throbber
CLlN'iCAL ORTHOPAEDlCS AND RELATED RESEARCH
`Number 354, PP 28w88
`© 1993 Lipp‘mcotl Williams & Wilkins
`
`Computer Assisted Orthopaedic
`Surgery With Image Based
`Individual Templates
`
`Klaus Rade‘rmacher, Dipl-Ing*; Frank Partheine, Dipl-Ing*;
`Marc Anton, Dipl-Ing**; Andreas Zimolong, Dipl-Ingl;
`,Gii'nther Kaspers, MD“; Giinter Ran, PI;D*;
`V
`and Hans~Walter Stazzdte, MD**
`
`in computer assisted
`Recent dovelopmems
`surgery offer promising solutions for the trans,-
`lation :of the high acwracy of the preoperative
`imagingand planning into precise intraopérw
`ti‘ve surgery. Broad clinical appliéation is him
`dared by high costs, additional time during in-
`tervention, problems of intraoperaiive man and
`machine into:action, and the spatially con»
`strained arrangement of additional Equipment
`within the operating theater. An alternative
`'tochniquo'for computerizod tomographic image
`basal preoperative three-dimensional gunning
`and precise surgery on bone structures using in»
`divifluai templates has lie-on tievel‘opofit For the
`preoperative customization of these mechanical
`tool guides, a desktop computer controlled
`milling device is. used 'as a three-dimensional
`printer to mold the shape. of small reference an
`cos of the bone 'suufaw automatioally into the
`boxiy of the template. Thus, theplannod position
`and orientation of the tool' guide in spatial rela-
`tion to bone is stated in a struCtural way and can
`be reproduced 'intraoporatively by adjusting the
`
`
`From the *Heimholt: institute for Biomedical Engl~
`nearing; Aachen University of Technology, Aachen,
`Germany; and ”Department for Orthopedic Surgery,
`District Hospital Marienhohe Wflrselcn Germany
`Suppottéxl in part by the Earopoan Commissionto the
`framework of the Tciemmics Applications Program:
`(TAP) project
`IGOS (imago Guided Gribopcdic
`Surgery) project number HClOZfiHC
`Reprints requests to Klaus Radetmacher, Dipl-Ing-,
`Helmholtz lustiiut for Biomedical Engineering, Aachen
`University of Technology, Pauwelsstrasse 2'0, D620”:
`Aachen, Germany
`'
`
`position of the customized contact faces of the
`template until the location of exact fit to the
`bone is fount’i. No additional computerized
`équlpment or time is needed during surgery.
`The feasibility of this approach has been shown
`in spine, hip, and knee surgery, and it has been
`applied clinically for pelvic repositioning os~
`mommies inzacetabular dyspiasia therapy.
`
`Recent research activities in the area of com
`purer assistod surgery have concentrated on
`tho introductidn of additional sensor and robot
`based guiding systems into the operating the»
`ater to ooable admoate computer assisted
`transform] of the high accuraCy of preopera—
`tivo imaging and planning to prociso surgery
`Different promising solutions have boon do-
`volopod concoming the related problems of
`multimodal information processing and regis~
`nation. safety and sensor concepts, and ado
`quato control
`stwttegi$5.539,22 Nevertheless,
`problems still remain such as the time needed
`,imraoperafivoly for the interaction with addi~
`tionai technical system components, for the
`additional intraoperative registration of bone
`structures,
`the spatial arrangement oi" dis—
`plays, sensors and robot systems within, the
`operating room, the overall costs of the sensor
`or robot based systems, and mismatches rev
`gaming ergonomic design aspects of cogni~
`lion and manual control." An exact medical,
`technical, and ergonomic analysis is neces~
`
`WMT 1006-1
`
`WMT 1006-1
`
`

`

`Number 354
`September-.1998
`sary to identify during which phases and se-
`quences of intraoperative work additional
`guiding systems or even robotic assistance
`contributing a specific complementaiy .func»
`tion would be required.
`In this context, the task sequences of dif—
`ferent conventional orthopaedic. interven»
`ti‘ons Were investigatedfl16 such as total hip
`and total knee replacement surgery being
`typical applications for computer assisted
`Surgery systems9.19 One result of these in»
`vestigatinns was that observable activities of
`direct orientation6 only took. approximately
`2% to 4% of the overall operating tinielf all
`activities are taken into account that have
`some connection with exact
`threeédimem
`
`Sional positioning, their share of total inter~
`ventinn time is
`approximately 10% to
`15%)”6 Hence, the potential tn shorten op“
`erating. time and the related time. slot. for the
`introduction of computer assisted guiding
`systems, seems lobe limited; Prolongatien of
`the Operating time by additional intraopera~
`tive tasks and interactions with additional in-
`
`traoperative equipment can be tolerated only
`to a limited degree because of medical, orga—
`nizational, and economic reasons. In every
`case, it would have to be justified bya‘signifis
`cant. enhancement of the therapeutic. outw
`come. Moreover,
`the costs of additional
`equipment must be balanced against the rew
`quirement to deliver higher quality treatment
`to a'iarger number of‘patients.
`The goal of the work described here was
`todevelop a relatively simple, low cost 5.0111»
`tion that facilitates exact, safe, anti fast im-
`plementation of planned surgery on bone
`situctures,. eliminates the need for continua-l
`rad‘i’egraphic monitoring; and, avoids over-
`burdening surgery with complex equipment
`and time consuming procedures
`I
`
`PRINCIPLE 0F INDIVIDUAL
`TEMPLATES
`
`In orthopaedic surgery standard, template sys»
`, terns are familiar technical means-to guide
`drills and saws in total knee replacement.
`
`Surgery With l'mageyBased. Individual Templates
`
`29.
`
`However, the design of these tool guides is
`based on averaged anatomic geometries. The
`positioning of the template onthe bone bears
`no precise relationship to the position defined
`by individual preoperative planning.
`Essentially, the missing information is the
`precise spatial correspondence between the
`individual bone structure in situ and. the in—
`
`tended position of the toolgu‘ides.
`The author‘s
`investigated a means of
`adding this missing information to the class
`sic templates by- providing. shape based phys—
`ical matching between the reference surface
`of the individual bone and the reference sup
`.face of the computer based model. This in—
`formation is incorporated into an individual
`'tetnplate.1'2“1.6
`Individual templates are customized on the
`basis of three»d3irnensi0nal reconstructions of
`the bone structures extracted from computer-
`ized tomographic (CT) image data in accor—
`dance with individual preoperative surgical
`planning. For preoperative customization, a
`low cost desktop milling machine is used, as a
`threenvdimens‘ienal printer to mold the shape of
`a small reference area on the individual, bone
`automatically into the template. By thistneans
`the,planned position and orientation ofthe tool
`guide in spatial relation to the bone is stored in
`a; stmctnral way andcan be teproduced in site
`adjusting the position of the contact faces of
`the template until they fit exactly on the bone
`(Fig 2). Neither iterative time consuming work
`under tadiographio control or registration pm»
`cedures, nor any additional computerized
`equipment is needn‘t intraoperatively. Mecham
`ice! guides for (hills, saws, Chisels, or milling
`tools are adaptable or integratedinto these. indi~
`vidual templates in predefmed positions for
`different types of interventions. Moreover,in»
`dividual templates also canbe used forfixat-ion
`of a referenee base for stamiaxd tool guides or
`other devices in a defined position on bone;
`The individual, templates can be autoclaved
`and delivered to the operating room with the
`conventional instrument sets. The feasibility
`and adaptability of this, approach has been
`shown on anatomic models andin cadaver tests
`
`WMT 1006-2
`
`WMT 1006-2
`
`

