Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: A multicenter study with a minimum 3-year follow-up

Puzzilli, Fabrizio; Gazzeri, Roberto; Galarza, Marcelo; Neroni, Massimiliano; Panagiotopoulos, Konstantinos; Bolognini, Andrea; Callovini, Gemma; Agrillo, Umberto; Alfieri, Alex

doi:10.1016/j.clineuro.2014.07.004

Cited by 44 publications

(28 citation statements)

References 32 publications

(46 reference statements)

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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%

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%

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

Gazzeri

Galarza

Neroni

et al. 2015

FOC

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“…Interspinous decompressor implants have been used for treating lower back pain in humans, such as the X‐STOP (Medtronic), approved by the Federal Drug Administration since 2005. The MTV procedure is derived from the same theory that served as a rationale for these interspinous distraction devices . The MTV procedure offers several advantages, including minimized surgical trauma and a relatively short duration of surgery, approximating 30 minutes.…”

Section: Discussionmentioning

confidence: 99%

Short‐term and long‐term effects of a minimally invasive transilial vertebral blocking procedure on the lumbosacral morphometry in dogs measured by computed tomography

Müller¹,

Schenk²,

Forterre³

2017

Veterinary Surgery

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“…1a). In a study comparing conservative treatment versus surgical intervention with X-STOP, symptom severity, physical function, and patient satisfaction were all found to be significantly greater in the X-STOP group at 1-, 6-, and 12-month follow-up periods [8]. Significantly improved visual analog scale (VAS) scores were seen in the X-STOP group over a 7-year follow-up period.…”

Section: This Article Is Part Of the Topical Collection On Motion Prementioning

confidence: 95%

“…Postoperatively, a steady rise in VAS has been reported to occur after 6 months [8], 1 year [19,39], and 2 years [18,34] of follow-up. Other studies have reported the maintenance of initially improved VAS up to 2 years [21, 27, 36•, 38] or even 3 years [13,23].…”

Section: Symptom Reliefmentioning

confidence: 99%

Interspinous implants: are the new implants better than the last generation? A review

Pintauro

Duffy

Vahedi

et al. 2017

Curr Rev Musculoskelet Med

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Purpose of review Interspinous process devices (IPDs) are used in the surgical treatment of lumbar spinal stenosis. The purpose of this review is to compare the first generation with the next-generation devices in terms of complications, device failure, reoperation rates, symptom relief, and outcome. Recent findings Thirty-seven studies were included from 2011 to 2016. Device failure occurred at a mean of 3.7%, with a lower tendency to happen with next-generation IPDs. Reoperations occurred at a lower rate with the nextgeneration devices, with a mean follow up of 24 months (3.7% vs. 11.1%). The clinical outcome is not influenced by the type of IPD. Summary The long-term functionality of these devices is questionable, with radiologic changes and recurrence of symptoms often seen by 2 years following implantation. Next-generation devices do not appear to be subject to the same "bounce back" effect of symptom re-emergence after several years.

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Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: A multicenter study with a minimum 3-year follow-up

Cited by 44 publications

References 32 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

Short‐term and long‐term effects of a minimally invasive transilial vertebral blocking procedure on the lumbosacral morphometry in dogs measured by computed tomography

Interspinous implants: are the new implants better than the last generation? A review

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