Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Laminectomy

NCT ID: NCT02436863

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-07-31

Brief Summary

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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

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

1. The cases in group of laminoplasty, the lamina and spinous process was replanted to maintain the anatomical intactness of spinal canal.
2. 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.

Conditions

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Disorders Following Clinical Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Surgical performance

Intervention Type PROCEDURE

Two different surgical performances

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.

Surgical performance

Intervention Type PROCEDURE

Two different surgical performances

Interventions

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Surgical performance

Two different surgical performances

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yuntao Lu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuntao Lu, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Nanfang neurosurgery research institution

Locations

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Nan fang hospital, Southern medical university

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuntao Lu, M.D., Ph.D

Role: CONTACT

+8613632101002

Yiping Mo, Bachelor

Role: CONTACT

+8620-61641806

Facility Contacts

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Chongyuan Xu, Ph.D

Role: primary

+8620-62787238

Other Identifiers

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SMU-spine-1

Identifier Type: -

Identifier Source: org_study_id

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