Carl Lauryssen1, Robert J Jackson2, Jeffrey M Baron3, Richard A Tallarico4, William F Lavelle4, Harel Deutsch5, Jon E Block6, Fred H Geisler7. 1. a Neurosurgical Spine Institute , Lakeway , TX 78738 , USA. 2. b Orange County Neurosurgical Associates , Laguna Hills , CA 92653 , USA. 3. c Tucson Orthopaedic Institute , Tucson , AZ 85712 , USA. 4. d Upstate Bone and Joint Center , East Syracuse , NY 13057 , USA. 5. e Rush University Medical Center , Chicago , IL 60612 , USA. 6. f Independent Scholar , San Francisco , CA 94115 , USA. 7. g Chicago Back Institute , Chicago , IL 60625 , USA.
Abstract
OBJECTIVE: To compare the two-year clinical outcomes of a prospective, randomized controlled trial of an FDA-approved interspinous spacer with the compilation of published findings from 19 studies of decompressive laminectomy for the treatment of lumbar spinal stenosis. METHODS:Back and leg pain, Oswestry disability index (ODI), and Zurich Claudication Questionnaire (ZCQ) values were compared between spacer- and laminectomy-treated patients preoperatively and at 12 and 24 months. RESULTS: Percentage improvements between baseline and 24 months uniformly favored patients treated with the spacer for back pain (65% vs. 52%), leg pain (70% vs. 62%), ODI (51% vs. 47%) and ZCQ symptom severity (37% vs. 29%) and physical function (36% vs. 32%). CONCLUSION: Both treatments provide effective and durable symptom relief of claudicant symptoms. This stand-alone interspinous spacer offers the patient a minimally invasive option with less surgical risk.
RCT Entities:
OBJECTIVE: To compare the two-year clinical outcomes of a prospective, randomized controlled trial of an FDA-approved interspinous spacer with the compilation of published findings from 19 studies of decompressive laminectomy for the treatment of lumbar spinal stenosis. METHODS: Back and leg pain, Oswestry disability index (ODI), and Zurich Claudication Questionnaire (ZCQ) values were compared between spacer- and laminectomy-treated patients preoperatively and at 12 and 24 months. RESULTS: Percentage improvements between baseline and 24 months uniformly favored patients treated with the spacer for back pain (65% vs. 52%), leg pain (70% vs. 62%), ODI (51% vs. 47%) and ZCQ symptom severity (37% vs. 29%) and physical function (36% vs. 32%). CONCLUSION: Both treatments provide effective and durable symptom relief of claudicant symptoms. This stand-alone interspinous spacer offers the patient a minimally invasive option with less surgical risk.
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