Physical Capability Outcomes After Single-Level ProDisc-L Total Disc Replacement or Single-Level Anterior Lumbar Interbody Fusion: a Multi-Center Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Change in physical capability outcomes (6 minute walk; squats; light board game task standing bent forward /kneeling; floor-to-waist lift; horizontal lift; static push/pull force)
研究概览
简要总结
The purpose of this study is to compare the physical capability outcomes of patients who undergo single-level ProDisc-L disc replacement with those of patients who undergo stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the first multi-center clinical study to use clearly measurable outcomes from physical tests to compare the results of lumbar disc arthroplasty with disc fusion.
详细描述
Physical capability testing will be conducted once before surgery and at 6 months and 1 year after surgery. Physical capability testing assesses the ability to perform a number of common tasks: the distance a subject can walk comfortably in 6 minutes; the amount of weight a subject can lift, push, pull, and carry; and the ability to squat and work bending forward in the kneeling and standing positions. The results of this testing will be evaluated to determine whether the subject's physical capability meets the physical requirements of their job, based on their responses to a pre-study questionnaire. Each physical capability testing session will require from 1 to 1 ½ hours of the subject's time. Physical capability testing will be provided without charge.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible patients will meet the following criteria based on clinically appropriate criteria per standard of care at individual institutions which may include but are not limited to
- •skeletally mature; BMI < 40
- •suffered from low-back pain with or without leg pain for 6 months or longer
- •no evidence of spinal deformity on plain radiograph
- •no evidence of angular instability on flexion extension radiographs
- •severe and incapacitating low-back pain, defined as a score of 40% or greater on the Oswestry Disability Questionnaire
- •a single level of degenerative disc disease at L34, L45, or L5-S1 on magnetic resonance imaging (MRI) scan
- •discography, if indicated, reproduces pain at the level of degeneration noted on the MRI scan and is negative for pain reproduction at adjacent levels
- •bone mineral density T-Score by DEXA Scan >-1.0 for any skeletal region
- •computed tomographic (CT) scan demonstrates the absence of pars defect at the index level
- •CT scan demonstrates the absence of significant facet arthropathy at the index level
- •considered reasonable candidates for surgery in regard to psychological factors as determined according to the standard of care at each participating center
排除标准
- •active systemic infection
- •evidence of alcoholism
- •spondylolisthesis of greater than grade 1
- •clinically significant lumbar spinal stenosis
- •allergy to implant materials
- •isolated radicular syndrome
- •vertebral body compromised by trauma at the index level.
结局指标
主要结局
Change in physical capability outcomes (6 minute walk; squats; light board game task standing bent forward /kneeling; floor-to-waist lift; horizontal lift; static push/pull force)
时间窗: pre-op, at 6mo., and at 12mo.
次要结局
- Oswestry Disability Index(pre-op, at 6mo., and at 12mo)
- EQ-5D Health Questionnaire(pre-op, at 6mo., and at 12mo.)
- Visual Analog Scale (VAS) scores for pain severity and frequency(pre-op, at 6mo., and at 12mo.)
- SF-36 scores for the 8 Domains(pre-op, at 6mo., and at 12mo.)
研究者
Humbert (Drew) Sullivan
Chair, Department of Neurosurgery
Gundersen Lutheran Medical Foundation