Correlation Among Standing-sitting Sagittal Spinal Alignment, Paravertebral Muscle and Postoperative Clinical Outcomes in Patients With Adult Degenerative Scoliosis

NCT04688437 | Unknown

• 1 other identifier: M2020322
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-center study. Patients with adult degenerative scoliosis are prospectively enrolled and followed. All patients will take standard standing and sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination before and after surgery. Functional evaluation and radiographs were assessed preoperatively and postoperatively.This study will focus on the correlation among standing-sitting sagittal spinal alignment, paravertebral muscle and postoperative clinical outcomes in patients with adult degenerative scoliosis.

Conditions

Degenerative Scoliosis

Keywords

Sitting; Standing; Sagittal alignment; Degenerative Scoliosis; Paravertebral Muscle

Outcome Measures

Primary Outcomes (11)

• 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) Cobb angle of the curves

  3 months after surgery

• 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) Cobb angle of the curves

  6 months after surgery

• 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) Cobb angle of the curves

  12 months after surgery

• The sagittal spinal parameters in millimeters

  SVA (sagittal vertical axis, The offset between the center of C7 and the plumb line drawn from posterosuperior corner of S1)

  3 months after surgery

• The sagittal spinal parameters in millimeters

  SVA (sagittal vertical axis, The offset between the center of C7 and the plumb line drawn from posterosuperior corner of S1)

  6 months after surgery

• The sagittal spinal parameters in millimeters

  SVA (sagittal vertical axis, The offset between the center of C7 and the plumb line drawn from posterosuperior corner of S1)

  12 months after surgery

• parameters of paraspinal muscles

  the cross-sectional area (square centimeter)

  12 months after surgery

• parameters of paraspinal muscles

  fatty infiltration rate of paraspinal muscles

  12 months after surgery

• functional outcomes of paraspinal muscles

  the time of paraspinal muscle strength test

  3 months after surgery

• functional outcomes of paraspinal muscles

  the time of paraspinal muscle strength test

  6 months after surgery

• functional outcomes of paraspinal muscles

  the time of paraspinal muscle strength test

  12 months after surgery

Secondary Outcomes (4)

• Disability assessed by the Oswestry Disability Index (ODI)

  3 months after surgery; 6 months after surgery; 12 months after surgery;

• Disability assessed by the Japanese Orthopaedic Association (JOA)

  3 months after surgery; 6 months after surgery; 12 months after surgery;

• Back pain assessed by the VAS

  3 months after surgery; 6 months after surgery; 12 months after surgery;

• Leg pain assessed by the VAS

  3 months after surgery; 6 months after surgery; 12 months after surgery;

Study Arms (1)

Patients with degenerative scoliosis

Radiation: standard standing-sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination

Interventions

standard standing-sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination RADIATION

Routine examination

Patients with degenerative scoliosis

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with adult degenerative scoliosis who will undergo corrective surgery in Peking university third hospital.

You may qualify if:

• Clinical diagnosis of adult degenerative scoliosis
• Cobb angle ≥10°

You may not qualify if:

• 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 (5)

• 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

• Zhou S, Xu F, Wang W, Zou D, Sun Z, Li W. Age-based normal sagittal alignment in Chinese asymptomatic adults: establishment of the relationships between pelvic incidence and other parameters. Eur Spine J. 2020 Mar;29(3):396-404. doi: 10.1007/s00586-019-06178-9. Epub 2019 Oct 29.

  PMID: 31664567 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

• Zhou S, Sun Z, Li W, Wang W, Su T, Du C, Li W. The standing and sitting sagittal spinopelvic alignment of Chinese young and elderly population: does age influence the differences between the two positions? Eur Spine J. 2020 Mar;29(3):405-412. doi: 10.1007/s00586-019-06185-w. Epub 2019 Oct 19.

  PMID: 31630266 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

Central Study Contacts

Siyu Zhou, Dr.

CONTACT

+8613718753161; bjmuzhousiyu@163.com

Wei Li, Dr.

CONTACT

+8613717727658; 1510301321@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 30, 2020
• Study Start: January 20, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2024
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

CN (1)