Finite Element Study of Biomechanical Changes After Unila... | NCT04957056

Studies
Finite Element Study of Biomechanical Changes After Unilateral Hemilamina and Facet Joint Resection of Cervical Spine

NCT04957056

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Jul 12, 2021Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Intraspinal Tumor

Interventions

Hospitalization

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jan 2022Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2021

Last Update Posted Date

Jul 12, 2021Actual

Name	Class
Peking University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Procedure: Hospitalization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hospitalization	Procedure	Hospitalization	Study object

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhen-Yu Wang	Contact	+86 136 2134 9770		wzyu502@163.com

Overall Officials

Name	Affiliation	Role
Zhen-Yu Wang	Peking University Third Hospital	Study Chair
Qi-Guo Rong	Peking University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital	Recruiting	Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013120	Spinal Cord Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006760	Hospitalization

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided