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: 6909097
• 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/6909097
• 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）：尽管我在学术环境中已经成为脊柱外科医生，在学术环境中取得了成功，建立了受人尊敬的临床实践并完成了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职业的动机，并且高质量的临床研究很复杂，需要长期承诺和长期的承诺和专业技能。我的环境很棒，可以与支持同事和支持董事长一起发展这些技能。我已经制定了五年的培训时间表，头三年致力于获得MPH学位。由三个杰出人士组成的团队致力于在接下来的五年中与我合作，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受人尊敬的研究人员团队进行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确定脊柱患者人群，衡量脊柱疾病的最终结果，并尤其是治疗和未经治疗的背痛和鞭打伤害的结果。 研究项目：将手术用于背痛正在迅速增长；迫切需要有关其安全性和结果的数据。我们提出了一项前瞻性队列研究，以衡量腰融合手术中并发症的频率，特定严重并发症的变化具有不同类型的腰部融合，对特定类型的并发症类型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。在两年的间隔内，我们建议招募1000名患者选择融合手术以治疗椎间盘退化，脊柱滑脱，脊柱狭窄和成人退行性脊柱侧弯。我们将关注这些患者两年，测量预测病人和治疗特征，并通过临床和功能结果来衡量后果。累积数据将存储在现有的中央数据库中。该分析将使用适当的单变量和多元技术来解决研究问题。这项研究将提供有关治疗背痛的腰融合手术相对益处和风险的数据。