Clinical trial NCT03105167: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Stenosis Lumbar
Lumbar Disc Herniation
Intervertebral Disc Degeneration
Keywords: CBT
RCT
TLIF
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Visual analogue scale(VAS)
timeFrame: up to 36 months
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: up to 48 months
measure: Symptomatic adjacent-segment disease (SASD)
timeFrame: up to 48 months
measure: Japanese Orthopedic Association (JOA)
timeFrame: up to 48 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
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