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        "titulo" => "El papel del aumento de los enlaces cruzados en la tasa de fusi&#243;n y la satisfacci&#243;n del paciente entre los pacientes con fractura traum&#225;tica de la columna vertebral toracolumbar&#58; un ensayo cl&#237;nico aleatorizado"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Generally in patients with thoracolumbar Spinal Fracture in cases of neurological deficits&#44; unstable vertebral fracture&#44; severe kyphosis&#44; posterior ligamentous damage&#44; and the vertebral collapse surgery is indicated in special circumstances&#46;<a class="elsevierStyleCrossRefs" href="#bib0090"><span class="elsevierStyleSup">1&#44;2</span></a> Surgical treatment usually includes vertebral fixation and fusion with or without spinal decompression&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">3</span></a> Creating a solid osseous bed in thoracolumbar spine open surgeries can lead to more stable constructs and help vertebral healing&#46; Fusion rates depend on several variables including fracture site&#44; fusion technique and levels of fixation&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">4</span></a> The fusion rate is evaluated by plain X-rays and CT-Scan&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">5</span></a> Posterior spinal fixation with pedicle screw insertion along with rods fixation and bone grafts is the standard surgical technique for thoracic and lumbar fractures stabilization&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">6</span></a> The cross-link is a metal bridge rod which connects both lateral rods to form a solid metal structure in order to maintain shape and firmness of the construct&#46; Cross-links between the rods are usually used as part of the posterior device structure in the lumbar fractures&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">7</span></a> Cross-link insertion is usually optional and takes little time&#46; Its mechanical effectiveness has been confirmed in posterior spinal fixations previously&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">8</span></a> The use of cross-link in the thoracolumbar traumatic spine fracture and its impact on fusion after the surgery has not been studied previously on clinical trials&#46; Most of the previous studies evaluating the effect of cross-links on spinal stability are performed in vitro settings on porcine samples or human spine segments and there is limited data regarding clinical benefits of cross link augmentation on human spines&#46;<a class="elsevierStyleCrossRefs" href="#bib0125"><span class="elsevierStyleSup">8&#8211;10</span></a> In this study&#44; we evaluated the effect of cross-links insertion and the number of cross-links between rods on the fusion rates and incidence of pseudoarthrosis among patients with traumatic thoracolumbar fractures who undergone open pedicle screw fixation&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methods</span><p id="par0010" class="elsevierStylePara elsevierViewall">This study was a randomized clinical trial on 60 patients suffering traumatic thoracolumbar vertebrae fractures&#46; All patients received an initial neurological evaluation of trauma and routine emergency care&#46; Plain radiography of the thoracolumbar spine &#40;Antero posterior and lateral&#41;&#44; CT scan &#40;Axial&#44; reconstructed coronal and sagittal&#41; and MRI &#40;T1&#44; T2 and Short Tau Inversion Recovery&#41; were performed&#46; Patients who were suspected for a pathologic fracture &#40;including osteoporosis&#41;&#44; fracture displacement&#44; previous history of spine surgery or had more than one vertebra fracture of the spine were excluded from study&#46; Before surgery patients were divided into three randomized groups &#40;A&#44; B and C&#41; by Randlist ver&#46; 1&#46;2&#44; and the trauma section secretary was the only person who was conscious about the arrangement of the patients&#46; We did balanced block randomization based on computer generated sequences and it was concealed in special sealed and numbered envelopes and kept by secretary of the ward&#46; Patients were operated at neurosurgery department according to the registered guidelines&#46; Thoracolumbar Injury Classification and Severity score &#40;TLCS&#41; was used to decide whether patient benefits surgical intervention or conservative management &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">8</span></a> Antibiotics&#44; anti-thromboembolic&#44; anti-inflammatory drugs and analgesics were used according to the routine protocols of the hospital&#46; Patients were lying prone on operating table and fractures were fixed using posterior titanium screws routinely 2 levels above and 2 below the fracture site&#46; In cases which construct ended to L1 or T12 we extended the construct one more level up or down in order to avoid ending construct in thoracolumbar junction&#46; Then bilateral rods were inserted&#46; Routine lateral fusion