Introduction: The thoracolumbar region is most commonly affected by various injury mechanisms.
The junction area has a propensity for injury as the mobile lumbar and
comparatively less mobile thoracic region meet each other, and there is a long
liver arm. The worldwide annual incidence of TL
fractures is about 30 in 100,000 inhabitants including osteoporotic fractures.
There is a trend to increase the fractures in the elderly population,
especially in developed countries, while an increase in motor vehicle accidents
in developing countries. The mortality rate among male elderly patients is
relatively high. The injury causes loss of vertebral body and subsequent
kyphosis which can cause neurological compromise in the lower limbs with loss
of bowel and bladder function. Effective decompression of neural structures,
restoration of vertebral body height, and rigid fixation and stabilization are needed.
The anterior approach for the reconstruction of the vertebral body involves
opening the thoracic or abdominal cavity or both for the procedure. The
posterior approach alone for the same procedure avoids all those complications,
and morbidity.
The rationale of the study supported by cited
literature:
Vertebral body reconstruction from the anterior
surgical approach needs thoracotomy or laparotomy or both. Anterior approaches have
disadvantages as compromise in pulmonary function, and injury to great vessels
and vital body organs. The reconstruction of the vertebral body from the posterior
approach alone avoids all those complications, and at the same time, it supports
the fractured vertebral body with metallic support. If the reconstruction is
not done with any approach, there is a report of loss of posterior fixation and
or kyphosis in around 40 percent of cases.
In the present study, a cohort of a thoracolumbar burst fracture
patients will be treated with the technique of decompression and fixation and the
other cohort will be treated with decompression and fixation along with reconstruction
of the shattered vertebral body using a cage. The comparison of functional
outcomes with radiological parameters will be done at after one year of the
operative management.
Hypothesis:
1.
“Decompression, vertebral body
reconstruction and posterior stabilization” (technique B) allow better anterior
decompression of the neural tissue, in comparison to the “decompression and
posterior stabilization only (technique B)” using the posterior approach alone
in the thoracolumbar burst fractures (T10-L2).
2.
Since the new technique
(technique B) allows reconstruction of the shattered vertebral body using the
same approach in a single operative setting, it may have better long-term
restoration of sagittal spine alignment, better function back score,
and improved neurological recovery.
Research questions:
Do decompression and posterior stabilization with
vertebral body reconstruction have improved functional and radiological outcome
in comparison to decompression and posterior stabilization only using the
posterior surgical approach alone in the
thoracolumbar burst fractures (T10-L2)?
Aims:
Comparison of functional and radiological
outcomes in patients with thoracolumbar burst fractures treated with decompression
and posterior stabilization with and without vertebral body reconstruction using
the posterior approach alone.
.
Objectives:
1. To evaluate the efficacy of decompression and posterior stabilisation with
or without vertebral body reconstruction in the thoracolumbar burst fractures
using the posterior approach alone.
2. To evaluate the efficacy of decompression and posterior stabilization with
or without vertebral body reconstruction in patients with thoracolumbar burst
fractures in terms of neurological recovery.
Detailed
methodology:
All the patients with thoracolumbar burst fractures with or without
neurological compromise will be evaluated successively with their presentation
in the department of emergency and in the OPD premises of Orthopaedics AIIMS,
Bathinda. On presentation of any patient with a spine injury, they will be
offered primary treatment on the lines of ATLS protocol with primary stabilisation.
A spine board will be utilized for the initial immobilization of the patients
to prevent further injury to the spine.
Upon vital stabilization, all the patients will undergo evaluation for imaging
such as radiographs of the part concerned and a non-contrast CT scan of the
injured spine. Neurological examination of the extremities will be done using the
American Spine Injury Association Impairment Scale ASIA Scale).
Based on the radiographs, the vertebral injury will be classified as per
the AO classification of the thoracolumbar fractures. The grading of injury to
the vertebral body will be done using the Mc Cormack Score.
Patient inclusion criteria:
1.
Thoracolumbar burst fractures
(T10 to L2) with acute trauma of less than 10 days old in the age group of 20
to 55.
2.
AO, ASIF Type A3, A4
3.
Mc Cormack Score 6 or higher
4.
Sagittal kyphosis 200 or
more
Exclusion criteria:
1.
Osteoporotic fractures,
patients older than 55 (the existing osteoporosis may bias the result)
2.
Pyogenic or tubercular
spondylodiscitis
3.
Patients are not willing to
participate in the study.
4.
Medically unfit for the
surgical intervention.
Once included in the study, the patients with or without neurological
deficit will be planned for the surgical stabilization (posterior only
approach) with a due fitness clearance from the anaesthesia department.
Written and informed consent will be taken for all cases for the surgical
procedure (utilization of posterior only approach for the stabilization of
anterior and posterior column of the spine). The patient will also be informed
and written due consent will be taken for their inclusion in the study. Patients
will be assured that the fact that findings of the study will not affect their
treatment protocol. Epidemiological and demographic factors will be documented.
Preoperative assessment of all the patients:
1.
Demographic parameters: Age,
sex
2.
Mode of injury
3.
Neurological examination of
with ASIA scoring system:
4.
AO classification of the
thoracolumbar fractures.
5.
TLICS score
6.
Load sharing classification of
Mc Cormack
7.
Pre-operative kyphosis at the
injured area (Cobb’s method)
8.
Percentage of the canal
compromised of the injured spine: an average of the adjacent normal spinal
canal will be taken in axial non-contrast MRI for reference purposes.
9. VAS score for back
10.ODI score
11.Low back outcome score
Operative
intervention:
All the patients of thoracolumbar burst fractures satisfying our
inclusion criteria will undergo for the operative posterior stabilization of
the injury with instrumentation. The patients will be operated using two
different techniques.
Group 1 will be treated with
surgical technique A (decompression and posterior stabilization) and group 2 with technique B
(decompression
and posterior stabilization with vertebral body reconstruction) using a single posterior
approach only. The method of allocation of type of treatment to each group will
be alternate allocation.
Intra-operative assessment:
1. Surgery duration,
2. Blood loss
3. Incidence of dural tear
Follow up- All the patients included in the study will be followed for
the minimum one year after their surgery and various functional and
radiological outcomes will be assessed.
Comparison:
Both groups will be
compared to various functional and radiological parameters in the
follow-up.
Outcome measures:
Various functional
scores for the back and radiological parameters of the spine
will be assessed and compared.
Post-operative assessment and documentation:
1. VAS for back at 6, and 12 months.
2. ODI at 6 and 12 months.
3. Low back outcome score at 6, and 12 months.
4. Local kyphosis angle at 12 months.
5. Bony fusion status at 12 months
6. Events: loss of fixation, implant breakage,
exaggeration of kyphosis, infection, etc. Or any other
7. ASIA Score for neurological assessment at 12
months
Data analysis plan: Data will be evaluated with
various parametric and nonparametric statistical test.
Review of literature:
Thoracolumbar fractures are
common injuries. Without appropriate treatment, their outcome can be
devastating. Commonly, treatment decision is based upon accurate radiological
diagnosis and concomitant use of a fracture classification system. (1)
The injury involves the
junctional area of the spine where the rigid thoracic and mobile lumbar spine meet.
This is the most common region of the injury in the spine. Out of all the
fracture types thoracolumbar injury is the most common. A common mode of injury
is a fall from a height and road traffic accidents with high energy of the
injury. The injury involves the breakdown of the vertebral body with
retropulsion of the bony fragments into the spinal canal, which is, in many
occasions, is the chief culprit for the neurological compromise. The
neurological deficit could vary from partial to complete cord injury. The bowel
and bladder function could be affected to varying severity. (2)
The usual principles of the
management of thoracolumbar fractures are immobilization of the spine from the
prehospital setting till spine stabilization to prevent further injury to the
neural tissue. Surgical stabilization of the unstable thoracolumbar spine is required
for neural decompression, correction post post-traumatic kyphosis, and
stabilization of the spine. The choices of the surgical approach for fixation
of the injury vary from anterior procedure to posterior or both in a single
setting or a staged procedure. (3)
Anterior surgery requires a thoracotomy
or retroperitoneal anterior spine approach to deal with the fracture. The
anterior approach has its own disadvantages like injury to the great vessels,
excessive bleeding, long surgery time, and approach-related morbidity.
Posterior only approach with vertebral body reconstruction entails. (4)
References:
1.
Curfs I et al. Reliability and Clinical Usefulness of Current
Classifications in Traumatic Thoracolumbar Fractures: A Systematic Review of
the Literature. Int J Spine Surg. 2020 Dec;14(6):956-969.
2.
Rajasekaran S, Kanna RM, Shetty AP. Management of thoracolumbar spine
trauma: An overview. Indian J Orthop. 2015 Jan-Feb;49(1):72-82. Doi: 10.4103 0019-5413.143914.
PMID: 25593358; PMCID: PMC4292328.
3.
Roblesgil-Medrano A et al.Thoracolumbar Burst Fractures: A Systematic
Review and Meta-Analysis on the Anterior and Posterior Approaches. Spine Surg
Relat Res. 2021 Oct 11;6(2):99-108.
4. Wilcox
et. Al. A Dynamic Study of Thoracolumbar Burst Fractures.The Journal of Bone & Joint Surgery 85(11): p 2184-2189, November 2003.
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