Clinical trial NCT04688437: Correlation Among Standing-sitting Sagittal Spinal Alignment, Paravertebral Muscle and Postoperative Clinical Outcomes in Patients With Adult Degenerative Scoliosis
Official title: Correlation Among Standing-sitting Sagittal Spinal Alignment, Paravertebral Muscle and Postoperative Clinical Outcomes in Patients With Adult Degenerative Scoliosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Scoliosis
Keywords: Sitting
Standing
Sagittal alignment
Degenerative Scoliosis
Paravertebral Muscle
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with adult degenerative scoliosis who will undergo corrective surgery in Peking university third hospital.

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.

Detailed description: The sagittal alignment of the spine, or sagittal balance, describe the ideal and normal sagittal spinal curvature distribution. With the deepening of the research on spinal morphology, function and pathology, more and more researchers pay attention to the role of sagittal alignment in the diagnosis and treatment of spinal deformity diseases. Some studies have shown that the restoration of patients with appropriate sagittal alignment can significantly improve their quality of life. Besides, paravertebral muscle can also influence the retaining of sagittal alignment. However, how to define the ideal sagittal alignment is still controversial for different patients with adult degenerative scoliosis(ADS) .

It was proved that the differences in sagittal parameters of the standing and sitting positions positions were influenced by age, gender and pelvic incidence(PI). In addition, patients with high PI are more prone to sagittal decompensation after long segment fixation (fixation of three or more segments) .Therefore, We speculate that the sagittal curvature of patients with large PI changes greatly from standing position to sitting position. So after long segment fixation, the spine in the state of standing position is more difficult to adapt to the changes of curvature and stress in sitting position, which is the possible reason that patients with high PI are more prone to sagittal decompensation. At present, how to design the proper corrective goals for patients according to both sagittal alignment and paravertebral muscle needs further research.

Thus, this study is aim to explore these three points about ADS patients: the characteristics of the sagittal spinal alignment changes from standing to sitting ; the adaption of the spine curvature in the standing and sitting position after long segment fixation surgery and the relationship among standing-sitting sagittal spinal alignment, paravertebral muscle and postoperative clinical outcomes.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The sagittal spinal parameters in degrees
timeFrame: 3 months after surgery
measure: The sagittal spinal parameters in degrees
timeFrame: 6 months after surgery
measure: The sagittal spinal parameters in degrees
timeFrame: 12 months after surgery
measure: The sagittal spinal parameters in millimeters
timeFrame: 3 months after surgery
measure: The sagittal spinal parameters in millimeters
timeFrame: 6 months after surgery
measure: The sagittal spinal parameters in millimeters
timeFrame: 12 months after surgery
measure: parameters of paraspinal muscles
timeFrame: 12 months after surgery
measure: parameters of paraspinal muscles
timeFrame: 12 months after surgery
measure: functional outcomes of paraspinal muscles
timeFrame: 3 months after surgery
measure: functional outcomes of paraspinal muscles
timeFrame: 6 months after surgery
measure: functional outcomes of paraspinal muscles
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Disability assessed by the Oswestry Disability Index (ODI)
timeFrame: 3 months after surgery; 6 months after surgery; 12 months after surgery;
measure: Disability assessed by the Japanese Orthopaedic Association (JOA)
timeFrame: 3 months after surgery; 6 months after surgery; 12 months after surgery;
measure: Back pain assessed by the VAS
timeFrame: 3 months after surgery; 6 months after surgery; 12 months after surgery;
measure: Leg pain assessed by the VAS
timeFrame: 3 months after surgery; 6 months after surgery; 12 months after surgery;
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Wei Shi Li, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.