Original Article
Pedicular dynamic stabilization system. Functional outcomes and implant-related complications for the treatment of degenerative lumbar disc disease with a minimum follow-up of 4 years
Sistema pedicular de estabilización dinámica. Resultados funcionales y complicaciones del implante en pacientes con enfermedad degenerativa discal lumbar, tras un seguimiento mínimo de 4 años
M. Segura-Trepichioa,
, D. Ferrández-Sempereb, F. López-Pratsa, J. Segura-Ibáñezb, L. Maciá-Solerc
Corresponding author
a Departamento de Cirugía Ortopédica y Traumatología, Hospital General Universitario de Elche, Elche, Alicante, Spain
b Departamento de Neurocirugía, Hospital General Universitario de Elche, Elche, Alicante, Spain
c Departamento de Ciencias de la Salud, Universidad Jaume I de Castellón, Castellón de la Plana, Spain
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"apellidos" => "Ferrández-Sempere" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "F." "apellidos" => "López-Prats" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "J." "apellidos" => "Segura-Ibáñez" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 4 => array:3 [ "nombre" => "L." "apellidos" => "Maciá-Soler" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Departamento de Cirugía Ortopédica y Traumatología, Hospital General Universitario de Elche, Elche, Alicante, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Departamento de Neurocirugía, Hospital General Universitario de Elche, Elche, Alicante, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Departamento de Ciencias de la Salud, Universidad Jaume I de Castellón, Castellón de la Plana, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Sistema pedicular de estabilización dinámica. Resultados funcionales y complicaciones del implante en pacientes con enfermedad degenerativa discal lumbar, tras un seguimiento mínimo de 4 años" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0015" "etiqueta" => "Figure 4" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr4.jpeg" "Alto" => 576 "Ancho" => 998 "Tamanyo" => 99410 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Dynamometric compass used to measure the length of the interpedicular spacer cylinder (the circle indicates the 3 markings or distraction strength levels. The greater the strength, the greater the distraction and, therefore, the greater the length of the spacer cylinder).</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Degenerative spine diseases have a great impact on functional capacity and pain. Among them is degenerative disc disease, associated or not with spinal canal stenosis. Traditionally, the accepted surgical treatment for these diseases has been decompression associated to fusion.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Such treatment has been associated to certain complications, such as loosening of screws, breakage of stems, hypermobility of the adjacent segment and nonunion of the instrumented segment, which in many cases lead to revision surgery.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Several dynamic stabilization systems, like the Dynesys<span class="elsevierStyleSup">®</span> system (Zimmer, Inc., Warsaw, IN, USA), have been developed in order to avoid these undesirable effects. The Dynesys<span class="elsevierStyleSup">®</span> dynamic stabilization system was presented by Dr. Gilles Dubois and was first used in France in 1994.<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,4</span></a> It was introduced into clinical practice in Europe in the year 2000 and was approved in the USA in 2009 to provide spinal stabilization for patients with degenerative spinal diseases causing lumbar and radicular pain.<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5,6</span></a> The system replaces rigid fusion stems by pedicular screws manufactured with Ti-Al-Nb and joined together by polyethylene terephthalate (Sulene-PET<span class="elsevierStyleSup">®</span>) strings running through the center of a polycarbonate-urethane (Sulene-PCU<span class="elsevierStyleSup">®</span>) cylindrical spacer, thus allowing a certain degree of flexibility of the instrumented segments<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). There is scarce literature assessing the functional outcomes and complications of long-term implantation in patients with degenerative lumbar disc disease. Only 1 study has been published in our country.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> The aim of our study is to evaluate the functional and lumbar pain results in these patients, and to evaluate the complications related to the material by measuring the prevalence of breakage and loosening of screws after a follow-up period of 4 years.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Type of study</span><p id="par0010" class="elsevierStylePara elsevierViewall">This was a retrospective case series study based on registry data conducted at Hospital General Universitario of Elche with patients undergoing interventions with the Dynesys<span class="elsevierStyleSup">®</span> technique between January and December 2008 and with postoperative follow-up during the 4 years after surgery.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Inclusion criteria</span><p id="par0015" class="elsevierStylePara elsevierViewall">Patients with lumbar and/or radicular pain resistant to conservative treatment with non-opioid analgesics (NSAIDs, paracetamol, metamizole), codeine, tramadol and/or buprenorphine, oxycodone and/or physical therapy for at least 6 months.