Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation

Study Overview
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Brief Summary
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Transforaminal lumbar interbody fusion (TLIF) had been favorable for effectively decrease pain and disability in specific spinal disorders; however, there has been concern regarding pedicle screw placement during TLIF surgery. Recently, several biomechanical studies had demonstrated that CBT technique achieves screw purchase and strength equivalent to or greater than the traditional method. Furthermore, Only 1 report examined the surgical outcomes of TLIF with CBT screws fixation compared with TLIF using traditional pedicle screws fixation. TLIF with CBT screws fixation may be effective for specific spinal disorders, but the evidence supporting this possibility is still limited.

Detailed Description
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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.

Official Title
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Transforaminal Lumbar Interbody Fusion With Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation: a Multicentre Randomised Controlled Trial

Conditions
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Spinal Stenosis Lumbar, Lumbar Disc Herniation, Intervertebral Disc Degeneration

Intervention / Treatment
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* Procedure: cortical bone trajectory screws
* Procedure: pedicle screws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of at least 18 years; All of participants will be informed consent; Chronic low back pain (visual analogue scale at least 3 out of 10 at rest and at least 5 out of 10 under physical strain) after having failed conservative treatment for 6 months; Single-segment lower lumbar vertebral disease (Including lumbar spinal cannal stenosis, foraminal stenosis, segmental instability, lumbar disc herniation, and painful disc degeneration (back disc); Exclusion Criteria: Serious deformity of lumbar vertebrae; Dysplasia of lumbar pedicle or vertebral laminar; Obvious osteoporosis of lumbar vertebrae; Metabolic bone diseases such as osteomalacia or Paget's disease; Spondylolisthesis > grade 2 (Meyerding); Caudaequina injury or severe radiculopathy; Post inflammatory instability of the vertebral spine; Body mass index > 30; Immunologic diseases or Metabolic syndrome; Therapy with systemic corticosteroids or immunosuppressants; Current using Coumadin (or Warfarin) or Heparin therapy for more than 6 months at the time of operation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-TLIF group<br>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<br>* cortical bone trajectory screws fixation takes the place of traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.<br>|
| Experimental: PS-TLIF group<br>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<br>* traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale(VAS) | pain score | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | The Oswestry Disability Index pain score | up to 48 months | 
| Symptomatic adjacent-segment disease (SASD) | Symptomatic adjacent-segment disease rate | up to 48 months | 
| Japanese Orthopedic Association (JOA) | Japanese Orthopedic Association score | up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, RCT, TLIF