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Surgical Technique - Global Orthopaedic Technology

1. 68 Proudly distributed by Global Orthopaedic gt Technology Unit 10 7 Meridian Place Norwest Business Park Baulkham Hills NSW 2153 Toll Free 1800 456 225 Phone O2 8887 0100 Fax 02 8887 0199 globalortho com au Reorder No PMC 004 Rev 07 11 Copyright 2011 OMNIlife science Inc All rights reserved OMNIIife science APEX Robotic Technology A R T APEX Knee Praxim Robotic Cutting Guide and Bone Morphing are trademarks of OMNIlife science Inc Praxim NanoBlock and Surgetics are trademarks of Praxim SA 7 OMNIIife science Inc 50 O Connell Way Suite 10 East Taunton 02718 www omnils com North America Tel 800 448 6664 Fax 508 822 6030 International Tel 1 508 824 2444 Fax 1 508 822 6030 OMNIlife science an Orthopaedic Synergy Company
2. Slope angle in the tibial cut degrees Tibial plateau resection height medial and lateral mm a Axial rotation ref pointer axis cut degrees GLOBAL VALUES Accuracy measure between the Flexion measure degrees pointer and the bone mm Axial rotation ref tibial plateaus 5 00 X Accuracy measure between the Angle measure when the leg is in the hyper extension degrees Accuracy measure between the Angle measure when the leg is in the pointer and the femur mm hyper flexsion degrees Hip Knee Ankle alignment measure in the frontal plane of the leg degrees d pointer and the tibia mm SZ Al 99 INSTRUMENT LIST NAVIGATION PRODUCT NUMBER DESCRIPTION DIAGRAM 0501 5000 POINTER P 2 REFERENCE 0501 5020 FEMUR F REFERENCE 0501 5030 TIBIA lt lt T gt gt REFERENCE 0501 5070 GUIDE lt lt G gt gt REFERENCE 4148 2000 MULTI DIAMETER QUICK SOCKET SELF TAPPING SELF DRILLING BONE SCREWS 4148 1001 4148 1002 FORT OR E REFERENCE 24 LENGTH 120MM 150MM 4149 5000 TWO PIN UNIVERSAL FIXATION UNIVERSAL REATTACHABLE JOINT 06 9 CUT CONTROLLER WITH REATTACHABLE 4161 5100 FIXATION INTERFACE DRILL GUIDE OMNI APEX W REATTACHABLE 4161 5400 FIXATION INTERFACE 4137 5000 NANOBLOCK 4137 2050 NANOBLOCK INITIALIZATION SOCKET 4146 5000 REATTACHABLE FIXATION FOR G 9 144
3. For a CR Trial Femoral Component KS 1410 to 5 1460 L amp R and after developing a satisfactory trial reduction the holes for the final femoral component are made with the Femoral Post Drill WS 10130 which passes through the corresponding distal orifices of the Trial Femoral Component Tibial Bone Preparation With the Trial Tibial Tray fixed in position the bone bed can be prepared to accept the tibial keel appropriate size Tibial Keel Broach WS 20124 to WS 20126 is attached to the Tibial Punch Guide WS 20123 by pressing its shaft button and is released once the broach is attached With the punch handle in the raised position place the Tibial Punch Guide on the Tibial Tray Assure that the face of the punch guide is flat against the tibial trial Impact the proximal strike plate with mallet blows until the Tibial Keel Broach is fully seated on the tibial tray trial Once the broach is fully seated retract the guide by hitting the handle in the reverse direction with the mallet 92 SURGICAL TECHNIQUE Final Component Implantation The APEX Knee system does not require a specific implantation sequence following steps describe the implantation process of implanting the components All trial components and resection surface tissue debris should be removed It is recommended that thorough cleaning of all bone surfaces and soft tissues be performed using pulse lavage Tibial Bas
4. head of the hip in the frontal and the sagittal plane the trans epicondylar or posterior condylar axis This will align the pins with the femoral resections in the sagittal plane the tip is in contact with the center of the anterior cortex in the area of the implant apex This will position the screws posterior to the anterior resection and length of Praxim Cancellous Bone Screws 4145 5003 or 4145 5004 Using a power drill equipped with a Multi Diameter Quick Socket 4148 2000 insert the Cancellous Bone Screws by drilling them until they disengage from the socket and are completely inserted into the Femur Bone Fixation Base Only a small portion of the screw ends should be protruding out of the fixation base Remove the clamp 20 Positioning of T and F Tighten the fixation base with the H3 5 screwdriver 9 144 Attach the F reference 0501 5020 to the Fixation Base with the 45 angled Reattachable Adaptor 4154 5100 and tight in position using the H3 5 screwdriver Align the optical markers of the femoral reference with the sagittal plane of the femur Note It is possible to replace the 45 angled Reattachable Adaptor 4154 5100 with the Universal Reattachable Joint 9 Adaptor 4154 5000 IMPORTANT Check that there will be no problem with line of sight to the camera and ancillary instrumentation used through range of motion of the femur and tibia Check visibility
5. debris the final tightening of the tibial baseplate retaining bolt is performed With the knee in flexion the Torque Wrench KS 31000 is used to achieve the final tightening of the bolt Note Turn the driver until the arrow reaches the first calibration line 60 in lb Take care not to tighten to the 100 in lb line 06 Final Alignment Validation A final check should be performed prior to closure Any remaining excess cement should be removed Final assessment of alignment stability range of dil E motion and patella tracking should be performed MR Press on the screenshot button if desired at any time to save a picture in the post operative report E FINAL ALIFNMENT CHECK Step on the blue pedal to record the final alignment and proceed to report recording The final varus valgus angle and the maximum flexion and extension can be measured at this stage Ihis information can then be compared to pre operative alignment results using the same test asuma icr t z Flex and extend the leg to check for any initial flexion deformity and the maximum flexion Optionally the screenshot button can be pressed to save the information for different positions Ihe leg position at the time of the validation will be automatically saved in the post operative report Step on the blue pedal with the leg in extension to record the final alignment and proceed to closure
6. of F and on the screen in maximum flexion and in extension Adjust the orientation of the references as necessary and proceed ase sere e E a s 1 _ 8l D Click on the blue arrow or step on the blue pedal to proceed to the next step 21 gt Begin the hip center acquisition by stepping on the blue pedal and then rotating the femur Ihe diameter of rotation around the femoral reference must be at least 15cm but the speed and direction of rotation does not matter Make sure the hip does not move otherwise the hip center will have to be reacqutred ANKLE SENTER Place the Pointer P on the most distal point of the medial malleolus D Step the blue pedal to record the position of this point Place the Pointer P on the most distal point of the lateral malleolus Step on the blue pedal to record the position of this point Except when Manual option is selected the PENE ad system uses tbe middle of tbe lateral and medial malleolus to determine the center of the ankle 22 Anatomical Acquisitions Calibration of the Femur Bone Fixation Base Calibrate the Femur Bone Fixation Base 4145 5100 by placing the tip of the pointer P in each of three 3 calibration cones located on the top surface Ae A E Check the visibility of P and references B Step on the blu
7. of the slope for positioning the implant 28 Anatomical Acquisitions Medial Tibial Cut Height Reference MENU Place the tip of the P on the medial cutting height reference B Step on the blue pedal to record the position of this point Lateral Tibial Cut Height Reference ETP Place the tip of the P on the lateral cutting height reference L Step on the blue pedal to record the position of this point Note The highest of these two cut height references is used by default to set the tibial resection level at 10mm 29 Anatomical Acquisitions Medial Tibial Side ETP Bone Morphing Technology Place the tip of the P on the medial border of the tibial plateau D Step on the blue pedal to start the acquisition Glide or paint the tip of the P until the green bar fills up maintaining constant contact Note This surface is used to determine the size and centering of the implant Cover a surface as large as possible in all directions Lateral Tibial Side ETP Bone Morphing Technology Place the tip of the P on the lateral border of the tibial plateau B Step on the blue pedal to start the acquisition Glide or paint the tip of the P until the green bar fills up maintaining constant contact Note This surface is used to determine the size and centering of the implant Cover a surface as large as possi
8. other axis with the H3 5 screwdriver Note Take care to properly align screws before tightening to avoid stripping the threads Praxim Robotic Cutting Guide Installation Connecting the Praxim Robotic Cutting Guide to the Control Box Keep the Praxim Robotic Cutting Guide and most of the connecting cable on the operating table and hand off the other end of the cable to a non sterile person to connect it to the Praxim Robotic Cutting Guide Control Box attached to the A R T station Ihe red dot on the connector should align with the red dot on the connection port of the Control Box Step the blue pedal to proceed to the next step Note Make two 30cm vide loops with the Praxim Robotic Cutting Guide cord to prevent any accidental pulling of the cable Draping Technique Carefully place excess cable under the sterile drape to avoid inadvertently pulling or stretching the cable during surgery Step on the blue pedal to test the Praxim Robotic Cutting Guide before proceeding to the next step SURGICAL TECHNIQUE Positioning of I and F Placement of the T reference Place the first 3 2mm Bone Screw 4148 1004 or 4148 1005 approximately four fingers below the tibial plateau using the Multi Diameter Quick Socket 4148 2000 The placement of the second screw can be done using the Two Pin Universal Fixation 4149 5000 as a drill guide For improved stability leave at leas
9. size or any size smaller than the tibial tray can be used This permits selection of the tibial insert that best matches patient anatomy while assuring that the tibial insert always matches the femur for optimum congruency stability and wear resistance 99 APEX ROBOTIC TECHNOLOGY Final Component Implantation Retaining Bolt Implantation The Insert Retaining Bolt is threaded into the tibial baseplate If the retaining bolt does not thread easily into the hole first check that the tibial insert has been completely pushed onto tibial baseplate Also check for debris that may be obstructing the insertion of the bolt Note Final tightening of the insert bolt should be performed after the patella has been prepared the cement has hardened and a final inspection for excess cement or debris 1s complete Patellar Component Implantation patella surface and the back of the patella component should be coated with cement Ihe patella component is then attached to the patella The Patella Reamer Clamp Foot Assembly WS 40020 is then attached to the Patella Reamer Handle Assembly WS 40015 and both are used to compress the patella component firmly onto the patella Note Gare must be taken to avoid excessive compression as this may damage the patella Excess cement should be removed Final Tightening of Retaining Bolt Once the cement has hardened and the tibial tray is inspected one last time for excess cement and
10. up maintaining constant contact Note This surface is used to determine the lateral posterior reference point Cover a surface as large as possible in all directions 24 Anatomical Acquisitions Medial Distal Condyle zx a cone Bone Morphing Technology Place the tip of the P on the medial distal condyle B Step on the blue pedal to start the acquisition Glide or paint the tip of the P the distal condyle until the green bar fills up maintaining constant contact Note This surface is used to determine the medial distal reference point which defines the distal resection height Cover a surface as large as possible in all directions Medial Side m i METHAL IDE Bone Morphing Technology Place the tip of the P on the medial side of the femur about 10mm from the distal medial surface B Step on the blue pedal to start the acquisition Glide or paint the tip of the P on the side of the femur until the green bar fills up maintaining constant contact Note This surface is used to visualize the ML size of the femur Cover as large a surface as possible in all directions 25 Anatomical Acquisitions Lateral Distal Condyle Cina Ty Bone Morphing Technology Place the tip of the P on the lateral distal condyle B Step on the blue pedal to start the acquisition Glide or paint the tip of the P on the distal condyle until the green ba
11. 4161 5100 by placing the tip of the Pointer P 20501 5000 in each of four 4 calibration cones located on its face Check the visibility of P and references B Step on the blue pedal to register each 4 cone Instrument Calibration Praxim Robotic Cutting Guide Cutting Guide Calibration Use the push button to attach the G reference 0501 5070 to the Praxim Saw Guide 1 27mm 4146 5200 using the Reattachable Fixation 4146 5000 Calibrate the cutting guide 4146 5200 by placing the tip of the Pointer P 20501 5000 in each of four 4 calibration cones located on its face Check the visibility of P and references Step on the blue pedal to register each 4 cone INSTRUMENT CALIBRATION RECOMMENDATIONS Do not push too hard on the pointer during calibration so as not to cause deflection of the tip of the pointer Position the pointer as perpendicular as possible to the face of the instrument where the cone is located during digitization Make sure that the ball tip of the pointer is completely seated inside the cone Make sure that the instruments are in the center of the camera field of view depth and centering during calibration Use the same side of the pointer when digitizing each cone of one instrument Praxim Robotic Cutting Guide Installation E Motor Insertion Guide Enclosure Body In
12. 48 1004 or 4148 1005 using the Multi Diameter Quick Socket 74148 2000 Always start with the center hole as this eases adjustability by providing a hinge point The two outer holes are converging Depending on bone quality use two or three pins to achieve stability 44 Tibial Cut Navigation IN T ae e e lt Navigated Adjustment Adjust each of the three 3 NanoBlock screws using the H3 5 Screwdriver 9 144 following the directions on the screen uu IESU I E 1 In the example above the yellow screw needs to be turned clockwise Once all the screws are green the final position is reached Place the NanoBlock Screw Head Stabilizer 44137 5051 onto all 3 screws Note The tibial cut height can be adjusted at this point Use the touchscreen to adjust the cut if desired and then adjust each of the 3 NanoBlock screws following the directions on the screen Step on the blue pedal to record the position of the NanoBlock and proceed to the next step 45 Tibial Cut Navigation aine zi eje 4i Cut For easier access remove the G from the NanoBlock using the push button on the reproducible fixation After the preliminary cut you may remove the center pin to complete the cut if necessary For the resection is important to use an oscillating saw blade of 0 050in or 1 27mm which matches the width of the slot to in order to achieve a precise cut Note If not using t
