Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation
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|ClinicalTrials.gov Identifier: NCT03105167|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : July 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Stenosis Lumbar Lumbar Disc Herniation Intervertebral Disc Degeneration||Procedure: cortical bone trajectory screws Procedure: pedicle screws||Not Applicable|
Methods and analysis: Blinded Randomized Controlled Trial (RCT) will be conducted. A total of 108 participants will be randomly allocated to either a CBT-TLIF group or a PS-TLIF group at a ratio of 1:1. The primary clinical outcome measures are: change in back and lower limb pain with Visual analogue scale (VAS) and change in quality adjusted life years (QALY) will be assessed by EQ-5D-5L. Measurements will be carried out at five fixed time points (pre-operatively and at 3, 6, 12 and 24 months).
Ethics and dissemination: The study had been reviewed and approved by the ethics committee of the Second affiliated hospital of the Wenzhou Medical University, Wenzhou, China(batch:2017-03). The results will be presented in peer-reviewed journals and related website within 2 years after the last operation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Transforaminal Lumbar Interbody Fusion With Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation: a Multicentre Randomised Controlled Trial|
|Actual Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||December 13, 2020|
|Estimated Study Completion Date :||December 13, 2021|
Experimental: CBT-TLIF group
Patients who are randomised to the CBT-TLIF group will have cortical bone trajectory screws instead of pedicle screws During the opreation. After preventive use of antibliotics,A small skin incision was made at the fused segment, an entry point for insertion of the CBT screws was drilled in the junction of the center of the superior articular process and 1 mm inferior to the inferior border of the transverse process according to Matsukawa et al.A straight probe was used to create a trajectory for the CBT screws from the entry point to the opposite corner of the pedicle and vertebral body under anteroposterior fluoroscopic guidance.nilateral facetectomy is performed to gain access to the intervertebral disc.Afterwards, interbody fusion was performed.Device: CBT screws.
Procedure: cortical bone trajectory screws
cortical bone trajectory screws fixation takes the place of traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.
Experimental: PS-TLIF group
Patients who are randomised to the PS-TLIF group will have pedicle screws During the opreation. A posterior midline incision, about 6 cm, was performed at the level of interest level under fluoroscopic guidance. Pedicle screws were inserted into the vertebral body by using freehand, and the inferior and superior articular processes and part pf the lamina were removed by using an osteotome. To expose the lateral border of the ipsilateral nerve root, the ligamentum flavum was removed. Afterwards, interbody fusion was performed.Device:traditional pedicle screws.
Procedure: pedicle screws
traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.
- Visual analogue scale(VAS) [ Time Frame: up to 36 months ]pain score
- Oswestry Disability Index (ODI) [ Time Frame: up to 48 months ]The Oswestry Disability Index pain score
- Symptomatic adjacent-segment disease (SASD) [ Time Frame: up to 48 months ]Symptomatic adjacent-segment disease rate
- Japanese Orthopedic Association (JOA) [ Time Frame: up to 48 months ]Japanese Orthopedic Association score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105167
|The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University||Recruiting|
|Wenzhou, Zhejiang, China, 325000|
|Contact: TING LI 057788002888 email@example.com|
|Principal Investigator: WENFEI NI|