Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation
NCT03105167 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2018-07-27
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.
Conditions
- Spinal Stenosis Lumbar
- Lumbar Disc Herniation
- Intervertebral Disc Degeneration
Interventions
- 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.
- PROCEDURE
-
pedicle screws
traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.
Sponsors & Collaborators
-
Second Affiliated Hospital of Wenzhou Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-05-07
- Primary Completion
- 2020-12-13
- Completion
- 2021-12-13
Countries
- China
Study Locations
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