Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

Background: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. Methods: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. Results: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. Conclusions: Further studies such as randomized controlled trials are needed to validate the findings.

Dispositivos interespinosos en discectomías lumbares primarias. ¿Favorecen la recurrencia de la hernia de discos? [Interspinous device in primary lumbar discectomy. Does it favor the recurrence of disc herniation?]

Objetivo: Evaluar si la colocación de los dispositivos interespinosos siliconados tipo DIAM favorecen una tasa más alta de recidiva de la hernia discal homolateral clínica y por imágenes comparada con la discectomía pura.Materiales y Métodos: Se realizó un estudio prospectivo, observacional, aleatorizado desde mayo de 2009 hasta mayo de 2013, en nuestro Centro. Se evaluó a 123 pacientes, 3 se perdieron en el seguimiento; l muestra incluyó 120 sujetos. Todos fueron operados por el mismo equipo quirúrgico. Se formaron dos grupos: grupo A: discectomía más colocación de dispositivo interespinoso siliconado, 30 pacientes (16 mujeres y 14 hombres), con mayor frecuencia L4-L5 (27 pacientes, 90%) y grupo B: discectomías puras, 90 pacientes (53 mujeres y 37 hombres) con más frecuencia L4 y L5 (72 pacientes, 80%).Resultados: Seis de los pacientes del grupo A (20%) tuvieron una recidiva clínica y por imágenes, y 3 (10%) fueron operados nuevamente; en el grupo B, hubo 4 recidivas discales (4,4%), uno fue operado nuevamente (1,1%). Se hallaron diferencias significativas en las tasas de recidiva y reintervención entre los grupos (p = 0,0073 y p = 0,0188, respectivamente).Conclusiones: Los beneficios de los dispositivos interespinosos para tratar el canal estrecho lumbar secundario a hernia de disco son controvertidos, pero en nuestro estudio, se halló una diferencia significativa según el grupo. Al mantener el movimiento del segmento y cambiar ligeramente las cargas fisiológicas aumentarían la tasa de recidiva discal; no obstante, son necesarios estudios con mayor evidencia científica para corroborar estas tendencias. AbstractObjective: The objective of this study was to evaluate if discectomy with placement of an interspinous silicon DIAM spacer is associated with a different rate of clinical and radiographic ipsilateral disc herniation recurrence than discectomy alone.Methods: A prospective, observational,randomized study was performed from May 2009 to May 2013 at XXXXX. Of the 123 patients included in the study, 3 were lost to follow-up, leaving 120 patients for data analysis. All patients were operated on by the same surgical team. Patients received one of two types of treatment. Group A consisted of 30 patients (16 women and 14 ment) who underwent discectomy with placement of an interspinous silicone DIAM spacer. Group B was composed of 90 patients (53 women and 37 men) who received discectomy alone.Results: Discectomy at L4-L5 was the most common level, occurring in 90% (27) Group A patients and 80% (72) Group B patients. Group A demonstrated clinical and radiographic disc herniation recurrence in 6/30 (20%) of patients. Disc herniation recurrence developed in 4/90 (4.4%) Group B patients. One patient underwent reoperation (1.1%). Both recurrence and reoperation was significantly higher in Group A (p = 0.007 and p = 0.019, respectively).Conclusions: The benefits of interespinosos devices for the treatment of the lumbar spinal stenosis secondary to herniated disc while they are controversial in the present study showed significant difference according to the Group. In this study, patients that underwent discectomy and interspinous spaceer placement had higher reoperation and recurrence rates than discectomy patients that did not receive an interspinous spacer. Interspinous spacers may increase the rate of disc herniation by maintaining movement at the level of prior disc herniation and changing the physiologic load. More studies are needed to corroborate and evaluate these trends.

Lumbar Spinal Stenosis and Neurogenic Claudication

Lumbar spinal stenosis is a degenerative condition that develops and progresses slowly over time. Lumbar spinal stenosis may be local, segmental, or generalized. The majority of lumbar spinal stenosis cases are acquired, degenerative stenosis, resulting from aging of the spine or following surgery or infection. Management of lumbar spinal stenosis is challenging and requires the integration of the history, clinical findings, and results of diagnostic imaging. Magnetic resonance imaging is the most commonly used imaging modality in diagnosing lumbar spinal stenosis. Typical features of spinal stenosis with neurogenic claudication include an increase in symptoms with extension and a decrease with flexion. With lateral recess stenosis or foraminal stenosis, isolated radiculopathy can occur. Spinal stenosis is classified as mild, moderate, and severe, ranging from one third to two thirds of the canal, and grade I to grade III classification of neurogenic intermittent claudication. Management of lumbar spinal stenosis is largely conservative except in cases of severe spinal stenosis and neurogenic claudication with or without paresis and other symptoms. Nonsurgical management of lumbar spinal stenosis includes drugs, physiotherapy, epidural injections, multidisciplinary rehabilitation, and spinal cord stimulation. Minimally invasive techniques include minimally invasive lumbar spinal decompression, interspinous spacers, and endoscopic surgical decompression. The final treatments include open surgery with decompression with or without fusion and spinal cord stimulation. Key words: acquired stenosis, central spinal stenosis, congenital stenosis, decompression with fusion, decompression without fusion, endoscopic spinal decompression, epidural injections, foraminal spinal stenosis, interspinous spacers, lateral spinal stenosis, lumbar spinal stenosis, minimally invasive lumbar decompression, neurogenic claudication, percutaneous adhesiolysis, shopping cart syndrome, spondylolisthesis, vascular claudication