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Completed

NCT Number: NCT04958590

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

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.

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Key information

Conditions

Sagittal Alignment

Age range

42 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • pregnant

Group 2 126 patients

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

Treatment and study plan

whole spine X-ray

Radiation

Group 1 underwent whole spine X-ray in standing and sitting positions.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. Group 2 Disability assessed by the Oswestry Disability Index (ODI)

    Time frame: 3 months after surgery

    The Oswestry Disability Index (ODI) (0-100) is used to assess disability.Higher scores mean a worse outcome.

  2. Group 2 Back pain assessed by the VAS

    Time frame: 3 months after surgery

    The Visual Analog Scale (0-10) is used to evaluate back pain.Higher scores mean a worse outcome

  3. Group 2 Leg pain assessed by the VAS

    Time frame: 3 months after surgery

    The Visual Analog Scale (0-10) is used to evaluate leg pain.Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 12, 2021
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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