AtrophyLSS - Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Pelvic incidence (PI): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
研究概览
简要总结
This study is to evaluate the correlation between muscle atrophy (MA), sagittal alignment, and stenosis degree in patients with lumbar spinal Stenosis (LSS). From existing radiological images, specific radiographic parameters will be extracted. General Information (Age, sex, levels of stenosis, duration of symptoms) will be extracted from patient files.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of degenerative lumbar spinal stenosis
- •Upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral head
- •MRI of the lumbar region with clear visibility of different muscle atrophy grade
- •Consent that health related information can be used for research was signed
排除标准
- •Other spinal disease such as severe scoliosis, fracture, spondylolisthesis and ankylosing spondylitis.
- •Neuromuscular diseases such as M.Parkinson or multiple sclerosis
- •Previous surgery of the spine
- •Infection and/or malignancy tumor with involvement of the bony or soft tissue structures of the spine
- •Presence of a documented consent dissent.
结局指标
主要结局
Pelvic incidence (PI): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
时间窗: single time-point at baseline
Pelvic incidence (PI): The angle between the line perpendicular to the sacral endplate at its midpoint and a line connecting this point to the axis of the femoral head.
Pelvic tilt (PT): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
时间窗: single time-point at baseline
Pelvic tilt (PT): The angle formed by a vertical line through the center of the femoral heads and the line from the center of the femoral axis and the midpoint of the sacral end plate.
Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine
时间窗: single time-point at baseline
Muscle atrophy stage will be observed using Goutallier classification * Stage 0: No fatty infiltration * Stage 1: Few fatty streaks within the muscle * Stage 2: Less than 50% fat within the muscle * Stage 3: 50% of fat within the muscle * Stage 4: more than 50% fat with in the muscle. The MA stage will be observed in MRI of 5 lumbar disc levels (L1-S1). The MA stage of patients will be calculated as average stage of five lumbar segments.
Severity of stenosis from supine MRI of lumbar spine
时间窗: single time-point at baseline
Stenosis grade will be observed using Schizas classification (Schizas et al., 2010) * Grade 1: Dural sac party occupied by the rootlets; Cerebrospinal fluid clearly visible; No stenosis * Grade 2: Rootlets occupy whole dural sac; Some cerebrospinal fluid visible; Moderate stenosis. * Grade 3: Rootlets not visible; No cerebrospinal fluid visible; Epidural fat posteriorly; Severe stenosis. * Grade 4: Rootlets not visible; No cerebrospinal fluid; No epidural fat; Extreme Stenosis. The most severe level will be regarded as the stenosis grade of the patients.
Sacral slope (SS): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
时间窗: single time-point at baseline
Sacral slope (SS): The angle formed between the horizontal and the sacral end plate.
Lumbar lordosis (LL): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
时间窗: single time-point at baseline
Lumbar lordosis (LL): The sagittal angle formed between the superior end plate of L1 and the sacral end plate
次要结局
未报告次要终点