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Clinical Trials/NCT02436863
NCT02436863
Unknown
Not Applicable

Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Cervical, Thoracic and Lumbar Laminectomy for Tumor Resection

Southern Medical University, China1 site in 1 country120 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disorders Following Clinical Procedure
Sponsor
Southern Medical University, China
Enrollment
120
Locations
1
Primary Endpoint
Vertebral deformity
Last Updated
10 years ago

Overview

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. 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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
July 2019
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Southern Medical University, China
Responsible Party
Principal Investigator
Principal Investigator

Yuntao Lu

Professor

Southern Medical University, China

Eligibility Criteria

Inclusion Criteria

  • Adult patients (\>=18 years) were enrolled.
  • The patients suffered with lesion inside the spinal canal, who underwent laminectomy to remove the lesion.
  • Pathology proved benign lesion.
  • Health condition of patients (KPS) \>= 70.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Vertebral deformity

Time Frame: 3 years

Secondary Outcomes

  • The influence of age on the vertebral deformity(3 years)

Study Sites (1)

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