Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation

NCT03105167 | Unknown

• 1 other identifier: SAHoWMU-CR2017-08-106
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis Lumbar; Lumbar Disc Herniation; Intervertebral Disc Degeneration

Keywords

CBT; RCT; TLIF

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale(VAS)

  pain score

  up to 36 months

Secondary Outcomes (3)

• Oswestry Disability Index (ODI)

  up to 48 months

• Symptomatic adjacent-segment disease (SASD)

  up to 48 months

• Japanese Orthopedic Association (JOA)

  up to 48 months

Study Arms (2)

CBT-TLIF group

EXPERIMENTAL

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

PS-TLIF group

EXPERIMENTAL

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

Interventions

cortical bone trajectory screws PROCEDURE

cortical bone trajectory screws fixation takes the place of traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.

CBT-TLIF group

pedicle screws PROCEDURE

traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.

PS-TLIF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (21)

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  PMID: 18790684 RESULT

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  PMID: 24253778 RESULT

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  PMID: 25099320 RESULT

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  PMID: 23104197 RESULT

• Matsukawa K, Kato T, Yato Y, Sasao H, Imabayashi H, Hosogane N, Asazuma T, Chiba K. Incidence and Risk Factors of Adjacent Cranial Facet Joint Violation Following Pedicle Screw Insertion Using Cortical Bone Trajectory Technique. Spine (Phila Pa 1976). 2016 Jul 15;41(14):E851-E856. doi: 10.1097/BRS.0000000000001459.

  PMID: 26796712 RESULT

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• Wu C, Hu X, Liu R, Xu C, Jiang Y, Ge Z, Zhou K, Zhang D, Wu A, Dou H, Xu H, Tian N, Hu Z, Ni W. Comparison of the clinical and radiographic outcomes of cortical bone trajectory and traditional trajectory pedicle screw fixation in transforaminal lumbar interbody fusion: a randomized controlled trial. Eur Spine J. 2024 Mar;33(3):1069-1080. doi: 10.1007/s00586-023-08086-5. Epub 2024 Jan 22.

  PMID: 38246903 DERIVED

• Feng Z, Li X, Tang Q, Wang C, Zheng W, Zhang H, Wu AM, Tian N, Wu Y, Ni W. Transforaminal lumbar interbody fusion with cortical bone trajectory screws versus traditional pedicle screws fixation: a study protocol of randomised controlled trial. BMJ Open. 2017 Oct 22;7(10):e017227. doi: 10.1136/bmjopen-2017-017227.

  PMID: 29061616 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement; Intervertebral Disc Degeneration

Interventions

Pedicle Screws

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bone Screws; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 7, 2017
• Study Start: May 7, 2018
• Primary Completion: December 13, 2020
• Study Completion: December 13, 2021
• Last Updated: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)