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

摘要 脊柱疾病，主要由退行性脊柱疾病、畸形、肿瘤和创伤引起， 大约一半的人口年龄在40岁以上。为了解决这些疾病，超过457，000例脊柱融合术 2011年在美国进行了约290，000例颈椎前路椎间盘切除术（年增长率为6%）， 和融合（ACDF）。ACDF手术切除1-4个椎间盘，并用椎间融合器替代 充满了植骨这在融合相邻椎骨的同时分散并固定神经根。 术后，关键是要认识到椎骨何时融合，这一结果决定了安全性。 恢复活动;相反，延迟融合可能表明需要额外的干预（例如，延长 项圈使用、改良的物理疗法、电刺激和注射如rhPTH）。不当 治疗可能导致不良结局、更严重的疼痛、手术翻修和神经功能缺损。不幸的是， 患者的愈合率差异很大，有些患者不能正常愈合，7%的患者需要昂贵的翻修 手术（123 000美元住院费）。 我们建议开发一种X线可见椎间融合器，以指示生物力学载荷（X-VISIBL）融合 该器械可帮助临床医生跟踪和检测骨融合。如果成功，该项目将验证一个简单的 报告器械负载以评估相邻骨融合的指示器。进行测量 使用屈曲/伸展X线摄影，其已经常规用于患者随访，但目前 检测延迟融合和骨不连的灵敏度不足。监测植入物载荷将为患者提供 和医疗团队的关键信息，以选择早期有针对性的干预措施，包括延长支具或项圈 使用、修改的物理治疗和返回工作方案、超声波或电刺激、药物 或注射，如rhPTH，并告知长期护理，以避免设备故障和相关的疼痛，残疾 和再次手术。 第一阶段小企业技术转让项目旨在评估负载的技术可行性。 表明颈椎椎间融合器。该方法在提供传感器以清楚地测量负载方面是创新的 在融合过程中，X射线读出已经是护理标准的一部分。为了证明可行性，我们必须 开发具有允许/鼓励融合（特别是刚度和屈服）的机械性能的原型， 在融合过程中检测生理负荷变化的精度。这将通过计算机来实现 模拟、机械原型制造和测试以及尸体模型中的放射线照相。 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方法来评估 生物力学融合，并协助医生制定康复方案和后续治疗。

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.