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

NCT04958590 | Completed

• 1 other identifier: M2018192
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Sagittal Alignment

Keywords

sagittal alignment; sitting; spinal fusion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Group 2 Disability assessed by the Oswestry Disability Index (ODI)

  3 months after surgery

• Group 2 Back pain assessed by the VAS

  3 months after surgery

• Group 2 Leg pain assessed by the VAS

  3 months after surgery

Study Arms (2)

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

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

Interventions

whole spine X-ray RADIATION

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

1 （asymptomatic）; 2 （patients）

Eligibility Criteria

• Age: 42 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (3)

• 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.

  PMID: 26689395 BACKGROUND

• 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.

  PMID: 27063999 BACKGROUND

• 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.

  PMID: 20386505 BACKGROUND

Study Officials

• Wei Shi Li, Dr.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 12, 2021
• Study Start: February 20, 2019
• Primary Completion: September 9, 2019
• Study Completion: March 1, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-06

Locations

CN (1)