was done for all patients by a mixture of auto graft and allograft&#46; Auto grafts were collected from surgical bed and was mixed with allografts to achieve appropriate volume for fusion&#46; To avoid donor site complications we didn&#8217;t harvest auto grafts from iliac crest or other parts&#46; Allografts were received from bone bank which were collected from corpses according to standard guidelines&#46; Patients in group A were operated without placement of any cross-links&#46; Group B patients get operated with one cross-link connecting mid-points of the rods and group C with two cross-links at a distance of 1&#47;3 of rod length from end points of the rods&#46; Thoracolumbar plain radiography was performed for all of the participants on the day after the operation to assess accurate placement of the devices&#46; Six months later&#44; radiological evaluations including flexion and extension functional radiographies&#44; CT scan &#40;to evaluate the fusion status&#41;&#44; and Clinical evaluations were performed&#46; The results of the radiological assessments were accurately evaluated by two different groups&#59; each group included a spine surgeon and a radiologist&#46; Fusion was defined successful when bone bridges were found at fusion sites in CT scan or plain X-rays and both observers agreed about successful fusion&#46; If any observer reported the studies as fusion failure the patient was considered as non-fusion case&#46; The radiographic definition for failure in fusion included&#58; Fracture or motion of the instruments&#44; bone graft reabsorption or collapse&#46; Also in cases with segmental motion more than 2<span class="elsevierStyleHsp" style=""></span>mm&#44; or angular movement of more than 10 degrees in the functional graphs the fusion was considered inappropriate and classified as no fusion&#46; Back pain was evaluated 6 months after surgery using Visual Analog Scale &#40;VAS&#41;&#46; VAS is a pain measurement scale that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured&#46; It is often used in epidemiologic and clinical research to measure the intensity of pain&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">11</span></a> According to this subjective scale&#44; the pain level of patients is evaluated based on a scaling score of 0 to 10 which increases with pain severity&#46; Patients&#8217; satisfaction after surgery was recorded in three &#40;fair&#44; good and excellent&#41; conditions&#46; Data were analyzed using SPSS version 22 software&#46; <span class="elsevierStyleItalic">p</span>-Values less than 0&#46;05 were considered significant&#46; Informed consent was obtained from all of the patients for participation in the study&#44; and the information was confidential and was kept secure and anonymous at all stages of the study&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">Trial registration number&#58; IRCT20120527009878N3&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0020" class="elsevierStylePara elsevierViewall">In this randomized clinical trial&#44; 60 patients were examined in three groups &#40;A&#44; B&#44; and C&#41; and each group contained 20 patients&#46; The mean age of the patients was 46&#46;6 &#40;29&#8211;71&#41;&#46; Out of 60 patients&#44; 34 patients &#40;54&#46;8&#37;&#41; were males and 26 &#40;41&#46;9&#37;&#41; were females&#46; It was observed that the highest rate of traumatic fracture was in L3 &#40;28&#46;3&#37;&#41;&#46; According to the obtained data on the fracture mechanism&#44; motorcycle and car crash &#40;27 patients&#41; was the most prevalent mechanism of injury &#40;45&#37;&#41;&#46; A clinical examination of Frankel&#39;s neurological clinical classification was performed to evaluate the extent of spinal cord injury by dividing patients to 5 groups from A to E&#46; Frankle D &#40;46&#46;7&#37;&#41; was the most prevalent subtype among all patients&#46; Three patients &#40;5&#37;&#41; had an infection after surgery&#44; 2 patients &#40;3&#46;3&#37;&#41; in group A and one patient &#40;1&#46;7&#37;&#41; was in group C&#46; In group B&#44; no infection was detected following surgical intervention &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#41;&#46; Fortunately&#44; in all 3 patients with infection&#44; MRI revealed that the extension of the infection was above the fascia so in surgical debridement neither devices nor fusions were removed&#46; Two patients had negative tissue and fluid cultures and responded well to first generation cephalosporin&#46; In third patient regimen was changed to Vancomycin based on antibiogram against Staphylococcus aureus positive culture&#46; Based on Thoracolumbar Injury Classification and Severity score &#40;TLICS&#41;&#44; the mean TLICS score of all patients was 6&#46;86<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;30&#46; The mean of TLICS scores in the A&#44; B and C groups were 7&#46;7&#44; 6&#46;80&#44; and 6&#46;80 respectively&#46; The least score in all three groups was 5 and the