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.

Study Overview

• Status: Completed
• Conditions: Sagittal Alignment
• Intervention / Treatment: Radiation: whole spine X-ray

• Study Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers Patients with lumbar degenerative disease who had undergone surgery in Peking university third hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group 2 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
Group 2 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
Group 2 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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Publications and helpful links

General Publications

• Lafage R, Schwab F, Challier V, Henry JK, Gum J, Smith J, Hostin R, Shaffrey C, Kim HJ, Ames C, Scheer J, Klineberg E, Bess S, Burton D, Lafage V; International Spine Study Group. Defining Spino-Pelvic Alignment Thresholds: Should Operative Goals in Adult Spinal Deformity Surgery Account for Age? Spine (Phila Pa 1976). 2016 Jan;41(1):62-8. doi: 10.1097/BRS.0000000000001171.
• Hey HWD, Teo AQA, Tan KA, Ng LWN, Lau LL, Liu KG, Wong HK. How the spine differs in standing and in sitting-important considerations for correction of spinal deformity. Spine J. 2017 Jun;17(6):799-806. doi: 10.1016/j.spinee.2016.03.056. Epub 2016 Apr 7.
• Cho KJ, Suk SI, Park SR, Kim JH, Kang SB, Kim HS, Oh SJ. Risk factors of sagittal decompensation after long posterior instrumentation and fusion for degenerative lumbar scoliosis. Spine (Phila Pa 1976). 2010 Aug 1;35(17):1595-601. doi: 10.1097/BRS.0b013e3181bdad89.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2019
• Primary Completion (ACTUAL): September 9, 2019
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (ACTUAL): July 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: sagittal alignment; spinal fusion; sitting
• Other Study ID Numbers: M2018192

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No