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Positive magnetic resonance imaging (MRI) scan for disc degeneration in stages 2, 3 and 4 of the Pfirrmann classification<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> (<a class="elsevierStyleCrossRef" href="#fig0010">Figs. 2 and 3</a>).</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">Changes in disc morphology consisting in disc prolapse, disc hernia and/or lumbar canal stenosis.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Exclusion criteria</span><p id="par0030" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><p id="par0035" class="elsevierStylePara elsevierViewall">Patients with degenerative disc changes of Pfirrmann grade 5.</p></li><li class="elsevierStyleListItem" id="lsti0010"><p id="par0040" class="elsevierStylePara elsevierViewall">Disc extrusion or disc sequestration.</p></li><li class="elsevierStyleListItem" id="lsti0015"><p id="par0045" class="elsevierStylePara elsevierViewall">Spondylolisthesis.</p></li><li class="elsevierStyleListItem" id="lsti0020"><p id="par0050" class="elsevierStylePara elsevierViewall">Lumbar scoliosis greater than 10 degrees.</p></li><li class="elsevierStyleListItem" id="lsti0025"><p id="par0055" class="elsevierStylePara elsevierViewall">Presence of malignant tumors.</p></li><li class="elsevierStyleListItem" id="lsti0030"><p id="par0060" class="elsevierStylePara elsevierViewall">Body mass index over 30<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span>.</p></li><li class="elsevierStyleListItem" id="lsti0035"><p id="par0065" class="elsevierStylePara elsevierViewall">History of alcohol or drug abuse.</p></li></ul></p><p id="par0070" class="elsevierStylePara elsevierViewall">All patients gave their informed consent to be assessed and the study was approved by the Bioethics Committee of our hospital.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Surgical procedure</span><p id="par0075" class="elsevierStylePara elsevierViewall">All surgical procedures were performed by the same surgeon (D.F-S) through a Wiltse paramedian approach.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> The titanium screws were anchored in the pedicle and vertebral body preserving the facet joints, under intraoperative radiographic control. After the pedicular screws were placed, the interpedicular distance was measured with the dynamometric compass included in the instrumentation, and distraction was performed up to mark number 1 of the 3 preset marks in the instrument. Next, the Sulene-PCU<span class="elsevierStyleSup">®</span> cylinder was cut to the resulting length and introduced using the Sulene-PET<span class="elsevierStyleSup">®</span> string (<a class="elsevierStyleCrossRef" href="#fig0015">Fig. 4</a>. In those cases requiring associated nerve root decompression, this was performed through an incision in the midline and unilateral or bilateral laminotomy, preserving the spinous apophysis and supra- and interspinous ligament.</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0080" class="elsevierStylePara elsevierViewall">Sitting and walking were allowed on the day after surgery, without a lumbar orthosis or any limitation of activities of daily living.</p><p id="par0085" class="elsevierStylePara elsevierViewall">Clinical and radiographic variables were collected from the medical records of patients and a personal interview conducted during the last outpatient visit.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Clinical assessment</span><p id="par0090" class="elsevierStylePara elsevierViewall">Functional outcomes were measured using the Oswestry disability index (ODI) in its Spanish version, whilst back and leg pain was assessed by means of a visual analog scale (VAS).<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> The ODI is represented on a scale of 0–100%, where higher values describe greater functional limitations. Between 0% and 20%: minimal functional limitations; 20–40%: moderate; 40–60%: severe; 60–80%: disability, and above 80%: maximum functional limitation.</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Radiographic assessment</span><p id="par0095" class="elsevierStylePara elsevierViewall">Lumbar radiographs in anteroposterior and lateral projections were obtained using the Risolution<span class="elsevierStyleSup">®</span> (MediAlfa Corp., Miami, FL, USA) digitized system. Each image was magnified and contrast was adjusted to obtain the best possible visualization. An orthopedic surgeon (M.S-T), reviewed the presence of breakage and loosening of the screws, considering as positive the presence, in both projections, of a radiolucent circumference around the screw of 1<span class="elsevierStyleHsp" style=""></span>mm or more, surrounded by a radiopaque bone line with greater density; “Double halo sign”<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> (<a class="elsevierStyleCrossRef" href="#fig0020">Fig. 5</a>).</p><elsevierMultimedia ident="fig0020"></elsevierMultimedia></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Statistical analysis</span><p id="par0100" class="elsevierStylePara elsevierViewall">We used the mean and standard deviation for quantitative variables with normal distribution and the frequency for categorical variables. We performed the Wilcoxon test for the analysis of repeated functional outcomes over time and the Mann–Whitney test was used to detect differences between different groups. The level of statistical significance was set at <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.05. Data were assessed using the software package SPSS<span class="elsevierStyleSup">®</span> version 15.0 (SPSS Inc., Chicago, IL, USA).