Intraspinal TumorNCT04957056
Finite Element Study of Biomechanical Changes After Unilateral Hemilamina and Facet Joint Resection of Cervical Spine
An observational study of Intraspinal Tumor, run by Peking University Third Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Intraspinal Tumor
- What is being tested?
- Hospitalization
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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
Who may be able to join
- A young patient hospitalized in the Department of Neurosurgery of the Third Hospital of Beijing University of Medicine underwent CT examination of cervical vertebrae.
Who cannot join
- Cervical bony deformity Cervical degeneration History of trauma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zhen-Yu Wang, +86 136 2134 9770, wzyu502@163.com
About this study
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
Read the 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
- Conditions
- Intraspinal Tumor
- Being tested
- Hospitalization
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HospitalizationProcedure or surgery
Hospitalization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of the model
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Feb 2018
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraspinal TumorStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- Zhen-Yu Wang, Study chair, Peking University Third HospitalQi-Guo Rong, Study director, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957056
- Sponsor's protocol ID
- M2018028
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finite Element Study of Biomechanical Changes After Unilateral Hemilamina and Facet Joint Resection of Cervical Spine
- ClinicalTrials.gov ID
- NCT04957056
- Acronym / sponsor ID
- M2018028
- Conditions
- Intraspinal Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study object | – | Procedure: HospitalizationA 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (1 listed)
- A young patient hospitalized in the Department of Neurosurgery of the Third Hospital of Beijing University of Medicine underwent CT examination of cervical vertebrae.
Key exclusion criteria (1 listed)
- Cervical bony deformity Cervical degeneration History of trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HospitalizationHospitalization | Procedure or surgery | Study object |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Intraspinal Tumor
Not yet recruitingPhase 4
Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery
Spinal Cord Neoplasms, Spinal Neoplasms
Active, not recruitingPhase 1/2
Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
Spinal Neoplasms
Not yet recruiting
Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
RecruitingObservational study
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
Degenerative Disc Disease (DDD), Spinal Stenosis
RecruitingObservational study
LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
Arrhythmias, Cardiac, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen-Yu Wang study chair
Peking University Third Hospital
Qi-Guo Rong study director
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraspinal Tumor, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen-Yu Wang (+86 136 2134 9770, wzyu502@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verification of the model (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.