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Vol. 33. Issue 3.
Pages 105-110 (May - June 2022)
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Vol. 33. Issue 3.
Pages 105-110 (May - June 2022)
Clinical Research
The role of cross-link augmentation on fusion rate and patient satisfaction among patients with traumatic thoracolumbar spinal fracture: A randomized clinical trial
El papel del aumento de los enlaces cruzados en la tasa de fusión y la satisfacción del paciente entre los pacientes con fractura traumática de la columna vertebral toracolumbar: un ensayo clínico aleatorizado
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Farhad Mirzaeia, Arad Iranmehrb, Ghaffar Shokouhia, Masoud Khadivib, Moslem Shakeria, Mohamad Namvarb,
Corresponding author
mohamad.namvar@gmail.com

Corresponding author.
, Ebrahim Rafieia, Bagher Matloubia
a Department of Neurosurgery, Tabriz University of Medical Sciences, Tabriz, Iran
b Department of Neurosurgery, Tehran University of Medical Sciences, Tehran, Iran
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Tables (5)
Table 1. TLICS (Thoracolumbar injury classification and severity score) scoring and management as per TLICS score.
Table 2. Demographic data of the participants. TLICS: Thoracolumbar injury severity classification system. MVA: Motor vehicle accident.
Table 3. Successful and failed fusion rates among studied groups.
Table 4. Mean VAS (Visual Analog Scale) score after surgery among examined groups and mean VAS score difference between groups.
Table 5. Patients’ subjective satisfaction results about the surgery.
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Abstract
Introduction and objectives

Most of the studies evaluating the effect of cross links on spinal stability are performed in vitro on porcine or human spine segments and there is limited data regarding clinical benefits of cross link augmentation in traumatic injuries. In this study we aimed to evaluate the effects of cross-links insertion between rods on the fusion rates and post-surgical patients’ satisfaction among patients with traumatic thoracolumbar fractures who underwent posterior spinal fixation with pedicle screws.

Materials and methods

This study was conducted as a randomized clinical trial on 60 patients suffering from traumatic thoracolumbar vertebrae fractures. Patients were randomized into three groups: A (without any cross-link), B (One cross-link insertion) and C (two cross-links insertion). Six months after surgery outcomes were evaluated: fusion rates (plain X-ray and CT scan), Back pain (Visual Analog Scale) and patient satisfaction (fair, good, excellent).

Results

In group A 13 (65%) patients had structured bone fusion, but in 7 (35%) patients bone fusion was not observed. In both groups B and C, 19 patients (95%) had bone fusion, but only in 1 patient (5%) fusion failed (p=0.009). In group A, fair satisfaction has the highest rate (8 patients (40%)) compared to the other groups. The highest reported severity of back pain was observed in group A while the lowest reported intensity of back pain was related to group B (p=0.001).

Conclusions

Adding cross link to posterior spinal fixations of patients with traumatic thoracolumbar fractures can be associated with better final fusion results and patients’ satisfaction. However it is necessary to design studies with greater sample sizes to confirm this theory.

Trial registration number: IRCT20120527009878N3.

Keywords:
Pedicle screw
Patient satisfaction
Spinal fracture
Resumen
Introducción y objetivos

La mayor parte de los estudios que evaluaron el efecto de los enlaces cruzados en la estabilidad de la columna vertebral se realizaron in vitro en segmentos de la columna vertebral porcina o humana, existen pocos datos sobre los beneficios del aumento de los enlaces cruzados en las lesiones traumáticas. El objetivo de este estudio era evaluar los efectos de la inserción de enlaces cruzados entre las varillas en las tasas de fusión y la satisfacción posoperatoria de los pacientes con fracturas traumáticas toracolumbares que se habían sometido a fijación vertebral posterior con tornillos pediculares.

Materiales y métodos

Este estudio se realizó como un ensayo clínico aleatorizado de 60 pacientes que presentaban fracturas vertebrales toracolumbares traumáticas. Los pacientes se aleatorizaron en 3 grupos: A (sin ningún enlace cruzado), B (inserción de un enlace cruzado) y C (inserción de 2 enlaces cruzados). Se evaluaron los resultados 6 meses después de la intervención quirúrgica: tasas de fusión (radiografía simple y TC), dolor de espalda (escala analógica visual) y satisfacción del paciente (correcta, buena, excelente).

Resultados

En el grupo A, 13 (65%) pacientes presentaban fusión ósea estructural, pero en 7 (35%) pacientes no se observó fusión ósea. En los grupos B y C, 19 pacientes (95%) presentaban fusión ósea y solo en un paciente (5%) se observó el fracaso de la fusión (p=0,009). En el grupo A, la satisfacción más alta era correcta (8 pacientes [40%]) en comparación con los otros grupos. La mayor intensidad del dolor de espalda notificada se observó en el grupo A, mientras que la menor intensidad del dolor de espalda notificada se observó en el grupo B (p=0,001).

Conclusiones

La inserción de enlaces cruzados a las fijaciones vertebrales posteriores de pacientes con fracturas toracolumbares traumáticas puede asociarse a mejores resultados finales de fusión y satisfacción del paciente. Sin embargo, es necesario diseñar estudios con muestras de mayor tamaño para confirmar esta teoría.

Número de registro del ensayo: IRCT20120527009878N3.

Palabras clave:
Tornillo pedicular
Satisfacción del paciente
Fractura de la columna vertebral

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