Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19259 Page 1 of 13
`
`
`
`EXHIBIT DTX-5150-R
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 1 of 13
`
`

`

`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19260 Page 2 of 13
`SPINE Volume 18 Number 14 pp 21062117
`1993
`Company
`
`Lippincott
`
`Carbon Fiber Implant
`Lumbar Fusion
`
`to Aid Interbody
`
`Two-Year Clinical Results in the First 26 Patients
`
`John
`
`Brantigan MD and Arthur
`
`Steffee MDt
`
`and
`
`postoperative
`
`collapse
`
`of
`
`the donor
`
`bone
`
`and
`
`The success of posterior
`
`lumbar
`
`has been
`
`PLIF
`
`deficiencies
`
`interbody fusion
`limited by mechanical
`and biologic
`bone The authors have
`the donor
`
`fiber-reinforced
`
`polymer
`and biologic
`
`functions
`
`designed
`car
`implant that separates the
`of PLIF The cagelike
`
`of
`
`bon
`
`mechanical
`
`implant provides an actual
`
`failed backs with
`
`cage
`
`levels
`
`statistically significant
`
`difference
`
`at
`
`good in 10/26
`results were
`
`poor
`
`fair
`
`problems
`plant achieved
`
`unrelated
`
`followed patients
`body fusion
`
`successful
`
`fusion
`
`treated
`
`for
`
`identifiable
`
`inter-
`
`multi-centered
`prospective controlled
`words interbody fusion
`study is being initiated
`PLIF AIJF carbon cage allograft
`screw
`
`pedicle
`
`the
`to meet
`device designed
`the do
`and
`mechanical
`requirements of PLIF
`replaces
`nor bone with autologous
`bone the best
`bone
`possible
`for heating The authors report 2-year follow-up results
`patients 18 of whom were
`for their first 26 consecutive
`total of 37 previous
`postsurgical
`surgeries At
`years 28 of 28 PLIF
`fusion
`of 1154.5% allograft
`and
`levels exhibited
`fusion
`radiographic
`00002 Clinical
`
`in 3/26
`
`excellent
`
`in 11/26
`in 2/26 Fair and
`
`results were
`and poor
`attributable
`to objective
`to the carbon cage The carbon im
`in 6/6 100% of
`failed ETO allograft
`
`pseudarthrosis
`In 1985 Cloward1 claimed 87 to 92% clinical
`in his 40 years of PLIF surgery
`and 92% fusion success
`82% clinical
`and 88%
`Lin1718
`success
`reported
`and Ma9 has
`83% clinical
`success
`and 85% fusion
`
`success
`
`reported
`
`has
`
`fusion
`
`success
`
`success Unfortunately
`many
`had
`results with
`
`unsuccessful
`
`other
`
`have
`
`surgeons
`uninstrumented
`PLIF
`and
`have
`abandoned
`the pro
`cedure In our experience Dr Steffee did an early series
`of 12 uninstrumented PLIF procedures many years ago
`100% failure
`rate because
`of continued
`and
`had
`
`instability
`
`published
`
`publishing
`
`developed
`
`of
`
`the surgical construct This series was never
`because
`
`and
`editors both dislike
`authors
`studies Dr William Gazale who
`PLIF chisel
`has
`commercially
`produced
`
`unsuccessful
`
`results of uninstrumented PLIF at
`his surgical
`presented
`90% failure rate
`several meetings with approximately
`This study also has not been published
`More recently
`the use of pedicle
`screws
`have allowed surgeons
`to reduce degenerative
`the lumbar
`and maintain accurate
`mities
`of
`spine
`the motion segment
`positional control
`and
`in normal
`and
`coronal
`
`alignment
`
`of
`
`in anatomic
`
`and plates
`
`defor
`
`fusion PLIF pioneered by
`lumbar
`Posterior
`interbody
`Dr Ralph Cloward
`biomechan
`in the 1940s91
`ically optimum fusion
`successful PLIF maintains
`disc height
`the nerve
`
`is
`
`the
`
`roots restores weight-
`
`structures
`immobilizes the unstable
`
`restores
`
`the anulus
`
`to
`
`in
`
`protects
`to anterior
`
`bearing
`
`tension and
`
`tervertebral disc area
`
`degenerated
`successful PLIF restores
`
`every
`spinal unit except
`
`bleeding
`
`included
`
`excessive
`
`bone
`
`mechanical
`function
`of the functional
`motion Problems with PUP have
`the need
`for donor
`usually epidural
`of acquired immune deficiency
`with risk
`syndrome
`and hepatitis prolonged healing time of donor
`
`bone the difficulty
`
`of cutting
`
`precise bony channels
`
`the
`
`difficulty
`
`of providing sterile
`
`donor
`
`bone
`
`of precise
`
`dimensions
`
`the potential
`
`of
`
`instability the risk
`
`of
`
`retropulsion
`
`of graft
`
`and
`
`consequent
`
`neural
`
`damage
`
`From
`
`of Surgery
`the Department
`University Omaha Nebraska
`Creighton
`Arthritis Center Cleveland Ohio
`August 19 1992
`for publication
`Accepted
`
`Division
`
`of Orthopaedics
`and the tCleveland
`and
`
`Spine
`
`balance.2728
`
`plane
`sagittal
`have not however elimi
`Pedicle screws
`nated the need for weight-bearing
`support in the anterior
`column The likely
`lack of anterior column
`result of
`
`problem that
`
`is not solved by
`
`support is broken screws
`screw If
`
`stronger
`
`deformity is corrected
`
`is
`
`be
`
`restored physiologic
`
`anterior
`
`regained
`
`by use of interbody
`
`the
`
`in
`
`and
`
`often local bone
`
`cancellous
`
`blocks
`
`13
`
`graft
`
`decompression
`
`designing
`and disc space
`height
`column
`support must
`bone graft
`Of the first 697 pedicle screw/VSP
`cases done at
`Cleveland Spine
`and Arthritis Center PLIF was done
`at least one level in 501 cases or 71% Our standard PLIF
`fixation using pedicle
`includes segmental
`procedure326
`VSP plates
`in
`oxide sterilized
`screws
`ethylene
`terbody allograft most commonly
`25 mm and autologous posterolateral
`13
`from the posterior
`results are
`achieved
`graft remains
`
`satisfactory
`
`clinical
`
`Generally
`however
`the failure
`at about 30%
`The current problem has been the quality of the bone
`
`rate of
`
`the interbody
`
`2106
`
`DTX-51 50
`
`...
`
`12%I\R
`
`\1
`
`BR0002960
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 2 of 13
`
`

