Metastatic Spine Tumors: Minimally Invasive Fracture Risk Analysis and Treatment

描述（由申请方提供）：确定癌症转移至骨性脊柱后，治疗临床医生必须做出手术决定。无论是手术治疗还是非手术治疗，这一决定对患者的影响都很大。如果脊柱被认为是不稳定的，有骨折的风险，那么病人将接受一个重大的脊柱手术，并往往花费大部分的余生从它恢复。相反，病人的脊柱被认为是稳定的，并接受非手术治疗的风险骨折和可能的瘫痪，如果稳定性分析是不正确的。此外，转移性疾病通常会进展，在整个病程中必须定期重复稳定性分析。脊柱稳定性的决定是经验性的，即使由经验丰富的脊柱临床医生做出，也可能是不准确的。该提案既涉及稳定性决定，又涉及被认为有骨折风险的患者的治疗性质。目的1描述了一个自动程序的开发，分析脊柱计算机断层扫描，并计算受影响的椎骨的剩余承载能力。目标2优化新型可注射材料，以微创方式恢复椎骨的承载能力，从而缩短脊柱大手术的恢复和康复时间。这一目标的成功实现将为许多此类患者提供开放手术的替代方案，从而减少他们的康复时间并增加他们的家庭时间。目标3涉及自动脊柱稳定性分析和微创脊柱重建的验证。这些体外和体内Aim 3临床前确认研究是使Aim 1自动诊断方法和Aim 2微创手术治疗方法更接近临床实践目标的必要步骤。 公共卫生相关性声明（由申请人提供）：对于癌症已扩散至脊柱的患者，计算机化脊柱稳定性评估将为患者提供更准确的脊柱手术需求诊断，并且患者及其家人更有可能在家附近进行评估，节省他们的时间，费用和不便。建议采用非手术治疗，以进一步确保脊柱骨折的风险较低。那些确实需要手术的患者通常会选择微创手术技术，这将缩短他们的住院时间，并允许他们回家与家人团聚。

DESCRIPTION (provided by applicant): The identification of cancer metastases to the bony vertebral column obligates the treating clinician to make a surgical decision. The consequences of that decision for the patient are significant whether the recommendation is for surgical or non-surgical treatment. If the spine is deemed unstable and at risk for fracture, then the patient will undergo a major spinal operation, and will often spend much of their remaining life recuperating from it. Conversely, the patient whose spine is deemed stable and receives non-surgical treatment risks fracture and possible paralysis if the stability analysis was incorrect. In addition, the metastatic disease usually progresses, and the stability analysis must be repeated at intervals throughout the disease course. The spinal stability decision is empirical and can be inaccurate, even when done by experienced spinal clinicians. This proposal addresses both the stability decision and, for those patients deemed at risk for fracture, the nature of the treatment. Aim 1 describes the development of an automated program that analyzes spinal computerized tomography scans, and calculates the residual load carrying capacity of the affected vertebra. Aim 2 optimizes novel injectable materials to restore the load carrying capacity of the vertebra in a minimally invasive manner, thus decreasing time in recovery and rehabilitation from major spine surgery. Successful achievement of this aim would offer an alternative to open surgery for many of these patients, thus decreasing their rehabilitation time and increasing their family time. Aim 3 addresses validation of both the automated spinal stability analysis and the minimally invasive spinal reconstruction. These in vitro and in vivo Aim 3 preclinical validation studies are requisite steps to position both the Aim 1 automated diagnostic methodology and the Aim 2 minimally invasive surgical treatment methodology closer to the goal of translation to clinical practice. Public Health Relevance Statement (provided by applicant): The computerized spinal stability assessment, for patients who have cancer that has spread to their spine, will offer more accurate diagnosis of the need for spine surgery to the patients, and with a much greater likelihood that the patients and their families can get the evaluation done near their home, saving them time, expense, and inconvenience. The recommendation for non-surgical treatment will be made with increased assurance that the risk of a spine fracture is low. Those patients, who do need surgery, will often chose minimally invasive surgical techniques that will shorten their hospital stay and allow them to return home to their families.