A Prospective, Single-center Study of the Utility of the ATEC IOA Imaging Platform Tool in Intraoperative Imaging for Patients Undergoing Adult Spinal Deformity Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in sagittal Vertical Axis (SVA)
研究概览
简要总结
The purpose of this study is to conduct a prospective study which assesses the utility of the ATEC Intraoperative Alignment (IOA) Imaging Platform tool in intraoperative imaging for patients undergoing adult spinal deformity surgery. The study aims to compare the precision of the ATEC IOA Imaging Platform to current standard 36" cassette intraoperative x-rays, as well as compare intraoperative versus postoperative standing alignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Skeletally mature patients
- •Able to give informed consent
- •Sagittal Spinal Deformity patients as defined by any of the following radiographic criteria:
- •Coronal cobb angle >20 degrees
- •Pelvic Tilt >25degrees
- •Sagittal Vertical Axis >50mm
- •Pelvic Incidence - Lordosis of >10 degrees
- •Thoracic Kyphosis >60 degrees
- •Or clinically indicated for spinal fusion T10-Pelvis or more levels fused
- •Or adult degenerative pathology requiring 2 or more levels fused
排除标准
- •Under the age of 18 years old
- •Skeletally immature patients
- •Active infection
- •Presence of inflammatory spinal disease (e.g. ankylosing spondylitis, Diffuse Idiopathic Skeletal Hyperostosis (DISH), Rheumatoid Arthritis)
- •Concurrent Spinal or pelvic fracture
- •Vulnerable patient (pregnant, prisoner, inability to consent)
研究组 & 干预措施
Spinal Deformity
Patients will receive preoperative standing electronic optical scan (EOS) radiographs, and first-erect postoperative standing EOS radiographs. Intraoperatively, patients will receive standard 36" cassette imaging as well as imaging with the ATEC IOA Imaging Platform.
干预措施: ATEC IntraOperative Alignment (IOA) Imaging Platform (Diagnostic Test)
Spinal Deformity
Patients will receive preoperative standing electronic optical scan (EOS) radiographs, and first-erect postoperative standing EOS radiographs. Intraoperatively, patients will receive standard 36" cassette imaging as well as imaging with the ATEC IOA Imaging Platform.
干预措施: Standard 36" cassette imaging (Diagnostic Test)
Spinal Deformity
Patients will receive preoperative standing electronic optical scan (EOS) radiographs, and first-erect postoperative standing EOS radiographs. Intraoperatively, patients will receive standard 36" cassette imaging as well as imaging with the ATEC IOA Imaging Platform.
干预措施: EOS radiographs (Diagnostic Test)
结局指标
主要结局
Change in sagittal Vertical Axis (SVA)
时间窗: Pre-operative, Intra-operative (up to 1 hour)
Distance from the C7 plumb line to the posterior-superior corner of S1; optimal is \< 5 cm.
Change in Pelvic incidence (PI)
时间窗: Pre-operative, 6 weeks post-operative
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Change in Pelvic incidence (PI)
时间窗: Pre-operative, 3 months post-operative
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Change in Pelvic incidence (PI)
时间窗: Pre-operative, 6 months post-operative
Pelvic incidence (PI) is a fixed anatomical parameter measuring the sagittal orientation of the sacrum relative to the hip joints (femoral heads), calculated as the angle between a line perpendicular to the midpoint of the sacral plate and a line connecting that midpoint to the axis of the femoral heads. The average PI angle in adults is generally between 40° and 55°.
Change in Lumbar lordosis (LL)
时间窗: Pre-operative, Intra-operative (up to 1 hour)
Lumbar lordosis (LL) measures the degree of inward, anteriorly convex curvature of the lower spine, usually quantified as an angle on lateral radiographs or imaging, often ranging between 30° and 80°
Change in PI-LL mismatch
时间窗: Pre-operative, Intra-operative (up to 1 hour)
Pelvic incidence-lumbar lordosis (PI-LL) mismatch measures the difference between a fixed pelvic parameter (PI) and the functional lumbar curve (LL). A mismatch \>10 degrees (specifically PI minus LL) signifies sagittal malalignment.
Change in T1-Pelvic Angle (TPA)
时间窗: Pre-operative, Intra-operative (up to 1 hour)
Angle between the center of the T1 vertebral body, the femoral heads, and the sacral endplate, representing both SVA and pelvic tilt.
Change in T10-pelivc angle (PA)
时间窗: Pre-operative, Intra-operative (up to 1 hour)
The angle between the center of the T10 vertebra, the hip center, and the midpoint of the S1 upper endplate.
Change in L1-pelivc angle (PA)
时间窗: Pre-operative, Intra-operative (up to 1 hour)
The angle between a line from the L1 vertebra center to the femoral head axis, and a line from the S1 superior endplate to the femoral head axis.
Intraclass correlation coefficient (ICC)
时间窗: End of study (up to 24 months)
ICCs will be used to assess for consistency and reproducibility of the radiographic measurements made by the various observers. ICCs will be assessed using the following ranges: excellent (0.75-1.0), good (0.60-0.74), fair (0.40-0.59), and poor (\< 0.40).
次要结局
未报告次要终点