X-STOP Surgical Implant for the Treatment of Lumbar Spinal Stenosis

Nielsen, Magan

doi:10.1097/jnn.0b013e318275b1e4

Cited by 4 publications

(2 citation statements)

References 12 publications

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“…If conservative treatment does not bring required effects, spine surgery is the recommended option. First implantation of metal implants within the spinous process was associated with their frequent falling out, which limited the development of this technique [17]. New-generation inter-process stabilizers are often used in surgical treatment of the spinal lumbar segment [2, 18, 19].…”

Section: Discussionmentioning

confidence: 99%

Radioisotopic assessment of bone metabolism of the operated vertebra after inter-process stabilizer implantation in the lumbar segment of the spine

Radek¹,

Radek²,

Rysz³

et al. 2017

aoms

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IntroductionLack of efficacy of pharmacotherapy and physiotherapy in spinal pain syndrome is an indication for intervertebral stabilizer implantation between the processes in the lumbar segment of the spine.Material and methodsThe group consisted of 32 patients qualified after radioisotopic single-photon emission computed tomography/computed tomography (SPECT/CT) examinations with assessment of bone metabolism and mineral density. For comparative purposes, the L2 vertebra was defined as normal. Parameters defined in the area of operated vertebrae were comparable to L2. Imaging examinations and a pain intensity test were performed before and 12 months after the procedure.ResultsIn SPECT, osteotropic isotope (OI) activity in spinous bodies and processes was close to L2 values. Density assessed in CT of analysed vertebrae was close to L2. In the control examination, activity of OI in spinous bodies and processes was higher in the procedure area. Under the stabilizer, there was a strong positive correlation with the L2 parameters. The differences were statistically significant (p = 0.0002). The increase of OI activity in the elements above the stabilizer was variable. In the control examination, there was higher density of spinous processes and bodies above and under the stabilizer. The difference, compared to the L2 density, was statistically significant.ConclusionsThe radioisotopic method with SPECT/CT allows for the precise assessment of bone metabolism in the spine. After the procedure, a negative correlation was observed between bone metabolism changes and pain intensity test results.

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Section: Discussionmentioning

confidence: 99%

Radioisotopic assessment of bone metabolism of the operated vertebra after inter-process stabilizer implantation in the lumbar segment of the spine

Radek¹,

Radek²,

Rysz³

et al. 2017

aoms

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“…Vertiflex has been demonstrated in clinical IDE studies to treat lumbar spinal stenosis (LSS) dynamically above L5–S1 to distract the foramen and limit extension, acting as an interspinous spacer ( 2 ). Dynamic extension block interspinous devices like Vertiflex and others such as X-Stop Interspinous Process Decompression System (Medtronic, Minneapolis, MN, USA) ( 3 ) and Coflex Interlaminar Stabilization device (Xtant Medical, Belgrade, MT, USA) ( 4 ), are not fixated to the spinous processes and therefore often fail by dislodgement, spinous process erosion, and fractures or loosening leading to continued symptoms ( 5 - 7 ). Interspinous fixation devices (IFD) emerged to provide greater fixation and are placed between the spinous processes as well as the lamina with teeth that bite into the spinous processes while there is a central hub to maintain distraction during extension such as the InSpan (InSpan LLC, Malden, MA, USA) ( 1 , 8 ) and Aspen (ZimVie, Westminster, CO, USA) ( 9 , 10 ).…”

Section: Introductionmentioning

confidence: 99%

Prospective 5-year follow-up of L5–S1 versus L4–5 midline decompression and interspinous-interlaminar fixation as a stand-alone treatment for spinal stenosis compared with laminectomies

Chin,

Seale,

Spayde

et al. 2023

J Spine Surg

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Background Spinal stenosis treatment includes laminectomies with or without fusion or with interspinous distraction with or without fixation. Lack of published data on interspinous fixation devices (IFD) at L5–S1 is less considered as an option due to the smaller anatomical S1 spinous process and the higher stresses from the immobile sacrum. Our objective was to evaluate the outcomes of an IFD used as a stand-alone treatment for spinal stenosis at L5–S1 and L4–5 compared to historical data on open laminectomies. Methods Prospective comparative cohort study (Level 2) looking at collected preoperatively and postoperatively Visual Analog Scores (VAS) and Oswestry Disability Index (ODI) data, complications, and revision rates on 100 consecutive patients with spinal stenosis treated with midline decompression and InSpan (InSpan LLC, Malden, MA, USA) IFD, at L5–S1 and L4–5, up to five-year follow-up. All patients were treated by a single surgeon in an academic private practice. Historical published outcome data for open laminectomies were compared. Results Among the 100 patients, 45 underwent surgery at L5–S1 with a mean VAS pain score that decreased by 75% and ODI improved by 63% (P<0.001). Fifty-five patients had surgery at L4–5 with mean VAS and ODI scores improved by 80% and 66% (P<0.001) respectively. Preoperative and postoperative ODI and preoperative VAS scores were similar at L5–S1 and L4–5, however, postoperative VAS scores were significantly less for L4–5 versus L5–S1 (P<0.01). All surgeries were completed in less than one hour. There was a total of one L4–5 revision (1.8%) and two L5–S1 revisions (4.4%). Comparable laminectomy data showed decrease in VAS and ODI scores by 51% and 62% (P<0.05). The reoperation rate for laminectomies at five to ten years varied up to 24%. Conclusions Spinal stenosis patients treated with midline decompression and InSpan IFD, used as a stand-alone treatment for interspinous-interlaminar fixation, at L4–5 and L5–S1, showed improved outcome scores and low complication and revision rates at five years and were comparable to historical open laminectomy data. InSpan is a successful substitute for laminectomies in selected patients and was performed in less than 60 minutes. We recommend choosing the appropriately sized implant to achieve adequate distraction decompression to avoid recurrent symptoms.

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Comparison of the Pull‐Out Strength between a Novel Micro‐Dynamic Pedicle Screw and a Traditional Pedicle Screw in Lumbar Spine

Qian

Chen

et al. 2020

Orthopaedic Surgery

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Objective This study aimed to investigate the strength of a novel micro‐dynamic pedicle screw by comparing it to the traditional pedicle screw. Methods Forty‐five lumbar vertebrae received a traditional pedicle screw on one side and a micro‐dynamic pedicle screw on the other side as follows (traditional group vs micro‐dynamic group): 15 vertebrae underwent instant pull‐out testing; 15 vertebrae underwent 5000‐cyclic fatigue loading testing; and 15 vertebrae underwent 10,000‐cyclic fatigue loading testing and micro‐computed tomography (micro‐CT) scanning. The peek pull‐out force and normalized peek pull‐out force after instant pull‐out testing, 5000‐cyclic and 10,000‐cyclic fatigue loading testing were recorded to estimate the resistance of two types of screws. Bone mineral density was recorded to investigate the strength of the different screws in osteoporotic patients. And the semidiameter of the screw insertion area on micro‐CT images after fatigue were compared to describe the performance between screw and bone surface. Results The bone mineral density showed a weak correlation with peek pull‐out force (r = 0.252, P = 0.024). The peek pull‐out force of traditional pedicle screw after 10,000‐cyclic fatigue loading were smaller than that of instant pull‐out test in both osteoporotic (P = 0.017) and healthy group (P = 0.029), the peek pull‐out force of micro‐dynamic pedicle screw after 10,000‐cyclic fatigue loading was smaller than that in instant pull‐out test in osteoporotic group (P = 0.033), but no significant difference in healthy group (P = 0.853). The peek pull‐out force in traditional group and micro‐dynamic group underwent instant pull‐out testing (P = 0.485), and pull‐out testing after 5000‐cyclic fatigue loading testing (P = 0.184) did not show significant difference. However, the peek pull‐out force in micro‐dynamic group underwent pull‐test after 10,000‐cyclic fatigue loading testing was significantly greater than that measured in traditional group (P = 0.005). The normalized peek pull‐out force of traditional groups underwent instant pull‐out testing, pull‐out test after 5000‐cyclic and 10,000‐cyclic fatigue loading testing significantly decreased as the number of cycles increased (P < 0.001); meanwhile, the normalized peek pull‐out force of micro‐dynamic groups remained consistent regardless of the number of cycles (P = 0.133). The semidiameter after the fatigue loading test of the traditional screw insertion area was significantly larger than that of the micro‐dynamic screw insertion area (P = 0.013). Conclusion The novel micro‐dynamic pedicle screw provides stronger fixation stability in high‐cyclic fatigue loading and non‐osteoporotic patients versus the traditional pedicle screw, but similar resistance in low‐cycle fatigue testing and osteoporotic group vs the traditional pedicle screw.

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X-STOP Surgical Implant for the Treatment of Lumbar Spinal Stenosis

Cited by 4 publications

References 12 publications

Radioisotopic assessment of bone metabolism of the operated vertebra after inter-process stabilizer implantation in the lumbar segment of the spine

Radioisotopic assessment of bone metabolism of the operated vertebra after inter-process stabilizer implantation in the lumbar segment of the spine

Prospective 5-year follow-up of L5–S1 versus L4–5 midline decompression and interspinous-interlaminar fixation as a stand-alone treatment for spinal stenosis compared with laminectomies

Comparison of the Pull‐Out Strength between a Novel Micro‐Dynamic Pedicle Screw and a Traditional Pedicle Screw in Lumbar Spine

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