The Standing and Sitting Spino-pelvic Sagittal Alignment in Chinese Population

Completed

• Conditions: Sagittal Alignment
• Interventions: Radiation: whole spine X-ray

• Registration Number: NCT04958590
• Lead Sponsor: Peking University Third Hospital

Brief Summary

This study is aimed to demonstrate the standing and sitting spino-pelvic sagittal alignment in Chinese population, then to explore the influence of spinal fusion on the changes when moving from standing to sitting positon.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Primary Completion: 2019-09-09
• Study Completion: 2020-03-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Group 1 90 Healthy Volunteers - age >40 years, no history of neck pain, back pain, or radicular pain in the previous six months, no history of chronic neck or back pain lasting more than three months, no history of spinal disease or surgery, no spinal deformity or lumbar spondylolisthesis, no history of hip or knee arthroplasty or other realignment surgery of the lower extremities, and no history of neuromuscular disorders.

Group 2 126 patients Clinical diagnosis of Lumbar degenerative disease

Read More

Exclusion Criteria

Group 1 90 Healthy Volunteers

• pregnant

Group 2 126 patients

• Neuromuscular diseases
• Arthritis
• Tumor
• A previous history of lumbar fusion surgery

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2 （patients）	whole spine X-ray	the patients who underwent posterior lumbar fusion surgery for lumbar degenerative disease has been followed up for three months.
1 （asymptomatic）	whole spine X-ray	the middle-aged and elderly Chinese asymptomatic population who underwent the whole spine X-ray in standing and sitting positions.

Primary Outcome Measures

Name	Time	Method
Group 2 The sagittal spinal parameters in degrees	3 months after surgery	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)
Group 1 The sagittal spinal parameters in millimeter	6 months after study started	SVA (sagittal vertical axis, The offset between the center of C7 and the plumb line drawn from posterosuperior corner of S1)
Group 1 The sagittal spinal parameters in degrees	6 months after study started	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)

Secondary Outcome Measures

Name	Time	Method
Group 2 Back pain assessed by the VAS	3 months after surgery	The Visual Analog Scale (0-10) is used to evaluate back pain.Higher scores mean a worse outcome
Group 2 Leg pain assessed by the VAS	3 months after surgery	The Visual Analog Scale (0-10) is used to evaluate leg pain.Higher scores mean a worse outcome.
Group 2 Disability assessed by the Oswestry Disability Index (ODI)	3 months after surgery	The Oswestry Disability Index (ODI) (0-100) is used to assess disability.Higher scores mean a worse outcome.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China