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((R)) 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 Keywords : adverse effects,Aged,Aged,80 and over,Back,diagnosis,Female,Follow-Up Studies,Humans,Infection,instrumentation,Laminectomy,Low Back Pain,Lumbar Vertebrae,Male,methods,Middle Aged,Minimally Invasive Surgical Procedures,Pain,Pain Measurement,Patients,Postoperative Complications,Prospective Studies,Prostheses and Implants,Quality of Life,Safety,secondary,Spinal Fusion,Spinal Stenosis,surgery,, Invasive,Treatment,Lumbar,Spinal, knee pain injections
Date of Publication : 2011
Authors : Shabat S;Miller LE;Block JE;Gepstein R;
Organisation : Spinal Care Unit, Sapir Medical Center, Kfar Saba, Israel
Journal of Publication : Clin Interv Aging
Pubmed Link : https://www.ncbi.nlm.nih.gov/pubmed/21966217
The London Spine Unit : Harley Street UK. Specialists in Cutting Edge Technologies for Spinal Surgery
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