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临床试验/NCT00984672
NCT00984672已完成不适用

Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
103
试验地点
1

研究概览

简要总结

Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved, has increased recently due to the morbidity associated with harvest of iliac crest bone graft in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT Cage, other clinical applications of these proteins is becoming widely adopted due to their effectiveness in forming bone and facilitating fusion. Clinicians have realized while these proteins are potent stimulators of bone formation there have been anecdotal reports of increased rates of radicular pain in the postoperative period when used in interbody arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to be due to the inflammatory effects of these proteins. Excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. No prospective studies have been performed assessing the incidence and etiology of this complication. The investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female age 18-75
  • candidate for TLIF
  • Lumbar levels L1-S1

排除标准

  • more than 3 TLIF levels
  • had a previous fusion attempt at involved level(s)
  • had more than 2 previous open, lumbar spine procedures at the involved level(s)
  • currently implanted with anterior instrumentation at the involved level(s)
  • active localized or systemic infection
  • presence of a disease entity or condition which significantly affects the possibility of bony fusion
  • has immunosuppressive disorder actively requiring treatment
  • pregnant or interested in becoming pregnant during the study
  • has a known sensitivity to device materials
  • mentally incompetent or is a prisoner
  • currently a participant in another study for the same indications

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Nassr

PI

Mayo Clinic

研究点 (1)

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