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Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation

Primary Purpose

Spinal Stenosis Lumbar, Lumbar Disc Herniation, Intervertebral Disc Degeneration

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

cortical bone trajectory screws

pedicle screws

About this trial

This is an interventional treatment trial for Spinal Stenosis Lumbar focused on measuring CBT, RCT, TLIF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CBT-TLIF group

PS-TLIF group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual analogue scale(VAS)

pain score

Secondary Outcome Measures

Oswestry Disability Index (ODI)

The Oswestry Disability Index pain score

Symptomatic adjacent-segment disease (SASD)

Symptomatic adjacent-segment disease rate

Japanese Orthopedic Association (JOA)

Japanese Orthopedic Association score

Full Information

NCT ID

NCT03105167

First Posted

March 28, 2017

Last Updated

July 25, 2018

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03105167

Brief Title

Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 7, 2018 (Actual)

Primary Completion Date

December 13, 2020 (Anticipated)

Study Completion Date

December 13, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Stenosis Lumbar, Lumbar Disc Herniation, Intervertebral Disc Degeneration

Keywords

CBT, RCT, TLIF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CBT-TLIF group

Arm Type

Experimental

Arm Description

Arm Title

PS-TLIF group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

cortical bone trajectory screws

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

pedicle screws

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual analogue scale(VAS)

Description

pain score

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

Oswestry Disability Index (ODI)

Description

The Oswestry Disability Index pain score

Time Frame

up to 48 months

Title

Symptomatic adjacent-segment disease (SASD)

Description

Symptomatic adjacent-segment disease rate

Time Frame

up to 48 months

Title

Japanese Orthopedic Association (JOA)

Description

Japanese Orthopedic Association score

Time Frame

up to 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

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

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

TING LI

Phone

057788002888

feclinicalresearch@163.com

First Name & Middle Initial & Last Name & Degree

WENFEI NI

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All of the patients' outcomes (without patients' personal information) will be public shared within 2 years after clinical trial complete.

Citations:

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16028736

Citation

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Citation

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Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation

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