GLOBUS MEDICAL, INC.
`EXHIBIT 1016
`IPR2015-to be assigned
`(Globus v. Bonutti)
`Page 1 of 8
`
`

`
`‘£3. Chet},
`
`Hs1;,H.E\¥‘8hih.ctaE
`
`31
`
`sitting Ofihfi ‘tmsi; {4} tmizifligtmxaittt 0fhes':3t axis; (5?)
`C-f taiecatcansai magic: {6} miiapse of miéfoat arch with
`resuiting ftatfijotfl. AM at thesis mabéems are caused by
`
`superior and Eztterai traattstzttiam tn? the tttiotsmsity ffiigfllfifli
`akmg the: ssttaar fracture tine, causing a dacraaae of c:2:E<:a~
`ma! height with tater:/at :3xtrt:stiot24-7”-33.
`'t3’ath:re K3 ctmect
`this diagataxcentent in the treatment of :5 ttzticamat fracture
`creams inabtitty to tséstabiish the twrgttai sttustttm cf the
`
`in an abntsrmat relatitrmghip (if the
`catcaneus, amt Y€8tH'ES
`catcamaus, with the ankle am? feat.
`
`in situ sstttrtaiat jnkttt fttszéazt may €ff€{:~
`C0t3'v<=.=;2t§€;t'::-at
`timely twat the subtettatr zttttttitis, but 363%: the 01122;: pmb~
`
`
`Ef catczmeat height, width and etiégtv
`lems tsntaacheaw
`meat ctmétf at}? his 3?‘§21§UIi’t§€_‘2§,Hy <3é)Z“1”ECi€Efi during 3 subtziiztt
`fusion, at bettar functicsttat rtastttt ceuki he expected. This
`is 0f the same bmmechatticai ptincipies as perfomting an
`ettthtodesis in the rt;2:_1}0rj<3irtts {sf 30%»/er extremity. Cat’: et
`al. haw: described 23. new mstttoé of subtaiat: ééstraction bone:
`
`black fugton ta regtorsz mat caicaneaaé might anti himtfaot
`alignment? Using the xwray fiinzs anti CT seat}, the au«
`tlmts det:idc:ct
`that ht-tigttt fut" e‘I%s%mt::t§:)t;
`its p&E?Rtfi’Ii§i‘kg 3
`subtzfiar arthrodcaisl. Th¢3t1‘m6ttt0d was modified htzra by
`changing the location sf iftCi?;i£)t’t
`if} minimize soft tissue
`disscatrtémt, and vveaigirzg the: %2<:ttt:>. bhjzgk to correct the va-
`rus,/vaigm: maiatigttmtznt of the hinzife-3t Em :;tSS(}Ciati()fi with
`correction of the heel height. This; rapstt is a zetrespsctive
`study afa series of matttttétm of caicatteat fractures treated
`by at ntodifim mzszthed of distractitm stibtaéar fusimt witti
`
`iaterai cortex decsmptession osteotomy described by Cart.
`
`rating syatem, pitta radiography, was
`A céitticai €tSS€SS}T1€i‘tE
`used to rietetminie ma etffecttvettsss (3? this tttettmd.
`
`MAYEIRIAE,
`
`From May E988 t0 W92, thcrc were 34 patients at
`Chang (jurtg Memmrial Haspitaf who re-cat:/ad distraction
`subtetiztr fusion and Eztterzfl dewmpressivrz osteetmny. A3}
`received f0Ii0w~up untii solid subtaiar fttsicyn was sbtainsti,
`thuugh oniy 32 0f the 34 patients were ztvafiztbie far thia
`examénarian. There were 25 mats patients and 7 female
`patiettts whaxe average age was 36 yesars; OM (fmm 21 to
`65).
`'B’wenty~tw0 of them hat} received rte treatment be-
`
`had citxsed axizfl r<:dm;:tie)n with c2«t~;t; The avarztge titm:
`from injury :0 this operation was 16 msimths {from 6; to 34
`mtmths}. AH ‘paEi6£’§ES had failed such notteperattve man-
`agement as nonstersjitietl antiinilamtttztturies, physical
`thsrapy, amt shoe madiftcatian. AH patisxnts had a pairtfui
`subtaiar jflitit, vams and widening beet with t:3E.caneus;~
`fibtsta abutment. The asszeeiateti abnartnatities inciuded
`
`platttar 90515;; pmttttdimg éefatirtity in eight, postetictr tar-
`sai tunnel syndmme in three, stiffrzese of the first
`
`rnetatamphalangeal joint caused by bony entrapement on
`the fiexm hathzx kmgua in am:
`Pm-Qpczrative radiogtaphic evaiuation inclttdted x—ray
`by tatetat and axizti views, and C-1” SC8;§’:. The taterai View
`Of Caicemeus tiematmtrated the congméty Laf sxmbtalat‘ jnini,
`caicatteat height, Eatetat talocaicaaeai angle, tibiotaiar abut-
`ment and talcmavictztar sttbtuxatiottg aztiat View showed the
`
`maialignmestt and widening cf the heel. “Pits CT i's‘Lf'<¥Il in
`corona! pizme couéé reveal the detail of patheanatamy of
`catcanea! maturtion. Basted on these findings, accurate
`
`height far distraction if} the subtatar jcint was decided
`meapetzttivaiy. Aha, the amount fer z‘esecti0;2 in the lat-
`csmt pmménzztme and the varttwvatgtjs hinéfoet
`malatignment angles iteeded far correction were estimated
`_prc:<,vpet2:tiveIy.
`At the feficww-up visit, the patients. wars anztiyzed by
`El Cimtcai assessment rating system and radiography. The
`ctitticai assegsmerzt system was modified fmm one d<:v<:1-
`oped by the American Orthopaeétc Foot atzd Amide Asso-
`ciation, which including the $Lfi?j€CZiV% and the ohjective
`evztluzttiott”.
`
`€'}PERt%.'E‘i‘%/ E FROCEDU RE
`
`The‘: p:st§t=,:tt was ptaced Iaterai tistcubittts fmsitiori or
`pmm) pesition. An incision 5 to 7 centimeter in length,
`czentered on the simtg tarsi and parallel ta the pemneai ten»
`dang, was made to expnste éhc laiczrzal suhtatar juimt amt} the
`p€‘!()¥}€3€:tl
`temisng. The pemnea} tendons were eievated from
`the calcaneus by a subpemstea} stripping of tha saft tissue
`
`on the Eaterai and posterier aspect 0f the catcaneus. The
`tmtging tiefmmity sf the Eatera} cortax was tdarztified and
`resectefi by an as/teotome. This procedure does fiecotmx
`
`fore, six had had castittg without redtzcticm, afid font" had
`
`press tentirtg pressure on the peronezii tendons and the sural
`
`Page 2 of 8
`Page 2 of 8
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`
`32
`
`Snhtaiar lfisitraerion Arthrorlesis
`
`nerve, cure the caleaneofibular abutment ané decrease the
`
`calcaneal width. As; this is being accomplished, the exten»
`sor digiiorurn brevis muscle was reflected upward to ex-
`pose the sinus tarsi. A larniiia spreader was plzreeei in the
`sinus tarsi to widely expose the sohtalar joinr. Afier re-
`moval of the interosseous ligament ofthe suhtalar joint. all
`of the facet joints 0? the sohtalar joint: could be fully visu—
`alizeé. All of the articular cartilage inside of the sohtalsr
`joint was removed to expose {he snhelionairal bone. The
`medial subtalar eapsuloiomy should be done at ihat time to
`allow of distraction. The iliac creet graft, about l.’Z to 1.5
`cm in thickness, was inserted at the posrerior face‘: to rnain—
`
`lf there exists a verus or valgns
`rain the distraction.
`rnalaligmnent of the hinrifoot, this melalignmenr eonlri he
`simotanconsly correetmi by adding the medial or lzneral
`height of the wedge bone graft. The anterior and media}
`
`facets of subraiar joints were filled with chips of Cancel»
`loos bone graft Once the riisiraeiion anal the realignmenr
`were accompllished by the wedge bone graft, the fixation
`was made by inserting a ezincellous screw {6.5mrn) from
`the posreroinferior cortex of the caleaneal toherosity, asp-
`werdly penetrating the bone graft and ending at the talar
`neck, The wonnrl was closed in layers with a h€:i’fl(LlV8,€.1‘dl.lfH,
`and 2; strap plaster splint who applied for two weeks, fol-
`lowed by an AR) brace till the onion. Ankle and foot
`motion exercises were eneourageai soon after operation.
`Portia? weighr-bearing was
`started six weeks
`posmoeratively, with an increasing ectiviiy level as :oier—
`atcd, unril union was achieveri.
`
`RESULT
`
`There were 32 patients who were reviewed in this lol-
`
`low~up, in a mean liollowdrp period of 54 months {range
`36 to 78 months). The solid suhtalar fusion was achieved
`
`in 31 patients with a mean fusion time of 8.2 weeks (range
`610 [6 weeks). Only one pznieni zlisplziyed 2: fibrous union
`wirhout the traheeulae crossing the fusion side as seen in
`radiography. The reason for nonunion
`inezlequate deco-
`rtication on the rains. This parieni received secondary sorr
`gery with bone grafting, and achieved solid fusion six weeks
`afier fhe seconrl operation.
`Subjective one objective ratings are surnmarized in
`
`Table l. Snhjeeriveiy, 26 were paimfree after work or ex-
`ercise, 4 had miicl discomfort, 2 had moderate pain; none
`
`had severe pain in any activity. None of the pariems com-
`
`plained oi‘ pain under iateral malleous. There were l6 pa~
`éients who returned to previous work, 8 had {he same job
`with some restriction, and 8 changed jobs. Eight patients
`
`claimed fihe ability of continuing preinjury sporzs; 20 pa»
`rients could run aiowly without pain; 4 patients who could
`walk well, neveriheiess jorngfr not“ run. Twenty-foo: pa-
`tients had no limitation in selecting footwear; however,
`eight patients eouiinued to wear wider shoes. Subjeetively,
`30 of the 32 cases were satisfied with the aurgery. Two
`
`cases rook analgesic meriicine occasionally for hindfoot
`pain; however, they 8§§p£‘r“.(.‘.ial'.€:€i
`the improvement, surgery
`haci achieved.
`
`Ohjectively, four pazients had moderate renéerness
`around the hindfoot. On rhe ealcameocuhoid joinr (2 pa-
`tients) and {he anterior ankle joint (2 cases). The range of
`motion of the ankle joint, as compare to the nninjuried side,
`was 27 cases of more than 85%, 4 cases of 85% to 75%,
`
`of hinrifoot was 26 in valgus
`and l cases of 70%. The
`or neutral, 4 in mild varus, 2 in moderate varus.
`
`Qverall, 28 cases (87.5%) were ralmi as good (16
`cases) to excellent (l2 cases), and 4 ( 22.5%) as fair.
`in the
`
`four patients with fair results, all were due to the severe
`previous injury with stiff joints and marked éefonnity in
`the hindfoot.
`
`By radiographie examination, the average increase of
`the calcaneal height was l.l centimeter in average (range
`0.5 to 38 centimeter).
`iiligure l, & Figure 2} The lateral
`taloeaileaneai angle
`increased ll degrees in average
`
`(range 6 re 28 degrees) (Table 2). From this review, no x-
`rriys films demonstrate the riegenemtive changes in the
`nearby joints of foot.
`"l"here were two superficial wound infection, treated
`by antibiotics. There was no wound disruption nor neu-
`roma formatiori. Four cases had problems with screw irri-
`tation. with two cases of the screw tip penetrating the talar
`neck, inducing anterior ankle pain; the others two cases
`had plantar heel pain at the inlet of the screw. These prob-
`lems subsided when the screw was removed after fusion.
`
`Page 3 of 8
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`

`
`Y}. Chen, KY. H511, ELM. Shfih, et ill
`
`33
`
`Table l. Clinical Assessment Rating Scale
`
`Subjective
`Score
`
`Number
`
`Objective
`Scare
`
`Number
`
`1. Pair:
`
`None
`Mild
`Moderate
`Severe
`
`2. Activity limitation
`None
`Mild
`l\/loderate
`Severe
`3. Work
`
`Same job
`Same with restrletimv
`
`Change job
`None
`4. Shae wear
`
`N0 limitatiesn
`Wider, {last
`Cus?;om—made
`
`3
`2
`l
`0
`
`3
`2
`l
`U
`
`3
`2
`
`E
`0
`
`Z
`I
`0
`
`26
`4
`'2
`G
`
`8
`20
`4
`0
`
`I6
`8
`
`8
`U
`
`24
`8
`ll
`
`1. Ankle martian
`
`100% to 85%
`85% to 75%
`less thafi 75%
`
`Feet motion
`l{)O% Its 75%
`75% ‘:0 50%
`less than 50%
`
`Tendemess
`
`Name or mild
`Mtmteraie
`
`Severe
`
`4‘ Hindfaot axis
`
`Valgus, neutral
`Mild \/a,rt1.~;
`Moderate varus
`Severe varus
`
`3
`2
`l
`
`3
`Z
`I
`
`2
`l
`
`G
`
`3
`2
`l
`0
`
`27
`4
`l
`
`8
`23
`l
`
`28
`4
`
`0
`
`26
`4
`2
`O
`
`* Scare system: Excellent, 2'2-20; Good, 19-14; Pair, 13-8; Poor, <
`** Excellent: l2 cases, Good, l6 eases; Fair, 4 cages.
`
`Table 2.
`
`Radiographic Results
`
`Lateral taloczalcaneal angle
`Heiglx1ofl1eel(Cm)
`
`Preoperative
`
`2‘: 3*(l l°°—32)**
`5.3(4.5-6.8)
`
`?oslopera§:ive
`
`32°(2()°-42°)
`6.4(5.2—7.5)
`
`lncrease
`
`ll°{£’3°—2{)°)
`l.l(0.5—l.8)
`
`* Average
`** Range
`
`BESCUSSEUN
`
`The treatment of calcaneal fracture received little at-
`
`temien in the past. Although 21 favorable result after ep-
`erative treatment had been reported after the l980’s, much
`controversy slill continued“ ’~19*m7. Different methods were
`still widely used in each limited number of series‘~““~‘*~"’~3°*'
`
`3‘-'~’6‘3”‘. Among thege series, late cempllcatizmg presented
`
`in many ways to cause clinical problems, with pztin the
`rims? freqxjemly e1r1cm31:te1‘e(l. The faeatien of pain cmxld
`be on the subtaslzlrjcint, ankle joint, lateral calcaneofibular
`space, retroealcancal space, medial tarsal tunnel and plantar
`faseia°~”‘”V‘4. Pain was cauaed primarily by subtalar arthri-
`
`tis and inccmgruenee, but the configuration change eel‘ the
`calezmeus; also can create pain at
`the ankle joint,
`caleaneofibular space and plantar l3eel4‘3"""'*"“~3""". Limping
`
`Page 4 of 8
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`

`
`34
`
`Sebtaiat fiistmetien Artiimciesis
`
`
`
`(A)
`
`{E}
`
`Fig 1: {A} Lateral raetttgettogragthy shewing Collapse of calcameus with tibiomlar neck abutment and talamnavicular sebiuxatitm,
`{B} Postoperative roentgenegraphy slwwing solid fusion with distraeaiots. The height and alignment at" hindfe-at cemplex were restored.
`
`gait and activity deterietatiori are always accompanied by
`pain, and can prevent 3. patient from workirig. Shoe wear
`
`difficulty was else a frequent c:3mglaint3~‘5~”.
`Cart et al, described these prolalems, analysing the
`pathemechanism in their report? Cil‘ scan on the coronal
`
`plane revealed the exact patheanatomy to explain the Clini-
`cal problernrs,
`imtliteiittg in:;t,mgrtiei1<_:e 0? stvbtalztr jtzint,
`widening of calezmeus to cause caleaxteofibular abutment
`and medial pesterier tarsal tunnel syndrome, coliagse ef
`
`calcaneal height 10 cause tibicvtalar meek impingement and
`leg length discrepancy and displacement of posterior tu-
`berosity to C3113?) vatus deformity ef the heel“*"‘~35~3". The
`
`lateral View of plane x~ray film, eomparecl t0 the norimtl
`side, can determine the Clizmge of talar tieczlination angle.
`talcicalcaneal amgle. and flatten of the 8.I”Cllz”“7. Based on
`the findings of plane radiography and Cfi" scan, Carr et al.
`clesignetl a method ta treat the maltmicm of ealeanetzs.
`in
`the past, the subtalar arthritis, no meter what the cause was
`fused in sit125’7~*5“"‘5““’~“*Z5. But severe malunion of the cal
`
`caneus associated with more than erie pathoariatemic
`changes may rm: be etimpletely eurecl by an in site gmlitalar
`atttirodesis. As mentiened above, the collapse of calea~
`meal height with lateral extrusion is the main causative fac-
`10? for the pr<3blems2~‘°‘3“‘27. Disirzttttitm ofthe wbtalar joint
`with a wedge bane graft in the present series is the key te
`solving not only the subtztlar azthritis but also the associ
`
`ateé pml3lems7. Distraction ef the aubtalar joint may
`reestablish ti ttermal relationship of l2il0C£§lC£}Jl€21i joint, in»
`crease the liintif<>0t’s height, tetiuee the talenavieular sub-
`lumtlaii, eliitiinate the tibiotalar Heel: abutment, increase
`
`the malleellcalezmeus space and restore the ztmli at the
`
`f0et2'7““""""-32'. Thus, a neariy anatomical reduction 0f the
`
`liind foe: complex eettltl be zztfttieveti, and 2; better
`biemeettamical function ofanlile and feet could be t‘€&5‘£Or6(l.
`The decerticatien of the wbtalar articular surface in an in
`
`site subtaiar fusion without distraction weuld even ciettrease
`
`the height at hindfoet an& the space betweeti the czztlcaneus
`and maileeli.
`lriemasii et al. describe a technique at" e0r~
`reetien ef the tleformity of the Calczmeus; by an esteotomy
`
`anti p€t'§‘§‘:ttS regmsitien»
`that recreates the primary il‘§l€ZiIli”€
`ing of the tubetesity relative t0 the medial stzstentacttlar
`fragment.
`it restores the calezmeal height amd tzarrews the
`heel. Finally, the stthéalztr attfrtrmlesis ablates the arthritic:
`joint between the talus aiéd the posterior faeet of the cal-
`Caneus. Results were repartedly satisfactory in 9 of 10
`treated feet”. Theeretically, the features of this method in
`restoring Calcatzeal height and wisith wete exactly the same
`as Carri: method. Hewever. the Romash method was tech~
`
`nically more ciifficult than the present one. The preaent
`
`metlfzod pmvides the zitlvainage at simplicity by perf(mn—
`mg distraction, realignment, bone grafting and arthrociesis
`in one procedure.
`
`Page 5 of 8
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`
`

`
`Yfi. Chen: K31’. H33, HN. Siiih, ei: 21‘:
`
`35
`
`Heel Pcssiiien is importam after siiijiaiai fusion and
`may be zi eomribiiiing factor 16 a peer 1‘E§SEli‘;20‘24. The wecige
`
`bone graft increases the heei heighi by me tiiicianess =3? the
`graft, and aim cmrects the vmfus defomiity (if the Eiiniifoet
`by 2:: medial/iaterai wedge of graft. Most of the hincifeot
`defoimizy in this series was warm.
`if the subtaiar joint
`was i'us;ed in 23 \2'25Tii§S pasiriam if. Wfiiiiii ii}Ci( ihe 1ra,m~zvet‘se
`tarsai join: and resulting in E‘: rigié forcfaoiw”-5°-9”. To pre-
`vent this, the medial side was distracted higher and a iat-
`
`erai wedge graft was inserted to add mere height in the
`medial subtaiar space. But in some severe vams deferm-
`ity cases, vaigus osteoiomy with iaterai tranalatieii ef ca}
`caneal tuberosity sheuici be added £0 achieve a compiete
`correction: .
`
`Resectien ef the iaiera} caieaneai wail weuid decom-
`
`presg the bamy abutment of the caicaixeofibuiar sisace, and
`the soft tissue impingement of peronaai teriéims and aural
`ne§ve’~”v’“~7/“'3. Pmmimen: éeformity (if the medical cortex
`was happenned in same severely irijured cases, Gauging
`
`entrapment cf {he fiemr ieiidons arié the pesierizir tibia
`nerve. Pasierior zassai itiiiinei ayizémme, causeii by the
`!}’i‘c1iuEii{}I'i of caiczmeus, has rarely been described before.