`

`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19261 Page 3 of 13
`Carbon Implant
`
`Brantigan and Steffee
`
`2107
`
`for PLIF
`
`Figure
`
`Carbon-fiberreinforced
`
`polymer
`
`implant has
`hollow areas
`
`struts
`
`to
`
`the structure
`
`is
`
`retropulsion
`and
`
`graft
`
`to allow
`
`packing
`
`support weight-bearing ridges
`of autologous
`radiolucent
`to allow
`visualization
`graphic methods
`
`to resist
`
`bone
`
`of healing
`
`by normal
`
`radio
`
`Figure
`
`Cage
`
`finish
`
`broach of
`
`15-mm
`to the 11- 13- and
`are sized
`implants
`the ADS PLIF Broach System AcroMed Corp.
`
`ware More
`recently cages were
`made from long-fiber
`carbon
`ketone ketone obtained
`
`ether
`
`fabricated
`
`from composite
`ketone
`
`in Ultrapek poly ether
`from BASF Structural Materials
`
`graft which is less than optimum both biologically and as
`device The
`donor
`bone
`of PLIF
`
`load-bearing
`
`is
`
`Anaheim California Both materials
`
`demonstrate
`
`resistance
`
`all
`
`solvents
`
`except
`
`sulfuric
`
`acid
`
`and
`
`appear
`
`equivalent
`
`to
`
`in
`
`expected to serve both mechanical
`function The PLIF bone must
`
`device
`
`function
`
`and
`
`the PLIF
`
`properties
`
`previous
`
`study1
`
`properties
`
`in the disc
`
`the
`
`to the
`
`and mechanical
`biologic
`The cage
`implants are implanted in horizontally
`opposed
`space using the ADS
`channels
`transverse
`prepared
`PLIF Broach System AcroMed Corp. Figure
`shows
`standard
`sizes of carbon
`three
`fiber implants adjacent
`15-mm finish broaches
`
`11-mm 13-mm and
`implants are sized
`Between May 1989
`had surgery
`were
`including interbody fusion with the carbon cages Patients
`for use of the carbon cage device if they had failed PLIF
`with ETO bone
`traumatic spondy
`if they had high-grade or
`
`to which
`
`the
`
`and July 1990
`
`26 patients
`
`selected
`
`of
`
`bone-growth
`biologic
`bear substantially all of the bodys weight above
`level while it is being
`by the erosive process
`incorporated
`of creeping substitution We explored the mechanical
`of allograft bone for PLIF in
`bone
`
`the
`
`to be
`
`inadequate for the
`
`and
`found
`average
`function
`required mechanical
`We
`have
`carbon-fiberreinforced
`developed
`implant shown in Figure
`polymer
`fusion The implant has ridges or
`
`to aid interbody
`
`teeth to resist retro
`
`hollow area to allow
`
`graft
`
`and
`
`the
`
`carbon
`
`packing
`
`structure
`by normal
`the device
`
`chanical
`
`to support weight
`pulsion struts
`of autologous bone
`is radiolucent
`to allow visualization of healing
`techniques The cage
`implant
`radiographic
`and biologic
`of PLIF by
`functions
`separates
`the me
`device
`providing an actual
`to meet
`designed
`the donor
`requirements of PLIF and replacing
`bone with autologous cancellous
`bone the best possible
`bone
`for healing Mechanical
`of
`the implant
`isolated motion segments in cadaver spines have shown
`loads
`that cage struts support all anticipated
`and
`
`tests
`
`in
`
`compression
`
`the ridges
`
`or
`
`teeth
`
`resist
`
`retropulsion
`
`with
`
`than
`measured resistance to pullout
`three times greater
`of donor bone.4 The carbon fiber material
`that of blocks
`has modulus of elasticity approximating that of cortical
`bone.7 The purpose of
`on
`this article is to report
`the first 26 patients treated with the carbon cage
`who have
`reached the 2-year
`follow-up interval
`
`implant
`
`results
`
`Materials
`
`and Methods
`
`Initial
`
`cages were machined
`from blocks of composite made
`of 68% long-fiber
`in PEEK poly ether
`carbon fiber
`pyrolytic
`ICI Advanced Materials Wilmington Dela
`
`ether
`
`ketone
`
`support because
`lolisthesis if they required strong anterior
`difficulties with other devices
`at surgery or if they had
`had
`failure of numerous other surgeries Several
`
`technical
`
`had
`
`patients
`
`cages
`
`as
`
`Table
`
`primary surgery
`lists each patient
`VSP fixation
`
`date of surgery surgeon
`cage
`levels PLIF levels
`carbon cage
`material
`levels
`done with ETO-sterilized bone 6- 12- and 24-month clinical
`for carbon cages and ETO PLIF levels
`are graded
`regarding reoperation Clinical
`
`status fusion status
`
`information
`
`and
`
`results
`
`fair or poor
`good
`excellent
`criteria summarized in Table
`
`according
`
`to generally
`
`accepted
`
`Radiographic
`
`evidence
`
`of
`
`fusion was
`to
`graded
`obvious
`pseudarthrosis
`radiographically solid by criteria summarized in Table
`
`fusion
`
`Results
`
`32
`there were 63 total
`fusion levels
`fusions 29 with the
`larger oval cage used
`and with
`had ETO donor bone PLIFs and 20
`fusion using autologous bone
`had posterolateral
`with pedicle screw and plate support without
`fusion Two-year
`on 31 cage
`There were no failed
`
`In the 26 patients
`
`levels
`
`had
`
`carbon
`
`PLIF cage
`anteriorly 11 levels
`
`Figure
`
`levels
`
`cage
`
`interbody
`
`follow-up
`
`roentgenograms
`
`tained
`
`patients
`
`levels
`
`and
`
`interbody
`were ob
`in 25
`
`11 allograft
`fusions with the carbon
`
`levels
`
`cage Successful
`
`radiographic
`
`fusion was achieved
`
`in 28
`
`BR0002961
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 3 of 13
`
`