13. ALLEN HEX KEY 3 5MM SELF TAPPING AND SELF DRILLING BONE SCREW 4148 1005 03 3MM L110MM THREAD 40MM 60 INSTRUMENT LIST NAVIGATION PRODUCT NUMBER DESCRIPTION DIAGRAM 4145 5100 FEMUR BONE FIXATION BASE 4145 1030 06 X 04 ARTICULATED CONNECTOR 4154 5100 45 ANGLED REATTACHABLE ADAPTOR 4145 3100 POSITIONING CLAMP FEMUR BONE FIX BASE 4145 2000 ORIENTATION ADJUSTMENT INTERFACE 4146 1000 CUTTING GUIDE FIXATION INTERFACE 4144 4000 PRAXIM ROBOTIC CUTTING GUIDE COVER 4144 7000 PRAXIM ROBOTIC CUTTING GUIDE ENCLOSURE 4144 8000 PRAXIM ROBOTIC CUTTING GUIDE INSERTION GUIDE 4146 5200 PRAXIM SAW GUIDE 1 27MM SHORT 4146 5300 PRAXIM SAW GUIDE 1 27MM SAFETY MODE 4145 5003 CANCELLOUS BONE SCREWS 05 5 X 50MM 4145 5004 CANCELLOUS BONE SCREWS 05 5 X 70MM 4137 5051 NANOBLOCK SCREW HEAD STABILIZER TOTAL KNEE SURGETICS OMNI APEX GREEN DISPOSABLES 61 INSTRUMENT LIST APEX KNEE PRODUCT NUMBER DESCRIPTION DIAGRAM WS 20123 TIBIAL PUNCH GUIDE WS 20124 TIBIAL PUNCH DART SIZE 1 2 WS 20125 TIBIAL PUNCH DART SIZE 3 4 WS 20126 TIBIAL PUNCH DART SIZE 5 6 WS 30060 SLAP HAMMER 710300 IMPACTOR HANDLE KS 80012 STEINMAN PINS KS 80021 THREADED STEINMAN PINS WS 30053 PIN DRIVER ZIMMER p d 800100 HEADED STEINMAN PIN M 800101 HEADED STEINMAN PIN LONG WS 30051 PIN HOLDER EXTRACTOR y K
14. Closure Closure is performed according to Surgeon P 5 5 preference 07 Pre operative Report Recording NAVIGATION REPORT To record the navigation report on CD ROM Click on the red cross located the top right of the screen and follow the instructions on the screen 98 SYMBOLS GRAPHICAL INTERFACE PLANNING AND NAVIGATION FEMUR Distal femoral cut height medial and lateral side mm Measure of antero posterior alignment Flexion angle degrees referenced off the anterior surface mm Distal cut Varus Valgus angle degrees Measure of antero posterior alignment referenced off the posterior surface mm Measure of axial rotation referenced off the epicondyles degrees maestus DIOS SIF SB por F120 ie Measure of axial rotation referenced implant apex referenced off the anterior S off the posterior condyles degrees cortical mm Medio lateral centering of the Measure of axial rotation referenced implant mm off the Whiteside line degrees Antero posterior offset distance mm Angular offset mm Femoral distal cut Varus Valgus angle referenced off the tibial cut measured Femoral posterior cut axial rotation angle referenced off the tibial cut measured PLANNING AND NAVIGATION TIBIA Anterior positioning of the tibial implant using the anterior cortex as reference mm Tibial resection height mm Axial rotation ref ipe Qr Ag
15. ERT TRIAL SIZE 2 X 12MM CONGRUENT INSERT TRIAL SIZE 2 X 11MM CONGRUENT INSERT TRIAL SIZE 2 X 10MM CONGRUENT INSERT TRIAL SIZE 1 X 16MM CONGRUENT INSERT TRIAL SIZE 1 X 14MM CONGRUENT INSERT TRIAL SIZE 1 X 12MM CONGRUENT INSERT TRIAL SIZE 1 X 11MM CONGRUENT INSERT TRIAL SIZE 1 X 10MM 63 INSTRUMENT LIST APEX KNEE PRODUCT NUMBER DESCRIPTION DIAGRAM WS 36169 WS 36168 WS 36166 WS 36164 WS 36162 WS 36161 WS 36160 WS 36159 5 36158 WS 36156 WS 36154 5 36152 WS 36151 WS 36150 WS 36149 WS 36148 WS 36146 WS 36144 WS 36142 WS 36141 WS 36140 WS 36139 WS 36138 WS 36136 WS 36134 WS 36132 WS 36131 WS 36130 WS 36129 5 36128 WS 36126 WS 36124 WS 36122 WS 36121 WS 36120 WS 36119 WS 36118 WS 36116 WS 36114 WS 36112 WS 36111 WS 36110 ULTRA INSERT TRIAL SIZE 6 X 20MM ULTRA INSERT TRIAL SIZE 6 X 18MM ULTRA INSERT TRIAL SIZE 6 X 16MM ULTRA INSERT TRIAL SIZE 6 X 14MM ULTRA INSERT TRIAL SIZE 6 X 12MM ULTRA INSERT TRIAL SIZE 6 X 11MM ULTRA INSERT TRIAL SIZE 6 X 10MM ULTRA INSERT TRIAL SIZE 5 X 20MM ULTRA INSERT TRIAL SIZE 5 X 18MM ULTRA INSERT TRIAL SIZE 5 X 16MM ULTRA INSERT TRIAL SIZE 5 X 14MM ULTRA INSERT TRIAL SIZE 5 X 12MM ULTRA INSERT TRIAL SIZE 5 X 11MM ULTRA INSERT TRIAL SIZE 5 X 10MM ULTRA INSERT TRIAL SIZE 4 X 20MM ULTRA INSERT TRIAL SIZE 4 X 18MM ULTRA INSERT TRIAL SIZE 4 X 16MM ULTRA INSERT TRIAL SIZE 4 X 14MM ULTRA INSERT TRIAL SIZE 4 X 12MM ULTRA INSERT TRIAL SIZE 4 X 11MM U
16. L TRAY TRIAL SIZE 6 RIGHT K2 1410L FEMORAL TRIAL SIZE 1 LEFT K2 1420L FEMORAL TRIAL SIZE 2 LEFT K2 1425L FEMORAL TRIAL SIZE 2 LEFT K2 1430L FEMORAL TRIAL SIZE 3 LEFT K2 1435L FEMORAL TRIAL SIZE 3 LEFT K2 1440L FEMORAL TRIAL SIZE 4 LEFT K2 1445L FEMORAL TRIAL SIZE 4 LEFT K2 1450L FEMORAL TRIAL SIZE 5 LEFT K2 1460L FEMORAL TRIAL SIZE 6 LEFT WS 2111L DOVETAIL TIBIAL TRAY TRIAL SIZE 1 LEFT WS 2112L DOVETAIL TIBIAL TRAY TRIAL SIZE 2 LEFT WS 2113L DOVETAIL TIBIAL TRAY TRIAL SIZE 3 LEFT WS 2114L DOVETAIL TIBIAL TRAY TRIAL SIZE 4 LEFT 5 21151 DOVETAIL TIBIAL TRAY TRIAL SIZE 5 LEFT 5 21161 DOVETAIL TIBIAL TRAY TRIAL SIZE 6 LEFT 65 INSTRUMENT LIST APEX KNEE PRODUCT NUMBER DESCRIPTION DIAGRAM KS 99210 PATELLA POST DRILL KS 40388 PATELLA TRIAL 38MM x 8MM KS 40368 PATELLA TRIAL 36MM x 8MM KS 40328 PATELLA TRIAL 32MM x 8MM KS 40298 PATELLA TRIAL 29MM x 8MM KS 40410 PATELLA TRIAL 41MM x 10MM KS 4 PATELLA TRIAL 38MM 10MM KS 40360 PATELLA TRIAL 36MM x 10MM KS 40320 PATELLA TRIAL 32MM x 10MM KS 40290 PATELLA TRIAL 29MM x 10MM KS 40260 PATELLA TRIAL 26MM x 10MM KS 99250 PATELLA CALIPER WS 40020 PATELLA REAMER DRILL GUIDE HEAD WS 40001 PATELLA REAMER DRILL GUIDE FOOT PATELLA REAMER HANDLE WS 40015 CEMENTING CLAMP ASSEMBLY WS PATELLA RESECTION GUIDE 66 67
17. LTRA INSERT TRIAL SIZE 4 X 10MM ULTRA INSERT TRIAL SIZE 3 X 20MM ULTRA INSERT TRIAL SIZE 3 X 18MM ULTRA INSERT TRIAL SIZE 3 X 16MM ULTRA INSERT TRIAL SIZE 3 X 14MM ULTRA INSERT TRIAL SIZE 3 X 12MM ULTRA INSERT TRIAL SIZE 3 X 11MM ULTRA INSERT TRIAL SIZE 3 X 10MM ULTRA INSERT TRIAL SIZE 2 X 20MM ULTRA INSERT TRIAL SIZE 2 X 18MM ULTRA INSERT TRIAL SIZE 2 X 16MM ULTRA INSERT TRIAL SIZE 2 X 14MM ULTRA INSERT TRIAL SIZE 2 X 12MM ULTRA INSERT TRIAL SIZE 2 X 11MM ULTRA INSERT TRIAL SIZE 2 X 10MM ULTRA INSERT TRIAL SIZE 1 X 20MM ULTRA INSERT TRIAL SIZE 1 X 18MM ULTRA INSERT TRIAL SIZE 1 X 15MM ULTRA INSERT TRIAL SIZE 1 X 14MM ULTRA INSERT TRIAL SIZE 1 X 12MM ULTRA INSERT TRIAL SIZE 1 X 11MM ULTRA INSERT TRIAL SIZE 1 X 10MM 64 INSTRUMENT LIST APEX KNEE PRODUCT NUMBER DESCRIPTION DIAGRAM K2 1410R FEMORAL TRIAL SIZE 1 RIGHT K2 1420R FEMORAL TRIAL SIZE 2 RIGHT K2 1425R FEMORAL TRIAL SIZE 2 RIGHT K2 1430R FEMORAL TRIAL SIZE 3 RIGHT K2 1435R FEMORAL TRIAL SIZE 3 RIGHT K2 1440R FEMORAL TRIAL SIZE 4 RIGHT K2 1445R FEMORAL TRIAL SIZE 4 RIGHT K2 1450R FEMORAL TRIAL SIZE 5 RIGHT K2 1460R FEMORAL TRIAL SIZE 6 RIGHT WS 2111R DOVETAIL TIBIAL TRAY TRIAL SIZE 1 RIGHT WS 2112R DOVETAIL TIBIAL TRAY TRIAL SIZE 2 RIGHT WS 2113R DOVETAIL TIBIAL TRAY TRIAL SIZE 3 RIGHT WS 2114R DOVETAIL TIBIAL TRAY TRIAL SIZE 4 RIGHT WS 2115R DOVETAIL TIBIAL TRAY TRIAL SIZE 5 RIGHT WS 2116R DOVETAIL TIBIA
18. Proudly distributed by Technology fo Global Orthopaedic ROBOTIC TECHNOLOGY APEX Knee Surgical Navigation with the PRAXIM Robotic Cutting Guide Independent Cuts Measured Resection E g Z I C d lt 8 g BE g OMNIlife science an Orthopaedic Synergy Company APEX ROBOTIC TECHNOLOGY Congratulations You are about to embark on a computer automated CAS and navigated total knee surgical technique that is truly cutting edge by integrating an automated interactive cutting block the Praxim Robotic Cutting Guide You will be performing a navigated imageless total knee replacement Ihe APEX Knee implants will be individualized with regard to position alignment and size with an extreme level of CAS validated accuracy In my experience this has led to a well balanced TKR with a history of no early failures due to malalignments improper sizing or malpositioning CAS TKR has made me a better and more accurate surgeon Jan Albert Koenig MD Dear User This guide is provided to aid in a surgical procedure and does not replace the system and software user manual or medical and surgical judgment Please carefully review the full Instructions for Use before using this device including the warnings and recommendations contained therein The APEX Robotic Technology A R T system includes many options that allow the clinician to individualize the protocol based on his prefer
19. RING TIBLA SIZE Y cr 4 2AT RT Q7 Resections mm AP Position Varus Valgus S Slope Cp Axial Rotation Check the proposed cut and the size of the tibial implant In the default profile the software measures resection depth from the least affected side of the tibial plateau This will produce 10mm resection If you choose to measure resection depth from the most affected side of the tibial plateau you should modity the corresponding parameter or adapt your user profile to use the most affected side automatically We recommend 2mm below the most effected side to start If necessary modify the parameters of the implant positioning using the panel on the left Step the blue pedal to validate the position of the tibial implant and proceed to the next step 43 Tibial Cut Navigation AEIR ele Hint The NanoBlock 84137 5000 must be set to neutral 2050 before navigating the tibial cut position using the NanoBlock Initialization Socket 4137 Manual Adjustment Manually adjust the position of the NanoBlock equipped with the G 0501 5070 until the cutting lines become blue aiuta us L Red cutting lines indicate that the NanoBlock is too far from the target line and must not be fixed in this position Fixation of the NanoBlock a TEA CUT NHEVIGETRON x When the cutting line is blue fix the NanoBlock to the tibia with 2 or 3 O3 2mm Pins 41
20. Recording 58 symbols Graphical Interface 59 Navigation Instrument List 60 APEX Knee Instrument List 62 Pre operative Planning Individualized implant positioning size and alignment Suggested Templating Method High quality radiographs are extremely important for precise preoperative planning Work from accurate radiographs Full length AP and lateral extremity roentgenograms should be obtained and the mechanical and anatomic axes identified The angle of these axes is useful in establishing the plane of the distal femoral resection and tibial resection It is helpful to draw the femoral and tibial resection lines on the films as an intra operative reference Radiographic templates are provided to permit preoperative estimation of implant size Ihe templates are overlaid on the x ray films It is recommended to check the magnification of the radiographs in order to choose the right size of the radiographic templates to be used Ihe APEX system is also present in several digital radiographic systems The size of the femoral component in the lateral view is of particular importance since under sizing will result in looseness in flexion as well as greater potential for notching of the anterior femoral cortex Over sizing can create tightness in flexion and increase the potential for increased excursion of the quadriceps mechanism The APEX Knee system permits the use of tibial inserts one size higher or any size lower tha
21. S 39000 TRIAL FORCEPS e ee WS 30090 ANGEL WING C WS 10071 FEMORAL INSERTER e KS 61108 FEMORAL POST DRILL WS 10151 FEMORAL IMPACTOR PAD KS 31001 60 TORQUE WRENCH WS 20151 TIBIAL TRAY IMPACTOR PAD 62 INSTRUMENT LIST APEX KNEE PRODUCT NUMBER DESCRIPTION DIAGRAM WS 35166 WS 35164 WS 35162 WS 35161 WS 35160 WS 35156 WS 35154 5 35152 5 35151 5 35150 5 35146 5 35144 5 35142 WS 35141 5 35140 WS 35136 5 35134 WS 35132 5 35131 5 35130 5 35126 5 35124 WS 35122 5 35121 WS 35120 WS 35116 5 35114 5 35112 5 35111 WS 35110 CONGRUENT INSERT TRIAL SIZE 6 X 16MM CONGRUENT INSERT TRIAL SIZE 6 X 14MM CONGRUENT INSERT TRIAL SIZE 6 X 12MM CONGRUENT INSERT TRIAL SIZE 6 X 11MM CONGRUENT INSERT TRIAL SIZE 6 X 10MM CONGRUENT INSERT TRIAL SIZE 5 X 16MM CONGRUENT INSERT TRIAL SIZE 5 X 14MM CONGRUENT INSERT TRIAL SIZE 5 X 12MM CONGRUENT INSERT TRIAL SIZE 5 X 11MM CONGRUENT INSERT TRIAL SIZE 5 X 10MM CONGRUENT INSERT TRIAL SIZE 4 X 16MM CONGRUENT INSERT TRIAL SIZE 4 X 14MM CONGRUENT INSERT TRIAL SIZE 4 X 12MM CONGRUENT INSERT TRIAL SIZE 4 X 11MM CONGRUENT INSERT TRIAL SIZE 4 X 10MM CONGRUENT INSERT TRIAL SIZE 3 X 16MM CONGRUENT INSERT TRIAL SIZE 3 X 14MM CONGRUENT INSERT TRIAL SIZE 3 X 12MM CONGRUENT INSERT TRIAL SIZE 3 X 11MM CONGRUENT INSERT TRIAL SIZE 3 X 10MM CONGRUENT INSERT TRIAL SIZE 2 X 16MM CONGRUENT INSERT TRIAL SIZE 2 X 14MM CONGRUENT INS
22. UT CHECK Step on the blue pedal to record the distal cut and proceed to the next step Note The cuts can be checked either after each cut or when all cuts have been performed depending on the chosen option 41 Femoral Cut Navigation Praxim Robotic Cutting Guide Anterior Cut Validation Place the G 0501 5070 equipped with the Cut Controller 4161 5100 flat on the performed anterior cut to check the final position of this cut a eer errant m 3 0 CUT CHECK 1 D Step on the blue pedal to record the distal cut and proceed to the next step Note It 1s important to carefully validate the femoral anterior cut as this information will be used by the system to calculate position of the implant for final alignment Alternatively cut validation can be performed using the Cut Controller OMNI Drill Guide 4161 5400 Once all the cuts have been completed and validated remove the Praxim Robotic Cutting Guide from its fixation base by unscrewing the inner screw using the H3 5 screwdriver 9 144 Proceed to the next step 42 Virtual Tibial Surgery 1 Select the parameter to be adjusted 2 Change value AXIAL ROT AP POSITION VARUS VALGUS ML CENTERING TIBIA SIZE IMIT cr 4 2 e Fi S TIBIA PLANNING LI 10 m EN EO 7 5 EUT SLOPE AXIAL ROT j 8 AP POSITION L t TTE T TERT ML CENTE
23. ble in all directions 30 Anatomical Acquisitions Anterior Tibial Surface Bone Morphing Technology Place the tip of the P on the anterior part of the tibial plateau Step on the blue pedal to start the acquisition Glide or paint the tip of the P until the green bar fills up maintaining constant contact Note This surface is used to determine the anterior position of the implant Cover a surface as large as possible in all directions Bone Morphing Validation Place the pointer P on the anatomical landmarks of the bone such as the anterior cortex and the medial and lateral borders of the proximal tibia The value indicated on the screen below the bone model represents the distance between the pointer and the bone model Check that the distance is less than or equal to 1mm in these key areas see Note U Step on the blue pedal to validate the generated 3D model Note This step allows checking the accuracy of the 3D model generated by the system If the increment of the validation measurement exceeds 1mm step on the yellow pedal to go back one step in the procedure and add points to the Bone Morphing data using the blue pedal Start and stop complementary acquisitions by stepping the blue pedal During acquisition the P must be in constant contact with the bone BONE MORPHING RECOMMENDATIONS It is important not to include osteophytes during Bone Morphing acquisition
24. bottom right Two LED lights should illuminate to indicate that the Control Box has powered on Ih TN LI b 7 er gt 5549241 Starting the System Dr AHIM When the PRAXIM Software Application screen TNT caet appears insert the provided Total Knee Surgetics OMNI APEX Start card in the appropriate slot marked SIM on the side of the Panel PC to start preHmirm the software S Select the flag corresponding to the desired language and press the right arrow to start the application After few seconds the welcome step appears on the screen Click on the blue arrow or step on the blue pedal to proceed to the next step Notes To move forward or backward in the workflow touch the screen or click the pedal B The blue arrow button or blue pedal advances the screen X The yellow arrow button or yellow pedal returns to the previous Screen Individualiz ing the Surgeon s User Profile Select an existing user on the touch screen then press the blue button or blue pedal to set up the surgical protocol To create a new user press the ADD USER button on the touch screen type in the user name and press SAVE D Click on the blue arrow or step on the blue pedal to proceed to the next step Select the Surgical Technique corresponding to the use of the Praxim Robotic Cutting Guide Select the NanoBlock and the Profile
25. e pedal to register each 3 cone Note If necessary it is possible to calibrate the Femur Bone Fixation Base later in the procedure To do so hide the pointer P and click on the blue pedal Femur Center Place the pointer P on the anterior arch of the distal femur to acquire the center of the femur Step on the blue pedal to record the position of this point Note The system will calculate the mechanical axis of the femur based on the line joining the hip center and center of the distal femur 23 zit FEMUR CENTER Anatomical Acquisitions Medial Posterior Condyle CENE Technology Place the tip of the pointer P on the medial posterior condyle B Step on the blue pedal to start the acquisition Glide or paint the tip of the P on the posterior condyle until the green bar fills up Focus on acquiring a large surface area as opposed to gathering many points in a small concentrated area It is important to keep P in constant contact with the bone during morphing or point acquisition Note This surface 15 used to determine the medial posterior reference point Lateral Posterior Condyle CEN Len roseo Bone Morphing Technology Place the tip of the P on the lateral posterior condyle B Step on the blue pedal to start the acquisition Glide or paint the tip of the P on the posterior condyle until the green bar fills
26. ella is clamped in the jaws of the Resection Guide the amount of resection is read from the stylus Swing the stylus to be perpendicular to the body of the patella The stylus can be moved up and down and calibration marks read to set the desired resection The patella clamp saw capture slots accommodate a 0 050in 1 27mm saw blade Drill Pegs Holes The holes for the 3 pegs on the patella are prepared using the Patella Reamer Handle Assembly WS 40015 with Drill Guide Foot WS 40001 loaded and the Patella Post Drill 4KS 99210 Size is read from the concentric rings on the bushing The hole pattern is the same for all size patella Note The patella post drill is grey to avoid confusion with femoral lug drill which 1s black 47 Trial Reduction and Final Component Selection Surgeon preferences vary concerning the sequence of implant placement Ihe APEX Knee System does not require that a specific implant placement sequence be followed To describe this surgical technique these are the steps to follow Note Additionally Flexion Extension Spacers KS 29510 to KS 29516 are available but not included to check the flexion extension alignment and ligament balance previously to the use of the trial components Trial Femoral Component Placement The chosen trial femoral component is placed on the cut femur using the Femoral Inserter KS 61108 Use the Femoral Inserter to guide the femoral component into po
27. emoral Inserter KS 61108 Once the component positioning has been confirmed final seating should be performed using the Femoral Impactor WS 10151 and the Impactor Handle 710300 If cement has been used any excess cement should be cleaned from the prosthesis edges Ihe implant surface should be meticulously free of cement or other debris If cement has been used it is recommended that as soon as the femoral and tibial components have been seated a trial tibial insert of the same size as the femoral component be placed on the tibial tray The knee should then be brought into full extension and held in position to pressurize the cement as it cures Any additional cement that is extruded during cement compression should be removed at this time Once the cement has hardened the knee can be brought back into flexion and the tibial trial is removed 94 SURGICAL TECHNIQUE Final Component Implantation Tibial Insert Implantation All extraneous cement must be removed from the borders of the tibial tray The surface of the tibial tray should be meticulously cleaned prior to placement of the tibial insert tibial insert slides onto the tibial tray in the anterior posterior direction The rails on the tibial tray engage the grooves on the bottom of the tibial trial Note The APEX Knee system requires that the tibial insert size match the femoral implant size Tibial inserts of one size larger same
28. eplate Implantation If a Cemented tibial tray is to be implanted the cement should be mixed and placed on both the resected tibial surface and the tibial tray base by hand or with a syringe The tray should be placed in the correct orientation following the previously defined steps and be fully seated by using the Tibial Tray Impactor Pad WS 20151 and the Impactor Handle 710300 All excess cement should be cleaned from all of the edges of the tibial component starting at the posterior surfaces moving towards the sides and to the anterior surfaces Uncemented porous coated tibial trays are inserted and impacted without cement Note This technique shows the implantation of the tibial baseplate separately from the tibial insert The Tibial insert and tibial tray can also be implanted as an assembled unit using instrument KS 70023 special order required 92 Final Component Implantation Femoral component implantation The APEX Knee system includes cemented and non cemented femoral components When implanting a cemented component a layer of cement should be applied to the resected surfaces of the femur and to the backside of the femoral component Note To avoid excessive posterior extrusion of cement a posterior excessive cement the quantity of cement applied to posterior condyles of the femoral component should be limited Final insertion of the femoral component should be performed using the F
29. he NanoBlock Stabilizer 14137 5050 monitor the position of the three 3 positioning screws during the cut because when subjected to strong vibrations one or more screws may turn If more than 12 of a rotation occurs on any screw go back to the tibial cut navigation step to check and readjust the NanoBlock into position Tibial Cut Validation Place the G reference 0501 5070 equipped with the Cut Controller 24161 5100 flat on the cut ra n NI CUT CHECK If necessary refine the cut and recheck Alternatively cut validation can be performed using the Cut Controller OMNI Drill Guide 24161 5400 Step on the blue pedal to record the final cut and D proceed to the next step 46 Preparation of the Patella Patella Sizing Patella thickness is measured using the Patella Caliper KS 99250 Ihe thickness of the patellar component in the APEX Knee System is either 8 or 10 mm Note It 1s recommended that the thickness of the patella after resection be at least 12mm to avoid excessive weakening of the patella Also the patella diameter is measured using the Patella Reamer Drill Guide Foot WS 40001 Ihe patellar component diameters in the APEX Knee System are 29 32 35 and 38mm Patella Resection The Patella Resection Guide WS 40071 for the APEX Knee System provides accurate repeatable measurement of patella resection As the pat
30. he surgery One software Start card Operating Room Set up Standard set up In the operating room the navigation system can be installed on either side of the operated knee It is recommended that the system be set up on the opposite side of the patient from the surgeon The camera needs to be placed about 5 to 6 feet 1 5 to 1 8 meters from the knee Set up A for a Left Knee Alternative Set up B with an External Screen The system be installed with an additional external screen connected via VGA cable The addition of a second external monitor should be in compliance with the individual hospitals Biomedical Department specifications The additional external screen is turned to the surgeon whereas the panel pc tactile screen is turned to the nurse for easy access to settings during surgery Plug the A R T Station into an electrical outlet using the power cord located on the right side inside the base of the system Start the A R T Station using the green on off button located at the base of the system The system should emit audio tones to indicate that the camera is powered and operational Connect the Praxim Robotic Cutting Guide Control Box to USB port 0 of the Panel PC using the USB cable Plug in the Praxim Robotic Cutting Guide Control Box to an electrical outlet using its own power cord Turn on the Praxim Robotic Cutting Guide Control Box using the on off button located on the
31. hold on blue pedal to move the Praxim Robotic Cutting Guide Recut can be required to avoid trochlea over stuffing After cutting it is strongly recommended to unlock and pull back the saw guide to avoid contact with bone as the Praxim Robotic Cutting Guide changes position for the next cut UB Step and hold down the blue pedal until the Praxim Robotic Cutting Guide is locked in position to move to next cut 39 Femoral Cut Navigation Praxim Robotic Cutting Guide Femoral Posterior Cut 0 perenne T Cut the femur using 1 27mm thick saw blade BP Step and hold down the blue pedal until the Praxim Robotic Cutting Guide is locked in position to move to next cut Femoral Anterior Chamfer Cut BLU CHO ALLE E Fifi mA T EI Pioi E C1 Cut the femur using a 1 27mm thick saw blade BP Step and hold down the blue pedal until the Praxim Robotic Cutting Guide is locked in position to move to next cut 40 Femoral Cut Navigation Praxim Robotic Cutting Guide Femoral Posterior Chamfer Cut Batu uiua E T Fiti y i a z Cut the femur using a 1 27mm thick saw blade Step on the blue pedal to proceed to the next step Distal Cut Validation Place the 20501 5070 equipped with the Cut Controller 4161 5100 flat on the performed distal cut to check the final position of this cut Au eral T 0 0 C
32. in the image motion Pi ret 7 Repeat the same procedure for the second screw AXTS ALIMENT Once the two screws become green the lines also become green and the target alignment position is reached D Step on the blue pedal to record the desired alignment and proceed to the next step 36 Femoral Cut Navigation Praxim Robotic Cutting Guide Praxim Robotic Cutting Guide Calibration Place the Praxim Saw Guide 1 27mm 4146 5200 in the most posterior position possible by rotating the two Praxim Robotic Cutting Guide axes Make sure that the Praxim Saw Guide 1 27mm is far enough from the bone and is tightly locked into position Note The Praxim Saw Guide 1 27mm must be engaged over the entire length of the dove tail groove to guarantee accuracy of the calibration BR Step and Hold down the blue pedal throughout the entire calibration process of the Praxim Robotic Cutting Guide The acquisition will complete when the green bar fills up and the Praxim Robotic Cutting Guide will position itself for the first cut and then release the pedal Note There is a slight lag before motion begins as the data points are set During the calibration process the Praxim Robotic Cutting Guide will automatically move around the femur IMPORTANT The Praxim Saw Guide 1 27mm 74146 5200 can be slid towards the bone to reduce skiving of the saw blade Do not move the cutting guide al
33. ith the surface of the NanoBlock NanoBlock Calibration Assemble the G reference 0501 5070 by aligning the three 3 holes on the Reattachable Fixation for G 24146 5000 to the three 3 pegs on the reference and tightening the thumb screw Use the push release button on the reference fixation to attach it to the NanoBlock Note Proper adjustment to zero position prior to Calibrating the Nanoblock before each case will assure optimal accuracy and cut validation All calibration should be performed on the back table prior to the start of surgery Instrument Calibration Calibrate the NanoBlock 4137 5000 by placing the tip of the Pointer P 0501 5000 in each 4 calibration cone located on the top surface MIULLLLIULIGUM Me hs 3 t 8 E Check the visibility of P and references Step on the blue pedal to register each 4 cone Note In order to aid in the calibration accuracy of the NanoBblock do not apply excessive force on the tip of the P and use the same face of the P and G towards the camera for all four cone acquisitions Instrument Calibration Cut Controller and Cut Controller OMNI Drill Calibration Use the push button to attach the G reference 0501 5070 to the Cut Controller 4161 5100 using the Reattachable Fixation for G 4146 5000 Calibrate the cut controller 7
34. l the way down into contact with the bone because this can cause deflection of the cutting guide After making each cut it is strongly recommended to unlock and pull back the saw guide to avoid contact with bone as the Praxim Robotic Cutting Guide changes position for the next cut Note The reference can be removed from the Praxim Saw Guide 1 27mm after the calibration process 1s complete 97 Femoral Cut Navigation Praxim Robotic Cutting Guide Femoral Distal Cut aTi cere Cut the femur using a 1 27mm thick saw blade Note The distal cut can be adjusted at this point Use the touchscreen to adjust the distal cut if desired and then step and hold on blue pedal to move the Praxim Robotic Cutting Guide Recut can be required in case of flexion contracture or to gain more knee extension After cutting it is strongly recommended to unlock and pull back the saw guide to avoid contact with bone as the Praxim Robotic Cutting Guide changes position for the next cut Step and hold down the blue pedal until the Praxim Robotic Cutting Guide is locked in position to move to next cut 30 Femoral Cut Navigation Praxim Robotic Cutting Guide Femoral Anterior Cut Au arena eem are 0 fmm m es Cut the femur using a 1 27mm thick saw blade Note The anterior cut height can be adjusted at this point Use the touchscreen to adjust the anterior cut if destred and then step and
35. n the tibial tray size his allows the use of the tibial tray with the best possible coverage of the tibial plateau with an insert that best matches the femoral component In all cases the numerical size of the tibial insert should match that of the femoral component including the plus sizes For example a size 2 tibial insert should be used with a size 2 or size 2 femoral component Notes The APEX Knee system instrumentation is designed to adapt to the surgical technique of any surgeon 10 describe this Surgical Technique the preparation of the femur has been chosen as the first step in the procedure Navigation System A R T Station The A R T Station includes the following elements 1 Optical camera 2 Panel PC with tactile screen 3 Praxim Robotic Cutting Guide Control Box 4 Drawer containing the foot pedal and power cord Instrument Set The Praxim Robotic Cutting Guide instrument set contains all the instruments specific to navigation that are required for use with the APEX Knee Surgical Navigation application In addition a portion of the OMNI APEX standard instrument set will also be required including but not limited to femur tibia finishing Instruments and trial implants Disposables and System Start Kit The A R T Disposables and System start kit includes the following elements One box of 20 disposable sterile markers One CD ROM to record the navigation report at the end of t
36. ould click into place to indicate proper attachment Take care not to damage the reflective surface of the markers when pressing them into position Pointer Calibration Calibrate the Pointer 40501 5000 by placing the tip in the calibration cone on top of the T reference 0501 5030 and facing the markers towards the camera a The letters I and P must appear in the field of visibility of the camera hey also appear in green at the top of the screen gt Step the blue pedal to begin the calibration Rotate the Pointer P to face the other 3 markers towards the camera The tip of the P should stay in the calibration cone of the T Check the visibility of T and P B Step on the blue pedal to finish the calibration Notes To help maximize calibration accuracy of the pointer P do not apply force on the P and place it as shown on pictures perpendicular to the face should be the middle of the camera field of view during calibration Instrument Calibration Adjustment of the NanoBlock Screws to Zero Position Adjust the initial position of each adjustment screw of the NanoBlock 4137 5000 using the provided NanoBlock Initialization Socket 4137 2050 The screws are in the correct position when the machined groove on the head of each screw appears in the center of the window when the initialization socket is in contact w
37. r cortex and distal and posterior condyles The value indicated on the screen below the bone model represents the distance between the pointer and the bone model Check that the distance is less than or equal to 1mm in these key areas see Note B Step on the blue pedal to validate the P generated 3D model Note This step allows checking the accuracy of the 3D model generated by the system If the increment of the validation measurement exceeds 1mm step on the yellow pedal to go back one step in the procedure and add points to the Bone Morphing data using the blue pedal Start and stop complementary acquisitions by stepping on the blue pedal During acquisition the P must be in constant contact with the bone zat ANTERIOR CORTETY DORE MORPHINE 21 Anatomical Acquisitions Tibia Center TP THI CENTER Place the tip of the P on the tibial eminence D Step on the blue pedal to record the position of this point Note The system will calculate the tibial mechanical axis based on the line joining the center of tibia and ankle center Tibial Rotation Reference Up Place the tip of the P on the medial 1 3 side of the anterior tibial tuberosity The rotational axis of the tibia will be defined using this point coupled with the tibial center Step on the blue pedal to record the position of this point Hint This reference needs to be taken carefully as it defines the direction
38. r fills up maintaining constant contact Note This surface is used to determine the lateral distal reference point Cover a surface as large as possible in all directions Lateral Side s LATERAL DE Bone Morphing Technology Place the tip of the P on the lateral side of the femur 10mm from the distal lateral surface B Step on the blue pedal to start the acquisition Glide or paint the tip of the P on the lateral side of the distal femur until the green bar fills up maintaining constant contact Note This surface is used to visualize the ML size of the femur Paint as large a surface as possible in all directions 26 Anatomical Acquisitions Anterior Femoral Cortex Bone Morphing Technology Place the tip of the P on the anterior cortex B Step the blue pedal to start the acquisition Glide the tip of the P on the entire anterior cortex including the area where the implant will rest maintaining constant contact The acquisition will complete when the green bar fills up Note This surface will allow checking for possible notching when navigating the anterior femoral cut The surface that will be potentially covered by the implant will need to be acquired especially the most proximal and most lateral parts to safeguard against notching the femur Bone Morphing Validation Place the pointer P on the anatomical landmarks of the bone including the anterio
39. ral Surgery Check the proposed cuts and size of the femoral implant Ihe surgeon may adjust the size and position of the implant specific to every patient based on the Bone Morphing model previously generated and is now displayed on the monitor FEMUR FLENNINO Use the X crossed implant button to hide the femoral component and visualize cuts on the 3D bone model The medial lateral sizing should be carefully checked Often especially in female patients the ideal M L size may be smaller than the A P size If the proper A P size is too wide for a size 3 or size 4 femur a plus size femoral component may be used For example 2 femoral component has the same A P box cuts as a size 3 but a smaller ML width Therefore there is no need to downsize the femur to compensate for potential M L overhang If necessary modify the parameters of the implant position using the panel on the left Step on the blue pedal to validate the position of the femoral implant proceed to the next step Note Standard cuts proposed with this software are equal to the thickness of the femoral component example 9mm on distal condyles The preferred method of establishing rotation 1s to externally rotate the femoral component 3 with respect to the posterior condyles However the surgeon has the option of changing the default value in the surgeon profile or adjusting the amount of rotation during this step in the surger
40. red surgical technique This guide includes guidelines tips and information on one technique Please contact your sales representative or our customer support for more information on other available options Indications for Use The TOTAL KNEE SURGETICS Navigation System with iBlock is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures It is specifically indicated for Total Knee Arthroplasty APEX ROBOTIC TECHNOLOGY OMNIlife science would like to thank Jan Albert Koenig MD for his assistance in editing this document TABLE OF CON TEN TS Table of Contents 3 Preoperative Planning 4 Navigation System 5 Operating Room Set up 6 Starting the System 7 Customizing the Surgeon s User Profile 9 Patient Information 10 Instrument Calibration 11 Praxim Robotic Cutting Guide Installation 16 Positioning of T and F 19 Anatomical Acquisitions 27 Pre operative Pathology 32 Virtual Femoral Surgery 99 Femoral Cuts Navigation Praxim Robotic Cutting Guide 35 Virtual Tibial Surgery 43 Tibial Cut Navigation NanoBlock 44 Preparation of the Patella 47 Trial Reduction and Final Components Selection 48 Alignment Validation 50 Final Bone Preparation s Final Component Implantation 53 Final Alignment Validation 5 Per operative Report
41. rial Trial Patella Component Placement The chosen Trial Patella Component KS 40298 to KS 40388 is placed into the holes previously drilled in the patella by using the Insert Trial Forceps 49 SURGICAL TECHNIQUE Trial Alignment Validation Alignment Validation m ee FINAL ALIGNMENT CHECK After the trial components are inserted adjust on the screen the size of the tibial implant and insert 4 thickness that are used and check leg alignment Stability Validation Knee extension and flexion stability must be checked Full extension should be possible with the trial components in place Extension stability should be 5 WIE checked with the knee flexed a few degrees to relax the posterior capsule Flexion stability should be checked with the knee in a flexion angle of 90 Appropriate stability has been achieved when the medial and lateral opening indicated on the screen is similar to a healthy knee when tension is applied in both valgus and varus positions Hint If desired press on the screen shot button at any time to save a picture in the pre operative report Flexion Extension Validation With the trials in place it should be possible to completely straighten the leg without the application of any force To check flexion the surgeon should elevate the thigh and allow gravity to flex the leg 90 Trial Alignment Validation Patellar Tracking Slide Validation D
42. s Removal of osteophytes before starting the Bone Morphing surface acquisitions process is recommended zat ANTERIDH AREA BONE MOETHINEEE 31 Pre operative Pathology The initial pathological varus valgus angle and the maximum flexion and extension can be measured at this stage prior to making any bone cuts Ihis P 4 information can then be compared to post operative Cit ALTSNNWENT 4 alignment results using the same test Flex and extend the leg to check for any initial flexion deformity and the maximum flexion Optionally the screenshot button can be pressed to save the information for different positions The leg position at the time of the validation will be automatically saved in the post operative report gt Step the blue pedal with the leg extension to record the initial alignment and proceed to the next step 32 Virtual Femoral Surgery FEMUR PLANNING 1 Select the parameter to be adjusted 0 2 Change value ML CENTERING DISTAL CUT HEIGHT AXIAL ROT VARUSIVALGUS FEMUR SIZE mm Post Q Ant T i 1 ri mi a FLEXION ML CENTERING DISTAL CUT HEIGHT AXIAL ROT VARUSIVALGUS FEMUR SIZE Distal Resections mm Anterior Notching mm Varus Valgus Flexion mm Axial Rotation CA C Posterior Resections mm a Virtual Femo
43. sertion of the Praxim Robotic Cutting Guide Motor Unit To ensure sterility the insertion of the Praxim Robotic Cutting Guide motor unit in its sterile enclosure requires two people one sterile and one non sterile 1 Sterile individual places the Praxim Robotic Cutting Guide Motor Insertion Guide 4144 8000 onto the Praxim Robotic Cutting Guide Enclosure Body 4144 7000 Non sterile individual drops the Praxim Robotic Cutting Guide Motor Unit 4144 6000 into the Praxim Robotic Cutting Guide Enclosure Body 2 Non sterile individual removes the Praxim Robotic Cutting Guide Insertion Guide 3 Sterile individual closes the Praxim Robotic Cutting Guide Enclosure Body with the Praxim Robotic Cutting Guide Cover 4144 4000 and locks it securely with the screw Cover Non sterile Sterile Praxim Robotic Cutting Guide Installation Locking of the Axes Tighten the central locking screws on both axes of the Praxim Robotic Cutting Guide Enclosure Body 4144 7000 with the H3 5 screwdriver 9 144 until the axes begin to turn Note When tightening the locking screws discussed above do not overti ghten the screws Locking of the Orientation Adjustment and Cutting Guide Fixation Interfaces Attach the Orientation Adjustment Interface 4145 2000 on the face of the dedicated axis with a H3 5 screwdriver 49 144 Attach the Cutting Guide Fixation Interface 74146 1000 on the face of the
44. sition and to avoid malpositioning or damage to the femoral cuts Final seating of the femoral trial should be completed using the Femoral Impactor WS 10151 and the Impactor Handle 710300 Note It 1s recommended not to drill the holes for the femoral component pegs until final trial reduction and a check of patella tracking has been completed in case adjustment of the ML position of the femoral component is required 40 Trial Reduction and Final Component Selection Trial Tibial Tray Placement Once the correct alignment of the components has been established the Trial Tibial Tray 5 2111 to WS 2116 L amp R of the selected size is placed using the Universal Handle WS 30071 and fixed in position with two of the provided headed fixation pins 800100 inserted through the pin holes in the trial tray To aid in positioning the final implant during insertion it is helpful to make two marks on the tibia on either side of the Universal Handle attachment point on the tibial tray trial Cruciate Retaining and Cruciate Sacrificing Tibial Insert Trial Placement A CR Congruent Tibial Trial Insert of the same size as the chosen Trial Femoral Component is placed on the Tibial Tray Trial using the Trial Forceps 5 39000 When the posterior cruciate ligament has been sacrificed or has compromised function the UC Ultra Congruent Tibial Insert Trial should be used in place of the CR Tibial Insert T
45. t one hole between the two screws Secure the Two Pin Universal Fixation manually on the two screws by tightening the thumbscrew It is important that the bone screws have solid bone fixation and the Two Pin Universal Fixation is firmly clamped onto the screws Attach the T reference 0501 5030 to the Two Pin Universal Fixation using the Universal Reattachable Joint 6 9mm Adaptor 4154 5000 align the optical markers with the sagittal plane of the tibia and tighten the thumbscrew on the adapter In the presence of soft bone a 4 0 mm bone screw 4148 1001 or 44148 1002 is available to gain additional stability APEX ROBOTIC TECHNOLOGY Positioning of I and F Placement of the F reference and Femur Bone Fixation Base m Position the Femur Bone Fixation Base against Point the fixation base stem towards the femoral Align the wing of the clamp in the axial plane with Slide and rotate the stylus on the clamp so that Taking into account the quality of bone and the prosthesis to be used select the appropriate position 4 Place the Femur Bone Fixation Base 4145 5100 between the jaws of the Positioning Clamp for Femur Bone Fixation Base 4145 3100 Close the clamp and engage the locking teeth the medial aspect of the distal femur with the wing of the clamp in contact with the medial distal condyle the drill guide just anterior to the attachment of the medial epicondyle
46. to be used for this procedure INDEPENDENT CUTS The bone cuts will be based on measured resection and leg alignment D Click on the blue arrow or step on the blue pedal to proceed to the next step Notes It 15 possible to select another PROFILE and or to MODIFY OPTIONS In this case please refer to the Instruction for Use for Total Knee Surgetics OMNI APEX USER IDENTIFICATION PROFILE SELECTION sida din 1 E Je Patient Information Enter the patient name ID and birth date DD MM YY YY via the on screen keyboard Choose the leg that is being operated on and continue to the References and Camera set up The information entered on this page will be recorded on the post operative CD ROM If you do not wish this information to appear please leave the fields blank Click on the blue arrow or step on the blue pedal to proceed to the next step It may be necessary to wait a few minutes while the system is loadin 0 the data for the surgery Instrument Calibration IMPORTANT To improve operative efficiency these steps should be performed on the back table prior to beginning the surgery Attach 18 reflective markers on the navigation references 3 on Femur F reference 0501 5020 3 on Tibia I reference 0501 5030 6 on Pointer P reference 40501 5000 Guide reference 40501 5070 The markers sh
47. uring the flexion extension check the patella should move smoothly within the patellar groove with little or no pressure on its lateral border and without the need to be medially stabilized If lateral subluxation should be present the lateral retinaculum may be released Note The APEX knee system has been specifically designed to reduce the need for lateral release for patella stability Note The same screen can be used to also check the final implants stability Readjustments Beginning with the 10mm Trial Tibial Insert ligamentous balance in both flexion and extension is evaluated In most cases it is desirable that the AO flexion and extension gaps be equal aber THIGHS 5 FINAL ALIGNMENT CHECK To modify the height of Trial Tibial Insert displayed on the screen select INSERT THICKNESS and press or button gt j If the flexion and extension gaps are not balanced it CN 1 E ki m may be necessary to adjust the tibial and or femoral resection level modify the tibial resection or femoral distal resection press the corresponding button on the left panel on the screen 313 ull ANE 51 APEX ROBOTIC TECHNOLOGY Final Bone Preparation The APEX Knee bone preparation system does not require specific implantation sequence following steps describe the process of preparing the bone for implanting the components Femoral Bone Preparation
48. y 34 Femoral Cut Navigation Praxim Robotic Cutting Guide Installation of the Praxim Robotic Cutting Guide Mount the Praxim Robotic Cutting Guide onto the Femur Bone Fixation Base 4145 5100 by inserting the centering post of the Orientation Adjustment Interface 4145 2000 piece into the outermost hole on the base i e the hole that is the furthest away from the bone Insert the sliding loose screw into the innermost hole of the base i e the hole that is the closest to the bone Finger tighten the screws with the H3 5 screwdriver 9 144 Insert the Praxim Saw Guide 1 27mm 4146 5200 mounted with the reference 0501 5070 in the dove tail groove Lock the saw guide in a position just far enough from the bone to allow movement of the Praxim Robotic Cutting Guide around the femur Praxim Robotic Cutting Guide Rotation Adjustments Note At this stage for increased accuracy tt 1s advised to place the guide in the anterior cut position Remember The Tortoise Beats the Hare Moving the Praxim Robotic Cutting Guide slowly in the suggested plane will make aligning the varus valgus position and axial rotation to acceptable values easier 39 Femoral Cut Navigation Praxim Robotic Cutting Guide Loosen one screw and follow the direction shown in the top third of the screen Lock the screw when it becomes green Go slowly as the tendency is to overshoot and there is a slight lag

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