Surgical Technique i.m.a.g.e. Patient Specific Instrumentation 4-in-1

Transcription

1 Surgical Technique i.m.a.g.e. Patient Specific Instrumentation 4-in- SCORE Primary Total Knee System Mobile bearing Cemented or cementless

2 Overview of SCORE TKS Overview of SCORE TKS The SCORE TKS is a PCL-sacrificing, mobile bearing implant in rotation for primary knee arthroplasty.. Femoral component: The stability is provided by saggital and frontal congruency through the extension to the flexion. Anterior cut at 6 Thickness: 8 mm Component in Cobalt Chrome. Dual coated cementless component (80 μm plasmasprayed titanium + 80 μm HAP). Cemented component is micro-blasted. Articulating surface with mirror finish Posterior cut at 2 Radius of curvature reducing over 00 in order to increase flexion Constant radius of curvature from complete extension up to 00 flexion Anterior edge respecting the anatomy design Trochlear groove is offset laterally by 6 allowing a better stress distribution Notch on each side for grasping Anatomic trochlea with a single radius of curvature 2 stabilisation pegs Ø 8 mm x 3 mm Not HAp coated in cementless version Trochlea closed in posterior guaranteeing the largest possible contact surface of the condyle with the insert Optimal shape of the intercondylar box ü For medio-lateral and sagittal stabilisations with regard to the insert: the contact surface is increased ü Reduced pressure on the patella 2 3

3 Overview of SCORE TKS Overview of SCORE TKS The polyethylene patellar implant are available in three versions: Tibial baseplate: Thickness: 8 mm Resurfacing patella with cement Inserted patella cemented Thickness: 7 mm Inserted patella cementless Thickness: 8,5 mm Anatomical coverage in rotation Anatomical posterior shape Mirror polish finish contact surface with mobile insert 3 sizes delta wings (sizes -2, 3-4-5, 6-7) 2. Tibial component: Rotative mobility of the tibial insert: UHMW PE component Lateral chamfers Cylindrical and conical plug Congruency of the femoral component with tibial insert in extension Central spinal massif ü medio-lateral stability Large anterior chamfer Component in Cobalt Chrome. Dual coated cementless component (80 μm plasmasprayed titanium + 80 μm HAP). Cemented component is micro-blasted. Possibility of using (e.g. in cases of uni revision, or TKA, or after osteotomy): - Tibial extension stems: - Ø 0 to 6 mm - Length 75 to 200 mm Conical tibial keel shape identical for all sizes Tibial extension stems: - Ø 0 to 6 mm - Length 75 to 200 mm - Tibial half-wedges: - Thickness 5 mm - Thickness 0 mm - Thickness 5 mm - Offset connectors: - 2 mm - 4 mm - 6 mm 4 5

4 Overview of SCORE TKS Overview of SCORE TKS 3. SCORE implant product range: 4. Components compatibility: Femoral components: - Cemented condyles: 7 sizes - Uncemented condyles: 7 sizes S S2 Femoral component & insert size S3 S4 S5 S6 S7 Δ AP: increment between sizes: 2.66 mm Δ ML: increment between sizes: 3.3 mm Patellar components: - Resurfacing patella with cement: Ø 30, 33 and 36 mm - Inserted patella cemented: Ø 23, 26 and 29 mm - Inserted patella cementless: Ø 23, 26 and 29 mm Tibial components: - Cemented tibial baseplate: 7 sizes - Uncemented tibial baseplate: 7 sizes S S2 S3 S4 Tibial baseplate size S5 S6 S7 AP Increment between sizes: 2.3 mm The SCORE femoral implant is compatible with the whole range of patellar implants. ML Increment between sizes: 3.5 mm - Tibial inserts: 7 sizes 5 thickness (0, 2, 4, 6 and 20 mm) AP Increment between sizes: 2. mm ML Increment between sizes: 3.3 mm 6 7

5 i.m.a.g.e. patient-specific instrumentation Overview i.m.a.g.e. patient-specific instrumentation is: - For single use. - Manufactured based on the patient s CT or MRI images. - Used to position the Pins on which the Distal Femoral, 4-in- Femoral, and Tibial Resection Guides will be placed. It allows intraoperative check of: - contact areas comparing with Phantoms. - femoral rotation - anterior femoral cut - tibial mechanical axis Removable 4-in- Distal Femoral Pin Guide The i.m.a.g.e. Process 5 steps: Online ordering Images sending 2 Segmentation Construction of mechanical axis Femur Phantom Hole used to check femoral rotation Femoral Pin Positioning Guide Material: polyamide Slot used to check anterior resection Removable 4-in- Femoral Pin Guide ü Femoral rotation can be adjusted intraoperatively 3 Three-dimensional planning +, ,5 4 Design of Pin Positioning Guides Manufactured by selective laser sintering Hole to check tibial mechanical axis Tibia Phantom Tibial Pin Positioning Guide Material: polyamide 5 Instrumentation delivered to hospital Decontamination and sterilization by hospital Removable Tibial Pin Guide 8 9

