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

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

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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 worlds first spinous process plating system

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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
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I nno va tive De vic e F e a ture s

L ar ge Bone Gr aft Windows Anatomic al Suppor t to Spinous Pr

  • c e sse s

T hr e ade d Body Bilate r al L

  • c king

Plate s (F ixe d Plate & Wings) Auto-L

  • c k

T e c hnology

Hig h Vo lume Bo ne Gra ft De live ry

Implant size Aspe n Window Ope ning Minute man G3 Window Ope ning Minute man G3 Bone Gr aft Volume 8mm 27mm² 89mm² 1.2c c 10mm 40mm² 89mm² 1.45c c 12mm 54mm² 105mm² 1.8c c 14mm 70mm² 109mm² 2.0c c 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

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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
  • 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

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L

  • 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
  • 7 mo nths po st-o p
  • 63 ye a r o ld ma le
  • 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

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 no statistic al diffe r e nc e in biome c hanic al stability c o mpa re d to b ila te ra l pe d ic le 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 .

Bio me c ha nic a l Study

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Clinic a l T ria l in the UK

 A pro spe c tive ra nd o mize d tria l o n the e ffic a c y a nd

q ua lity o f life fo llo wing tre a tme nt o f lumb a r spina l ste no sis o r d e g e ne ra tive d isc d ise a se with the Minute ma n impla nt ve rse s surg ic a l d e c o mpre ssio n.

Inte r im Re por t sc ope

  • T

hre e surg ic a l site s in U.K .

  • 32 o f 50 pa tie nts e nro lle d
  • 5yr mo nito ring o b je c tive s:
  • VAS L

e g & Ba c k pa in sc o re s

  • Oswe stry Disa b ility I

nde x

  • Zuric h Cla udic a tio n

Que stio nna ire

  • Physic a l func tio n
  • PGI

C/ CGI C

  • de vic e a dve rse e ve nts
  • E

mplo yme nt sta tus c ha ng e s 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 ha d re a so na b le e xpe rie nc e with inte r-spino us d istra c tio n d e vic e s. T his <d e vic e > ha s b e e n ve ry 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 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.

Minute man re sults c ompare d to De c ompre ssion:

  • Sho rte r surg ic a l pro c e d ure time
  • Minima l po st-surg ic a l pa in
  • Ne g lig ib le b lo o d lo ss
  • Sho rte r ho spita l sta ys (re a d y to d isc ha rg e in

fe w ho urs)

  • E

ffe c tive le g pa in re d uc tio n (a s g o o d o r b e tte r in the inte rim pe rio d tha n the g o ld sta nd a rd d e c o mpre ssio n) with minima l surg ic a l pa in

  • 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

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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

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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

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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

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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

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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

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Sizing I mpla nt Using F luo ro sc o py L

  • 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

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F ina l I ma g e s F ina l I ma g e s

  • 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

  • ac h – Minima l tissue disruptio n, b lo o d lo ss o r re c o ve ry time
  • Imme diate , R

igid Stabilization – No sta tistic a l d iffe re nc e b e twe e n 4 pe d ic le 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

  • …

A Clinic a lly Pro ve n So lutio n fo r Po ste rio r Co lumn Sta b iliza tio n & F usio n

Summa ry: Clinic a l Be ne fits

Spac e r

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T hank you! Que stions?

MINUT E MAN IMPL ANT : 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
  • ss
  • Ra dia tio n E

xpo sure

  • Re po sitio n the pa tie nt
  • Infe c tio ns
  • Surg ic a l Co mplic a tio ns
  • Pa in