`

`Clinical Oithopaedics
`and Related Research
`Radermacher at al
`.30
`
`
`3i HPRNClPLFOFlNDlViDUAL TEMPLATES ‘ Z.
`
`ix; {drill guide
`
`.
`
`
`
`Fig 1 Padid'e screw placement: (A) the principle
`of individual templates baseo on preoperative C?
`imaging and computer based planning; (3) com;
`outer assisted planning of a podicis screw place‘
`ment with the DISCS planning aysiemf- (C)
`interactive specification of the refemnce contam-
`taco; (D) iormclosod lniraoperative fitting of the
`iem'piate; and {E} radiographio control of
`the
`placement oi 5mm rods in {he pedicles without
`any perioration‘in situ
`
`for various applications-Almflé Results of in
`vim; studies on accuraoy- have been reported in
`previous'pilblioafionsfimfi
`Among the applications of this technique-
`are pefliclo screw placement (especially in sow
`liosis
`therapy; Fig 3};
`reposgiziomng
`0&-
`ieotomies in Spine surgery; puncture of a cystic
`cavity in the; femoral head; intemochanteric
`repositioning osicotomy; initial reference QS~
`teo‘tomies. for total liner: repiacemeni
`(espe—
`cially in. the case of pathologic defonnations};
`pedanetabular repositioning ostootomies; open
`door decompression in.
`the Cervical spine;
`transcorpoml decompression in the cervical
`Spine; and decomprossion in the lumbal spine,
`
`To depict ih’e spootrum and. potential of_
`various implementations of {he principle. of
`individual templates, four typical exampies
`will be, described in more detail, with ompha~
`sis on the clinical application of triple repo—
`sitioning osteotomies for the treatment of ac—
`etabular djysplasiafi‘ziMAS-m22
`
`.PEDICLE SCREW PLACEMENT
`
`Tho selection of a podicle screw of the. appro-
`priate lengthrand caliber and its accurate fixa-
`tion in the cortical bone of the. pedicles and the-
`vemab‘ra‘l body is essential for good anchoring.-
`Perforations are me major specific complim-
`tion of pediclescrew placements; implying a
`high risk of bone weakening or lesions of the
`spinal cord nerve roots, or blood vesscis37 To
`monitor
`the placement of
`the
`piloting
`Kirsohner wire and finally the screw as many
`as four to five radiographs in diffeient planes
`are recommended per screw placement} ”She.
`auihois selected this application for their initial
`investigations of {he principle of inciividual
`templates”'3 (Fig .1) Human anatomic speci-
`mens of lumbar Spinos were scanned with CT
`(slices. 2~mm thick and 2mm again). The im
`age data were. transferred fio the, personal oom—~
`puter based. DISCS planning workstation
`(Gamma mbH, Aachen, Gonnany}. Based on
`ihreodimensional accumulations auiomalj~
`cally provided by the system, the surgcon se~
`lects «an approgriato screw and defines itsiopti
`mal glacemant (Fig {B}. The position and
`orientation of the related drill, goiéo .lhen is
`specified: and can he incomrated into the indi«
`vidual temolate. To provide Shape based intra—
`oparative matching, small referoncc contact
`faces to the Vertabral bone have to be specified
`on the display in thervioiniiy of the; transverse
`process, the arch, or the spinous procoss. To
`this end, the surgoon interactively selects and
`positions an appropriate templatc, within the
`three~dimensional View of the vertebral bone
`structure (Fig 1C). The surgeon is supported by
`the systom, which automatioally constrains the
`positioning to the {inaction of {he definedbore
`axis and ovalllates this Quality of the contact,
`
`WMT 1006-3
`
`

`

`Number 854.
`
`SurgeryWilh Image Based Individual Templates
`September, 1998
`
`31
`
`
`
`Fig 2A,-B. Total knee arthroplasty: (A) laboratory- investigation on a plastic hone model (1'): individ—
`ual template guiding the reference osteotomy- (a) in tibial. bone, optional fixation with a bone pin (4);
`(,8) Customized reference contact taco. (5)1and copying profile (6) limiting cutting depth (7) to the dor~
`sat contour (6), of tibial bone.
`
`faco..Aftorward,rtho system automatically gem
`exams the. manufacturing program and Gus-
`tomizes the semifinishod. template with its into~
`grated drilling guides.
`Intraoperatt'Vely,
`the
`defined gosition of the: bore is reproduced by
`placing the self locating template when: it fits
`exactly on the bone. Additionally, an optional
`radiographie manual of the. position of the:
`stainless- steel {killing guide is possible, 136*
`cause the plastic maiotial of the template body
`is radiolucont. In two cadaver studios, in which
`
`one maceraled sgecimon and. one specimen
`with soft tissue were used, 5~mm horas, have
`been reproduced exactly according to the pre-
`operative planning without any perforation it;
`sttu.
`
`TOTAL KNEE ARTHRQPLASTY
`
`In total knee arthroglasty accurato placoment
`of implant components. with respect to the
`individual mechanical axis of the leg is es,~
`sential. Conventionally,modular mechanical
`(lettings. corrosponding to the‘intrin'sle shape
`of the, implant componoms am used to guide
`the os‘teotomies- and bows for thoprepataiion'
`of the, implant’s seat.- By- motlnting these
`conventional tool guide systems on an indi-
`vidual 'tomplato as a basic customized. refer-
`ence, it is possible to reproduce the p‘tt’ooper~
`atlvely ‘plannotl posltion exactly even in the
`
`case of sevotely deformed bone. Mommas,
`for proser‘vationof the posterior cruciate lig—
`aments and the nerves and vessels inthe holv
`
`low of the knee, not'onl’y' the reference sup
`face of the: bone but also .3 copying surface
`limiting the cutting depth to tho dorsal com
`tour of tho tibia can be molded into the tem-
`
`plate (Fig ;23). The geometry of the saw has
`to Abok-noWn and a calibrated copying cam
`has to be mounted on the conventional Saw.
`Figure 2 shows a feasibility study with a
`CT image based indiyidual template for the
`.reference_ tibial out for total knee replacement
`on a plastic bone model.15 The geometry of
`the cut with its position, orientation, andlimi~
`nations was; planned on the basis of CT images
`(slices 24mm thick and 2mm apart). In addi»
`tion, topogtams could be» used. to identify the
`bone; axis. A conventional saw guide: can be
`mounted on the individual. template, :Whléh
`serves as a reference base :er subsequent
`work on the‘bone. The template hasfbeen ens;
`tomized in the areas :of‘ the reference surface
`
`the individual copying yrofile. corre~
`and,
`sponding to the dorsal contour of the tibial
`bone within the out plane. The accuracy of- the.
`reproduction was measured: directly (on the
`bone model using a conventional precision
`goniomotor and 3 cannot gauge. The prede~
`fmod-cut plane and the position of'the copying
`profile limiting the cutting depth were repro-
`
`WMT 1006-4
`
`WMT 1006-4
`
`