highest score was 9 which mean that all patients in the study had an indication for surgical treatment&#46; Demographic data about the participants is demonstrated in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#46; According to the <a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#44; in group A&#44; 13 &#40;65&#37;&#41; patients had structured bone fusion&#44; but in 7 &#40;35&#37;&#41; patients bone fusion was not observed&#46; In both groups B and C&#44; 19 patients &#40;95&#37;&#41; had bone fusion&#44; but only in 1 patient &#40;5&#37;&#41; fusion failed &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;009&#41;&#46; Based on VAS score&#44; highest reported severity of back pain was observed in group A and the lowest reported intensity of back pain was related to group B &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">Table 4</a>&#41;&#46; Our analysis showed a significant difference in the mean score of back pain severity between the groups &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; As we can see&#44; in group A&#44; fair satisfaction has the highest rate &#40;8 patients &#40;40&#37;&#41;&#41; compared to the other groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0025">Table 5</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><elsevierMultimedia ident="tbl0020"></elsevierMultimedia><elsevierMultimedia ident="tbl0025"></elsevierMultimedia></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0025" class="elsevierStylePara elsevierViewall">In our study&#44; bone fusion rates in cross link augmented patients were significantly better than patients without cross-link &#40;95&#37; overall&#41;&#46; Only two out of 40 augmented patients didn&#8217;t reach favorable bone fusion while 7 out of 20 patients without cross links didn&#8217;t experience adequate fusion &#40;35&#37; failure&#41;&#46; Lee et al&#46; showed that percutaneous pedicle screw fixation without fusion is as safe and effective as open surgery with fusion in terms of both clinical and radiological parameters and even has less complications&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">12</span></a> But this technique is not available in traditional settings and also costs more&#46; In a study by Rantakokko et al&#46; bone fusion was reported at 71&#37; of patients who their spinal instrumentations were augmented with bioactive glass on one side&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">6</span></a> A novel cross-link configuration that features cross-link devices passing through the base of the spinous processes increased the mechanical resistance in pullout and flexion-compression testing compared to un-cross-link constructs&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">13</span></a> Previously it has been reported that Cross-Links do not improve clinical or radiographic outcomes of posterior spinal fusion with pedicle screws in adolescent idiopathic scoliosis in a multi-center cohort study&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">14</span></a> Also&#44; in a retrospective review for cerebral palsy-related scoliosis&#44; cross links did not show any improvements in the achieved correction or the maintenance of correction at 2 years for the major curve&#44; pelvic obliquity&#44; kyphosis&#44; or lordosis&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">15</span></a> In a laboratory investigation by Lazaro et al&#46; it has been shown that cross link augmentation to human spine segments fixation could reduce axial rotation range of motions significantly&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">9</span></a> Lynn et al&#46; revealed that adding two cross links increased the rotational and lateral bending stiffness values in eight embalmed thoracolumbar spine segments&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">8</span></a> Dick et al&#46; demonstrated that adding two cross link to construct had superiority to one cross link and both of them could limit torsional motion but it does not increase stiffness in lateral flexion mode&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">16</span></a> It seems that most of these biomechanical studies can prove the advantages of cross link augmentation but almost all of them are done in laboratory studies and there is limited data as clinical studies&#46; In one clinical study&#44; Kulkarni et al&#46; didn&#8217;t advise placement of cross links due to no additional benefits beside its cost and related complications&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">17</span></a> But their patients had multiple etiologies and we presume that in traumatic patients cross links may benefit more&#46; It seems that better reduction of spinal movements in cross link augmented patients could prepare an appropriate fusion bed leading to optimal fusion results but we couldn&#8217;t show the superiority of two cross links to one cross link&#46; In our study the highest reported severity of back pain was