Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03105167
Study type Interventional
Source Second Affiliated Hospital of Wenzhou Medical University
Contact
Status Recruiting
Phase N/A
Start date May 7, 2018
Completion date December 13, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05277818 - Post-marketing Clinical Follow-up of the Medical Device DIVA®
Recruiting NCT05467072 - PMCFU of an Annular Closure System
Withdrawn NCT03252691 - Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
Withdrawn NCT01622413 - Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy N/A
Completed NCT04329598 - Effects of Whole-Body Electromyostimulation Application in Individuals With Lumbar Disc Hernia N/A
Completed NCT04061759 - Physiotherapy in Lumbar Disc Pathologies N/A
Completed NCT04073095 - Erector Spinae Plane Block and Modified-Thoracolumbar Interfascial Plane Block Following Lumbar Spinal Surgery N/A
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Active, not recruiting NCT05613179 - Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI N/A
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Recruiting NCT05663437 - Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study N/A
Recruiting NCT06076408 - Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients N/A
Completed NCT05999253 - Comparison of the Efficacy of Thoracolumbar Interfascial Plane Block and Erector Spina Plane Block in Lumbar Discectomy
Recruiting NCT03002207 - Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation N/A
Not yet recruiting NCT05487690 - Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries N/A
Completed NCT05003726 - Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation N/A
Completed NCT05556538 - The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
Not yet recruiting NCT04083703 - Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse N/A
Completed NCT03832036 - The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation N/A
Not yet recruiting NCT05584774 - Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty N/A