annual Reports; Barium; Biocompatible Materials; Bone Cements; Bone remodeling; Cadaver; Carpal Tunnel Syndrome; Case Study; Chemistry; Clinical; Complement; Complex; Complex Regional Pain Syndromes; Complication; Compression Fracture; Contrast Media; Development; Devices; Distal; Elderly; Evaluation; Failure; Fluoroscopy; Formulation; Fracture; Funding; Government; Hand; High Prevalence; Histology; Hospitals; Human; Infection; Inferior; Injections; Injury; Investigation; Lead; Mechanics; Medical; Medicare; Metals; Metatarsal bone structure; Mission; Modeling; Monitor; Open Fractures; Operating Rooms; Operative Surgical Procedures; Orthopedics; Osteoporosis; Osteoporotic; Outcome Study; Patients; Performance; Persons; Phase; Procedures; Property; Publishing; Quality of life; Radial; Radius Fractures; Reporting; Research; Rupture; Sampling Studies; Sheep; Surgeon; Technology; Tendon structure; Testing; Time; Translations; Trauma; Upper Extremity; aged; aging population; base; biomechanical test; bone; bone healing; cone-beam computed tomography; falls; healing; image guided; improved; in vivo; innovation; irritation; mechanical properties; mortality; novel; older patient; payment; phase 2 study; primary outcome; procedure cost; research and development; sample fixation; scaffold; standard of care; standing height; usability

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.

项目摘要/摘要 从站立高度和其他低能创伤跌落，占所有骨科骨折的87％ 老年。远端半径片段（DRF）是这些片段中最常见的类型之一，大约 每年在65岁的人中报告的675,000多个DRF案件中，有40％ 年龄较大。不幸的是，这些伤害导致执行最基本的日常任务的困难，而对于较早的人来说 患者可能导致独立性丧失，生活质量的下降甚至死亡率增加。 DRF伤害的当前护理标准是涉及的开放减少内部固定（ORIF）程序 放置金属硬件，例如伏拉板和/或K线。这些开放手术方法的结果 混合了；据报道，并发症发生率高达36％，涉及 腕管综合症，复杂区域疼痛综合征的发作，导致肌腱刺激和破裂， 深层感染，并需​​要重新开放以除去板。 为了解决这个问题 可以将骨碎片粘合在一起，填充骨骼空隙并将骨粘附到金属的生物材料。随着时间的流逝 创新的材料充当脚手架，促进愈合并允许骨头长大到最终 用新的，重要的骨头代替它。当将剪切负荷施加到各种 底物已被证明比市场上的非粘骨骨水泥明显大。然而 当正确混合时，TN的流量特性使其成为经皮递送的理想选择。独特的，可以加载TN 使用BASO4没有明显降解的机械性能，使外科医生有可能 实时通过荧光镜监视其在体内的位置，而无需开放手术。 在该项目的第一阶段中，对TN粘合剂化学反应进行了特征和优化，以产生与 足够的机械和微结构特性，可以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 使用优化公式的经皮处理。在这个成功的I阶段项目和其他基础上建立 初步研发，TN的翻译为治疗DRF损伤的临床指示 通过完成以下完成的第二阶段研究：目标1：经皮递送的优化 用于DRF程序的TN和目标2：在大动物中安全有效地使用TN 学习。 这项翻译的动物研究的结果，通过外科医生经过验证的模拟使用Cadaver完成 测试将被用作向FDA提出调查设备豁免（IDE）的基础 人类研究。长期，LPM的使命是为外科医生提供一种新型产品，以增强固定性， 减少与DRF程序相关的并发症和修订手术。