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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
Sponsor:
Information provided by (Responsible Party):
Wenfei Ni, Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

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

Detailed 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Visual analogue scale(VAS) [ Time Frame: up to 36 months ]
    pain score


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: up to 48 months ]
    The Oswestry Disability Index pain score

  2. Symptomatic adjacent-segment disease (SASD) [ Time Frame: up to 48 months ]
    Symptomatic adjacent-segment disease rate

  3. Japanese Orthopedic Association (JOA) [ Time Frame: up to 48 months ]
    Japanese Orthopedic Association score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age of at least 18 years;
  2. All of participants will be informed consent;
  3. 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;
  4. 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:

  1. Serious deformity of lumbar vertebrae;
  2. Dysplasia of lumbar pedicle or vertebral laminar;
  3. Obvious osteoporosis of lumbar vertebrae;
  4. Metabolic bone diseases such as osteomalacia or Paget's disease;
  5. Spondylolisthesis > grade 2 (Meyerding);
  6. Caudaequina injury or severe radiculopathy;
  7. Post inflammatory instability of the vertebral spine;
  8. Body mass index > 30;
  9. Immunologic diseases or Metabolic syndrome;
  10. Therapy with systemic corticosteroids or immunosuppressants;
  11. Current using Coumadin (or Warfarin) or Heparin therapy for more than 6 months at the time of operation.

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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


Locations
China, Zhejiang
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: TING LI    057788002888    feclinicalresearch@163.com   
Principal Investigator: WENFEI NI         
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wenfei Ni, director, Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03105167     History of Changes
Other Study ID Numbers: SAHoWMU-CR2017-08-106
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the patients' outcomes (without patients' personal information) will be public shared within 2 years after clinical trial complete.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wenfei Ni, Second Affiliated Hospital of Wenzhou Medical University:
CBT
RCT
TLIF

Additional relevant MeSH terms:
Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases