Studies to improve bone augmentation procedures using injectable biomaterials

使用可注射生物材料改进骨增量手术的研究

• 批准号: RGPIN-2015-05437
• 负责人: Baroud, Gamal
• 金额: $ 1.82万
• 依托单位: Université de Sherbrooke
• 依托单位国家: 加拿大
• 项目类别: Discovery Grants Program - Individual
• 财政年份: 2018
• 资助国家: 加拿大
• 起止时间: 2018-01-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=644687
• 关键词: Studies; improve; bone; augmentation; procedures

There are currently no effective therapies for Vertebral Fractures VF, the most common complications of osteoporosis. The mortality rate associated with VF is reported to be 8%. Since the VF incidence is expected to escalate as the population ages, it is essential to find solutions.******Bone augmentation is a novel procedure to treat bone fractures. In it, a self-hardening cementitious polymethyl methacrylate PMMA, percutaneously injected into the porous structure of the bone. The PMMA, once hardened, stabilizes the fractured bone. The main benefit is that the patient experiences relief from pain, almost immediately after the procedure, at a fraction of the cost of other surgical treatments.******The research program is delineated in 3 projects to address 3 major challenges of the procedure.******The 1st challenge is the mismatch of the stiffness of the hardened PMMA cement and bone, causing high stresses in the adjacent bone. Higher stresses can lead to new adjacent damage or migration of the PMMA. The 1st objective is to aerate the viscoelastic PMMA paste, with sterile air, to reduce this mismatch. Specifically, the air-containing mixture produces porous cement and its stiffness can be adapted by the percentage of contained air. The solution, considering the issue of new materials facing regulatory challenges, resides in a mixing device.******Calcium phosphate CP is a material recently introduced to address the biological shortcoming of PMMA. Yet, CP comes with new injection problems. The 2nd objective is to vibrate and fluidize the CP particle paste to prevent the suspending liquid phase from separating from the CP particle paste, which results in a non-uniform CP paste extrudate. As a result of the vibrofluidization, the liquid and paste may remain percutaneously injectable and the extrudate homogeneous.******The 3rd challenge is the inability of physicians to intraoperatively evaluate the trabecular bone strength, which largely defines the vertebral strength and stability of transpedicular screws that are essential for anchoring a multi-component mechanical construct in the osteoporotic spine. The decision is made subjectively whether or not to augment the transpedicular screws. The 3rd objective is to develop a percutaneous indentation process, in which the trabecular bone is considered as a porous solid, and to use a rigid probe to objectively measure its strength.******The research program comprises both computational and experimental methods to effectively study the physical and geometric interactions in the 3 objectives.******The expected outcomes will be 3 novel medical technologies: a piezo-instrumented syringe, an aeration mixer, and a bone strength probe to reliably screen patients for osteoporosis.******The prime beneficiaries are patients suffering from bone fractures. The socioeconomic impact of these developments is potential health care savings and commercial exploitation of devices by the medical industry.

目前还没有有效的治疗方法来治疗椎体骨折VF，这是骨质疏松症最常见的并发症。据报道，与VF相关的死亡率为8%。由于VF发病率预计将随着人口老龄化而上升，因此必须找到解决方案。骨增量是治疗骨折的一种新方法。在它，一个自硬化水泥聚甲基丙烯酸甲酯PMMA，percently注入到骨的多孔结构。PMMA一旦硬化，就能稳定骨折。主要的好处是，病人经历缓解疼痛，几乎立即在程序后，在一小部分的其他手术治疗的费用。该研究计划被划分为3个项目，以解决该程序的3个主要挑战。第一个挑战是硬化的PMMA骨水泥和骨的硬度不匹配，导致相邻骨中的高应力。更高的应力可能导致新的邻近损伤或PMMA移位。第一个目标是用无菌空气对粘弹性PMMA糊剂进行充气，以减少这种不匹配。具体地，含空气混合物产生多孔水泥，并且其刚度可以通过所含空气的百分比来适应。考虑到新材料面临监管挑战的问题，该解决方案存在于混合设备中。磷酸钙CP是最近引入的一种材料，用于解决PMMA的生物学缺陷。然而，CP带来了新的注入问题。第二个目的是振动和搅拌CP颗粒糊以防止悬浮液相从CP颗粒糊中分离，这导致不均匀的CP糊挤出物。作为振动流化的结果，液体和糊状物可以保持可持续注射并且挤出物是均匀的。第三个挑战是医生无法在术中评估骨小梁强度，这在很大程度上决定了椎弓根螺钉的椎体强度和稳定性，而这对于将多部件机械结构锚定在脊柱内是必不可少的。主观决定是否加固经椎弓根螺钉。第三个目标是开发一种经皮压痕方法，其中骨小梁被视为多孔固体，并使用刚性探针客观地测量其强度。******该研究计划包括计算和实验方法，以有效地研究3个目标中的物理和几何相互作用。预期成果将是3种新的医疗技术：压电仪器注射器，通气混合器和骨强度探针，以可靠地筛查患者的骨质疏松症。主要受益者是骨折患者。这些发展的社会经济影响是潜在的医疗保健储蓄和医疗行业对设备的商业开发。