The Sagittal Plane Shear Index (SPSI) for Planning Whether to Fuse After Decompressing a Stenotic Lumbar Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning
研究概览
简要总结
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple treatment algorithm. The objective spinal stability metric is calculated from flexion-extension radiographs using previously validated methods.
详细描述
Patients with previously diagnosed lumbar spinal stenosis and spondylolisthesis, who have consented to surgical treatment consisting of either decompression alone or decompression plus fusion will be invited to participate in the study. The initial surgical plan will be recorded prior to reviewing the sagittal plane shear index (SPSI). The sagittal plane shear index will be calculated flexion-extension radiographs. The measurements required to calculate SPSI will be obtained using previously validated methods. SPSI greater than 2 indicates that the translation-per-degree of rotation (TPDR) is above the upper limit of the 95% confidence interval observed in several hundred asymptomatic and radiographically normal individuals. SPSI will be reported to the surgeon after recording the pre-SPSI surgical plan. The surgeon will then decide whether to change the surgical plan. For example, if the initial surgical plan was to only decompress a level, and SPSI is greater than 2, the surgeon may plan to add fusion to the decompression. Conversely, if the initial plan was decompression plus fusion, and the SPSI indicates that the level is objectively stable, the post-SPSI plan may be to only decompress the level. The proportion of surgical plans that change after reviewing the SPSI report will be determined. If the proportion of surgical plans that change is greater than 15%, further research will be undertaken to explore whether deciding, based on objective measurement of spinal stability, whether to add fusion to decompression of a stenotic lumbar level will have a significant effect on clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Symptoms consistent with single level lumbar spinal stenosis based on judgment and experience of the investigator
- •Central and or foraminal stenosis confirmed by MRI as per the investigators clinical standards
- •Grades 1 (10 to 25%) or 2 (26 to 50%) anterior or retro-spondylolisthesis using the Meyerding scale [43]
- •Absence of lateral spondylolisthesis
- •No prior lumbar spinal surgery
- •Absence of American Society of Anesthesiologists (ASA) class IV or higher disease
- •The single level surgical technique planned (prior to viewing the spinal motion report) to decompress the level is not expected to destabilize the spine (fusion is not deemed necessary due to probable iatrogenic instability)
- •Prior to viewing the spinal motion report, the surgical plan includes decompression or decompression and fusion of only one level
- •Based on the investigators subjective assessment, the patient is able to flex and extend sufficiently to facilitate acceptable flexion and extension radiographs
- •The fusion technique planned prior to viewing the spinal motion report is the following: Instrumented posterior (pedicle screws and rods) with / without postero-lateral interbody fusion cage
- •Subject is able to understand and sign the study Informed Consent Form
- •Subjects is at least 18 years of age.
- •Subject has willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions
排除标准
- •Lumbar stenosis without spondylolisthesis
- •Severe lumbar stenosis that requires a wide decompression where the investigator believes (based on experience and available research studies) that the decompression will destabilize the spine and fusion surgery is required regardless of preoperative SPSI
- •Pregnant women
- •Scoliosis involving a lumbar curve greater than 10 degrees
- •Stenosis at the level of a transitional vertebra
- •Lateral spondylolisthesis (Coronal plane translational misalignment between vertebrae)
- •Prior lumbar spinal surgery
- •American Society of Anesthesiologists (ASA) class IV or higher disease
结局指标
主要结局
Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning
时间窗: Pre-surgery
The surgeons will record their surgical plan (decompression alone or decompression plus fusion) prior to receiving the SPSI report. The surgeon will then integrate the data in the SPSI report into their surgical planning and record a post-SPSI report surgical plan. The proportion of lumbar spinal stenosis surgery plans that change after an objective metric for spinal stability is included in the surgical planning will be determined. If the proportion of plans that change after integration of the SPSI report is greater than expected due to subjectivity in surgical planning, then the SPSI report will be considered clinically effective and further research will be pursued.
次要结局
- Association Between the Preoperative SPSI and the Facet Fluid Sign Observed in a Preoperative MRI(Pre-surgery)
- The Proportion of Surgically Decompressed Levels Where SPSI Was at Least One Standard Deviation Higher at 12 Months Compared to Preoperatively.(One year after surgery)
- Reoperation Rate at 1 and 2 Years Following Surgery(12 and 24 months)
- Are the ODI Scores at 12 Months Following Lumbar Fusion Surgery Dependent on Whether the Treated Level is Fused, With Fusion Defined as Intervertebral Rotation < 2 Degrees and an Absence of Radiographic Signs of a Non-union.(12 months)
- Is Leg Pain at 12 Months Following Lumbar Fusion Surgery Dependent on Whether the Treated Level is Fused, With Fusion Defined as Intervertebral Rotation < 2 Degrees and an Absence of Radiographic Signs of a Non-union(12 months)