</p></span></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Results</span><p id="par0105" class="elsevierStylePara elsevierViewall">The total sample consisted of 23 patients, of whom 22 were included in the study (1 patient could not be examined due to a change of residence). The gender distribution was 11 females and 11 males, and the mean age was 44.40<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>11 years. The mean follow-up period was 53.45 months (range: 48–60 months). A total of 20 patients (91%) were implanted with the Dynesys<span class="elsevierStyleSup">®</span> system through a Wiltse paramedian approach without any associated decompression maneuvers, whilst 2 patients (9%) were implanted after a unilateral laminectomy and discectomy due to a herniated disc. The mean body mass index (BMI) was 26.74<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2.57<span class="elsevierStyleHsp" style=""></span>kg/cm<span class="elsevierStyleSup">2</span>. A monosegmental stabilization was performed in 8 patients (36.4%), whilst 2 segments were instrumented in 11 (36.4%) cases, and 3 segments in 3 cases (13.6%) (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>).</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Clinical monitoring</span><p id="par0110" class="elsevierStylePara elsevierViewall">The assessment of back and leg pain by a VAS (0–10<span class="elsevierStyleHsp" style=""></span>mm) improved from a preoperative value of 8.04<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.28 to 5.63<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.48, with a mean decrease of 2.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2.06<span class="elsevierStyleHsp" style=""></span>mm (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.0001) (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>).</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0115" class="elsevierStylePara elsevierViewall">The preoperative value of the ODI on the absolute scale from 0% to 100% was 52.36<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16.56% (severe functional limitation). After surgery, this value was 34.27<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>17.87% (moderate functional limitation), with a mean decrease of 18.09<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16.03% (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.001). The results were slightly better in the 2 patients in whom laminectomy was associated, with a decrease in the ODI of 30% in one case and 20% in the other.</p><p id="par0120" class="elsevierStylePara elsevierViewall">When comparing the clinical outcomes by gender, males presented better results on the ODI scale, without this difference being statistically significant (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.075). No correlation between functional outcome and BMI or age was found.</p><p id="par0125" class="elsevierStylePara elsevierViewall">A total of 19 patients (86.4%) reported that their symptoms improved after surgery, while 3 patients (13.6%) reported a worse outcome after surgery. Of these 3 patients, 2 worsened their ODI scores by 10 points, while the third patient worsened by 30 points. The 3 patients were female and did not differ in age and BMI compared to patients who reported improvement.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Radiographic monitoring</span><p id="par0130" class="elsevierStylePara elsevierViewall">A total of 4 (18%) patients presented signs of loosening of screws. The improvement in ODI among these patients was lower than in patients without these signs, specifically 9.75 points compared to 19.94 points (on the absolute scale of 0–100%). This difference was not statistically significant (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.10).</p><p id="par0135" class="elsevierStylePara elsevierViewall">One patient (4.5%) suffered breakage of 1 screw. The patient did not suffer a worsening of clinical status relative to the preoperative condition (<a class="elsevierStyleCrossRef" href="#fig0025">Figs. 6 and 7</a>).</p><elsevierMultimedia ident="fig0025"></elsevierMultimedia></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Discussion</span><p id="par0140" class="elsevierStylePara elsevierViewall">This retrospective observational study presents the experience of the authors with the Dynesys<span class="elsevierStyleSup">®</span> system. According to the study published by Ostelo et al. (establishing the relevant minimum difference as 10 points in the ODI and 1.5 points in the VAS scale) patients included in our study achieved a clinically relevant reduction of pain and disability after surgery.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> When we compare our results with those reported by other published series of cases, we can see that the margin of improvement in our patients was not as extensive as those reported by other studies. In this regard, Lee et al.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> published the largest decrease in the ODI recorded to date, with a variation of 57.43%, from 79.58% to 22.17% (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001), in 19 patients with spondylolisthesis and lumbar stenosis. Sapkas et al.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> also obtained better results than those in our study, with a variation in the ODI of 35% in 114 patients with degenerative disc disease and spinal canal stenosis. Recently, Fay et al.