`

`
`32 , Radermaeher et‘ at
`
`Clinical Orthopaedics.
`and Related Research
`
`duced with an accuracy better than 1 mm in
`all directions and 1° inclination in the sagittal
`and transverso planes.
`
`OPEN DOOR DECOMPRESSION IN
`CERVICAL SPINE
`
`The authors investigated the possibility of exp
`plying this principle to open door decompres-
`sion in» the cervical spine, which involves
`even more delicate constraints on the required
`accuracy of imaging, planning, and imple~
`meniscionJ‘tel5 The task is to mill away one
`side of the lamina completely and to preserve
`the anterior cortical layer on the other side,
`which acts as a hinge for. the dorsal open door
`laminoplasty.‘ Figure 3 shows a corresponding
`design-of an individual template and the le~
`ning and intraoperatiye implementation in the,
`framework of la cadaver studyflii"! Applying
`the principle of copying profiles, a miniatun
`sized copying: cam corresponding to. the geom~
`.etry of the. milling tool was mounted on a
`standard micromilling machine, with a sliding
`jig piste to guide flie‘micromill perpendicular
`to the template. A boats with a defined depth
`was provided in the template» for a final on site
`calibration of ' the length of the milling tool.
`with respect to the copying cam Then, both
`laminetomies were performed within less
`than 19 minutes, subsequently removing sev»
`era} layers of bone to less then 1 mm on the
`left side and approximately 1 mm on the right
`side The mieromillin'g tool was guided by the
`copying profile, leaving the anterior cortical
`hinge of the right lamina intact. It perforated.
`only slightly at two. points on the left; side
`without damaging the dura'(Fig BEE-F).
`
`TRELE OSTEOTQMY on PELVIC
`some non THE TREATMENT on A
`ovsseasrrc HIP JOINT
`
`Periacetabular triple osteotomy for the. treat,~
`ment‘ of hip dysplasia was chosen asthe first
`exemplary clinical application of individual
`templates.Wt“8 in acetabular dysplasia the-
`taslc is to enlarge the weightbearing part of the.
`
`acetabulum covering the femoral head to re~
`duce- the pressure on this» area to physiologic
`limits. The major metapeutic goals are relief
`from pain and prevention of premature os—
`‘teoarthrosis.
`
`Using the operative procedure reported by
`'l‘onnis20 and Tennis and coworkers,2i the ac»
`
`etabulurn has to be mobilized by three os—
`teotomies, which have to be pert-buried in a.
`defined position and orientation in relation. to
`the acetabulum. If the distance from the so
`etabulum is too short there is, a higher risk of
`avascular necrosis, and, if the acetabular frag
`.ment becomes too large its free rotation may
`be impeded]?l Moreover, the inclination of
`the out planes influences the ability to rotate
`the fragment freely :in' a specific direction.
`Conventionally, the three osteotomies have to,
`be pertonned under repeated radiographic
`control. The iSChial osteotomy has to meet
`the obturator foramen and preserve the sciatic
`nerve and the sacral ligaments. Although the
`public osteOtomy is less oxides}, it is directly
`adjacent tothe femoral vein. For the manipw
`lation and repositioning of the acetabnlum‘, a
`Schanz screw has to be fixed on the acetabu-
`iar fragment. The final iliac osteotomy has to
`meet the distal part of the incisura ischiadic‘a.
`This is the longest and most difficult os-
`teotomy and has the greatest, influence onthe
`mobiiity of the .acetabular fragment and the
`initial stability of the fixation.
`For the repositioning of the acetabulum,
`empiric standard values still are based on bi~
`planar xray projections» in the antsroposterior
`(A?) and fans profile planes. According to
`Tennis at lel lateral center edge and anterior
`center edge angles of approximately 30° to
`3.5" should be achieved; Additionally, three—-
`dimensional CT imaging is recommended
`for diagnosis
`and surgical planning to
`achieve more accurate and reliable {1338532
`merit of the individual anatomic and Home
`
`chemical conditions in the weight'oearing‘
`area of the hipJ'ZtB-sm Nevertheless, the au-
`thors know of no Validated. standards based
`on three~dimensional imaging, comparable
`with the empiric data provided by, Tonnis et
`
`WMT 1006-5
`
`

