Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Laminectomy

• Conditions: Disorders Following Clinical Procedure
• Interventions: Procedure: Surgical performance

• Registration Number: NCT02436863
• Lead Sponsor: Southern Medical University, China

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical perfomance (Laminoplasty)	Surgical performance	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 perfomance (Internal fixation)	Surgical performance	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.

Primary Outcome Measures

Name	Time	Method
Vertebral deformity	3 years

Secondary Outcome Measures

Name	Time	Method
The influence of age on the vertebral deformity	3 years

Trial Locations

Locations (1)

Nan fang hospital, Southern medical university; 🇨🇳 Guangzhou, Guangdong, China