Cyclic Loads Do Not Compromise Functionality of the Interspinous Spacer or Cause Damage to the Spinal Segment: An In Vitro Analysis

Goyal, Amanesh; Goel, Vijay K.; Mehta, Ankit I.; Dick, David; Chinthakunta, Suresh; Ferrara, Lisa

doi:10.1615/jlongtermeffmedimplants.v18.i4.30

Cited by 11 publications

(7 citation statements)

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“…In the largest study in interspinous spacer use in patients with low-grade slip, patients treated with interspinous spacer (n = 42) had a similar reintervention rate (12%) as subjects treated nonoperatively (n = 33) 33. Implantation of an interspinous spacer prevents motion at the implanted level41 and results in no progression of spondylolisthesis over time 33. Most studies of interspinous spacers allow enrolment of patients with grade I slip, and no compelling evidence exists to exclude these patients from treatment consideration 23,34…”

Section: Discussionmentioning

confidence: 97%

Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer

Shabat¹,

Miller²,

Block³

et al. 2011

CIA

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PurposeTo assess the safety and effectiveness of a novel, minimally invasive interspinous spacer in patients with moderate lumbar spinal stenosis (LSS).MethodsA total of 53 patients (mean age, 70 ± 11 years; 45% female) with intermittent neurogenic claudication secondary to moderate LSS, confirmed on imaging studies, were treated with the Superion® Interspinous Spacer (VertiFlex, Inc, San Clemente, CA) and returned for follow-up visits at 6 weeks, 1 year, and 2 years. Study endpoints included axial and extremity pain severity with an 11-point numeric scale, Zurich Claudication Questionnaire (ZCQ), back function with the Oswestry Disability Index (ODI), health-related quality of life with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-12, and adverse events.ResultsAxial and extremity pain each decreased 54% (both P < 0.001) over the 2-year follow-up period. ZCQ symptom severity scores improved 43% (P < 0.001) and ZCQ physical function improved 44% (P < 0.001) from pre-treatment to 2 years post-treatment. A statistically significant 50% improvement (P < 0.001) also was noted in back function. PCS and MCS each improved 40% (both P < 0.001) from pre-treatment to 2 years. Clinical success rates at 2 years were 83%–89% for ZCQ subscores, 75% for ODI, 78% for PCS, and 80% for MCS. No device infection, implant breakage, migration, or pull-out was observed, although two (3.8%) patients underwent explant with subsequent laminectomy.ConclusionModerate LSS can be effectively treated with a minimally invasive interspinous spacer. This device is appropriate for select patients who have failed nonoperative treatment measures for LSS and meet strict anatomical criteria.

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Section: Discussionmentioning

confidence: 97%

Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer

Shabat¹,

Miller²,

Block³

et al. 2011

CIA

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“…A finite element model of a lumbar spine that underwent laminectomy revealed that removal of the posterior elements resulted in increased flexion-extension and axial rotation at the surgical site and the authors concluded that minimization of bone and ligament removal, such as with the Superion procedure, results in greater lumbar stability [34] and potentially lowers risk for fusion surgery. In fact, a cadaver study demonstrated that implantation of the Superion device prevents supraphysiological motion at the symptomatic level and has no adverse impact on the local anatomy [35]. …”

Section: Discussionmentioning

confidence: 99%

Minimally Invasive Treatment of Moderate Lumbar Spinal Stenosis with the Superion® Interspinous Spacer

Bini¹,

Miller²,

Block³

2011

TOORTHJ

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Purpose:We evaluated the safety and effectiveness of the minimally invasive Superion® Interspinous Spacer (VertiFlex, Inc., San Clemente, CA) in patients with moderate LSS.Methods:This single-arm prospective study enrolled 121 patients with moderate LSS between February 2008 and August 2009 and were followed up at 1 (n=111), 3 (n=96), 6 (n=81), and 12 (n=52) months. All patients were treated with the Superion Interspinous Spacer. Main outcomes were back function with the Oswestry Disability Index (ODI), extremity and axial pain severity with an 11-point scale, health-related quality of life with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36, and adverse events through 12 months.Results:ODI improved 64% (p<0.001) through 12 months and clinical success was 92%. Extremity and axial pain improved 53% and 49% (both p<0.001), respectively, through 12 months with clinical success of 76% for axial pain and 86% for extremity pain. Health-related quality of life improved 41% for PCS and 22% for MCS (both p<0.001) through 12 months. PCS clinical success was 81% and MCS clinical success was 62% at 12 months. Four (5.9%) explants were performed although 3 were unrelated to the device. Eight procedure-related adverse events, observed in 6 (5.0%) patients, included superficial incision seroma (n=5), minor wound pain (n=2), and infection (n=1).Conclusions:Preliminary results with the Superion Interspinous Spacer suggest that it is an effective and safe treatment option for patients with moderate LSS who are unresponsive to conservative care.

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“…Spacers placed between the lumbar spinous processes have become relatively common minimally invasive surgical treatment alternatives for a variety of spinal pathologies. 6,8,11,14,21,30 They provide an unloading distractive force to the stenotic motion segment and have the potential to relieve symptoms of degenerative disc disease among patients who experience relief in spine flexion. 2,37,41,48 Over the past several years, interspinous process spacers have provided alternatives to arthrodesis in older patients with degenerative lumbar disease.…”

Section: Neurosurg Focus 39 (4):e14 2015mentioning

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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Cyclic Loads Do Not Compromise Functionality of the Interspinous Spacer or Cause Damage to the Spinal Segment: An In Vitro Analysis

Abstract: Interspinous spacer effectively prevents the motion at the implanted level and does not change the anatomy significantly.

Cited by 11 publications

References 0 publications

Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer

Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer

Minimally Invasive Treatment of Moderate Lumbar Spinal Stenosis with the Superion® Interspinous Spacer

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

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