One-Year Results of X STOP Interspinous Implant for the Treatment of Lumbar Spinal Stenosis

Siddiqui, Manal; Smith, Francis W.; Wardlaw, Douglas

doi:10.1097/brs.0b013e31805b7694

Cited by 98 publications

(71 citation statements)

References 24 publications

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“…Clinical reports have provided promising early data for a number of different interspinous implants including the X-stop [12,16], DIAM [7], and Wallis [9] for degenerative spinal conditions. Four-year results were obtained for the longest followed of these implants [5] and demonstrated an improved quality of life versus non-operative management [3].…”

Section: Discussionmentioning

confidence: 99%

“…Lumbar interspinous spacers, although not a new concept [14], is such an alternative for use in the degenerative conditions such as spinal canal and foraminal stenosis [5,12,16], segmental instability [1], and back pain [7,9]. Theoretically the implants are designed to unload the facet joints, and indirectly decompress the spinal canal or intervertebral foramen by providing distraction through the spinous processes and limiting extension at the implanted segment.…”

Section: Introductionmentioning

confidence: 99%

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An anatomic study of the interspinous space of the lumbosacral spine

et al. 2011

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Purpose The purpose of this study is to quantify the interspinous anatomy at the L4/5 and L5/S1 levels. Methods One hundred reconstructed computer tomography scans of the lumbosacral spine were reviewed by two separate surgeons. Data were collected from the midline sagittal reconstructed image at the L4-5 and L5-S1 levels. Measurements obtained included the disc angle, anterior and posterior disc height, and maximum interspinous space in both the anterior-posterior and cephalad-caudal directions. The disc height and disc angle were correlated with the interspinous height. Results The mean age of the patients reviewed was 47 years (range: 16-91; standard deviation: 20). According to our data population, the average length of the interspinous space was larger at the L4-5 level (13 mm) than the L5-S1 level (9 mm). The interspinous height was similar between the two levels. A poor correlation existed between the disc height or disc angle and the interspinous height. There was no correlation between measurements and age. Conclusions The interspinous space available, as defined by computer tomography, at the L5/S1 level, is less able to accommodate current interspinous devices compared to the adjacent L4/5 level. The limiting factor is the length of the sacral part of the L5-S1 interspinous space.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An anatomic study of the interspinous space of the lumbosacral spine

et al. 2011

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“…Another approach has been to insert an IPS to maintain segmental flexion or prevent extension, thereby indirectly decompressing nerve tissues. The use of various IPSs has been reported with acceptable clinical outcomes [2,9,10,13,19]. However, most currently available IPSs require open surgery which includes detaching muscles from bone or cutting ligaments.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, a procedure using an interspinous process spacer (IPS) has also been developed to maintain segmental flexion or prevent extension of the lumbar spine with relatively less invasion [2,9,17,18], and acceptable clinical outcomes for posture-dependent LSS using this method have been reported [10,13,17,19]. However, inserting IPS mostly requires open surgery including a relatively large skin incision as well as detaching muscle from bone.…”

Section: Introductionmentioning

confidence: 99%

“…Additional problem of this technique is that the revision rate is relatively high. Follow up studies have revealed a 6-20% revision rate that has required decompressive surgery [2,9,10,13,19]. However when revision surgery for the implanted IPS is required, usually destructive procedures including cutting ligaments or bone are inevitable to remove it.…”

Section: Introductionmentioning

confidence: 99%

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Development of percutaneously insertable/removable interspinous process spacer for treatment of posture-dependent lumbar spinal-canal stenosis: preclinical feasibility study using porcine model

et al. 2011

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Purpose A procedure using an interspinous process spacer (IPS) was recently developed for the treatment of posture-dependent lumbar spinal-canal stenosis (LSS) patients. We developed a novel IPS which can be inserted with simpler procedures and removed percutaneously. The objectives of this study were: (1) to evaluate the feasibility and safety of this novel technique, and (2) to assess the effectiveness of this spacer in terms of preventing an increase of epidural pressure in lumbar extension using a porcine model. Methods Eight young pigs were used. Under general anesthesia and image guidance, the spacers were inserted. Three months after operation, MR images were taken and all spacers were removed. Blood samples were obtained before and 1, 3, 7 days after surgery. After killing the animals, the lumbar spines were observed macroscopically. Another six animals were used. Under general anesthesia and image guidance, a flexible pressure transducer was inserted into the epidural space and epidural pressure was measured in neutral and at maximum extension with and without spacer insertion. Results Percutaneous insertion and removal of the spacer was successful for all animals through small skin incisions. MR images showed minimal damage to the muscle.No significant up-regulation of Interleukin-6 (IL-6) and CRP was detected. Macroscopic observation of the lumbar spine 3 months after the operation revealed that the area of the interspinous process contacting with the inserted spacer showed some bone erosion/remodeling. Insertion of the spacer did not affect the epidural pressure in neutral but significantly prevented an increase of epidural pressure in lumber extension. Conclusions This study demonstrated that the percutaneous insertion and removal of a novel IPS was feasible and safe using a simple technique. Furthermore, this procedure can be recognized as minimally invasive surgery from the viewpoint of skin incision, short insertion track, inflammatory mediators, and muscle damage. Improvements should be attempted in future studies using softer or more elastic materials for the spacer to lessen bone erosion/ remodeling at contacting area of the inserted spacer.

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CT/X-Ray-Guided Technique in Lumbar Spinal Canal and Foramina Stenosis: Spacers

Bonaldi

Manfrè

2016

Spinal Canal Stenosis

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One-Year Results of X STOP Interspinous Implant for the Treatment of Lumbar Spinal Stenosis

Cited by 98 publications

References 24 publications

An anatomic study of the interspinous space of the lumbosacral spine

An anatomic study of the interspinous space of the lumbosacral spine

Development of percutaneously insertable/removable interspinous process spacer for treatment of posture-dependent lumbar spinal-canal stenosis: preclinical feasibility study using porcine model

CT/X-Ray-Guided Technique in Lumbar Spinal Canal and Foramina Stenosis: Spacers

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