Correlation Among Standing-sitting Sagittal Spinal Alignment, Paravertebral Muscle and Postoperative Clinical Outcomes in Patients With Adult Degenerative Scoliosis

Study Overview
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Brief Summary
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This is a prospective single-center study. Patients with adult degenerative scoliosis are prospectively enrolled and followed. All patients will take standard standing and sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination before and after surgery. Functional evaluation and radiographs were assessed preoperatively and postoperatively.This study will focus on the correlation among standing-sitting sagittal spinal alignment, paravertebral muscle and postoperative clinical outcomes in patients with adult degenerative scoliosis.

Detailed Description
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The sagittal alignment of the spine, or sagittal balance, describe the ideal and normal sagittal spinal curvature distribution. With the deepening of the research on spinal morphology, function and pathology, more and more researchers pay attention to the role of sagittal alignment in the diagnosis and treatment of spinal deformity diseases. Some studies have shown that the restoration of patients with appropriate sagittal alignment can significantly improve their quality of life. Besides, paravertebral muscle can also influence the retaining of sagittal alignment. However, how to define the ideal sagittal alignment is still controversial for different patients with adult degenerative scoliosis(ADS) . It was proved that the differences in sagittal parameters of the standing and sitting positions positions were influenced by age, gender and pelvic incidence(PI). In addition, patients with high PI are more prone to sagittal decompensation after long segment fixation (fixation of three or more segments) .Therefore, We speculate that the sagittal curvature of patients with large PI changes greatly from standing position to sitting position. So after long segment fixation, the spine in the state of standing position is more difficult to adapt to the changes of curvature and stress in sitting position, which is the possible reason that patients with high PI are more prone to sagittal decompensation. At present, how to design the proper corrective goals for patients according to both sagittal alignment and paravertebral muscle needs further research. Thus, this study is aim to explore these three points about ADS patients: the characteristics of the sagittal spinal alignment changes from standing to sitting ; the adaption of the spine curvature in the standing and sitting position after long segment fixation surgery and the relationship among standing-sitting sagittal spinal alignment, paravertebral muscle and postoperative clinical outcomes.

Official Title
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Correlation Among Standing-sitting Sagittal Spinal Alignment, Paravertebral Muscle and Postoperative Clinical Outcomes in Patients With Adult Degenerative Scoliosis

Conditions
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Degenerative Scoliosis

Intervention / Treatment
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* Radiation: standard standing-sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of adult degenerative scoliosis Cobb angle ≥10° Exclusion Criteria: Neuromuscular diseases Arthritis Tumor A previous history of lumbar fusion surgery

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with degenerative scoliosis<br> | Radiation: standard standing-sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination<br>* Routine examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sagittal spinal parameters in degrees | The parameters included TPA (T1 pelvic angle,the angle between the line from the axis of the femoral head to the center of T1 and the line from the axis of the femoral head to the midpoint of the S1 endplate), lumbar lordosis (LL,the angle between the upper endplate of L1 and S1), thoracic kyphosis (TK,The angle between the upper endplate of T4 and the lower endplate of T12), pelvic incidence (PI,The angle between the line perpendicular to the midpoint of the sacral plate and the line connecting this to the midpoint of the hip axis), pelvic tilt (PT,The angle between the line from the middle of the sacral plate to the middle of the hip axis and the vertical line), sacral slope (SS,The angle between the sacral endplate and the horizontal line) Cobb angle of the curves | 3 months after surgery | 
| The sagittal spinal parameters in degrees | The parameters included TPA (T1 pelvic angle,the angle between the line from the axis of the femoral head to the center of T1 and the line from the axis of the femoral head to the midpoint of the S1 endplate), lumbar lordosis (LL,the angle between the upper endplate of L1 and S1), thoracic kyphosis (TK,The angle between the upper endplate of T4 and the lower endplate of T12), pelvic incidence (PI,The angle between the line perpendicular to the midpoint of the sacral plate and the line connecting this to the midpoint of the hip axis), pelvic tilt (PT,The angle between the line from the middle of the sacral plate to the middle of the hip axis and the vertical line), sacral slope (SS,The angle between the sacral endplate and the horizontal line) Cobb angle of the curves | 6 months after surgery | 
| The sagittal spinal parameters in degrees | The parameters included TPA (T1 pelvic angle,the angle between the line from the axis of the femoral head to the center of T1 and the line from the axis of the femoral head to the midpoint of the S1 endplate), lumbar lordosis (LL,the angle between the upper endplate of L1 and S1), thoracic kyphosis (TK,The angle between the upper endplate of T4 and the lower endplate of T12), pelvic incidence (PI,The angle between the line perpendicular to the midpoint of the sacral plate and the line connecting this to the midpoint of the hip axis), pelvic tilt (PT,The angle between the line from the middle of the sacral plate to the middle of the hip axis and the vertical line), sacral slope (SS,The angle between the sacral endplate and the horizontal line) Cobb angle of the curves | 12 months after surgery | 
| The sagittal spinal parameters in millimeters | SVA (sagittal vertical axis, The offset between the center of C7 and the plumb line drawn from posterosuperior corner of S1) | 3 months after surgery | 
| The sagittal spinal parameters in millimeters | SVA (sagittal vertical axis, The offset between the center of C7 and the plumb line drawn from posterosuperior corner of S1) | 6 months after surgery | 
| The sagittal spinal parameters in millimeters | SVA (sagittal vertical axis, The offset between the center of C7 and the plumb line drawn from posterosuperior corner of S1) | 12 months after surgery | 
| parameters of paraspinal muscles | the cross-sectional area (square centimeter) | 12 months after surgery | 
| parameters of paraspinal muscles | fatty infiltration rate of paraspinal muscles | 12 months after surgery | 
| functional outcomes of paraspinal muscles | the time of paraspinal muscle strength test | 3 months after surgery | 
| functional outcomes of paraspinal muscles | the time of paraspinal muscle strength test | 6 months after surgery | 
| functional outcomes of paraspinal muscles | the time of paraspinal muscle strength test | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability assessed by the Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) (0-100) is used to assess disability.Higher scores mean a worse outcome. | 3 months after surgery; 6 months after surgery; 12 months after surgery; | 
| Disability assessed by the Japanese Orthopaedic Association (JOA) | Japanese Orthopaedic Association (JOA)(-6-29) Scores is used to assess disability.Higher scores mean a better outcome. | 3 months after surgery; 6 months after surgery; 12 months after surgery; | 
| Back pain assessed by the VAS | The Visual Analog Scale (0-10) is used to evaluate back pain.Higher scores mean a worse outcome. | 3 months after surgery; 6 months after surgery; 12 months after surgery; | 
| Leg pain assessed by the VAS | The Visual Analog Scale (0-10) is used to evaluate leg pain.Higher scores mean a worse outcome. | 3 months after surgery; 6 months after surgery; 12 months after surgery; | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sitting, Standing, Sagittal alignment, Degenerative Scoliosis, Paravertebral Muscle