Clinical trial NCT04958590: The Standing and Sitting Spino-pelvic Sagittal Alignment in Chinese Population
Official title: The Standing and Sitting Spino-pelvic Sagittal Alignment in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sagittal Alignment
Keywords: sagittal alignment
sitting
spinal fusion
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 216
Sex: ALL
Minimum age (years): 42
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers Patients with lumbar degenerative disease who had undergone surgery in Peking university third hospital.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Group 2 The sagittal spinal parameters in degrees
timeFrame: 3 months after surgery
measure: Group 1 The sagittal spinal parameters in degrees
timeFrame: 6 months after study started
measure: Group 1 The sagittal spinal parameters in millimeter
timeFrame: 6 months after study started
Secondary outcomes:
measure: Group 2 Disability assessed by the Oswestry Disability Index (ODI)
timeFrame: 3 months after surgery
measure: Group 2 Back pain assessed by the VAS
timeFrame: 3 months after surgery
measure: Group 2 Leg pain assessed by the VAS
timeFrame: 3 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: 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: 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.