Influence of Laminoplasty and Internal Fixation on Verteb... | NCT02436863

Studies
Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Laminectomy

NCT02436863

Sponsor

Southern Medical University, China

Status

Unknown status

Last Update Posted

Apr 19, 2016Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Disorders Following Clinical Procedure

Interventions

Surgical performance

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

Apr 2016

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

Jan 2015

Primary Completion Date

Dec 2018Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

May 4, 2015

First Submission Date that Met QC Criteria

May 6, 2015

First Posted Date

May 7, 2015Estimated

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

Apr 18, 2016

Last Update Posted Date

Apr 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuntao Lu, Professor, Southern Medical University, ChinaPrincipal Investigator

Lead Sponsor

Southern Medical University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The lesion located inside the spinal canal caused big trouble for clinical treatment. Traditional laminectomy will destroy the biomechanics and influent the vertebral stability, which might cause kyphosis or other deformity. So in some centers, neurosurgeries praised laminoplasty to make the intactness of posterior column. They thought the laminoplasty can maintain the vertebral stability, and meanwhile the range of motion won't change so much. However, some other scholars thought laminoplasty had no helps for stability because of the pseudarthrosis. They preferred screw and stick system for internal fixation. And we did meet several patients after laminectomy suffered with spinal deformity. So we thought it is necessary for investigating the benefit of patients from laminoplasty and internal fixation.

Detailed Description

After laminectomy for removal of the cervical, thoracic and lumbar lesions, the recruited cases were randomly divided into two groups.

The cases in group of laminoplasty, the lamina and spinous process was replanted to maintain the anatomical intactness of spinal canal.
On the other hand, the cases in internal fixation group, the pedicle screws were implanted, and tickets were used to complete the internal fixation.

During 3 years follow up, the vertebral deformity and the range of motion were investigated and evaluated. And in the meantime, the patient's age will also be analyzed to detect it's influence for the prognosis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical perfomance (Laminoplasty)		After the lesions inside the spinal canal were surgical removed by laminectomy, the lamina and spinous process were replanted with titanium plates and screws.	Procedure: Surgical performance
Surgical perfomance (Internal fixation)		After the lesions inside the spinal canal were surgical removed by laminectomy, the pedicle screws (Thoracic and lumbar vertebra) or lateral mass (Cervical vertebra) and sticks were used for internal fixation.	Procedure: Surgical performance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical performance	Procedure	Two different surgical performances	Surgical perfomance (Internal fixation) Surgical perfomance (Laminoplasty)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vertebral deformity		3 years

Secondary Outcomes

Measure	Description	Time Frame
The influence of age on the vertebral deformity		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- 1. Adult patients (>=18 years) were enrolled. 2. The patients suffered with lesion inside the spinal canal, who underwent laminectomy to remove the lesion.

3. Pathology proved benign lesion. 4. Health condition of patients (KPS) >= 70.

Exclusion Criteria:

1. Children cases (<18 years) were excluded.
2.The cases with pathological malignant tumors were excluded from this study.
3. KPS of patients < 70.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients (>18 years) were enrolled.
The patients suffered with lesion inside the spinal canal, who underwent laminectomy to remove the lesion.
The cases with pathological malignant tumors were excluded from this study.
Health condition of patients (KPS) > 70.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuntao Lu, M.D., Ph.D	Contact	+8613632101002		lllu2000@163.com
Yiping Mo, Bachelor	Contact	+8620-61641806

Overall Officials

Name	Affiliation	Role
Yuntao Lu, M.D., Ph.D	Nanfang neurosurgery research institution	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nan fang hospital, Southern medical university	Recruiting	Guangzhou	Guangdong	510515	China

Condition Browse Module

MeSH Terms

ID	Term
D000013	Congenital Abnormalities

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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