`

`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19262 Page 4 of 13
`
`2108
`
`Spine
`
`Volume 18 Number 14
`
`1993
`
`N-
`
`Table
`
`Outcome
`
`Summaries for
`
`lnterboy_EusiJsing
`
`Carbon Cages
`
`Number
`
`Date
`
`of
`
`Prior
`
`Surg
`
`Cage
`
`Surgical
`
`Surgery
`
`Indication
`
`Surgeon
`
`Cage
`
`Material
`
`Cage
`
`Levels
`
`ETO
`Levels Mo
`
`12
`Mo
`
`24
`Mo
`
`ETO
`
`Cage
`
`Fusion
`
`Fusion
`
`Re-op
`Y/N
`
`Purpose
`
`of Re-op
`
`Clinical
`
`Status
`
`5/09/89
`
`Failed
`
`ETO
`
`PLIF
`
`7/21/89
`
`Failed
`
`ETO
`
`PLIF
`
`1/02/91
`
`Failed
`
`ETO
`
`PLIF
`
`Instability
`
`Instability
`
`8/08/89
`
`8/09/89
`
`8/11/89
`
`ADS
`
`ADS
`
`JWB
`
`JWB
`ADS
`
`L4-S1
`
`L4-S1
`
`none
`
`L4-S1
`
`L4-L5
`
`L5-S1
`
`L4-S1
`
`L5-S1
`
`none
`
`L4-S1
`
`L3-S1
`
`L4-L5
`
`L3-L4
`
`none
`
`L4-L5
`
`L4-S1
`
`L4-L5
`
`PEEK
`
`PEEK
`
`PEEK
`
`Failed
`
`ETO
`
`PLIF L5
`
`Remove
`
`plate
`
`Patient
`
`AP
`
`LD
`GMP
`
`BA
`
`PR
`
`MSC
`IWT
`
`SRD
`MK
`
`MS
`JB
`
`MJD
`
`FA
`
`ADS
`
`ADS
`
`ADS
`ADS
`
`ADS
`
`ADS
`
`ADS
`
`ADS
`
`Spondylo
`
`below
`
`HRI
`
`10/11/89
`
`Failed
`
`ALIF
`
`12/05/89
`
`Failed
`
`PLIF
`
`12/11/89
`
`Gr
`
`Ill Spondylo
`
`1/05/90
`
`1/08/90
`
`1/15/90
`
`1/19/90
`
`Failed
`
`PLIF
`
`Stenosis at
`
`fusion
`
`Spondylo
`
`Dislocation
`
`L5-S1
`
`i/i 9/90
`
`D-Spondylo
`
`1/31/90
`
`Failed
`
`PLIF
`
`none
`
`L2-S1
`
`L3-L4
`
`L2-L3
`
`L5-Si
`
`L4-Si
`
`L2-S1
`
`L4-S1
`
`L2-S1
`
`L4-S1
`
`L5-S1
`
`L5-S1
`
`L4-L5
`
`L5-S1
`
`L2-L3
`
`L5-S1
`
`none
`
`none
`
`L2-L4
`
`none
`
`L4-L5
`
`none
`
`L4-S1
`
`L4-S1
`
`L5-Si
`
`L5-S1
`
`L4-L5
`
`none
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`Repair
`
`burst
`
`fx
`
`Remove
`
`vSP
`
`Myelo
`
`graphic
`
`block
`
`EEH
`
`HF
`
`RJL
`
`MP
`
`LH
`
`DER
`
`AG
`DEL
`
`SED
`
`DDD
`
`ADS
`ADS
`ADS
`ADS
`
`ADS
`
`RSB
`
`RSB
`
`ADS
`
`ADS
`ADS
`JWB
`
`2/21/90
`
`3/07/90
`
`3/07/90
`
`3/13/90
`
`3/14/90
`
`L-Spondylo
`
`D-Spondylo
`
`Post-
`
`discectomy
`
`Failed
`
`Perk
`
`Post
`
`discectomy
`
`3/19/90
`
`Failed
`
`chymo-
`
`3/19/90
`
`3/30/90
`
`4/18/90
`
`papain
`
`D-Spondylo
`
`Failed
`
`Zielke
`
`Post-
`
`discectomy
`
`4/25/90
`
`D-Spondylo
`
`7/09/90
`
`Failed
`
`PLIF
`
`PEEK
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`PEEK
`
`L4-S1
`
`L4-L5
`
`L4-S1
`
`None
`
`None
`
`L5-Si
`
`L4-L5
`
`L4-S1
`
`L5-S1
`
`L5-S1
`
`L4-L5
`
`none
`
`none
`
`none
`
`none
`
`L4-S1
`
`L5-S1
`
`L4-L5
`
`L2-L5
`
`L2-L1