`

`.
`Number 354
`
`September. 1998
`Surgery With image Based individual Templates
`33
`
`
`
`Fig“ 3. Open door: decompression in-ihe cervical spine: (A) daslgn of an lndiwduai templata (2} with
`a cap’ying pmfile (6) limiting cutting depth 0f the milling head {7) is the anterior cortical layer of the
`lamina (1); a micmmiliin‘g machine (4) is equipped with a-s‘iiding jig platé (8); (B) planning of the
`milling work on bone, arrows. indicating the specified are of bone to be removed; ((1) the; reference to
`the bone structure is provided by .an individual contact lace (9); the two individual parts of the tem-
`plate are cemented by a simple adapter (10): (D) intraoperative eXecutian in the framework of a ca~
`daver study; (E) result on the left side showing the intact-slum; and (F) result on the'righl side with the
`intact cOrllcal hinge.
`'
`
`WMT 1 005-5.
`
`WMT 1006-6
`
`

`

`
`
`34 Radermaoher et at
`
`Clinical Orthopaedics
`andReleted Research
`
`al?‘ Therefore, in addition to the conven-
`tional technique, the authors use a combina—
`tion of anterior center edge and lateral center
`edge angle measurements in AP and faux
`profile xray projections reconstructed from
`CT data. automatic measurements of the an-
`terior center edge and lateral center edge an-
`gles on the reconstructed threevdimension‘al
`hone model, and an analysis of the surface
`coverage of the femoral head in the weight~
`bearing zone. Comparison and evaluation of
`these different assessment methods are sub~
`jects of ongoing research.
`Computed tomographic scans» of the pa-
`tients normally are done at 3‘ to 4—mm slice
`distances with 30 to 40 images including one
`AP topogram. The data are transmitted to the
`DISCS planning. system with which a non—
`technieal user can generate individual tem~
`plates antenomously. The entire computer
`based surgical planning session of approxiv
`mately 5 to it) minutes is subdivided into
`sections,
`for
`three~dimensioiial diagnosis,
`planning of osteOtomi-es, Simulation: and bio!
`mechanical analysis of the repositioning, and
`the specification of appropriate reference
`Contact faces of the template on bone.u At
`the beginning'of the planning session the
`surgeon selects the type of intervention and
`the specific surgical technique. After this se-
`lection. he or- she is guided along the subse—
`quent steps of surgical planning according to
`established guidelines and handbooks
`To plan an osteotomy, the surgeon defines
`a margin of safety of 14 to 20 mm of all cuts
`from the acetabulnm. The system automativ
`Cally generates a corresponding periacetabu-
`lar safety sphere and automatically constrains
`the Specification of all three osteotornies to
`be tangential to this sphere (Fig 4A}. Thus,
`the interactive manipulation and definition of
`the osteotomiesis facilitated significantly be—
`cause ~only the inclination of the cut planes
`has to be adjusted interactively in the Sagittal
`and transverse planes, and optimal mobility
`of the acetabular fragment is. guaranteed. A?»
`ter.
`the virtual
`implementation of V the» os«
`teo‘tornies and automatic segmentation of the
`
`acetabulum and the femoral bone, the acetab~
`ular fragment Can be manipulated directly by
`the surgeon in the transverse and sagittal
`planes just as it Would be done during
`surgery (Fig 4B). For each position, the sys-
`tem automatically calculates the resulting an~
`terlor center edge and lateral center edge aria
`gles from the three-dimensional} model and
`enables three-dimensional analysis of the
`coverage of'the. femoral head; Moreover, the
`mobility of the acetabular fragment can be
`analyzed to become "aware of potential collie
`alone with the surrounding bone struatures
`and the possibilities of fixating the fragment
`canbe assessed The entire planning session
`is documented by the system, and printouts
`of all relevant planning stages and parame-
`ters, including the exact angles o'f'the’ correc‘
`tion- in the sagittal and transverse planes. nec»
`essary to achieve the planned lateral center
`edge and anterior center edge angles, can he
`provided automatically
`the Surgeon cle—
`After this, planning step,
`eides for which osteotomies he or she wants to
`use a customized {tool guide, The pubic out is
`not critical and does not require an individual
`template. Clinical trials also have shown that
`the ischial osteotomy is facilitated sufficiently
`by the preoperative planning step and the in»
`traoperative identification of the appropriate
`anatomic landmarksNevertheless, individual
`templates for the iscltial osteotomy can be
`manufactured if. desired and have been used in
`some clinical cases.“ In contrast, an individ—
`ual template always is, used for the most criti-
`cal iliac deteotomy. As the positioning of the
`template already is defined partially after plan-
`ning of the osteotomy,
`the surgeon can be
`guided by the system in an efficient and into—
`itive way. He or she uSes the three—"dimen—
`sional View to specify the direction of his or
`her surgical approach. and the desired position
`of the template on the bone The final step in-
`volves the automatic milling of the template
`Then, after 5 to 10 minutes ofinteractive sur-
`gical planning and 10 to 20 minutes. automatic
`desktop customization. (Fig. 4C), the individual
`templates can be labeled, packed, and Sterilr
`
`WMT’ 1 006-7
`
`WMT 1006-7
`
`

`

`i
`
`Number 854
`September. 1998
`
`
`
`Surgery With image Baaed Individual Templates 35
`
`m
`
`Fig 4‘, Triple pelvic osteotomy: (A) planning of the iiium asteoiomy; (B) simulation of the repositia’n—
`ing; (0) DiSQS pianning station with a desktoga maiwfacturing unit; (0) the intracperaflve imiset with
`different individual templates (-1). adaptabie stainless 'steei too! guides (2). and optionai bane pins
`'(3); (E) intraoperatiVe 'use;tand {F} radiographic wntmi; PC, a: personal computer.
`
`izsd by conventional swam, Because the tem~
`plates can be autflciaved to 135°C, they can‘be
`ready for surgery within less than 1. hour afier
`the transmission ofvthe CT image data.
`Data an 24 triple osteommies collected be~
`tween March 1996 and March 1998 are
`shown in Tabla 1. in this group, 11 intarvew
`'tions have been done in the conventional
`manner and 13 interventions have, been done
`using individual templates, In four cases mi:
`templates could not be‘positioned exactly. Be-
`cause. of very strong soft. tissue:g the comact
`
`face bstwaen the template and bone ihat had
`been specified during pianning the i11t¢rven~
`tion was not accessible without additional’ra‘
`section of 39ft tissue. This prbblem has man
`overcome by a new éesign of the templates
`and the tool guide‘, Positioning of the refer,—
`ence contact face of the; iliac. tempiate on the
`anterior supcarior iliac spine medial and cm»
`nial to the cutpl'ane allows the best access to
`the bone. surface through 31658 invasive surgi~
`cal approach. After these modifications the
`templates could be. positioned appropriately.
`
`WMT 1006-8
`
`WMT 1006-8
`
`

