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

摘要 脊柱疾病，主要由脊柱退行性疾病、畸形、肿瘤和创伤引起，影响 大约一半的人口年龄在40岁以上。为了解决这些疾病，超过45.7万例脊柱融合术 2011年在美国进行了手术(年增长率为6%)，其中包括约29万例前路颈椎摘除术 和融合(ACDF)。ACDF手术切除1-4个间盘，用椎间隔板取而代之 里面装满了骨移植。这会分散神经根并使其减压，同时融合相邻的椎骨。 手术后，识别椎骨何时融合是至关重要的，这一结果决定了安全性。 恢复活动；相反，融合延迟可能意味着需要额外的干预(例如，延长 项圈的使用、改良的物理疗法、电刺激和注射如重组人甲状旁腺素)。不适当 治疗可能会导致不良结局、更严重的疼痛、手术翻修和神经功能障碍。不幸的是， 患者的愈合率差异很大，一些患者不会正确愈合，7%的患者需要花费高昂的修复费 手术费(12.3万美元住院费)。 我们建议开发一种X光可见的指示生物力学载荷的椎间间隔物(X-VISIBL)融合 辅助临床医生跟踪和检测骨融合的设备。如果成功，这个项目将验证一个简单的 报告设备上的负载以评估相邻骨骼融合的指示器。进行了测量 使用已经在患者随访中常规使用的屈曲/伸展X线片，但目前 对延迟融合和骨不连的检测不够敏感。监测植入物负荷将为患者提供 和医疗团队的关键信息，以选择早期有针对性的干预措施，包括延长支架或项圈 用法、改良的理疗和重返工作岗位方案、超声波或电刺激、药物治疗 或注射如重组人甲状旁腺素，并告知长期护理，以避免设备故障和相关的疼痛、残疾 和再手术。 该第一阶段小型企业技术转让项目旨在评估负载的技术可行性 表明颈椎椎间间隔物。该方法的创新之处在于提供了一种传感器来清楚地测量负载 在与X射线读数融合期间，这已经是护理标准的一部分。要显示可行性，我们必须 开发具有允许/鼓励融合(特别是刚性和屈服)的机械性能的原型，并 在融合过程中检测生理负荷变化的精度。这将用计算机来完成 模拟、机械原型制造和测试，以及身体模型的射线照相。 这项研究与公共卫生有关，因为它提供了一种客观的、非侵入性的手段来评估 生物力学融合和协助医生开出康复方案和辅助疗法。

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.