`
`L3-S1
`
`none
`
`T12-S1
`
`L3-L4
`
`L4-L5
`
`L3-Si
`
`L4-L5
`
`L5-Si
`
`L4-L5
`
`L3L5
`
`none
`
`none
`
`none
`
`DC
`JC
`
`7/09/90
`
`Burst
`
`fx Li
`
`JWB
`ADS
`JWB
`
`UPEK
`
`none
`
`T12-L2
`
`none
`
`lndicates
`
`anterior
`
`interbody
`
`fusion with
`
`large oval
`
`cage
`
`Clinical
`
`result
`
`excellent
`
`good
`
`fair
`
`poor
`
`Cage material
`
`PEEK
`
`carbon
`
`fiber in PEEK UPEK
`
`carbon
`
`fiber in Ultrapek
`
`-e-J3
`
`1j.j.jJ
`
`.4
`
`Fusion
`
`result
`
`collapse
`
`of construct
`
`probable
`
`pseudarthrosis
`
`fusion
`
`status radiographically
`
`uncertain
`
`probable
`
`radiogra
`
`hic fusion
`
`radioaraphic
`
`fusion
`
`Surgeon
`
`ADS
`
`Arthur
`
`Steffee
`
`JWB
`
`John
`
`Brantigan
`
`RSB
`
`Robert
`
`Biscup
`
`of 28 100% followed levels
`In the same patients PLIF with ETO-sterilized
`PLIF cage
`bone
`achieved
`donor
`54.5% The difference
`0.0002
`the
`
`treated with the rectangular
`
`radiographic
`
`fusion
`
`in 6/11
`
`in fusion rates is significant at
`
`In seven
`by the chi-square
`test
`patients the carbon cage was used to treat pseudarthrosis
`ETO donor
`PLIF or ALIF In one
`from failed
`bone
`
`level
`
`patient we could not obtain
`follow-up roentgenogram
`The other six failed PLIFs treated with the carbon cage
`fusion
`resulted in successful
`
`Clinical
`
`results
`
`at
`
`and
`
`in Table
`
`At
`
`years are given
`10/26 good
`years 10/26 patients were excellent
`3/26 fair and 2/26 poor clinical
`results Results improved
`during the second
`year At 24
`
`slightly
`
`postoperative
`
`months one patient was lost
`at previous examination
`
`excellent
`
`to follow-up but had been
`
`Of
`
`clinical
`
`results
`
`each
`
`had
`
`burst
`
`including
`
`the poor
`clearly
`to the carbon
`demonstrable reason for failure unrelated
`fracture at Li She
`cage Patient PR originally had
`had four prior procedures by other surgeons
`fusions at L4S and L5Si using bovine bone
`interbody
`fifth surgery by A.D.S to repair the two-level
`She had
`failed ALIF This surgery
`included
`resection
`of pedicles
`of L4 and L5
`at L5 osteotomy at L5 joining the bodies
`fusion at L34 and
`an ETO
`carbon cage
`at L23 At
`follow-up she
`fusion
`allograft
`interbody
`continued to have back pain her allograft PLIF level was
`long fusion ended
`two cephalad
`not healed and her
`
`interbody
`
`at
`
`BR0002962
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 4 of 13
`
`