reported in the non-augmented patients while cross-linked patients reported lower intensities of post-surgical back pain &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; Also patients who were augmented with cross links were more satisfied about the results of their surgery&#46; There is limited data regarding direct effects of cross-link augmentation on post-operative back pain&#46; In a study by Rantakokko et al&#46; in 2012&#44; the mean scores for back pain in patients undergoing surgical intervention using a bioactive glass device were reported to be equal to 1&#44; which is consistent with our study&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">6</span></a> It is hypothesized that instability of the spinal elements could cause significant back pain&#46; So in pathologic situations reducing spinal movements by building more rigid constructs &#40;as we did in this study by cross link&#41; may reduce post-operative back pain&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">8</span></a> As a limitation&#44; we didn&#8217;t compare the severity of pain in baseline or just post-op with the values after six months so the percentage of evolution didn&#8217;t reached&#46; So in this situation some factors like pseudoarthrosis could act as confounding factor for pain assessment&#46; Our studied groups were slightly inhomogeneous in terms of neurological injury and level of damage so that the group without connectors had more severe cases&#46; It can lead to misinterpretation of the results and we consider it as our limitation however these differences were insignificant&#46; Although adding cross-link connectors can cause discomfort due to its mechanical pressure to the adjacent tissues&#44; we presume that benefits of mechanical stability and reduced axial rotations of vertebrae can overcome to mechanically induced pain leading to more favorable results&#46; Adding cross link to posterior spinal fixations of patients with traumatic thoracolumbar fractures can be associated with better final fusion results and patients&#8217; satisfaction&#46; However it is necessary to design studies with greater sample sizes to confirm this theory&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conclusions</span><p id="par0030" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">-</span><p id="par0035" class="elsevierStylePara elsevierViewall">Cross link augmentation may be related to increased rates of spinal fusion in spinal instrumentation of traumatic fractures&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">-</span><p id="par0040" class="elsevierStylePara elsevierViewall">Adding cross-link may be associated with better subjective outcomes of the surgery&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">-</span><p id="par0045" class="elsevierStylePara elsevierViewall">Two cross-links insertion had no superiority to one cross-link&#46;</p></li></ul></p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Ethical approval</span><p id="par0050" class="elsevierStylePara elsevierViewall">The devices are FDA approved or approved by corresponding national agency&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Funding</span><p id="par0055" class="elsevierStylePara elsevierViewall">This research did not receive any specific grant from funding agencies in the public&#44; commercial&#44; or not-for-profit sectors&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Conflict of interests</span><p id="par0060" class="elsevierStylePara elsevierViewall">There is no conflict of interests&#46;</p></span></span>"
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    "fechaRecibido" => "2020-10-02"
    "fechaAceptado" => "2021-01-04"
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          "palabras" => array:3 [
            0 => "Tornillo pedicular"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">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&#46; In this study we aimed to evaluate the effects of cross-links insertion between rods on the fusion rates and post-surgical patients&#8217; satisfaction among patients with traumatic thoracolumbar fractures who underwent posterior spinal fixation with pedicle screws&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Materials and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">This study was conducted as a randomized clinical trial on 60 patients suffering from traumatic thoracolumbar vertebrae fractures&#46; Patients were randomized into three groups&#58; A &#40;without any cross-link&#41;&#44; B &#40;One cross-link insertion&#41; and C &#40;two cross-links insertion&#41;&#46; Six months after surgery outcomes were evaluated&#58; fusion rates &#40;plain X-ray and CT scan&#41;&#44; Back pain &#40;Visual Analog Scale&#41; and patient satisfaction &#40;fair&#44; good&#44; excellent&#41;&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">In group A 13 &#40;65&#37;&#41; patients had structured bone fusion&#44; but in 7 &#40;35&#37;&#41; patients