TY - JOUR
T1 - Minimally invasive treatment of lumbar spinal stenosis with a novel interspinous spacer
AU - Shabat, Shay
AU - Miller, Larry E.
AU - Block, Jon E.
AU - Gepstein, Reuven
PY - 2011
Y1 - 2011
N2 - Purpose: To assess the safety and effectiveness of a novel, minimally invasive interspinous spacer in patients with moderate lumbar spinal stenosis (LSS). Methods: A 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. Results: Axial 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. Conclusion: Moderate 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.
AB - Purpose: To assess the safety and effectiveness of a novel, minimally invasive interspinous spacer in patients with moderate lumbar spinal stenosis (LSS). Methods: A 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. Results: Axial 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. Conclusion: Moderate 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.
KW - Axial pain
KW - Extremity pain
KW - Superion
UR - http://www.scopus.com/inward/record.url?scp=80755143272&partnerID=8YFLogxK
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AN - SCOPUS:80755143272
SN - 1176-9092
VL - 6
SP - 227
EP - 233
JO - Clinical Interventions in Aging
JF - Clinical Interventions in Aging
IS - 1
ER -