Safety of Lumbar Fusion Surgery for Chronic Back Pain

腰椎融合手术治疗慢性背痛的安全性

• 批准号: 6758068
• 负责人: Sohail K Mirza
• 金额: $ 12.53万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6758068
• 关键词: back injury; backache; clinical research; epidemiology; functional ability; head /neck injury; human subject; human therapy evaluation; longitudinal human study; outcomes research; patient oriented research; postoperative complications; spinal fusion; spine disorder

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.

描述（由申请人提供）：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性资助的项目完成脊柱生物力学研究，但我意识到临床研究最直接地解决了我选择学术的动机职业生涯，高质量的临床研究是复杂的，需要长期的承诺和专业技能。我的环境非常好，可以培养这些技能，同事和主席都非常支持我。我制定了一个五年的培训计划，前三年专门用于获得公共卫生硕士学位。由三名杰出人士组成的团队致力于在未来五年与我合作并指导我的职业发展。我的近期目标是通过与这支经验丰富且备受尊敬的研究人员团队进行为期五年的前瞻性研究来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识别脊柱患者群体，总体测量脊柱疾病的最终结果，并特别确定已治疗和未治疗的背痛和颈部扭伤的结果。 研究项目：背痛手术的使用正在迅速增长；迫切需要有关其安全性和结果的数据。我们提出一项前瞻性队列研究，以测量腰椎融合手术并发症的发生频率、不同类型腰椎融合术中特定严重并发症发生率的变化、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并发症。我们建议在两年内招募 1000 名选择融合手术治疗椎间盘退变、脊椎滑脱、椎管狭窄和成人退行性脊柱侧凸的患者。我们将跟踪这些患者两年，测量预测患者和治疗特征，并测量临床和功能结果的后果。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。这项研究将提供有关腰椎融合手术治疗背痛的相对益处和风险的数据。