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Posterior Stabilization vs Global Reconstruction for Thoracic & Thoracolumbar Spinal Tuberculosis
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May 2022
Posterior Stabilization vs Global Reconstruction for Thoracic & Thoracolumbar Spinal Tuberculosis
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:1
Posterior-only stabilization versus global reconstruction in thoracic and thoracolumbar spinal tuberculosis; a prospective randomized study
Int Orthop . 2022 Mar;46(3):597-603.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
Fifty-eight patients with thoracic or thoracic-lumbar spinal tuberculosis with borderline anterior vertebral defects were randomized to undergo either posterior stabilization (n=29) or global reconstruction (n=29). All patients received anti-TB chemotherapy. The primary outcomes were clinical (including neurological), radiological, and functional outcomes. There were no differences in clinical (including neurological), functional [Visual Analog Scale (VAS) & Oswestry Disability Index (ODI) scores], and radiological outcomes (Cobb's angle, kyphosis correction, loss of correction, angle loss rate, & fusion time) between the two groups. No differences in complications were noted.
Publication Funding Details
Funding
Not Reported
Funding Details
N/A
Disclosures
None disclosed
Why was this study needed now?
Although the guidelines for surgical indications in spinal tuberculosis (TB) are well-established, ambiguity still exists in deciding between posterior-only stabilization and global reconstruction in patients with thoracic and thoracolumbar disease with borderline vertebral destruction. Therefore, a trial to compare the safety and efficacy of these two surgical interventions was needed.
What was the principal research question?
In a population of thoracic and thoracic-lumbar (TL) spinal tuberculosis (TB) patients with a borderline anterior vertebral defect, are clinical, radiological, and functional outcomes similar or different among posterior-only stabilization versus global reconstruction?
What were the important study characteristics?
Population
58
Total Sample Size
Patients with spinal tuberculosis involving thoracic and thoracolumbar spine with pre-operative vertebral body loss between 0.5 and 1.
Intervention
29
Posterior Stabilization
Posterior instrumentation was done using pedicle screws and rods extending two to three levels proximal and distal to the diseased segment. In patients without neurological deficit, a transpedicular debridement was performed taking care to avoid a radical debridement thereby preventing significant anterior defect. Midline laminectomy was performed in the presence of neuro-deficit.
Comparison
29
Spinal Reconstruction
After posterior instrumentation described in posterior stabilization, anterior debridement and reconstruction was performed using strut grafts or titanium cages filled with bone grafts through transpedicular, tranfacetal, or costotransversectomy approaches.
Outcomes
Operative time
Resource consumption
Lower = Better
Intraoperative blood loss
Blood Loss
Lower = Better
Length of stay
Resource consumption
Lower = Better
Kyphosis
Alignment
Lower = Better
Visual analogue scale (VAS) - pain
Pain
Lower = Better
Scale: 0.0 to 10.0 mm
Oswestry Disability Index (ODI)
Disease-specific Index
Lower = Better
American Spinal Injury Association (ASIA) impairment scale
Disease-specific Index
Time to fusion
Resource consumption
Lower = Better
Correction angle
Alignment
Higher = Better
Loss of correction
Alignment
Lower = Better
Incidence of dehiscence
Adverse events
Lower = Better
Incidence of neurological deterioration
Adverse events
Lower = Better
Incidence of hepatotoxicity
Adverse events
Lower = Better
Incidence of implant related adverse event
Adverse events
Lower = Better
Methods
RCT
Randomized Controlled Trial
Single-Centered
Locations: India
Blinding
N/A
Who was blinded? N/A
Paradigm
Superiority
Time
Baseline
Outcomes: Alignment, Disease-specific Index, Pain
2 Years
Outcomes: Adverse events, Alignment, Disease-specific Index, Pain
6 Weeks
Outcomes: Disease-specific Index
Time to event
Outcomes: Resource consumption
Perioperative
Outcomes: Alignment, Blood Loss, Resource consumption
What were the important findings?
Blood Loss, Hospital Stay, Loss of Correction, Angle Correction, Fusion Time, Adverse Events, Pre-operative Kyphosis, Post-operative Kyphosis, Adverse Events
Significantly Better
No Difference
Significantly Better
Posterior Stabilization
Spinal Reconstruction
Alignment
Risk of Bias
Mean (Lower = Better)
Kyphosis
2 Years
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
Mean (Higher = Better)
Correction angle
Perioperative
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
Pain
Risk of Bias
Mean (mm, 0-10 mm, Lower = Better)
Visual analogue scale (VAS) - pain
2 Years
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
Disease-specific Index
Risk of Bias
Mean (Lower = Better)
Oswestry Disability Index (ODI)
2 Years
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
High Risk of Bias
Some Concern
Low Risk of Bias
Risk of Bias
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Blinding Healthcare Professionals: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Overall risk of bias
What should I remember most and how will this affect the care of my patients?
Posterior-only or global reconstruction, represent effective management of spinal tuberculosis disease affecting thoracic and thoracolumbar vertebrae. The results of this trial suggest that clinical, functional, and radiological outcomes were comparable. The results of the current trial are limited by a single-centre design and sample size.
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