Skip to main content
Clinical Trials/NCT04958590
NCT04958590
Completed
Not Applicable

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

Peking University Third Hospital1 site in 1 country216 target enrollmentFebruary 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sagittal Alignment
Sponsor
Peking University Third Hospital
Enrollment
216
Locations
1
Primary Endpoint
Group 2 The sagittal spinal parameters in degrees
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2019
End Date
March 1, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Group 1 90 Healthy Volunteers
  • Group 2 126 patients
  • Neuromuscular diseases
  • Arthritis
  • A previous history of lumbar fusion surgery

Outcomes

Primary Outcomes

Group 2 The sagittal spinal parameters in degrees

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Group 2 Back pain assessed by the VAS(3 months after surgery)
  • Group 2 Leg pain assessed by the VAS(3 months after surgery)
  • Group 2 Disability assessed by the Oswestry Disability Index (ODI)(3 months after surgery)

Study Sites (1)

Loading locations...

Similar Trials