Clinical trial NCT02436863: Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Laminectomy
Official title: Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Cervical, Thoracic and Lumbar Laminectomy for Tumor Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disorders Following Clinical Procedure
Keywords: Laminectomy
Laminoplasty
Internal fixation
deformity
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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. The cases with pathological malignant tumors were excluded from this study.
4. Health condition of patients (KPS) \> 70.

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.

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.

Primary outcomes:
measure: Vertebral deformity
timeFrame: 3 years
Secondary outcomes:
measure: The influence of age on the vertebral deformity
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nan fang hospital, Southern medical university
state: Guangdong
Study officials:
affiliation: Nanfang neurosurgery research institution
name: Yuntao Lu, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: