5/19/2017 I nte rspino us Pro c e ss F ixa tio n with the Minute - PDF document

5/19/2017 I nte rspino us Pro c e ss F ixa tio n with the Minute ma n G3 L L OYDI NE J. JACOBS, MD CAST E L L VI SPI NE ME E T I NG MAY 13, 2017 Wha t is the Minute ma n G3 The world’s first spinous process plating system that is:  Minimally Invasive  minimal soft tissue dissection and disruption  Done through a lateral approach  guide wire and fluoroscopic guidance Minimal blood loss   About 5cc per level Achieves rigid fixation  Achieves fusion  Ho w Do e s it Wo rk? Actually achieves rigid fixation and FUSION through: • Bo ne pre pa ra tio n fo r fusio n via de c o rtic a tio n • Bo ne is ta ppe d so tha t thre a ds o f the sc re w fully e ng a g e b o ne • T hre a ds a re Hydro xya pa tite (HA) c o a te d • Hig h vo lume o f b o ne g ra ft de live ry • Rig id fixa tio n re spe c tful o f b o ne q ua lity 1

5/19/2017 I nno va tive De vic e F e a ture s Bilate r al L oc king Plate s Anatomic al (F ixe d Plate & Suppor t to Wings) Spinous Auto-L oc k Pr oc e sse s T e c hnology L ar ge Bone Gr aft T hr e ade d Body Windows Hig h Vo lume Bo ne Gra ft De live ry Aspe n Window Minute man G3 Minute man G3 Implant size Ope ning Window Ope ning Bone Gr aft Volume 8mm 27mm² 89mm² 1.2c c 40mm² 89mm² 1.45c c 10mm 12mm 54mm² 105mm² 1.8c c 70mm² 109mm² 2.0c c 14mm 16mm 87mm² 115mm² 2.5c c Ante r ior Cage s Bone Gr aft Volume Str yke r T L IF Cage 0.34c c – 1.00c c Biome t T L IF Cage 0.55c c – 1.87c c Sa fe Appro a c h • Appro a c h is po ste rio r to the fa c e t jo ints • Virtua lly no risk o f da ma g ing ne uro va sc ula r struc ture s, do e s no t re q uire ne uro mo nito ring • No irre ve rsib le da ma g e to pe dic le s o r fa c e t jo ints • No ne e d to re mo ve b o ne o r strip a ny musc le 2

5/19/2017 Pre se rve s Ana to mic a l Suppo rt Struc ture s • I nta c t Supra spino us L ig a me nt ma inta ins po ste rio r sta b iliza tio n Mo st I SP de vic e s re q uire c o mple te re mo va l o r se c tio ning o f the Supra spino us L ig a me nt • Minima l re mo va l o f the I nte rspino us L ig a me nt • “ Size d to fit” b o ne ta p lig htly de c o rtic a te s, fo r b le e ding b o ne a t the g ra ft lo c a tio n I nd ic a tio ns fo r use : De ge ne r ative Disc Dise ase • Inc lud ing the fo llo wing po te ntia l c o nd itio ns re sulting fro m DDD • L umb a r spina l ste no sis with ne uro g e nic c la ud ic a tio n • Syno via l c ysts • Re c urre nt d isc he rnia tio n • F o ra mina l Ste no sis Spondylolisthe sis T rauma T umor Ca n b e Use d with XL I F fo r Po ste rio r Sta b iliza tio n  T he Minute ma n d e vic e s c a n b e use d a s po ste rio r a d junc ts to XL IF pro c e dure s b y using the sa me inc isio n witho ut ha ving to c ha ng e the pa tie nt po sitio n fro m the la te ra l po sitio n  Ho spita ls ha ve the a b ility to c o de fo r a full 360° fusio n a nd inc re a se re imb urse me nt 3

5/19/2017 L o ng T e rm Re sults  800+ c a se s wo rld wid e  No impla nt fa ilure s o r re po rta b le e ve nts  No re po rte d spino us pro c e ss fra c ture s during surg e ry • • 90 ye a r o ld fe ma le 63 ye a r o ld ma le • • 7 mo nths po st-o p 2.5 mo nths po st-o p Bio me c ha nic a l Study Minute ma n d e vic e ve rsus pe d ic le o r fa c e t sc re ws, with la te ra l c a g e s. Mo tio n pla ne s me a sure d we re : • F le xio n-E xte nsio n • L a te ra l Be nd ing • Axia l Ro ta tio n MM MM Bio me c ha nic a l Study T he Minute ma n d e vic e , whe n use d in c o njunc tio n with a la te ra l c a g e , pro vid e s e nc e in biome c hanic al stability c o mpa re d to b ila te ra l pe d ic le no statistic al diffe r sc re ws (plus la te ra l c a g e ). T he fo ra mina l d istra c tio n a nd mo tio n te st re sults ind ic a te the Minute ma n G3 ac hie ve s and maintains distr ac tion of the for aminal spac e . 4

5/19/2017 Clinic a l T ria l in the UK Pr inc ipal Inve stigator ’s asse ssme nt to date : “We ha ve fo und this ne w a nd inno va tive <Minute ma n> d e vic e ve ry pro mising . We ha ve  A pro spe c tive ra nd o mize d tria l o n the e ffic a c y a nd ha d re a so na b le e xpe rie nc e with inte r-spino us q ua lity o f life fo llo wing tre a tme nt o f lumb a r spina l d istra c tio n d e vic e s. T his <d e vic e > ha s b e e n ve ry ste no sis o r d e g e ne ra tive d isc d ise a se with the d iffe re nt d ue to its a b ility o f fo rming a fusio n. So fa r we ha ve n’ t ha d a ny d e vic e ta ke n o ut fo r Minute ma n impla nt ve rse s surg ic a l d e c o mpre ssio n. the re a so n o f re c urre nt ste no sis, unlike o ur pa st e xpe rie nc e with o the r d e vic e s. Inte r im Re por t sc ope • T hre e surg ic a l site s in U.K . Minute man re sults c ompare d to • 32 o f 50 pa tie nts e nro lle d De c ompre ssion: • • Sho rte r surg ic a l pro c e d ure time 5yr mo nito ring o b je c tive s: • Minima l po st-surg ic a l pa in • VAS L e g & Ba c k pa in sc o re s • Ne g lig ib le b lo o d lo ss • Oswe stry Disa b ility I nde x • Sho rte r ho spita l sta ys (re a d y to d isc ha rg e in • Zuric h Cla udic a tio n fe w ho urs) Que stio nna ire • E ffe c tive le g pa in re d uc tio n (a s g o o d o r • Physic a l func tio n b e tte r in the inte rim pe rio d tha n the g o ld • PGI C/ CGI C sta nd a rd d e c o mpre ssio n) with minima l • de vic e a dve rse e ve nts surg ic a l pa in • E mplo yme nt sta tus c ha ng e s • E ffe c tive o n ste no sis” Pa tie nt # 1  AR, 90 y/ o F with se ve re rig ht le g pa in  Co mple te ly inde pe nde nt, live s a lo ne  Be d rid d e n fo r o ve r 1 we e k, c a n no lo ng e r a mb ula te  Diffic ult to g e t a n e xa m b e c a use o f e xc ruc ia ting pa in Pre o pe ra tive I ma g e s 5

5/19/2017 Pre o pe ra tive I ma g e s: T 12-L 1 Pre o pe ra tive I ma g e s: L 1-2 Pre o pe ra tive I ma g e s: L 2-3 6

5/19/2017 Pre o pe ra tive I ma g e s: L 3-4 Pre o pe ra tive I ma g e s: L 4-5 Sta g e 1: L 1-2, L 2-3 De c o mpre ssio n a nd F usio n 7

5/19/2017 Sta g e 2: T 12-L 1, L 3-4, L 4-5 De c o mpre ssio n a nd F usio n Sta g e 2: T 12-L 1, L 3-4, L 4-5 De c o mpre ssio n a nd F usio n- POD 0 Pa tie nt # 2  L D, 83 y/ o F  Histo ry o f L 4-5 inte rb o dy c a g e s pla c e d fo r spo ndylo listhe sis in 2010  L e g pa in did no t re so lve a fte r surg e ry  Pre se nte d to me with spina l ste no sis with ne uro g e nic c la udic a tio n  Ca nno t wa lk mo re tha n a fe w ya rds witho ut we a kne ss a nd pa in 8

5/19/2017 Pre o pe ra tive I ma g e s Pre o pe ra tive I ma g e s: L 3-4 Pre o pe ra tive I ma g e s: L 4-5 9

5/19/2017 Ma rk L e ve ls On Skin AP a nd L a te ra l Pla ne s Guid e wire Pla c e me nt in AP a nd L a te ra l Pla ne s I ntra o p Vid e o 10

5/19/2017 Sizing I mpla nt Using F luo ro sc o py L o a d I mpla nt, Pla c e Allo g ra ft, I nse rt I mpla nt De plo y Wing s a nd Co mpre ss Pla te s 11

5/19/2017 F ina l I ma g e s F ina l I ma g e s Summa ry: Clinic a l Be ne fits • Indir e c t De c ompr e ssion – inc re a se s spa c e in the c a na l a nd fo ra mina b ila te ra lly • L ate r al MIS Appr oac h – Minima l tissue disruptio n, b lo o d lo ss o r re c o ve ry time • igid Stabilization – No sta tistic a l d iffe re nc e b e twe e n 4 pe d ic le Imme diate , R sc re ws & 2 ro d s • F ull F usion Site Pr e par ation – T he mo st b o ne g ra ft vo lume a nd the b e st fusio n te c hniq ue with ta pping , d e c o rtic a tio n a nd lo c king pla te te c hno lo g y All L e ading T o… A Clinic a lly Pro ve n So lutio n fo r Po ste rio r Co lumn Spac e r Sta b iliza tio n & F usio n 12

5/19/2017 MINUT E MAN IMPL ANT : T hank you! INCR E ASE S • Pa tie nt Sa tisfa c tio n • Surg e o n E ffic ie nc y • Surg e o n Re imb urse me nt • Pro c e dura l Pro fita b ility DE CR E ASE S • OR T ime • Ho spita l Sta y • Blo o d L o ss • Ra dia tio n E xpo sure • Re po sitio n the pa tie nt Que stions? • Infe c tio ns • Surg ic a l Co mplic a tio ns • Pa in 13