Metastatic Spine Tumors: Minimally Invasive Fracture Risk Analysis and Treatment

描述（由申请人提供）：肿瘤转移到骨性脊柱的鉴定使治疗临床医生有义务做出手术决定。该决定对患者的影响是显著的，无论推荐手术或非手术治疗。如果认为脊柱不稳定，有骨折的危险，那么患者将接受一次大的脊柱手术，并且通常要花很长时间从手术中恢复过来。相反，如果稳定性分析不正确，认为脊柱稳定并接受非手术治疗的患者有骨折和可能瘫痪的风险。此外，转移性疾病通常会进展，稳定性分析必须在整个病程中间隔重复。脊柱稳定性的决定是经验性的，可能是不准确的，即使是由经验丰富的脊柱临床医生完成的。本建议既解决了稳定性的问题，也解决了那些被认为有骨折风险的患者的治疗性质。目标1描述了一种自动化程序的开发，该程序可以分析脊柱计算机断层扫描，并计算受影响椎体的剩余承载能力。目的2优化新型注射材料，以微创方式恢复椎体的承载能力，从而减少大脊柱手术后的恢复和康复时间。这一目标的成功实现将为许多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。目的3讨论了自动脊柱稳定性分析和微创脊柱重建的验证。这些体外和体内的Aim 3临床前验证研究是使Aim 1自动诊断方法和Aim 2微创手术治疗方法更接近于转化为临床实践目标的必要步骤。

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.