X-ray Visualized Interbody Spacer Indicating Biomechanical Load (X-VISIBL) Fusion Device

X 射线可视化椎间垫片指示生物力学负荷 (X-VISIBL) 融合装置

• 批准号: 10157213
• 负责人: John David DesJardins
• 金额: $ 25.21万
• 依托单位: SPINEFRONTIER, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-18 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10157213
• 关键词: 3D Print; Address; Affect; Anatomy; Anterior; Biological; Biomechanics; Bone Growth; Bone Transplantation; Businesses; Cadaver; Calibration; Caring; Cervical; Cervical spine; Characteristics; Clinical; Clinical effectiveness; Computer Simulation; Consumption; Deformity; Development; Devices; Diagnosis; Diagnostic radiologic examination; Disease; Electric Stimulation; Elements; Equipment Malfunction; Goals; Gold; Growth; Hospital Charges; Hospital Costs; Human; Impaired healing; Implant; In Vitro; Injections; Innovation Corps; Interobserver Variability; Intervention; Intervertebral disc structure; Interview; Lead; Length; Liquid substance; Long-Term Care; Measurement; Measures; Mechanics; Medical; Methods; Modeling; Modulus; Monitor; Motion; Muscle Contraction; Neck; Neck Pain; Nerve; Neurologic Deficit; Operative Surgical Procedures; Outcome; Pain; Patients; Performance; Pharmaceutical Preparations; Phase; Physical activity; Physical therapy; Physicians; Physiological; Plant Roots; Population; Postoperative Period; Procedures; Process; Protocols documentation; Public Health; Radiation Dose Unit; Radiculopathy; Rehabilitation therapy; Repeat Surgery; Reporting; Research; Research Project Grants; Roentgen Rays; Scanning; Second Look Surgery; Series; Shapes; Small Business Technology Transfer Research; Spinal Diseases; Spinal Fusion; Symptoms; Technology Transfer; Testing; Time; Trauma; Ultrasonography; Vertebral column; Voice; Work; X-Ray Computed Tomography; aged; base; bone; bone healing; bone quality; cost; design; disability; follow-up; healing; imaging study; implant design; in silico; individual patient; innovation; instrumentation; mechanical properties; models and simulation; novel; physical therapist; programs; prototype; response; sensor; sex; simulation; spine bone structure; standard of care; tumor

Abstract Spine disorders, primarily caused by degenerative spine conditions, deformity, tumors, and trauma, affect approximately half of the population aged over 40. To address these disorders, over 457,000 spine fusions were performed in the US in 2011 (6% annual growth), including about 290,000 anterior cervical discectomy and fusions (ACDF). ACDF surgery removes 1-4 intervertebral discs and replaces them with interbody spacers filled with bone graft. This distracts and decompress the nerve roots while fusing the adjacent vertebrae. Postoperatively, it is critical to recognize when the vertebrae have fused, an outcome that determines safe return to activity; conversely, delayed fusion may indicate need for additional interventions (e.g., prolonged collar usage, modified physical therapy, electrical stimulation, and injections such as rhPTH). Improper management can lead to poor outcomes, worse pain, surgical revision and neurological deficits. Unfortunately, patients heal at rates that vary greatly, and some patients will not heal properly with 7% needing costly revision surgery ($123,000 hospital charges). We propose to develop an X-ray Visible Interbody Spacer Indicating Biomechanical Load (X-VISIBL) fusion device to assist clinicians in tracking and detecting bony fusion. If successful, this project will validate a simple indicator that reports load on the device to assess fusion of the adjacent bones. Measurements are made using flexion/extension radiography which is already routinely used in patient follow-up but is currently insufficiently sensitive to detect delayed fusion and non-union. Monitoring implant load will provide the patient and medical team critical information to select early targeted interventions including prolonged brace or collar usage, modified physical therapy and return-to-work protocols, ultrasound or electrical stimulation, medications or injections such as rhPTH, and inform long term care to avoid device failure and associated pain, disability and reoperations. This Phase I Small Business Technology Transfer project aims to assess technical feasibility for a load indicating cervical interbody spacer. The approach is innovative in providing a sensor to clearly measure load during fusion with X-ray readout that is already part of the standard of care. To show feasibility, we must develop prototypes with mechanical properties that allow/encourage fusion (especially stiffness and yield) and the precision to detect physiological load changes during fusion. This will be accomplished with computer simulations, mechanical prototype fabrication and testing, and radiography in cadaveric models. The research is relevant to public health because, it provides an objective non-invasive means to assess biomechanical fusion and assist physicians prescribing rehabilitation protocols and adjunctive therapies.

抽象的 脊柱疾病主要由退化性脊柱状况，畸形，肿瘤和创伤引起 大约一半的人口超过40岁。为了解决这些疾病，超过457,000个脊柱融合 2011年在美国进行（年增长6％），其中包括大约290,000个前颈椎切除术 和融合（ACDF）。 ACDF手术去除1-4个椎间盘，并用跨体间隔器代替它们 充满骨移植。这会分散注意力并解压缩神经根，同时融合相邻的椎骨。 术后，必须识别椎时何时融合至关重要，这是确定安全的结果 返回活动；相反，延迟的融合可能表明需要其他干预措施（例如，延长 衣领使用情况，修饰的物理疗法，电刺激和注射（例如RHPTH）。不当 管理会导致不良的结局，疼痛较差，手术修复和神经系统缺陷。很遗憾， 患者以差异很大的愈合，有些患者无法正常愈合，需要昂贵的修订，有7％ 手术（医院费用为123,000美元）。 我们建议开发一个X射线可见的室内间隔器，表明生物力学负载（x-visibl）融合 帮助临床医生跟踪和检测骨融合的设备。如果成功，该项目将验证一个简单的 指示报告在设备上加载以评估相邻骨骼的融合。进行了测量 使用屈曲/扩展X线照相，该X线片已常规用于患者随访，但目前是 不足以检测延迟的融合和非工会。监测植入物负载将为患者提供 和医疗团队的关键信息，以选择早期有针对性的干预措施，包括长时间的支撑或项圈 用法，修改的物理疗法和重返工作方案，超声或电刺激，药物 或诸如RHPTH之类的注射，并告知长期护理以避免设备失败和相关疼痛，残疾 和重新运行。 该阶段I小型企业技术转移项目旨在评估负载的技术可行性 指示宫颈间间隔器。该方法在提供一个传感器清楚测量负载方面具有创新 在与X射线读数融合过程中，已经是护理标准的一部分。为了显示可行性，我们必须 开发具有允许/鼓励融合（尤其是刚度和产量）的机械性能的原型原型 在融合过程中检测生理负荷变化的精度。这将通过计算机完成 尸体模型中的仿真，机械原型制造和测试以及射线照相。 该研究与公共卫生有关，因为它提供了一种客观的非侵入性手段来评估 生物力学融合和协助处方康复方案和辅助疗法的医生。