Interlaminar Decompression For Lumbar Stenosis: When is Less More? Kris Radcliff, MD Associate Professor Department of Orthopedic Surgery Associate Professor of Neurosurgery and Hospitals The Rothman Institute Philadelphia, PA
Disclosures 4 Web Medical: Unpaid consultant ACSR: Board or committee member Altus Spine: Paid consultant DePuy, A Johnson & Johnson Company: Paid consultant; Research support; Unpaid consultant Globus Medical: IP royalties; Paid consultant; Research support LDR: Unpaid consultant Medtronic: Paid consultant; Research support NEXXT Spine: Other financial or material support Nuvasive: Other financial or material support Orthofix, Inc.: Paid consultant Orthopedic Sciences, Inc: IP royalties; Paid consultant Pacira pharmaceuticals: Research support Paradigm Spine: Research support Stryker: Other financial or material support
When is it too much? First do no harm
Pawar Neurological Research 2017
Outline Favorable Data
3 Year IDE Data IDE study, 36 Month Data 21 sites, Coflex vs Fusion Both groups improved N=322, 90% followup 3 years K-M Analysis Device survival: 86% ILS vs 88% Fusion Reoperation and epidurals: 76% vs 79% Fusion Bae Neurosurgery 2016
3 Year IDE Data Among event free patients, 89.6% of ILS and 75.7% of fusion patients experienced at least 15 point improvement in ODI Of the spondy patients, 59.3% ILS vs 59.5% fusion met success criteria Recommend: 96% vs 84% Satisfied: 95% vs 86% Bae Neurosurgery 2016
3 Year IDE Data 13% vs 12% Reop Rate 8% ASD in Fusion Cohort Bae Neurosurgery 2016
Degenerative Spondylolisthesis Subanalysis of Coflex IDE data 99 Degenerative Spondy Coflex vs 51 Fusion Outcomes mostly equivalent 14% reop rate in Coflex vs 5.9% in fusion control Davis JNS Spine 2013
5 Year IDE Data Musacchio IJSS 2016 PRCT, n=322, No Significant Difference in Success Criteria (50% ILS vs 44% Fusion) Reoperation Rate 16% ILS vs 18% Fusion 5 Years: 68% ILS vs 66% Fusion patients free of secondary surgery or epidural
Coflex for Stenosis SWISSSPINE Registry N=50 matched pairs with stenosis and LBP Coflex vs Laminectomy Superior outcome in Coflex group
Non IDE Data N=67, consecutive, unconflicted Pawar Neurological Research 2017
IDE Cost Study Data from Coflex IDE used in base case analysis Coflex Higher Utility and Lower Cost
Outline Favorable Data Unfavorable Data
Coflex IDE Data IDE Data
Coflex IDE Data Through 24 months of follow up, the overall reoperation rate was 10.7% in the coflex@ group and 7.5% in the fusion control. Based on available patient data through 48 months, the coflex revision rate is 15.8% and the fusion control revision rate is 15.9%.
Non-IDE Data PRCT, double blind, 1 year followup, n=159, Netherlands No difference in VAS, ZCQ, RMDQ 29% reoperation rate vs 8% laminectomy Moojen BMJ 2013
Non-IDE Cost Data PRCT, double blind, spinal stenosis van den Akker-van Marle, TSJ 2016 Nonsignificant lower QALY Coflex Nonsignificant higher costs Coflex Not cost effective
Coflex Pros Lower Morbidity Less EBL OR Time LOS Easy Revision Strategy Cons Osteoporosis More Narrow Decompression? L5S1 Limited Data Multilevel Strategy Potential for Disease Progression? Higher Reoperation Rate? Cost Effectiveness
Conclusion Longer Followup Needed Does One Technique Fit All Which Patients Are Best Suited to Which Techniques
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