Implant Survival Analysis and Failure Modes of the X-Stop Interspinous Distraction Device

Tuschel, A; Chavanne, A; Eder, Claudia; Meissl, M; Becker, Philipp; Ogon, M

doi:10.1097/brs.0b013e31820b86e1

Cited by 32 publications

(12 citation statements)

References 16 publications

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“…4,7,10,19,32,45,47,49,51 In our study, the overall reoperation rate was 9.6%: We performed removal of the interspinous spacer and decompressive surgery in 24 patients, additional instrumented fusion with pedicle screws in 63 cases, removal of the interspinous spacer only in 8 cases, and insertion of a new interspinous implant in 12 cases. We removed the IPD with no further spinal fixation or decompression in older patients with multiple comorbidities in whom major spinal surgery could have been life threatening.…”

Section: Discussionmentioning

confidence: 99%

“…45 Fourteen cases had to undergo revision surgery due to worsening pain within the first 12 months in 11 cases, implant dislocation in 2 patients, and fracture of the spinous process in 1 case. In 1 case, spacer dislocation was secondary to trauma from a skiing accident.…”

Section: Discussionmentioning

confidence: 99%

“…16,26,24,28,29,31,39 They can be categorized as static or dynamic, and material compositions include titanium, polyetheretherketone (PEEK), and elastomeric compounds. 1,13,15,17,25,27,31,35,36,45 Surgical indications have been extended, ranging from degenerative spinal stenosis, discogenic low-back pain, facet syndrome, disc herniations, and low-grade instability. These devices are used either as "stand-alone" implants or to augment open decompression by preventing instability.…”

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confidence: 99%

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Failure rates and complications of interspinous process decompression devices: a European multicenter study

Gazzeri

Galarza

Neroni

et al. 2015

FOC

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OBJECT Spacers placed between the lumbar spinous processes represent a promising surgical treatment alternative for a variety of spinal pathologies. They provide an unloading distractive force to the stenotic motion segment, restoring foraminal height, and have the potential to relieve symptoms of degenerative disc disease. The authors performed a retrospective, multicenter nonrandomized study consisting of 1108 patients to evaluate implant survival and failure modes after the implantation of 8 different interspinous process devices (IPDs). METHODS The medical records of patients who had undergone placement of an IPD were retrospectively evaluated, and demographic information, diagnosis, and preoperative pain levels were recorded. Preoperative and postoperative clinical assessments in the patients were based on the visual analog scale. A minimum of 3 years after IPD placement, information on long-term outcomes was obtained from additional follow-up or from patient medical and radiological records. RESULTS One thousand one hundred eight patients affected by symptomatic 1- or 2-level segmental lumbar spine degenerative disease underwent placement of an IPD. The complication rate was 7.8%. There were 27 fractures of the spinous process and 23 dura mater tears with CSF leakage. The ultimate failure rate requiring additional surgery was 9.6%. The reasons for revision, which always involved removal of the original implant, were acute worsening of low-back pain or lack of improvement (45 cases), recurrence of symptoms after an initial good outcome (42 cases), and implant dislocation (20 cases). CONCLUSIONS The IPD is not a substitute for a more invasive 3-column fusion procedure in cases of major instability and spondylolisthesis. Overdistraction, poor bone density, and poor patient selection may all be factors in the development of complications. Preoperatively, careful attention should be paid to bone density, appropriate implant size, and optimal patient selection.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Failure rates and complications of interspinous process decompression devices: a European multicenter study

Gazzeri

Galarza

Neroni

et al. 2015

FOC

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“…The dimension of the scaffold used in this study was 4 × 4 × 4 mm. The main reason for using mPCL-TCP was to provide a three-dimensional cage spacer space similar to what is commonly employed in contemporary surgical practice [30,32,33]. For implantation, all animals were induced with 5% isofluorane and maintained with 2% isofluorane and oxygen general anesthesia.…”

Section: Animal Surgery and In Vivo Bioactivity Of Implanted Carriersmentioning

confidence: 99%

In vivo bioactivity of rhBMP-2 delivered with novel polyelectrolyte complexation shells assembled on an alginate microbead core template

Abbah

Liu

Lam

et al. 2012

Journal of Controlled Release

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“…It should be noted that this range is not dissimilar to that reported for open surgical decompression. Interspinous process spacers are also considered to be less invasive than open surgery, but reports of safety and patient outcomes remain highly controversial with these implants [22][23][24][25].…”

Section: Treatment Of Lumbar Spinal Stenosismentioning

confidence: 99%

Minimally Invasive Lumbar Decompression for the Treatment of Spinal Stenosis of the Lumbar Spine

Deer¹

2012

Pain Manage.

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SUMMARY Lumbar spinal stenosis is one of the most common degenerative diseases of the elderly population, and a major cause of debilitating pain and decreased function. Lumbar spinal stenosis is almost always associated with neurogenic claudication characterized as pain worsened by standing or walking and relieved by lumbar flexion or sitting. While initial treatment of lumbar spinal stenosis may involve conservative therapies, as patients become more symptomatic the traditional treatment path has generally led to open laminectomy and other invasive, potentially destabilizing, procedures. More recently, less invasive alternatives to wide laminectomy have been developed. This article describes a new method of percutaneous lumbar decompression for treatment of neurogenic claudication secondary to lumbar spinal stenosis, the minimally invasive lumbar decompression procedure. We review the steps of successfully decompressing the hypertrophic ligamentum flavum and lamina, thereby alleviating pressure on neural structures. This is a major innovation in patient care and a step to reduce risks while minimizing costs.

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Implant Survival Analysis and Failure Modes of the X-Stop Interspinous Distraction Device

Abstract: Clinical outcome after X-Stop implantation might be considerably less favorable than when it was being published previously. Patient selection might be a reason for early revision surgery. More criteria for better X-Stop indications might be needed.

Cited by 32 publications

References 16 publications

Failure rates and complications of interspinous process decompression devices: a European multicenter study

Failure rates and complications of interspinous process decompression devices: a European multicenter study

In vivo bioactivity of rhBMP-2 delivered with novel polyelectrolyte complexation shells assembled on an alginate microbead core template

Minimally Invasive Lumbar Decompression for the Treatment of Spinal Stenosis of the Lumbar Spine

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