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
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
- 否
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
Galvan Ernesto Eduardo
MD
American British Cowdray Medical Center
