- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04957056
Finite Element Study of Biomechanical Changes After Unilateral Hemilamina and Facet Joint Resection of Cervical Spine
Study Overview
Detailed Description
The finite element method was used to simulate unilateral hemilaminectomy of cervical spine and different degrees of facet joint resection, and the range of motion and the stress changes of ligaments, intervertebral discs and endplates were calculated immediately after the operation.
Finite element method was used to simulate unilateral hemilaminectomy of cervical spine and facet joint resection of different degrees, and the range of motion and the stress changes of ligament, intervertebral disc and endplate were calculated immediately after operation.
Study Design:
This study is a retrospective and general observational study.In this study, a young patient who was hospitalized in the Neurosurgery Department of the Third Hospital of Beijing University of Medicine and had undergone CT examination of cervical vertebra was selected. The patient had no cervical bony deformity, no cervical degeneration, and no history of trauma.
CT imaging data were collected, and a three-dimensional finite element model of C2-T1 segment of human cervical spine was established by finite element software. On the basis of this model, two and three levels of unilateral hemilamina and different degrees of facet joint resection were simulated.The lower end of the T1 vertebral body was fixed as the boundary condition, and three loading modes were adopted, namely, 2.0nm pure torque was applied to the upper surface of the C2 vertebral body along the sagittal plane, coronal plane and axial plane, respectively.The range of motion between vertebral segments was calculated and compared in different lamina surgical models. The tension of ligaments, the pressure of endplates and the pressure of intervertebral discs were obtained by finite element post-processing
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zhen-Yu Wang
- Phone Number: +86 136 2134 9770
- Email: wzyu502@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
Contact:
- Zhen-Yu Wang
- Phone Number: +86 136 2134 9770
- Email: wzyu502@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
A young patient hospitalized in the Department of Neurosurgery of the Third Hospital of Beijing University of Medicine underwent CT examination of cervical vertebrae.
Exclusion Criteria:
Cervical bony deformity Cervical degeneration History of trauma
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study object
A young patient hospitalized in the Department of Neurosurgery of the Third Hospital of Beijing University of Medicine underwent CT examination of cervical vertebrae.
The patient had no cervical bony deformity, no cervical degeneration, and no history of trauma
|
Hospitalization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Verification of the model
Time Frame: Through study completion, an average of 1 year
|
In this study, the pure torque of 2.0Nm was applied to the upper surface of C2 vertebral body along the 1, 2 and 3 coordinates according to the right hand helical rule to generate the corresponding pure torque in the sagittal plane, coronal plane and axial plane, and to simulate the cervical spine flexion and extension, lateral bending and left-right rotation in real life
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Zhen-Yu Wang, Peking University Third Hospital
- Study Director: Qi-Guo Rong, Peking University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2018028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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