`

`36
`
`Radermacher at al
`
`Clinical Orthopaedics
`and Related Research
`
`TABLE 1 . Triple Osteotomy Interventions March 1996 to March 1998
`
`Number
`of
`Interventions
`
`Number of
`Interventions
`Without individual
`Templates
`
`I Number of
`intervemions
`With, individual
`Templates
`
`Optimal,
`Positioning
`of Template
`and Cut‘!
`
`Failed
`Positioning
`oi
`Templates
`
`10
`10
`4
`24
`
`7
`3
`1
`l 1
`
`8
`1 t 6*”
`31111
`'1-3»
`
`1
`5
`3
`9
`
`‘2
`2
`01:
`4
`
`Year
`
`1996
`1997
`1998
`Total
`
`‘Subiectively assessed by means of radiographs.
`“With the new integrated DiSOS'planning'and manufacmring's‘ystem,
`
`Intraoperatively the main benefit of pre-
`operative planningof individual templates is
`avoiding ,an iterative search of the optimal,
`cut planes and correction angles. under rea
`\peate'd radiographio control, better mobility
`of'the ace‘tabulumt, and a shorter time of in~
`tervention. The template can be fixed option»
`ally by a bone pin orheldby the assistant ns~
`ing- a .flieitiblo handle (Fig 4D—E). A single
`radiograph is used to confirm the po‘sitionof
`the tool guide, after which the osteotorny can
`be performed with an oscillating saw and 013+
`tion‘ally finishedrwith a chisel (Fig 4F).
`In addition to redesigning templates for a
`more medial approach to the iliac wing; nu«
`merous other changes have been made in, the
`course of developing the approach described
`in this gape; These include modified patient
`positioning (lateral and supine as described
`by Tonnis. at £11“) and the ass of a new type
`of saw (jigsaw). Only data from interwar)»
`lions that were done under comparable eon—
`dltions have been considered for additional
`analysis; All
`templates were planncd and
`manufactured using the new integrated
`DISGS station, and all patients have been
`operated on by the same surgeon, who had
`more than 12 years-eXpetience with this type
`of intervention.
`
`In a first analysis of data from 10 intern
`venti‘ons of. this type collected during an on
`going. comparative study between January
`1997 and March 1-998-(Table ,2), the mean ef~
`festive time of ,intraoperative xray monitor»
`ing was reduced by morethan.75%, and the
`
`mean time of intervention was reduced by
`25% compared with the conventional proce-
`dures without individual templates. The ex—
`act positioning of the osteotomies resulted in
`optimal mobility of the acetabulum, which
`could be repositioned according to the.
`planned values. No additional soft tissue had
`mine removed and the periosteum was pro»
`served in every case.
`
`BISCUSSION
`
`Although the number of cases has been, too
`small to derive reliable statistical data,
`the
`preliminary results are promising. The indie
`vidual template approach represents a rela-
`tively simple, low .cost; and easy to use. solu—
`tion.
`that
`facilitates precise. preoperative
`planning and. appropriate intraoperative im~
`‘plementation. The eoHVentional, intracpexa
`tive procedure is preserved and no additional
`intraoperative registration steps, computer-.
`ized equipment,
`space, or personnel are
`needed, Continual fluoroscopic monitoring
`can be avoidori, fewer radiographs are needed;
`and the duration of intervention is reduced ..
`The position of best‘fit for positiouing the
`template can be found easily by hand, be—
`cause no significant free motion of the tem—
`plate should occur while pressing the tem—
`plate slightly against thel'bione. Because of
`the structured surface 0f the templates’ con».
`tact faces and the redundancy of the surface
`based matching; the templates are suffi-
`ciently robust against. preparation artifacts
`
`-WMT 1006-9
`
`WMT 1006-9
`
`

