Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04495400 |
| Other study ID # |
STU 042018-004 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 23, 2018 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In this single-center retrospective study, the investigators will include all patients
admitted to Parkland Hospital who underwent surgical fixation of thoracolumbar fractures
between the years 2000 and 2017. The study investigators will gather demographic,
radiographic, and operative information. Patients will be matched according to demographic
information in a case-control style. The primary outcome of the study will be comparing the
clinical and radiographic outcomes of two surgical techniques in order to establish the best
treatment approach for this disease.
Description:
Thoracolumbar (TL) fractures occur in 8-15% of blunt trauma patients cared for in major
trauma centers. These fractures can be devastating and commonly occur in patients who endure
high-energy trauma (e.g. motor vehicle accidents). TL fractures occur mainly between T10 and
L2. The "3 Column Model" attempts to identify criteria that can predict instability of TL
fractures. This model divides the spine into anterior, middle, and posterior areas. Stability
is dependent on the integrity of two out of three of the columns. Major spine injuries are
those that involve mechanical or neurologic instability.
The four major types of injury include compression, burst, seat-belt, and
fracture-dislocation. Compression fractures account for 50-70% of all TL fractures and
usually consist of compression failure of the anterior column. Burst fractures comprise
approximately 14% of all TL injuries. These injuries usually involve compression of both the
anterior and posterior column. Seat-belt fractures (aka flexion-distraction fractures)
account for 10% of TL injuries and occur most commonly in patients who are wearing only the
lap belt (i.e. no chest belt) during motor vehicle trauma. These injuries typically involve
compression of the anterior column with distraction failure of both the middle and posterior
columns. Finally, the fracture-dislocation type fracture occurs with massive direct trauma to
the back, causing failure of all three columns and translational injury.
Patients with TL fractures may present with TL spine pain, midline TL spine tenderness, TL
spine bony deformity, or neurologic deficit. Oftentimes these patients were in high-velocity
traumatic scenarios, including falls from heights, crush injuries, motor vehicle crashes with
ejection, unenclosed vehicles (ex. motorcycles), or automobile versus pedestrian accidents.
Diagnosis is confirmed via computed tomography (CT) imaging or plain radiographs. CT imaging
is typically more accurate than plain radiographs but can be poor in certain subtypes of
injury. MRI can be utilized to assess the integrity of the ligaments and surrounding soft
tissues.
There is currently no universally accepted system for classifying the severity of TL
fractures. One proposed system is the Thoracolumbar injury classification and severity score
(TLICS). Points are awarded based on radiographic findings, neurologic status, and the
integrity of posterior ligamentous complex. The final numeric score is used to guide
treatment, with higher scores indicating need for surgery. Neurologic deficit favors surgery.
There is no clear consensus on the best treatment approach for TL fractures. For situations
where conservative management is decided (i.e. surgery is not required or is
contraindicated), patients are treated with recumbency and delayed ambulation in orthosis
with serial radiographs to determine need for further intervention. The surgical management
for more severe/unstable fractures usually involves posterior instrumentation with
percutaneous or open pedicle screw fixation.3 While the traditional open pedicle screw
fixation technique has demonstrated good radiologic and clinical outcomes, a minimally
invasive percutaneous approach has been increasingly used in recent years. The minimally
invasive technique potentially carries the advantage of less operative blood loss, shorter
operative time, smaller incisions, potentially less postoperative pain, and overall shorter
hospital stay. There are a few studies published in the literature, but more studies are
needed to establish the treatment modality that is the most efficacious and safe for these
patients.
At the University of Texas Southwestern (Parkland Hospital), the investigators evaluate and
treat a large population of patients with TL fractures. Previous trials in the literature
comparing open and percutaneous fixation of TL fractures have been series of ~100-200
patients. These studies have shown variable results, with many concluding similar outcome
results for the two surgical techniques. The purpose of this study is to compare a larger
number of patients (~500) who have undergone either surgical approach to determine the best
technique in terms of clinical and radiographic outcomes. The investigators believe this
study will provide neurosurgeons with invaluable information about the safety and efficacy of
different treatment modalities for TL fractures in this patient population.