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> have reported a decrease of 4.1 points on the VAS scale (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001) and 23.3% in the ODI (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001) in patients with similar characteristics to the previous set. These differences between the aforementioned studies and our own, assuming that the patients were comparable, could be due to the fact that the former associated decompression in 100% of patients, whereas in our study only 2 (9%) patients underwent decompression along with the Dynesys<span class="elsevierStyleSup">®</span> device. It seems clear that, in cases in which a decompressive maneuver is associated, this could act as a confounding factor, making it impossible to isolate the effect of Dynesys<span class="elsevierStyleSup">®</span> per se. In this sense, our study, in which 91% of patients did not undergo decompression, provides an approximate reference to the functional improvement that may be obtained by using the Dynesys<span class="elsevierStyleSup">®</span> device alone.</p><p id="par0145" class="elsevierStylePara elsevierViewall">The ODI results were slightly better in the 2 cases (9%) in which decompression was associated. This is consistent with the results published by Grob et al. and Bothmann et al.,<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">17,18</span></a> who found better results when dynamic stabilization was combined with decompression of the spinal canal or nerve root. All this evidence suggests that, as is the case with fusion, the main maneuver is decompression, with dynamic stabilization providing scarce additional benefit in those cases requiring decompression of the spinal canal or foramen due to a stenosing lesion.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a></p><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Dynesys<span class="elsevierStyleSup">®</span> versus fusion</span><p id="par0150" class="elsevierStylePara elsevierViewall">The Dyensys<span class="elsevierStyleSup">®</span> system has not demonstrated superior functional results compared to fusion. In this regard, Yu<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> found no significant differences in the ODI when comparing a group of patients treated with the Dynesys<span class="elsevierStyleSup">®</span> system versus another group treated with posterior interbody fusion (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.254). Moreover, during the clinical trial conducted to obtain approval of the Dynesys<span class="elsevierStyleSup">®</span> system by the FDA in the USA in 2009 the Dynesys<span class="elsevierStyleSup">®</span> system was compared against rigid posterolateral fusion and the difference in the functional results was not statistically significant at 2 years follow-up (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.34). However, it should be mentioned that some authors argue that, with all results being equal, the Dynesys<span class="elsevierStyleSup">®</span> system provides other benefits, as it does not require an extraction of iliac crest graft and it also shortens the surgical time.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0155" class="elsevierStylePara elsevierViewall">In the Spanish context, 1 study has been published which reported positive results regarding the improvement in disability at 2 years follow-up. However, this study did not specify whether these differences were statistically significant nor the percentage of patients undergoing decompression together with the Dynesys<span class="elsevierStyleSup">®</span> system.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> At an international level, only 4 studies have published results with the Dynesys<span class="elsevierStyleSup">®</span> system with more than 4 years follow-up.<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">15,21–23</span></a> In this sense, the long-term results are still uncertain, with the most extensive records to date being those reported by Hoppe,<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a> with 7.1 years follow-up.</p><p id="par0160" class="elsevierStylePara elsevierViewall">In the analysis of screw loosening we obtained similar results to those published by other authors with this technique. In this sense, Wu et al.<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">24</span></a> found 19.8% of cases with radiographic signs of loosening among 126 patients treated with this technique. Some authors argue that the percentage of screw loosening with the dynamic system may be lower than with rigid systems because the flexible stems would allow some degree of mobility, reducing the load on the pedicular screws.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> However, the studies by Yu et al.<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">20,25</span></a> compared these 2 systems and obtained a similar percentage of screw loosening with the Dynesys<span class="elsevierStyleSup">®</span> system compared to the rigid fusion system; 14.3% versus 20% of patients, respectively (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.728).</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Limitations</span><p id="par0165" class="elsevierStylePara elsevierViewall">There are several stages within degenerative disc disease.