`

`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19263 Page 5 of 13
`
`Carbon Implant
`
`for PLIF
`
`Brantigan and Steffee
`
`2109
`
`Table
`
`Description
`
`of Excellent Good Fair and Poor Surgical Results by Author
`
`Author
`
`Excellent
`
`Result
`
`Good Result
`
`Henderson
`
`1966
`
`Returns to former occupation
`
`no pain or minimal
`
`pain
`
`sports
`
`or
`
`recreational
`
`activities
`
`unrestricted
`
`Ma 1985
`
`Returns to original
`
`work
`
`regular
`
`activites
`
`minimal medication
`
`occasional episodes of pain
`
`no neuro deficits
`
`fusion
`
`solid
`
`by X-ray
`
`Returns to former occupation
`
`occasional
`
`pain
`
`not per
`
`sisting more than 12 hours
`
`not
`
`restricted
`
`from less
`
`strenuous
`
`sports
`
`Returns to original
`occasional medication
`
`work
`
`resumes
`
`regular
`
`activities
`
`takes
`
`for episodes
`
`of back or
`
`leg pain
`
`no neuro deficits
`
`radiographic
`
`solid
`
`or questionable
`
`Naylor
`
`1974
`
`No complaints
`
`whatsoever
`
`and
`
`no residual
`
`ill effects
`
`fusion
`
`Relief
`
`of
`
`residual
`
`minor
`
`the major symptom of pain but with minor
`as numbness
`such
`
`paresthesias
`
`symtpoms
`backache
`
`to
`
`Spengler
`
`1990
`
`no excellent
`
`category
`
`acknowledged
`
`Relief
`
`of most
`
`76-100%
`previous work minimal
`
`of back pain able to return
`minimal
`
`of activities
`
`limitation
`
`White 1987
`
`Complete
`
`recovery
`
`free
`
`of
`
`all
`
`limitations
`
`never
`
`have
`
`pain greater
`
`Return to full
`
`activities
`
`medications
`
`the same job or prophylactic
`sports
`no daily
`70% relief of pain
`
`than mild pain patient
`
`aware
`
`of but not bothered
`
`by
`
`limitation
`
`to light work
`
`Prolo
`
`1986
`
`No pain or minimal
`
`and work
`
`score
`
`pain able to
`or 10
`
`participate
`
`in full
`
`activities
`
`Fair Result
`
`habituating
`Mild pain with some strenuous activities
`
`medications
`
`limited
`
`by
`
`pain
`
`Score
`
`or
`
`Poor
`
`Result
`
`Henderson
`
`1966
`
`Restricted
`
`Ma 1985
`
`restricted
`
`Returns to original
`
`or
`
`and
`
`recreational
`
`activities
`
`Unable
`
`to work
`
`pain level
`
`no better
`
`than pre-operatively
`
`problem
`
`of activities
`
`Changes
`
`to lighter work
`
`or disabled
`
`limitation
`
`of activities
`
`to lighter work
`sports
`less pain the pre-op but pain still
`some limitation
`lighter work
`more frequent
`
`back
`
`or
`
`occasional medication
`
`leg pain minor
`
`Naylor
`
`1974
`
`Improved relief
`
`of
`
`the major pain symptom but with residual
`
`neuro
`
`deficit
`
`fusion
`
`questionable
`
`or pseudarthrosis
`
`frequent medication
`by XR
`
`pseudarthrosis
`
`failure no relief
`
`incapacitating
`
`pain or neuro
`
`deficit
`
`Spengler
`
`1990
`
`Partial
`
`or
`
`requiring
`to previous work
`limited meds used
`
`further
`
`treatment
`
`Little
`
`or no relief 0-25% of pain disabled for work
`or narcotic
`
`activities
`
`greatly
`
`limited strong analgesic
`
`numbness
`paresthesias
`relief of pain 26-75% able to return
`with limitations
`lighter work
`
`or backache
`
`activities
`
`White 1987
`
`Patient
`
`able to work
`
`but at
`
`lighter
`
`capacity
`
`less
`
`frequently
`
`than 70% pain
`
`No improvement
`
`or worsening
`
`25% or
`
`less
`
`subjective
`
`medication
`
`used
`
`frequently
`
`Prolo
`
`1986
`
`Moderate
`
`continuing
`
`some limitation
`
`relief
`
`or daily
`
`activities
`
`limited occasional
`pain meds
`
`episodes of severe pain
`
`relief
`
`of pain episodes
`
`of severe pain disability
`
`or
`
`reoperation
`No improvement
`
`of
`
`all
`
`activities
`
`or
`
`of non-strenuous
`
`pain with severe episodes
`Score
`
`or
`
`activities
`
`limitation
`
`of pain disability marked
`or worsening
`Score
`
`damaged disc levels
`She
`
`subsequently
`
`Clinical expectations
`
`related to an old burst
`
`fracture at Li
`
`several
`further
`had
`has
`surgeries
`for her are limited Patient DEL has
`of an ETO PLIF level at
`
`but has failure
`
`There were no cage
`no prolongation of hospitalization
`no removals of the cage or
`fusion No retropulsion
`cage was noted
`
`device-related
`
`complications
`
`revisions
`
`of
`
`the cage
`
`interbody
`
`or change
`
`in position
`
`of any
`
`in any
`
`level
`
`the
`
`leg
`he
`
`clinical
`
`improvement
`
`from
`
`level
`
`good
`
`clinical
`
`reoperations
`
`patient
`within
`the
`in 5/26 patients
`Reoperations were done
`In Patient EC failed ETO PLIF
`1224-month interval
`carbon cage Patient GMP had
`revised to
`was further
`removal of one VSP plate then pyriformis tendon release
`year she had some
`because of residual nerve pain At
`nerve discomfort but still
`had
`good
`residual
`summa
`result Patient PR had
`series of
`rized in the clinical summary Patient MK had removal of
`fragment of bone
`VSP and nerve root
`foramenotomy
`fusion was found to be compro
`from the posterolateral
`foramen at the L5 root Patient JB was
`mising the neural
`for myelographic block at L45 one level
`re-explored
`than the L5S1 cage
`fusion She had been treated
`at L5 Si and was
`traumatic
`dislocation
`in anatomic
`fusion solidly healed
`have the cage
`above
`the fusion In retro
`but had bony arachnoiditis
`cage myelogram showed the bony
`spect her preoperative
`result was substantially im
`Her clinical
`arachnoiditis
`
`higher
`
`for
`
`found to
`
`position
`
`poor result
`above
`
`L3
`
`the carbon cage
`results Patient MSC has collapse of
`Of the fair
`fusion Patient MK was
`L45 disc
`above
`the cage
`working full-time at 12 months
`teacher
`high school
`as
`He stopped work because of
`coach
`and wrestling
`symptoms of reflex sympathetic dystrophy however
`plays golf twice week His 24-month
`status was
`Fair Patient LH claims minimal
`is high examination is benign
`surgery but function
`fusion He is
`illiterate and
`shows
`
`roentgenogram
`and social dysfunction
`
`alcoholic
`
`may be
`
`significant
`
`in his result
`
`factor
`Complications were minimal There were no surgical
`numbness
`One patient
`had
`infections
`caused by damage
`to sensory
`There were no cases of motor deficit
`no cauda equina syndromes
`tears occurred in several patients
`dural
`
`postoperative
`of one nerve root
`
`fibers
`
`Incidental
`
`in these
`
`cases and
`
`durotomy
`however
`
`i.e
`
`there
`
`were
`
`no
`
`cases
`
`of
`
`postoperative
`
`cerebrospinal
`
`fluid
`
`leakage
`
`no requirement
`
`for secondary
`
`dural
`
`repair
`
`and
`
`proved by her surgery
`
`BR0002963
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 5 of 13
`
`

`

`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19264 Page 6 of 13
`
`2110
`
`Spine
`
`Volume 18 Number 14
`
`1993
`
`Table
`
`Description
`
`of Fusion Result
`
`Obvious
`
`small
`
`lucency
`
`of
`
`the construct
`
`loss of disc height vertebral shp broken screws
`
`of
`
`graft
`
`of
`
`or major lucency or gap visible in the
`
`just
`bone
`
`portion
`
`of
`
`area at approximately the density
`the fusion
`area with
`
`least half of
`
`originally achieved
`
`the graft area showing
`
`surgically
`no
`
`at
`
`on collapse
`radiographic pseudarthrosis based
`displacement
`the bone
`of the carbon cage or
`resorption
`Probable radiographic
`the bone graft
`on significant
`pseudarthrosis based
`resorption
`mm or more around the entire periphery of
`fusion
`the graft or cage
`area
`uncertain Bone graft
`status
`is visible in the fusion
`Radiographic
`lucency or gap may be visible involving
`between
`and vertebral
`the graft bone
`Probable radiographic fusion Bone
`should be no lucency
`Radiographic
`fusion The bone
`surgery Optimally there
`graft and vertebral
`bone
`
`between
`
`bridges
`the donor
`
`the entire fusion
`
`bone
`
`and vertebral
`
`area with
`bone
`
`at
`
`least
`
`the density
`
`originally achieved
`
`at surgery There
`
`in the fusion
`
`area
`
`is no interface
`
`between
`
`indicates
`
`fusion Other
`
`signs
`
`is radiographically
`the donor
`bone
`
`and more mature than originally achieved
`more dense
`and the vertebral bone
`however
`line between
`sclerotic
`include mature bony
`of solid fusion
`trabeculae
`the graft within the disc
`
`in
`
`the
`
`bridging
`
`fusion
`
`the fusion
`
`area
`
`of facet
`
`joints the
`
`of anterior
`resorption
`ring phenomenon
`
`spurs anterior progression of
`vertebral
`traction
`on CT or 3D imaging evidence
`
`space
`
`Case Reports
`
`Table
`
`Clinical Results at 12 and 24 Months
`
`Excellent
`
`Good
`
`Fair
`
`Poor
`
`Lost
`
`l2Months
`
`10
`
`24 Months
`10
`_______________________________________________
`
`11
`
`Case
`Patient AP was
`the time of his
`man at
`54-year-old
`had
`been
`carbon
`surgery His first surgery
`at L4L5 in 1987 He
`and disc excision
`of back
`and right leg pain
`In January 1988 he
`
`experienced early recurrence
`with some right-sided weakness
`
`cage
`
`laminectomy
`
`Figure
`
`Lateral
`
`roentgenogram
`
`on Patient
`
`AP taken
`
`January
`
`allograft
`
`bone
`
`shows
`
`good
`
`restoration
`
`of
`
`disc
`
`height
`
`and
`
`1988
`
`shows
`
`postdiscectomy
`
`segmental
`
`instability
`
`placement
`
`of grafts
`
`Figure
`
`1988
`
`Up-angled
`
`anteroposterior
`
`view taken
`
`February
`
`25
`
`month
`
`after surgery
`
`2-level
`
`PLIF
`
`using
`
`ETO-sterilized
`
`BR0002964
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 6 of 13
`
`

`

`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19265 Page 7 of 13
`
`Carbon Implant
`
`for PLIF
`
`Brantigan and Steffee
`
`2111
`
`complained
`
`of marked
`
`severe
`
`tolerance
`
`of
`
`limitation of activity
`continuous moderate
`pain and
`frequent
`episodes
`shown in Figure
`pain The roentgenogram
`slip at L4S with
`demonstrated an unstable degenerative
`mild slip was also noted
`loss of disc height
`complete
`at L5S1
`On January 25 1988 he
`reduction
`of disc height
`including
`
`had
`
`second
`
`surgery
`
`reduction
`
`of
`
`the
`
`fixation
`segmental
`spondylolisthesis
`screws and VSP plates with two-level
`
`using
`pedicle
`PLIF using ETO
`
`allograft
`
`Roentgenograms
`shown in Figures
`he complained
`
`taken
`
`and
`
`of decreasing
`
`pain By February
`
`procedure Figures
`
`1989
`and
`
`are
`
`activity
`
`on February 25 1988
`After initial satisfactory results
`level and increasing
`his ETO PLIF
`
`year after
`show that all
`
`four grafts have
`have broken the slip has
`lost He
`
`height
`
`was
`
`again
`
`collapsed five of six screws
`and
`
`disc
`
`space
`
`recurred
`
`urgently
`requested
`On May
`1989 the patient
`removal of broken
`including
`ration of alignment and disc
`and revision
`height
`at L45 and L5S1 During his
`PLIF using carbon cages
`visit on July 20 1989 he reported moderate daily
`
`further
`
`treatment
`
`had
`
`screws
`
`space
`
`further surgery
`resto
`and plates
`
`office
`
`If
`
`Anteroposterior
`
`roentgenogram
`
`taken
`
`February
`
`year after surgery allograft
`screws are broken
`
`PLIF
`
`has collapsed several
`
`shows
`
`that
`
`the allograft
`
`and the disc
`
`height
`
`is
`
`Figure
`
`1989
`
`lost
`
`activity and
`
`roent
`
`visit
`
`no pain Two-month postoperative
`are shown in Figures
`and
`genograms
`On October 17 1989 the patient
`reported absolutely
`to work as
`no pain at all and returned
`radio dispatcher
`for Columbia Gas of Ohio On his 1-year follow-up
`no pain he was working
`on June 19 1990 he reported
`to normal
`full-time and motor strength
`had
`returned
`12 show solid
`in Figures 10 11 and
`both interspace
`levels
`are no
`bridging
`intact Alignment and disc
`broken screws
`Implants are all
`height are normal He has continued to have an excellent
`
`Roentgenograms
`bone
`
`There
`
`result at
`years after
`surgery Two-year
`genogram is shown in Figure 13
`
`lateral
`
`roent
`
`had
`
`pain
`
`that
`
`the time of her
`
`she
`
`con
`
`limitation of
`
`fall causing
`
`Case
`Patient LD was
`56-year-old woman at
`carbon cage surgery She had had
`fusion
`posterolateral
`at L5S1 with facet screw fixation In 1970
`in 1968
`discectomy at L45 followed by constant
`caused chronic
`tinuing back
`activities In June 1989 she was injured in
`back
`and
`increased
`radicular pain Roentgenograms
`at L45 The poster-
`
`Figure
`
`Lateral
`
`good
`
`correction
`
`roentgenogram taken
`of spondylolisthesis
`
`February 25 1988 shows
`
`showed Grade
`
`spondylolisthesis
`
`BR0002965
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 7 of 13
`
`

`

`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19266 Page 8 of 13
`Volume 18 Number 14 1993
`
`2112
`
`Spine
`
`olateral
`
`fusion appeared radiographically
`
`intact After
`
`she had
`conservative
`of
`period
`by
`treatment
`surgery
`J.W.B The surgical plan was segmental stabilization with
`and VSP plates with PLIF using allograft
`pedicle screws
`donor bone The small pedicle at L4 on the right was
`donor
`bone
`during screw insertion Available
`fractured
`was soft and mechanically
`insufficient The posterolateral
`at L5S1 was not united Permission then was
`fusion
`from the family to use the carbon cages which
`had not been
`The surgical
`anticipated
`preoperatively
`PLIF at L45 pedicle
`carbon cages
`included
`construct
`screw fixation at L4S1 on the left and L5S1 on the
`right with autologous posterolateral
`bone grafting bilat
`
`obtained
`
`erally
`
`the patient experienced early relief of
`Postoperatively
`both leg and back pain She returned
`to work less than
`months
`family business
`to
`surgery
`maintaining mobile homes At
`years after surgery
`reported mild residual heaviness in her
`but
`walking distances
`no
`limitation Her 2-year
`roentgenograms
`and 15 Continuous
`bone
`14
`
`after
`
`reported
`
`selling
`
`and
`
`she
`
`left
`
`leg after
`
`or
`
`pain
`activity
`are shown in
`the in
`
`Figures
`
`bridges
`area She demonstrates classic
`terbody fusion
`successful PLIF including
`
`continuous
`
`signs of
`bone
`
`trabecular
`
`Figure
`
`Lateral
`
`loss of disc
`
`height
`
`roentgenogram
`and recurrence
`
`taken
`
`February
`of slip deformity
`
`1989 shows
`
`Figure
`
`20 1989
`
`implants
`
`Up-angled
`anteroposterior
`roentgenogram
`months after surgery revision
`shows
`the cage PLIF
`of
`
`early appearance
`
`PLIF with
`
`taken
`
`July
`
`the carbon
`
`fusion area There is extension
`the interbody
`bridging
`the disc space She demonstrates
`bone graft throughout
`bone with vertebral
`cortical continuity
`of the interspace
`Her son
`bone
`above
`and
`below the interspace
`cage PLIF included
`three-level
`
`of
`
`in this
`
`body
`
`subsequently
`
`had
`
`report
`
`11 Discussion
`
`Results in lumbar fusion surgery are usually evaluated
`determining rate of clinical
`and
`success
`rate of
`fusion
`
`by
`
`success
`
`Although
`
`there
`
`definitions
`
`results
`
`as
`
`of excellent
`summarized
`
`are some
`variations
`in the
`good fair and poor surgical
`in Table
`the parameters
`
`addressed
`
`include
`
`status
`
`activity
`
`pain
`occupational
`level and use of medication.141920212426
`We have compared
`the literature Reports of surgical
`treatment
`shown an
`discectomies11216723253 have
`success of 66.5% and an average
`fusion success of
`85.1% Reports of
`by number of
`lev
`fusion
`success
`have shown an average
`fusion success of 90.0%
`els61322
`attempts 77.2% with two-level
`at one-level
`attempts
`and 65.4% with three-level attempts Our surgical
`
`our results with other
`
`clinical
`
`reports
`
`in
`
`of
`
`failed
`
`average
`
`results
`
`BR0002966
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 8 of 13
`
`

`

`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19267 Page 9 of 13
`
`Carbon Implant
`
`for PLIF
`
`Brantigan and Steffee
`
`2113
`
`or
`success
`interpreting
`The ETO allograft pseudarthrosis
`clearly evidenced
`
`by crushing
`
`failure
`
`of
`
`collapse
`
`of
`
`the surgical
`
`construct
`
`and
`
`in Figures
`the PLIF graft and
`by broken
`indicated
`
`is
`
`of
`
`radiographic
`
`fusion
`
`screws
`
`and
`
`vertebral
`
`displacement Cage
`
`fusions
`
`have
`
`the highest
`consistently met
`descriptive
`example the successful carbon cage
`and 12 is indicated
`bone bridging
`by mature trabecular
`interspaces with no lucencies in the fusion
`the vertebral
`The numeric format will
`in database
`be useful
`
`category For
`fusion in Figures 11
`
`areas
`
`comparisons
`
`of
`
`that
`
`larger patient study groups
`fusion both for
`Interpretation of successful
`interbody
`donor bone and for the carbon composite cages requires
`be parallel
`to the endplates Any
`the
`x-ray projection
`the interface
`view of
`obscures
`the essential
`
`plane Figure
`
`obliquity
`between graft and vertebra This is particularly true in the
`straight AP view in
`10 shows
`coronal
`to either L45 or
`is not parallel
`which
`the projection
`L5S1 These
`appear somewhat amorphous
`interspaces
`The up-angled projection
`in Figure 11
`to the
`is parallel
`L45 interspace and clearly shows
`detail not apparent in
`
`Figure
`
`restoration
`
`cage PLIF
`
`Lateral
`
`of disc height
`
`July 20
`roentgenogram
`and alignment with early appearance
`
`taken
`
`1989
`
`shows
`
`of
`
`favorable when compared with these previous
`appear
`reports Exact
`however
`comparisons
`because most of our patients
`backs
`causes Certainly the results
`of varying
`
`difficult
`
`failed
`
`are postsurgical
`
`are
`
`statistical
`
`are
`
`favorable
`
`to warrant
`
`multicentered
`
`pro
`into prog
`and
`inclusion
`
`are divided
`
`specific
`
`sufficiently
`spective study in which patients
`groups by
`and randomized
`
`nostically
`
`distinct
`
`exclusion
`
`criteria
`
`treatment
`to different
`by the Food
`study has been approved
`and Drug Administration and has been initiated
`have
`been
`Pseudarthrosis
`studied
`long
`been done During this century
`fusion
`surgeries
`most authors have agreed that
`the quoted fusion statistics
`of normal
`by uncertainties
`are flawed
`radiographic
`of determining fusion Authors who have used
`more precise methods
`fusion have reported
`of assessing
`rate as compared with authors
`twice the pseudarthrosis
`From Hibbs in 192915
`to
`using less precise criteria.82533
`in 1991 many authors
`in 197429
`Thompson
`have
`differ
`stated that only direct surgical exploration
`entiates fusion and pseudarthrosis
`We have outlined
`standard
`Table
`and
`have defined
`
`methods Such
`
`methods
`
`rates
`
`have
`
`as
`
`as
`
`to Brodsky
`
`radiographic
`
`criteria
`
`in
`
`5-point
`
`numeric scale for
`
`June
`19 1990
`10 Anteroposterior
`roentgenogram taken
`Figure
`not show the cages
`does
`year after surgery carbon cage
`PLIF
`does
`the
`the
`not parallel
`interbody graft because
`
`projection
`
`or
`
`disc
`
`space
`
`BR0002967
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1055, p. 9 of 13
`
`

`

`Figure
`
`cages
`
`as
`
`the details of the
`
`autograft
`bone
`
`view in
`
`the
`
`density
`
`postoperative
`cages are indistinct
`because
`have approximately the same radiographic
`the cancellous
`In Figure 11 at
`year after
`has become relatively more
`is now relatively
`the
`of
`
`Case 3:08-cv-01512-CAB-MDD Document 407-6 Filed 10/27/11 PageID.19268 Page 10 of
` 13
`Volume 18 Number 14
`
`2114
`
`Spine
`
`1993
`
`Relative radiodensities
`
`the straight AP view Optimum visualization of L5S1
`would require
`angle
`greater projection
`of carbon composite and bone
`provide an interesting index of arthrodesis
`for the cage
`PLIF The carbon
`not
`
`is
`
`radiolucent
`
`radiotransparent
`
`composite cage
`In the 2-month
`
`surgery the autograft
`dense in the interspace
`more lucent showing
`sign of maturing arthrodesis
`of 31/31 or 100% apparent successful
`using the several
`
`and
`
`cage
`
`the visible
`
`rectangular
`
`pattern
`
`configurations
`
`of
`
`struts
`
`as
`
`cage
`Our experience
`fusion
`
`interbody
`carbon
`
`is
`
`in surgical
`improvement
`cage
`significant
`for the PLIF procedure as compared with donor
`bone The fusion
`54.5% with
`rate of
`ETO-sterilized
`is typical of our experience
`allograft
`PLIF procedures in patients with this degree
`The fusion
`rate is also consistent
`complexity
`with the results
`
`results
`
`success
`
`6/11
`
`in
`
`of clinical
`
`success
`
`fusions
`
`goats
`
`of our histologic
`in goats In
`
`killed at
`
`study of
`interbody
`have
`year we
`
`Figure
`
`12 Lateral
`
`mature healed PLIF with
`
`roentgenogram
`the carbon cages
`
`taken
`
`June
`
`19 1990
`
`shows
`
`achieved 100% fusion with the carbon cages and 67%
`fusion with the ETO-ster