`
`Three patients in this series received both the iaterai and
`media} curiexyresecztianl.
`in we of the three, the flexor
`haiiux iongzis was noted ta be cempictciy entrapped inside
`the osteophyte, and the §3€}S‘£8I'iDE‘
`tibia nerve was highly
`tamed by the egteophyte. After medial Cartex osteotomy,
`the motion are of the first metatarsophaiarigeai jeint was
`
`
`
`
`
`Fig 2:
`
`(B)
`{A}
`(A) Laierai roentgenograpliy demonstrating stizbtaiar arthritis, Emu of the heel height, decreased E3111: deciirmtiozi zmgfe, and zwuision fracture of
`p0ste1‘i{)rtubEr0s;:€y.
`(B) Emstopergtive roemgenogmpfiy clemonsiratmg the solid §Ui)§2ii£il‘ fiusxisn with nicreaszng of caicanezl heigm and (am: ifeclzneiimn. The Achilles
`tendon was reattached too.
`
`greatly improved, and numbness along the posterior tibiai
`nerve was subsided.
`
`in their I‘t°.p€¥fi, Cari: et ai. had suecessfuiijz treated i3
`of 16 cases if caieaneai malimion with an incycasc in heel
`
`hight of 1.8 cm and iaierai taioeaicaneai angie for 11 in
`
`in this series, 2: 97% union rate in 21 singie aur-
`average?‘
`gery, with short union time, (average 8.2 weeks) was
`achieved. This was re9.ultedi‘1"<>m the extensive (‘i6CG1‘IiCd.~
`
`rigid Csmpressicm. The effects {if bone grafting in ihe
`present series were t0 maintain dimaction, correcting ihe
`vams deformity and enhance the unicm procesgi
`The subtaiar joint makes some contribution to the
`range: 'm€'}ii0§'l of plantar flexinn anti zinrsiflexiim of the
`himifoot C0{Ti{}iCX3‘l8‘20‘24. After subtaiar fusiim, the dOfSi—
`fiexion of foot decreases 2,1 iittie. In the eariier cases of this
`
`seriersi, there were {we instances cf solici subialar uziiem,
`
`tian of aii the articular surfaces Of the siibmiar joint, bone
`grafting and 2:,
`(25? mm ciiametei caiiceiieoizs .<;i.:;"eW Wiiii
`
`with cempiaints of mild iimiiation of dorsifiexion ("if the
`zmkie gain: and difficuity in squatting. Later in me series,
`
`Page 6 of 8
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`

`
`3 6
`
`Snbtalar Distraction Arthrodcsis
`
`pierced in a
`when tlfic-3, snbt2s,ia,r joint was fixed, the foot
`in this way,
`position of dorsiflexion of the ankle joint.
`even the ankle motion was
`rnilciéy éccreasctl
`
`postoperatively, with less cffoct on tlorsificxion of the foot.
`To improvc the range of motion of othcr foot joints, cfctrly
`motion exercise is advised; use of an AFC brace instead of
`
`2: cast allowcd daily active exercise of the ankle and the
`midfoot joint.
`There has been controversy between suntalnr arthro-
`
`desis and triple artiiroclosis in treating rnalunitcd calcaneal
`fractnrosg‘“”‘5"“’~25v3‘t The reasons for performing snlitalar
`arthrodcsis was because the damage of the present cases
`
`involved thc snbtalzir joint alone. A second reason was
`that, by prcsorving the Clropar1"s joint, the motion of tire
`hindfoot complex might be partially saved. Because the
`transverse tarsal joint is not fuseci, after .3 subtalar fusion
`
`with the heel in valgus, the foot is more supple than a foot
`with a triple artl1rodesis7"'77. Triple artlnodcsis was recom-
`mended when the fracture involved the calcancocaboid joint
`
`or the talonayicular joint7“"““"~3l.
`It has boon cxperien«::€
`licre that many maltmited cal-
`caneal fracture patients snffor from late complications. as
`mentioned above. With 21 thorough understanding of the
`
`pathomechanistn, these problems can be solved by the
`biomcchanical principles to rcconstruct the hindfoot. Thus,
`we can help patients return to previous activity and work.
`However, long—term effect on nearby joints after subtalsr
`fusion still needs further follow up2-"V27-""32.
`
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