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临床试验/NCT01918943
NCT01918943Unknown不适用

Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain in the Presence of Lumbar Instability and Degenerative Disk Disease

American British Cowdray Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Oswestry Disability Index Score Change

研究概览

简要总结

Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis.

Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device.

In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Oswestry Disability Index score >30%
  • Diagnosis of low back pain and/or radicular pain associated to spinal instability
  • Diagnosis of low back pain and/or radicular pain associated to degenerative disc disease
  • Elective single level surgery
  • Signed informed consent form

排除标准

  • Previous surgery with complete laminectomy, pars defect, etc
  • Patients that during the surgery requires complete laminectomy at level of the surgery
  • Structural lesion to facet joints
  • Osteoporosis
  • Systemic or local infection
  • Pregnant or planning to become pregnant

结局指标

主要结局

Oswestry Disability Index Score Change

时间窗: 12 months

Change between Oswestry Disability Index between pre-operative and final 12 months socores

次要结局

  • Bone fusion (arthrodesis)(12 months)
  • Rolland Morris Score(12 months)
  • Visual Analogue Scale(12 months)

研究者

发起方
American British Cowdray Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Galvan Ernesto Eduardo

MD

American British Cowdray Medical Center

研究点 (1)

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