Prevention of spinal cord injury during thoracic spine surgery

胸椎手术中脊髓损伤的预防

• 批准号: 7509324
• 负责人: Blair Calancie
• 金额: $ 27.48万
• 依托单位: UPSTATE MEDICAL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7509324
• 关键词: Bone Screws; Chest; Deformity; Electromyography; Feedback; Frequencies; Gender; Goals; Health; Human; Image; Implant; Incidence; Injury; Intervention; Lead; Left; Location; Lower Extremity; Medial; Metals; Methods; Monitor; Muscle; Nerve; Neurostimulation procedures of spinal cord tissue; Numbers; Operative Surgical Procedures; Outcome Measure; Patients; Pattern; Physiologic pulse; Placement; Plant Roots; Positioning Attribute; Postoperative Period; Prevention; Property; Protocols documentation; Public Health; Pulse taking; Purpose; Randomized; Relative (related person); Risk; Site; Spinal; Spinal Canal; Spinal Cord; Spinal cord injury; Staging; Stimulus; Study Subject; Surgeon; Symptoms; Testing; Time; Tissues; Training; Trauma; Upper arm; Vertebral column; X-Ray Computed Tomography; base; bone; cohort; implantation; improved; information gathering; innovation; instrumentation; novel; prevent; prospective; relating to nervous system; response; retinal rods; spine bone structure

DESCRIPTION (provided by applicant): Surgery involving the thoracic spine sometimes requires the implantation of metal rods to stabilize and fuse the vertebrae. One increasingly-popular method of anchoring these rods is to place large bone screws through the pedicles that connect the `back' part of each vertebra (i.e. the lamina) with its `front' part (i.e. the body), and then connecting the rods to these implanted screws. Typically a narrow `awl' (or pedicle finder) is forced through the pedicle (creating the pedicle track), and then a screw is placed along this track. Ideally the screw should be fully- contained within bone, but if it `misses' towards the midline (i.e. medially) at any level within the thoracic spine, it may hit and injure the spinal cord. The goal of this study is to develop a new intra-operative monitoring (IOM) test of spinal cord conduction to prevent medial malplacement of thoracic pedicle screws, thereby preventing spinal cord injury. In the first of 2 Specific Aims, we will establish the relationship between the amount of energy needed to electrically stimulate spinal cord and nerve roots through the pedicle track (i.e. prior to screw implantation) and the position of that screw relative to the pedicle, once the screw is placed. We anticipate that pedicle tracks which have broken through the bone of the medial pedicle wall will lead to spinal cord stimulation with weak current intensities. We will retrospectively develop rules to tell us when it is safe to put a screw in a particular pedicle track. In Specific Aim #2, we will apply these rules in a prospective manner to actively prevent screw malplacement during surgery in new subjects. Moreover, we will randomize these subjects into two cohorts. In one group we will actively stimulate through a modified pedicle finder while the surgeon is making a pedicle track, to provide immediate feedback to the surgeon if the orientation of the pedicle track needs to change. We anticipate that there will be fewer cases of medially-malplaced thoracic pedicle screws in subjects studied in Specific Aim #2 compared to those tested with the protocol from Specific Aim #1. Moreover we expect that those subjects who receive active stimulation through the pedicle finder will have the lowest incidence of medial screw malplacement of all subjects tested. By the end of this study period, we will have developed and validated a novel form of intra- operative monitoring for thoracic pedicle screw placement. Not only will this test lower the risk of spinal cord injury, but it will also lower the numbers of subjects who require additional surgery to revise screw placements that " while not causing spinal cord injury per se" are still encroaching upon the canal space enough that they would eventually lead to symptoms if left in place. PUBLIC HEALTH RELEVANCE: Surgery to the thoracic spine to treat deformity or trauma places the spinal cord at relatively high risk for injury, particularly when screws are implanted into the pedicles of the spine. This project will develop a novel method to prevent accidental screw placement into the spinal cord, thereby preventing spinal cord injury.

描述（由申请人提供）：涉及胸椎的手术有时需要植入金属棒以稳定和融合椎骨。一种越来越流行的固定这些杆的方法是通过椎弓根放置大的骨螺钉，该椎弓根将每个椎骨的“后”部分（即椎板）与其“前”部分（即主体）连接，然后将杆连接到这些植入的螺钉。通常，迫使狭窄的“锥子”（或椎弓根探测器）穿过椎弓根（形成椎弓根轨道），然后沿该轨道沿着放置螺钉。理想情况下，螺钉应完全包含在骨内，但如果它在胸椎内的任何水平处“错过”中线（即内侧），则可能会撞击并损伤脊髓。本研究的目的是开发一种新的术中脊髓传导监测（IOM）测试，以防止胸椎椎弓根螺钉内侧错位，从而防止脊髓损伤。在2个特定目标的第一个中，我们将建立通过椎弓根轨迹电刺激脊髓和神经根所需的能量（即螺钉植入前）与螺钉相对于椎弓根的位置之间的关系，一旦放置螺钉。我们预计，椎弓根轨道已经突破了内侧椎弓根壁的骨将导致脊髓刺激与弱电流强度。我们将回顾性地制定规则，告诉我们何时在特定椎弓根轨道中放置螺钉是安全的。在具体目标2中，我们将以前瞻性方式应用这些规则，以积极预防新受试者手术期间螺钉错位。此外，我们将这些受试者随机分为两个队列。在一组中，我们将在外科医生制作椎弓根轨迹时通过改良的椎弓根探测器主动刺激，以便在椎弓根轨迹的方向需要改变时向外科医生提供即时反馈。我们预计，与使用特定目标1的方案进行试验的受试者相比，在特定目标2中研究的受试者中胸椎椎弓根螺钉内侧错位的病例将更少。此外，我们预计通过椎弓根探测器接受主动刺激的受试者的内侧螺钉错位发生率最低。到本研究期结束时，我们将开发并验证一种新型的胸椎椎弓根螺钉放置术中监测。这项测试不仅会降低脊髓损伤的风险，而且还将减少需要额外手术来修改螺钉放置的受试者数量，这些螺钉放置“虽然本身不会引起脊髓损伤”，但仍然会侵占椎管空间，如果留在原位，最终会导致症状。公共卫生关系：治疗胸椎畸形或创伤的手术使脊髓处于相对较高的损伤风险，特别是当螺钉植入脊柱椎弓根时。该项目将开发一种新的方法，以防止意外螺钉置入脊髓，从而防止脊髓损伤。