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> We present our experience in cases suffering mild disc degeneration, Pfirrmann stages 2, 3 and 4, and with healthy joints facets, where most cases (91%) were treated with the Dynesys<span class="elsevierStyleSup">®</span> device alone. In our clinical practice we would opt for fusion surgery and/or decompression in those cases presenting a more advanced stage of disc degeneration and/or facet arthrosis. This means that we must be cautious when comparing our results to other populations with different stages of disc disease and undergoing interventions which combine dynamic stabilization after decompression.</p></span></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Conclusion</span><p id="par0170" class="elsevierStylePara elsevierViewall">Surgery with the Dynesys<span class="elsevierStyleSup">®</span> device presents favorable long-term clinical outcomes in patients with degenerative lumbar disc disease. However, the range of improvement in our series was lower than those reported by other studies. This could be due to the difference in the percentage of decompressions associated with Dynesys<span class="elsevierStyleSup">®</span> in the results reported by other authors. Comparative studies between the Dynesys<span class="elsevierStyleSup">®</span> device and decompression should be performed in order to isolate the benefit offered by dynamic stabilization from that offered by decompression. Complications associated with loosening of the material are not uncommon.</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Level of evidence</span><p id="par0175" class="elsevierStylePara elsevierViewall">Level of evidence IV.</p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Ethical responsibilities</span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Protection of people and animals</span><p id="par0180" class="elsevierStylePara elsevierViewall">The authors declare that this investigation adhered to the ethical guidelines of the Committee on Responsible Human Experimentation, as well as the World Medical Association and the Declaration of Helsinki.</p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Confidentiality of data</span><p id="par0185" class="elsevierStylePara elsevierViewall">The authors declare that they have followed the protocols of their workplace on the publication of patient data and that all patients included in the study received sufficient information and gave their written informed consent to participate in the study.</p></span><span id="sec0105" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0165">Right to privacy and informed consent</span><p id="par0190" class="elsevierStylePara elsevierViewall">The authors declare having obtained written informed consent from patients and/or subjects referred to in the work. This document is held by the corresponding author.</p></span></span><span id="sec0110" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0170">Conflict of interests</span><p id="par0195" class="elsevierStylePara elsevierViewall">The authors declare that they do not have any financial or personal relationship with any institution related to the content of this publication which could entail a conflict of interests.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:13 [ 0 => array:2 [ "identificador" => "xres322597" "titulo" => array:5 [ 0 => "Abstract" 1 => "Introduction" 2 => "Material and methods" 3 => "Results" 4 => "Conclusions" ] ] 1 => array:2 [ "identificador" => "xpalclavsec304955" "titulo" => "Keywords" ] 2 => array:2 [ "identificador" => "xres322598" "titulo" => array:5 [ 0 => "Resumen" 1 => "Introducción" 2 => "Material y métodos" 3 => "Resultados" 4 => "Conclusiones" ] ] 3 => array:2 [ "identificador" => "xpalclavsec304954" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Methods" "secciones" => array:7 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Type of study" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Inclusion criteria" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Exclusion criteria" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Surgical procedure" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Clinical assessment" ] 5 => array:2 [ "identificador" => "sec0040" "titulo" => "Radiographic assessment" ] 6 => array:2 [ "identificador" => "sec0045" "titulo" => "Statistical analysis" ] ] ] 6 => array:3 [ "identificador" => "sec0050" "titulo" => "Results" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0055" "titulo" => "Clinical monitoring" ] 1 => array:2 [ "identificador" => "sec0060" "titulo" => "Radiographic monitoring" ] ] ] 7 => array:3 [ "identificador" => "sec0065" "titulo" => "Discussion" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0070" "titulo" => "Dynesys versus fusion" ] 1 => array:2 [ "identificador" => "sec0075" "titulo" => "Limitations" ] ] ] 8 => array:2 [ "identificador" => "sec0080" "titulo" => "Conclusion" ] 9 => array:2 [ "identificador" => "sec0085" "titulo" => "Level of evidence" ] 10 => array:3 [ "identificador" => "sec0090" "titulo" => "Ethical responsibilities" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0095" "titulo" => "Protection of people and animals" ] 1 => array:2 [ "identificador" => "sec0100" "titulo" => "Confidentiality of data" ] 2 => array:2 [ "identificador" => "sec0105" "titulo" => "Right to privacy and informed consent" ] ] ] 11 => array:2 [ "identificador" => "sec0110" "titulo" => "Conflict of interests" ] 12 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2013-04-17" "fechaAceptado" => "2013-10-06" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec304955" "palabras" => array:5 [ 0 => "Pedicular dynamic stabilization system" 1 => "Degenerative disc disease" 2 => "Lumbar stenosis" 3 => "Functional outcomes" 4 => "Screw loosening" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec304954" "palabras" => array:5 [ 0 => "Sistema de estabilización dinámica" 1 => "Enfermedad degenerativa discal" 2 => "Estenosis de canal lumbar" 3 => "Resultados funcionales" 4 => "Aflojamiento de tornillos" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The Dynesys<span class="elsevierStyleSup">®</span> system is a non-fusion pedicular dynamic stabilization system. The aim of our study is to evaluate the clinical outcomes in patients with degenerative disc disease and/or stenosis, and to measure the prevalence of screw loosening and breakage after 4 years of follow up.