Correlation Among Standing-sitting Sagittal Spinal Alignment, Paravertebral Muscle and Postoperative Clinical Outcomes in Patients With Adult Degenerative Scoliosis
NCT ID: NCT04688437
Last Updated: 2020-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2021-01-20
2024-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with degenerative scoliosis
standard standing-sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination
Routine examination
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
standard standing-sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination
Routine examination
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cobb angle ≥10°
Exclusion Criteria
* Arthritis
* Tumor
* A previous history of lumbar fusion surgery
45 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Third Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wei Shi Li, Dr.
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Da Zou, M.D.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M2020322
Identifier Type: -
Identifier Source: org_study_id