Safety of Lumbar Fusion Surgery for Chronic Back Pain

描述(申请人提供)：虽然我在学术环境中作为一名脊柱外科医生取得了成功，建立了受人尊敬的临床实践，并为竞争对手资助的项目完成了脊柱生物力学研究，但我意识到，临床研究最直接地满足了我选择学术职业的动机，而且高质量的临床研究是复杂的，需要长期的承诺和专业技能。我处在一个很好的环境中，可以发展这些技能，有支持我的同事和支持我的主席。我制定了一个为期五年的培训计划，前三年致力于获得公共卫生硕士学位。一个由三个杰出的人组成的团队承诺在接下来的五年里与我合作，指导我的职业发展。我的近期目标是通过与这个经验丰富且备受尊敬的研究团队进行一项为期五年的前瞻性研究，获得实际的临床研究经验。我的长期职业目标是帮助更具体地确定脊柱患者群体，总体上衡量脊柱疾病的最终结果，并特别确定治疗和未治疗的背痛和鞭打损伤的结果。研究项目：手术治疗背部疼痛的使用正在迅速增长；迫切需要关于其安全性和结果的数据。我们提出了一项前瞻性队列研究，以衡量腰椎融合手术中并发症的发生率、不同类型腰椎融合手术中特定严重并发症发生率的差异、特定类型并发症的临床和功能后果，以及预测特别严重并发症的患者或治疗特征。在两年的时间间隔内，我们建议招募1000名选择融合术治疗腰椎间盘退变、腰椎滑脱、椎管狭窄和成人退行性脊柱侧弯的患者。我们将对这些患者进行为期两年的跟踪，衡量预测患者和治疗特征，并根据临床和功能结果衡量后果。积累的数据将存储在现有的中央数据库中。分析将使用适当的单变量和多变量技术来解决研究问题。这项研究将提供腰椎融合术在治疗背痛方面的相对益处和风险的数据。

DESCRIPTION (provided by applicant): Although I have been successful as a spine surgeon in an academic environment, building a respected clinical practice and completing spine biomechanics research for competitively funded projects, I realize that clinical research most directly addresses my motivation for choosing an academic career, and that high-quality clinical research is complex, requiring a long-term commitment and specialized skills. I am in an excellent environment to develop these skills, with supportive colleagues and a supportive chairman. I have developed a five-year training schedule, with the first three years devoted to obtaining an MPH degree. A team of three outstanding individuals has committed to working with me for the next five years and guiding my career development. My immediate goal is to gain practical clinical research experience by conducting a five-year prospective study with this team of experienced and highly respected researchers. My long-term career goals are to help identify spine patient populations more concretely, measure end-results of spinal disorders in general, and define outcomes for treated and untreated back pain and whiplash injuries in particular. Research Project: The use of surgery for back pain is rapidly growing; data on its safety and outcomes are sorely needed. We propose a prospective cohort study to measure the frequency of complications in lumbar fusion surgery, variation in rates of specific serious complications with different types of lumbar fusion, clinical and functional consequences for specific types of complications, and patient or treatment characteristics that predict particularly severe complications. Over a two-year interval, we propose to enroll 1000 patients choosing fusion surgery for treatment of disc degeneration, spondylolisthesis, spinal stenosis, and adult degenerative scoliosis. We will follow these patients for two years, measure predictor patient and treatment characteristics, and measure consequences with clinical and functional outcomes. Accumulating data will be stored in an existing central database. The analysis will use appropriate univariate and multivariate techniques to address the study questions. This study will provide data on the relative benefits and risks of lumbar fusion surgery in treating back pain.