`

`Number 354
`September. 1998,
`
`
`Surgery With Image Based IndividualTemplmes
`37
`
`TABLE 2 Preliminary Results of the Comparative Clinical Evaluation
`10 InterventionsWith StandardizedTechnique
`and Boundary Condlfle‘ns
`
`Five Interventions
`Fina Interventions With
`
` January 1 997 to March 1998 Individual Templates Without- Individuai Temp/ates
`
`
`105485
`105430.
`Time of intervention (minutes)
`157
`118
`Average (minutes)
`170
`120
`Median (minuies)
`0.08% .45
`0,064.34
`'lntIaoperative radiograph time (minutes)
`0.65
`0.15.
`Average (minutes)
`0:07
`0.23
`'MedIan (minutes)
`
`(such as small quantities of remaining soft
`*tisSue or small defects in the modeled sur~
`face} The periostcum can, be preserved.
`one main drawback of the, approach is
`that it depends. on preoperative CT imaging.
`Moreover, no percumneous applications are
`possible, (except in dental or maxillofacial
`surgery}. Lamellar contactvfa‘ce‘s (with ribs or
`arrays of pins) could. be manufactured to
`Campgns‘ate' to a limited. extent for: remaining
`soft tissue.” But as in mast sensor based sun
`face registration techniquesr the accuracy
`and reliability of this {echniqun depn'nds 0n
`{the .ac‘cassibiiity and apprnpziate intraoperaw
`tine identification of the rigid. reference
`structures. segmented am} modeled in the
`preoperative image data.
`Fumra research wiil be dedicated to the:
`ongoing clinical evaluatinn oi? the nemom
`Skater system ’er pelvic surgery in crisper»
`mien with additional clinical centers. The >
`bannfit for less expnrienced surgwns and
`the infinénce on the intervention specific
`learning curve will be investigated in more
`detail. Because postoperative 'CT scanning
`of patients docs n0: seem justifiable, acidi~
`tiona'l cadaver” studies will be conducted :0
`obtain more quantitative. data'on. the, overall
`accuracy of the technique. It is planned In
`intngrate additional tool‘s into Ina system (in
`particular for hip, knee, and spine surgery),
`magnetic mannance image processing mad,—
`
`ules and enhanced, models fOr efficient bio—
`
`mechanical analysis.
`
`References
`
`(I.
`
`I. Abel ME. Sutherland DH, Wenger? DR. ‘et rah'E‘valIIa»
`Iion of CT. scans and 3.13 Iefoxma’lted images "for;
`quantitative assessment of the hip. 3 Pediatrv Onhop.
`{4:48413 3994
`,
`2,, Axum H Taned'a H i‘garashi H: Evaluation of ac«
`- elabular coverage: Three-dimensional CT imaging
`and modifiad pals/w inlet view J Pediatr Orthop‘
`113654769 1991
`3. Bauer R Kerschbaumer F, Poise! S: OnhopadIsche
`Walicflsleme. Stuttgart, ThiemeNeflag 1994,.
`‘4; Brunner R, Robb 1: Inaccuraey nf the migratinn per
`centage and cenLer~edge angle in predicting femoral
`head IiispiacementIn cerebral 13111831.} Radian Or-
`thop 5:239L2411996
`' 5. Cinquin P, Bainville E,Barbe C, at 81: Computer as:
`sisted mehical intewencinns IBEE Eng Med Rial
`14:254~»263, 1995‘
`'Facaoaru C Fricling B; Ve‘xfahren zur Ermitllungm~
`fonnatonscher Belasmngw Z Arbeitswismnsnhafi
`39:63—72,1985
`7) Jerosch 3, Malms 3 Castro WHM Wagner R,
`Wicsncr L: Lagekomrnlle. vnn PedikelschI-auben
`flashmmumzntiermr domain: Fusion der Lendenv
`wirbalsfiulnlmthop1302479483 1992
`‘8'. Kiwi: KL, Wallin A, Ganz R: (LT eValuation of seven
`age and cong’mency of the hippnor to osteoto‘my
`Clin Onhnp 232:15~25 1988
`9'. Matsen 113 FA Garbini 1L, Sidles 3A, et-al: Robotic-
`assistance: in nnhopaedic surgery: Aproof of princi-
`ple using distal femoral aahroplasty Clin thop
`296: 178486, 1993.
`10. ,Millis MB Murphy SB: Use of computed tonic»
`graphic rcwnstmmion in planning asteotomies of
`vthehipClinOrt’hop 2741544159 1992
`l}. Ponheine F, Radermachcr K Ztmolong A et a1:
`Development of a Clinical Dcmonsnator fer
`
`WMT 1 006-1 0
`
`WMT 1006-10
`
`

`

`38
`
`Clinical Orthopaedics
`Radermaoher et al
`and Related Research
`
`Computer Assisted Orthopedic Surgery with CT
`Image Based Individual Templates. In ’Lemke EU.
`Vannier-MW, Inam‘ura K (eds). Computer As~
`vsisred Radiology and Surgery. Amsterdam, Else
`vier'944—949, 1997.
`,
`,
`,
`Radermachor K, Prothoine‘ F, Zimolong A. et al:
`Image Guided Orthopedic Surgery Using Individ~
`ual Templates~~Experimental Results and As-
`pects of the Development of a. Demonstrator for
`Pelvis Surgery.

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket