- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02436863
Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Laminectomy
Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Cervical, Thoracic and Lumbar Laminectomy for Tumor Resection
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yuntao Lu, M.D., Ph.D
- Phone Number: +8613632101002
- Email: lllu2000@163.com
Study Contact Backup
- Name: Yiping Mo, Bachelor
- Phone Number: +8620-61641806
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Nan fang hospital, Southern medical university
-
Contact:
- Chongyuan Xu, Ph.D
- Phone Number: +8620-62787238
-
Principal Investigator:
- Yuntao Lu, M.D., Ph.D
-
Sub-Investigator:
- Lin Pen, M.D.
-
Sub-Investigator:
- Hai Wang, M.D., Ph.D
-
Sub-Investigator:
- Jin Shi, Master
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
Two different surgical performances
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vertebral deformity
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The influence of age on the vertebral deformity
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yuntao Lu, M.D., Ph.D, Nanfang neurosurgery research institution
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SMU-spine-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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