bone fusion was not observed&#46; In both groups B and C&#44; 19 patients &#40;95&#37;&#41; had bone fusion&#44; but only in 1 patient &#40;5&#37;&#41; fusion failed &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;009&#41;&#46; In group A&#44; fair satisfaction has the highest rate &#40;8 patients &#40;40&#37;&#41;&#41; compared to the other groups&#46; 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 &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Adding cross link to posterior spinal fixations of patients with traumatic thoracolumbar fractures can be associated with better final fusion results and patients&#8217; satisfaction&#46; However it is necessary to design studies with greater sample sizes to confirm this theory&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Trial registration number&#58; IRCT20120527009878N3&#46;</p></span>"
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            "titulo" => "Introduction and objectives"
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            "titulo" => "Materials and methods"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n y objetivos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">La mayor parte de los estudios que evaluaron el efecto de los enlaces cruzados en la estabilidad de la columna vertebral se realizaron <span class="elsevierStyleItalic">in vitro en</span> segmentos de la columna vertebral porcina o humana&#44; existen pocos datos sobre los beneficios del aumento de los enlaces cruzados en las lesiones traum&#225;ticas&#46; El objetivo de este estudio era evaluar los efectos de la inserci&#243;n de enlaces cruzados entre las varillas en las tasas de fusi&#243;n y la satisfacci&#243;n posoperatoria de los pacientes con fracturas traum&#225;ticas toracolumbares que se hab&#237;an sometido a fijaci&#243;n vertebral posterior con tornillos pediculares&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Materiales y m&#233;todos</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Este estudio se realiz&#243; como un ensayo cl&#237;nico aleatorizado de 60 pacientes que presentaban fracturas vertebrales toracolumbares traum&#225;ticas&#46; Los pacientes se aleatorizaron en 3 grupos&#58; A &#40;sin ning&#250;n enlace cruzado&#41;&#44; B &#40;inserci&#243;n de un enlace cruzado&#41; y C &#40;inserci&#243;n de 2 enlaces cruzados&#41;&#46; Se evaluaron los resultados 6 meses despu&#233;s de la intervenci&#243;n quir&#250;rgica&#58; tasas de fusi&#243;n &#40;radiograf&#237;a simple y TC&#41;&#44; dolor de espalda &#40;escala anal&#243;gica visual&#41; y satisfacci&#243;n del paciente &#40;correcta&#44; buena&#44; excelente&#41;&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">En el grupo A&#44; 13 &#40;65&#37;&#41; pacientes presentaban fusi&#243;n &#243;sea estructural&#44; pero en 7 &#40;35&#37;&#41; pacientes no se observ&#243; fusi&#243;n &#243;sea&#46; En los grupos B y C&#44; 19 pacientes &#40;95&#37;&#41; presentaban fusi&#243;n &#243;sea y solo en un paciente &#40;5&#37;&#41; se observ&#243; el fracaso de la fusi&#243;n &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;009&#41;&#46; En el grupo A&#44; la satisfacci&#243;n m&#225;s alta era correcta &#40;8 pacientes &#91;40&#37;&#93;&#41; en comparaci&#243;n con los otros grupos&#46; La mayor intensidad del dolor de espalda notificada se observ&#243; en el grupo A&#44; mientras que la menor intensidad del dolor de espalda notificada se observ&#243; en el grupo B &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">La inserci&#243;n de enlaces cruzados a las fijaciones vertebrales posteriores de pacientes con fracturas toracolumbares traum&#225;ticas puede asociarse a mejores resultados finales de fusi&#243;n y satisfacci&#243;n del paciente&#46; Sin embargo&#44; es necesario dise&#241;ar estudios con muestras de mayor tama&#241;o para confirmar esta teor&#237;a&#46;</p><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">N&#250;mero de registro del ensayo&#58; IRCT20120527009878N3&#46;</p></span>"
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                  \t\t\t\t\ttop\n
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                  \t\t\t\t">1 &#40;5&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">9 &#40;15&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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Vol. 33. Núm. 3.
Páginas 105-110 (mayo - junio 2022)
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Vol. 33. Núm. 3.
Páginas 105-110 (mayo - junio 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
Visitas
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Farhad Mirzaeia, Arad Iranmehrb, Ghaffar Shokouhia, Masoud Khadivib, Moslem Shakeria, Mohamad Namvarb,
Autor para correspondencia
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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Tablas (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

Artículo

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