</p> <span class="elsevierStyleSectionTitle" id="sect0015">Material and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">All patients who underwent surgery with Dynesys<span class="elsevierStyleSup">®</span> system in 2008 were reviewed. The surgery was performed in cases of low back pain of more than 6 months duration and a positive MRI for degenerative disc disease and/or stenosis.</p> <span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">A total of 22 patients (11 females, 11 males) with a mean age of 44.40<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>11 years were included, 20 patients (91%) underwent Dynesys<span class="elsevierStyleSup">®</span> without any associated decompression maneuver. The evaluation of back and leg pain (0–10<span class="elsevierStyleHsp" style=""></span>mm) showed a mean decrease of 2.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2.06<span class="elsevierStyleHsp" style=""></span>mm (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.0001). The preoperative value of the Oswestry disability index was 52.36<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16.56% (severe functional limitation). After surgery, this value was 34.27<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>17.87% (moderate functional limitation) (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.001) with a decrease of 18.09<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16.03% (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.001). A total of 4 (18%) patients showed signs of loosening screws. One patient (4.5%) had a screw breakage.</p> <span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Surgery with Dynesys<span class="elsevierStyleSup">®</span> shows favorable long term clinical results, however the range of improvement in our series is lower than those reported in other studies. Comparative studies between Dynesys<span class="elsevierStyleSup">®</span> and decompression need to be performed in order to isolate the benefit of the dynamic stabilization system. Implant-related complications are not uncommon.</p>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0035">Introducción</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">El sistema de estabilización Dynesys<span class="elsevierStyleSup">®</span> es un sistema pedicular de estabilización dinámica sin fusión. El objetivo de nuestro estudio es evaluar los resultados clínicos en pacientes con enfermedad degenerativa discal y/o estenosis, así como medir la prevalencia de aflojamiento de tornillos tras 4 años de seguimiento.</p> <span class="elsevierStyleSectionTitle" id="sect0040">Material y métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se trata de un estudio de serie de casos retrospectivo donde fueron incluidos todos los pacientes intervenidos desde enero a diciembre de 2008 con Dynesys<span class="elsevierStyleSup">®</span>. Se indicó la cirugía si presentaban dolor lumbar de más de 6 meses de evolución y una RM positiva para enfermedad degenerativa discal y/o estenosis.</p> <span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Veintidós pacientes (11 mujeres y 11 varones) con una edad media de 44,40<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>11 años fueron evaluados. Veinte pacientes (91%) recibieron el implante Dynesys<span class="elsevierStyleSup">®</span> sin ninguna maniobra de descompresión asociada. La evaluación del dolor de espalda y piernas (0–10<span class="elsevierStyleHsp" style=""></span>mm) registró una disminución media de 2,4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2,06<span class="elsevierStyleHsp" style=""></span>mm (p<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,0001). El valor preoperatorio del índice de discapacidad de Oswestry fue de 52,36<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16,56% (limitación funcional severa). Tras la cirugía este valor fue de 34,27<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>17,87% (limitación funcional moderada) con una disminución de 18,09<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16,03% (p<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0,001). Cuatro pacientes (18%) mostraron signos de aflojamiento de tornillos. Un paciente (4,5%) presentó rotura de tornillo.</p> <span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">La cirugía con Dynesys<span class="elsevierStyleSup">®</span> muestra resultados clínicos favorables, sin embargo el rango de mejoría en nuestra serie es menor a los comunicados por otros autores. Estudios comparativos entre Dynesys<span class="elsevierStyleSup">®</span> y descompresión deberían realizarse para poder aislar el beneficio de la estabilización dinámica del obtenido por la descompresión. Las complicaciones relacionadas con el implante no son infrecuentes.</p>" ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0030">Please cite this article as: Segura-Trepichio M, Ferrández-Sempere D, López-Prats F, Segura-Ibáñez J, Maciá-Soler L. Sistema pedicular de estabilización dinámica. Resultados funcionales y complicaciones del implante en pacientes con enfermedad degenerativa discal lumbar, tras un seguimiento mínimo de 4 años. Rev Esp Cir Ortop Traumatol. 2014;58:85–91.</p>" ] ] "multimedia" => array:7 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1373 "Ancho" => 2168 "Tamanyo" => 240423 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Dynesys<span class="elsevierStyleSup">®</span> dynamic stabilization system.</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figures 2 and 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2v3.jpeg" "Alto" => 702 "Ancho" => 1298 "Tamanyo" => 188130 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Patient suffering degenerative disc disease, Pfirrmann 3 and 4, in segments L2–L3–L4, stabilized with the Dynesys<span class="elsevierStyleSup">®</span> system. The image shows the MRI obtained before (above) and after (below), with reabsorption of a small L2–L3 disc protusion (white arrows).</p>" ] ] 2 => array:7 [ "identificador" => "fig0015" "etiqueta" => "Figure 4" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr4.jpeg" "Alto" => 576 "Ancho" => 998 "Tamanyo" => 99410 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Dynamometric compass used to measure the length of the interpedicular spacer cylinder (the circle indicates the 3 markings or distraction strength levels. The greater the strength, the greater the distraction and, therefore, the greater the length of the spacer cylinder).</p>" ] ] 3 => array:7 [ "identificador" => "fig0020" "etiqueta" => "Figure 5" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr5.jpeg" "Alto" => 667 "Ancho" => 1297 "Tamanyo" => 95410 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Right L4 screws showing a “double halo sign” (radiolucent line surrounded by another radiopaque line of bone with greater density).</p>" ] ] 4 => array:7 [ "identificador" => "fig0025" "etiqueta" => "Figures 6 and 7" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr6v7.jpeg" "Alto" => 978 "Ancho" => 1299 "Tamanyo" => 203312 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Tear of the right L5 screw of the Dynesys<span class="elsevierStyleSup">®</span> dynamic stabilization system.</p>" ] ] 5 => array:7 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:3 [ "leyenda" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">BMI: body mass index; ODI: Oswestry disability index; VAS: analog visual scale.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Age (years)</span><a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">44.40<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>11 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="2" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="2" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Gender</span><a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">b</span></a></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Male \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11/22 (50%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Female \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">11/22 (50%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="2" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">BMI (kg/m</span><span class="elsevierStyleSup"><span class="elsevierStyleItalic">2</span></span><span class="elsevierStyleItalic">)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26.74<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2.57 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">VAS (0</span>–<span class="elsevierStyleItalic">10</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">mm)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8.04<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.28 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">ODI (0%–100%)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">52.36<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16.56 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Instrumented lumbar segments</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 level 8 (36.4%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 levels 11 (50%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 levels 3 (13.6%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Follow-up (months)</span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">57.13<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>8.06 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="2" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " colspan="2" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleItalic">Intervention</span></td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Dynesys<span class="elsevierStyleSup">®</span> without decompression \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">20 (91%) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Dynesys<span class="elsevierStyleSup">®</span> with decompression <a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">c</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 (9%) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab470460.png" ] ] ] "notaPie" => array:3 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "a" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Data expressed as mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>standard deviation.</p>" ] 1 => array:3 [ "identificador" => "tblfn0010" "etiqueta" => "b" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Data expressed as number of subjects (percentage).</p>" ] 2 => array:3 [ "identificador" => "tblfn0015" "etiqueta" => "c" "nota" => "<p class="elsevierStyleNotepara" id="npar0015">Decompression was carried out as a partial laminectomy following placement of the Dynesys<span class="elsevierStyleSup">®</span> device.</p>" ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Baseline characteristics of the patients in the sample.</p>" ] ] 6 => array:7 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:3 [ "leyenda" => "<p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">ODI: Oswestry disability index; VAS: analog visual scale.</p><p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">Significant difference using the Wilcoxon test, <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.05.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Clinical results \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Preoperative \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Postoperative \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" style="border-bottom: 2px solid black">Mean decrease \t\t\t\t\t\t\n \t\t\t\t</td></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">VAS (0–10<span class="elsevierStyleHsp" style=""></span>mm)<a class="elsevierStyleCrossRef" href="#tblfn0020"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8.04<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.28 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5.63<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.48 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>−<span class="elsevierStyleHsp" style=""></span>2.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2.06 <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001<span class="elsevierStyleSup">*</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">ODI (0–100%)<a class="elsevierStyleCrossRef" href="#tblfn0020"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">52.36<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16.56 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">34.27<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>17.87 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="char" valign="\n \t\t\t\t\ttop\n \t\t\t\t">−<span class="elsevierStyleHsp" style=""></span>18.09<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>16.03 <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001<span class="elsevierStyleSup">*</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Screw loosening<a class="elsevierStyleCrossRef" href="#tblfn0025"><span class="elsevierStyleSup">b</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4/22 (18%) patients \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Screw breakage<a class="elsevierStyleCrossRef" href="#tblfn0025"><span class="elsevierStyleSup">b</span></a> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1/22 (4.5%) patients \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab470459.png" ] ] ] "notaPie" => array:2 [ 0 => array:3 [ "identificador" => "tblfn0020" "etiqueta" => "a" "nota" => "<p class="elsevierStyleNotepara" id="npar0020">Data expressed as mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>standard deviation.</p>" ] 1 => array:3 [ "identificador" => "tblfn0025" "etiqueta" => "b" "nota" => "<p class="elsevierStyleNotepara" id="npar0025">Data expressed as number of subjects (percentage).</p>" ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Clinical results and complications of the implant after 4 years follow-up.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:25 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "R. 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| 2024 October | 23 | 4 | 27 |
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| 2023 September | 49 | 2 | 51 |
| 2023 August | 51 | 12 | 63 |
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| 2023 June | 73 | 17 | 90 |
| 2023 May | 98 | 14 | 112 |
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| 2023 March | 78 | 12 | 90 |
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| 2022 July | 22 | 19 | 41 |
| 2022 June | 14 | 13 | 27 |
| 2022 May | 19 | 19 | 38 |
| 2022 April | 25 | 24 | 49 |
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| 2022 February | 22 | 5 | 27 |
| 2022 January | 19 | 7 | 26 |
| 2021 December | 32 | 22 | 54 |
| 2021 November | 15 | 6 | 21 |
| 2021 October | 31 | 18 | 49 |
| 2021 September | 8 | 8 | 16 |
| 2021 August | 5 | 13 | 18 |
| 2021 July | 10 | 9 | 19 |
| 2021 June | 16 | 10 | 26 |
| 2021 May | 11 | 4 | 15 |
| 2021 April | 33 | 20 | 53 |
| 2021 March | 18 | 11 | 29 |
| 2021 February | 9 | 13 | 22 |
| 2021 January | 9 | 6 | 15 |
| 2018 February | 15 | 2 | 17 |
| 2018 January | 16 | 2 | 18 |
| 2017 December | 15 | 1 | 16 |
| 2017 November | 16 | 2 | 18 |
| 2017 October | 12 | 5 | 17 |
| 2017 September | 16 | 1 | 17 |
| 2017 August | 22 | 5 | 27 |
| 2017 July | 23 | 4 | 27 |
| 2017 June | 30 | 8 | 38 |
| 2017 May | 24 | 4 | 28 |
| 2017 April | 17 | 3 | 20 |
| 2017 March | 12 | 14 | 26 |
| 2017 February | 78 | 3 | 81 |
| 2017 January | 10 | 0 | 10 |
| 2016 December | 14 | 8 | 22 |
| 2016 November | 16 | 2 | 18 |
| 2016 October | 23 | 4 | 27 |
| 2016 September | 14 | 4 | 18 |
| 2016 August | 6 | 2 | 8 |
| 2016 July | 6 | 1 | 7 |
| 2016 June | 6 | 6 | 12 |
| 2016 May | 13 | 8 | 21 |
| 2016 April | 4 | 11 | 15 |
| 2016 March | 9 | 10 | 19 |
| 2016 February | 0 | 9 | 9 |
| 2016 January | 0 | 15 | 15 |
| 2015 December | 0 | 8 | 8 |
| 2015 November | 0 | 9 | 9 |
| 2015 October | 0 | 10 | 10 |
| 2015 September | 0 | 9 | 9 |
| 2015 August | 0 | 2 | 2 |
| 2015 May | 0 | 1 | 1 |
| 2014 April | 1 | 2 | 3 |
| 2014 March | 0 | 1 | 1 |
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