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: 2019
• 资助国家: 加拿大
• 起止时间: 2019-01-01 至 2020-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=681175
• 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.

椎体骨折VF是骨质疏松最常见的并发症，目前尚无有效的治疗方法。据报道，与室颤相关的死亡率为8%。由于VF的发病率预计会随着人口的老龄化而上升，因此寻找解决方案是至关重要的。*骨强化是治疗骨折的一种新方法。在它中，一种自硬化的胶凝聚甲基丙烯酸甲酯PMMA，经皮注射到骨的多孔结构中。PMMA一旦硬化，骨折的骨骼就会稳定下来。主要的好处是，患者在手术后几乎立即就能感受到疼痛的缓解，而费用只是其他手术治疗的一小部分。*该研究计划分为三个项目，以解决该手术的三个主要挑战。*第一个挑战是硬化的PMMA水泥和骨骼的硬度不匹配，导致相邻骨骼中的高应力。较高的应力可能导致新的相邻损伤或PMMA的迁移。第一个目标是用无菌空气给粘弹性PMMA糊充气，以减少这种不匹配。具体地说，含有空气的混合物会产生多孔水泥，其硬度可以根据所含空气的百分比进行调整。考虑到新材料面临监管挑战的问题，解决方案存在于混合设备中。磷酸钙CP是最近推出的一种材料，旨在解决PMMA的生物缺陷。然而，CP带来了新的注入问题。第二个目的是对CP颗粒糊进行振动和流态化，以防止悬浮液相从CP颗粒糊中分离出来，从而导致CP糊挤出物不均匀。作为振动流态化的结果，液体和膏体可以保持经皮注射和挤出物均匀。*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体强度和椎弓根螺钉的稳定性，这对于在骨质疏松脊柱中锚定多组分机械结构是必不可少的。是否增加椎弓根螺钉是主观的决定。第三个目标是开发一种经皮压痕过程，将骨小梁视为多孔固体，并使用刚性探头客观地测量其强度。*研究计划包括计算和实验方法，以有效地研究这三个目标中的物理和几何相互作用。*预期结果将是三种新的医疗技术：压电式注射器、充气混合器和骨强度探头，以可靠地筛查骨质疏松患者。*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节省和医疗行业对设备的商业开发。