6 Summary of surgical technique Summary of surgical technique Positioning of Tibial Pin Positioning Guide Insertion of tibial Pins Positioning of 4-in- Resection Guide Femoral cuts Set the Removable Tibial Pin Guide on the Tibial Pin Positioning Guide. Place these components on the proximal tibia. Make sure the Tibial Pin Positioning Guide is stable (unique position). Insert two Pins into the Tibial Pin Guide using the Motorised Hand-piece, while holding the Pin Positioning Guide firmly in place. Check the tibial mechanical axis. Remove the Tibial Pin Guide and then the Tibial Pin Positioning Guide Put the Headless Pins back in the distal holes. Place the 4-in- Femoral Resection Guide corresponding to the planned size on the distal Pins in the middle holes (neutral position). Use the Resection Gauge to ensure the anterior resection will respect the anterior cortex. Secure the Resection Guide with 2 lateral Pins. Make the anterior and posterior cuts. Remove the distal Pins using the Pin Extractor. Make the two chamfer cuts Tibial cut Positioning of Femoral Pin Positioning Guide Trochlear groove preparation Tibial plateau preparation Place the Tibial Resection Guide on the Pins in the 0 mm position. Use 3 converging Headed Pins to stabilise the Resection Guide. Make the tibial cut. The +2 and +4 positions will be used if the tibia needs to be recut. 3 4 Set the Removable 4-in- Distal Femoral Pin Guide and Removable 4-in- Femoral Pin Guide +0 Rotation on the Femoral Pin Positioning Guide. Place these components on the anterior and distal femur. Make sure the Femoral Pin Positioning Guide is stable (unique position). Note: After determining the flexion gaps, additional external rotation of.5, 3 or 4.5 can be added to the planned rotation with the Removable Femoral Pin Guides. 9 Impact the femoral trial in the most suitable mediolateral position. Drill and plug the 2 pegs. Prepare the trochlear groove with the rasp corresponding to the size of the trial. The rasp is guided on two planes. Using the osteotome provided, remove the posterior osteophytes leaving the femoral trial in place. 0 Position the appropriate sized trial baseplate. A smaller or larger size as compared to the femur may be selected. Important: remove the remaining two headless pins. Position the appropriate sized routing guide onto the trial baseplate. Ream using the tibial reamer to the stop. Impact the appropriate sized tibial stem punch. Insertion of femoral Pins Distal femoral cut Patellar preparation Patellar reaming option Assemble the clamp corresponding to the chosen patellar implant size onto the locking patellar reaming forceps. The inferior jaw on the reaming forceps must rest against the anterior side of the patella. Use the thumb knob to tighten the reaming forceps. Ream the patella until the stop is reached. Remove the patellar reaming forceps, place the trial cemented patellar implant and test the articulation of the patella in the trochlea. Assemble the patella binding clamp onto the locking patellar reaming forceps. Insert the chosen patellar component. Insert two Headless Pins into the 4-in- Distal Femoral Pin Guide using the Motorised Handpiece (with the Universal or AO Connector) and two other Pins in the 4-in- Femoral Pin Guide +0 Rotation, while holding the Pin Positioning Guide firmly in place. Check the anterior cut and the planned external rotation. Remove the 4-in- Femoral Pin Guide and the distal Pins. Remove the 4-in- Distal Femoral Pin Guide, and then the Femoral Pin Positioning Guide. 5 6 Place the Distal Femoral Resection Guide on the Headless Pins in the 0 mm position, flush against the femoral trochlea. Check the cut thickness with the Resection Gauge. Use two other converging Pins to stabilise the Resection Guide. Perform the distal cut. Patella preparation Resurfacing option Position the patella guide with the lugs facing the anterior side of the patella. Using the adjustment wheel, slide the 8 mm sensor into the slot such that it touches the joint face. The jaws of the forceps must be opened. Tighten and lock the forceps. Perform the resection through the slot. 2 0

7 Preoperative planning based on CT scan Preoperative planning Patient-specific instrumentation is designed according to the preoperative planning in order to insert the Pins for the Tibial, Distal Femoral and 4-in- Femoral Resection Guides. Preoperative planning is performed using the i.m.a.g.e. Planning Software. The i.m.a.g.e. Planning Software is used to determine the size and the position of the SCORE total knee implants before the procedure. Preoperative planning based on MRI The following parameters can be adjusted in the software: - On the femur: - Femoral component size - Anterior/posterior position - Flexum/recurvatum - Internal/external rotation - Height of distal cut - Medial/lateral positioning - Varus/valgus positioning - On the tibia: - Anterior/posterior slope - Height of tibial cut - Anterior/posterior position - Medial/lateral positioning - Varus/valgus positioning - Internal/external rotation - Estimated cartilage height for the tibial and distal femoral resection height reference (only for planning based on CT images). Changing these parameters will update in real-time the three-dimensional bone model generated based on the patient s CT or MRI images. The Planning Software, instructions for its use and the imaging protocols can be downloaded from Please contact your Amplitude sales rep for access. 2 3

8 Recommendations We do not recommend using the system in patients who have an existing implant near the device s application site. Examples: osteotomy plate, nail, staple, screw, etc... These could induce artefacts that could alter the quality of the CT or MRI images. Before starting the procedure, make sure the patient-specific data on each Pin Positioning Guide and Phantom are correct. Do not use these items if the patient identification is not clearly visible. Example of patient identification: F-SUR-X-PN : 7-digit number - F: first letter of patient s first name - SUR: first 3 letters of patient s surname - X: operated side, left (L) or right (R) - PN: surgeon s initials Do not resect any of the osteophytes because they are needed to position the Pin Positioning Guides. If an osteophyte that is not under a contact area interferes with exact positioning of the Pin Positioning Guide, remove this osteophyte and try again to set the Pin Positioning Guide in place. The surgeon can start with either the tibial cut or the distal femoral cut. REMINDER: The purpose of this surgical technique description is to provide instructions on how to use the instrumentation properly. The surgeon is fully responsible for choosing and performing the approach and surgical technique. 4 5

9 Positioning of Tibial Pin Positioning Guide Set the Removable Tibial Pin Guide on the Tibial Pin Positioning Guide. Carry out the following steps before placing these components on the proximal tibia: - Flex the knee. - Perform medial and lateral meniscectomy. - Use the Tibia Phantom to locate the contact areas on the tibia. - Make sure there is no fibrous tissue on the tibial contact areas that will be used to position the Pin Positioning Guide. Make sure the Tibial Pin Positioning Guide is stable (unique position) and rests against the anterior tibia. Insertion of tibial Pins Insert two Pins into the Tibial Pin Guide using the Motorised Hand-piece (with the Universal or AO Connector), while holding the Pin Positioning Guide firmly in place (if needed, the Pin holes can be pre-drilled with an Ø3.2 mm Drill Bit). NOTE: Insert the medial Pin first to prevent the Tibial Pin Positioning Guide from tipping. Check the tibial mechanical axis (varus/valgus and slope) by inserting the Extramedullary Alignment Rod in the hole on the Tibial Pin Positioning Guide. Remove the Tibial Pin Guide and then the Tibial Pin Positioning Guide (make sure the Pins are stable). 6 7

10 Tibial cut Place the Tibial Resection Guide (right or left) on the Pins in the 0 mm position and make sure it is flush with the anterior tibial cortex. NOTE: At this point, two checks can be performed: - The resection height can be checked using the Tibial Stylus or the Resection Gauge. This check is recommended in the context of CT planning because the cartilage thickness used as the resection height reference is an estimate. - The tibial mechanical axis can be checked with the Alignment Gauge and Extramedullary Alignment Rod. Use three converging Headed Pins to stabilise the Resection Guide. Make the tibial cut. Remove the Headed Pins with the Pin Extractor. Slide the Resection Guide off the Pins, by leaving the Pins in place in case a recut is necessary (the +2 and +4 holes will be used at that time). NOTA : Depending on the bone quality, a 45 mm long, Ø 3,2 mm Drill Bit can be used to make pilot holes for the Pins. Flexion and extension gaps It is then possible to check gaps using a 0 mm Spacer mounted on the Universal Handle which may accomodate Extramedullary Alignment Rods. 2 mm and 4 mm Spacers may also added to the 0 mm Spacer to improve ligament tension. 8 9

11 Positioning of Femoral Pin Positioning Guide Place the Removable 4-in- Distal Femoral Pin Guide in the anterior holes of the Femoral Pin Positioning Guide. Place the Removable 4-in- Femoral Pin Guide +0 Rotation in the distal holes of the Femoral Pin Positioning Guide. Carry out the following steps before placing these components on the anterior and distal femur: - Flex the knee Use the Femur Phantom to locate the contact areas on the femur. - Make sure there is no fibrous tissue on the femoral contact areas that will be used to position the Pin Positioning Guide. - Expose the femur in the frontal plane using Hohmann Retractors. Make sure the Femoral Pin Positioning Guide is stable (unique position) and rests against bone in the anteromedial and anterolateral aspects (cartilage/bone boundary) and in the mediolateral aspect (cartilage/bone boundary). NOTE: After determining the flexion gaps, an additional external rotation of.5, 3 or 4.5 can be added to the planned rotation. To do this, remove the 4-in- Femoral Pin Guide +0 Rotation and replace it with the 4-in- Femoral Pin Guide +.5, +3 or +4.5 Rotation (make sure to use the side labelled «RIGHT» on the right knee and the side labelled «LEFT» on the left knee). Insertion of femoral Pins Insert two Headless Pins into the 4-in- Distal Femoral Pin Guide using the Motorised Hand-piece (with the Universal or AO Connector), while holding the Pin Positioning Guide firmly in place (if needed, the pin holes can be pre-drilled with an Ø3.2 mm Drill Bit). NOTE: The Universal Connector can be assembled with the Universal T-handle. If the four other resections will be made using the i.m.a.g.e. System, insert two Headless Pins distally, while holding the Pin Positioning Guide firmly in place and making sure it is stable. Check the anterior rescetion using the Resection Gauge and check the external rotation using the Blunt K-wire. Remove the 4-in- Femoral Pin Guide and the distal Pins. Remove the 4-in- Distal Femoral Pin Guide, and then the Femoral Pin Positioning Guide. NOTE: If the 4-in- Femoral Resection Guide is positioned using the i.m.a.g.e. System, we recommend marking the distal holes made by the Headless Pins with methylene blue to make them easier to find later on. 20 2

12 Distal femoral cut Place the Distal Resection Guide on the Headless Pins in the 0 mm position, against the femoral trochlea. Check the cut thickness with the Resection Gauge. Use two other converging Pins to stabilise the Distal Resection Guide. Perform the distal cut using a Medium AMPLITUDE Saw Blade that matches the instrumentation set and Motorized Handpiece. Extract the converging Pins with the Handpiece or Pin Extractor. Slide the Distal Resection Guide off the Pins in the 0 holes, but leave the Pins in place in case recutting is necessary

13 OPTION : 4-in- femoral cuts using the i.m.a.g.e. System Put the Headless Pins back in the distal holes that were marked with methylene blue. Place the 4-in- Femoral Resection Guide corresponding to the planned size on the distal Pins in the middle holes (neutral position). NOTE: At this step the femoral size can still be changed. Place the choosen 4-in- Femoral Resection Guide on the Pins: - With a larger size, the posterior cut is unchanged but the anterior cut will be 2.6 mm smaller. - With a smaller size, the posterior cut is unchanged but the anterior cut will be 2.6 mm larger. Make sure the 4-in- Femoral Resection Guide is flush with the distal cut. Use the Resection Gauge to ensure the anterior resection will respect the anterior cortex. If the femoral cuts need to be adjusted in the anteroposterior direction, shift the 4-in- Femoral Resection Guide on the distal Pins by placing it in the lower holes (flexion gap increased by mm) or upper holes (flexion gap reduced by mm). Secure the Resection Guide with 2 lateral Headless Pins or Collared Threaded Pins. In patients with osteoporosis, better fixation can be achieved by adding a Pin in the intercondylar notch, connect the two Handles on the Resection Guide. Make the anterior and posterior cuts using a Medium AMPLITUDE Saw Blade that matches the instrumentation set and Motorized Handpiece. Remove the distal Pins using the Pin Extractor. Make the 2 chamfer cuts. - mm + mm O mm Reference mark 24 25

14 OPTION 2 : Ligament Balancer + 4-in- Pin Positioner Extension gap measurement Ligament balancing while in extension: This step is carried out after performing the distal femoral and tibial cuts. The goal is to achieve a rectangular gap in extension when the ligaments are under tension. The resulting gap will be measured and should be the same when the knee flexed. Insert the ligament balancer into the knee joint with the knee extended. Read degrees here to verify the cuts are parallel to each other Insert the H5 ratcheting screwdriver into the balancer s cog wheel. Turn the H5 screwdriver to operate the distraction mechanism and apply the desired amount of tension. Do not apply excessive distraction, otherwise the knee will flex. The knee must stay extended during the measurements. Make sure the tibial and distal femoral cuts are parallel, and check the height of the tibiofemoral gap. If the tibiofemoral gap is less than the 8 mm minimum gap needed (0 mm for the tibial component plus 8 mm for the femoral component), redo the tibial or distal femoral cut. Read extension gap here (mm) Minimum gap in extension : 8 mm = 0 mm (tibial component) + 8 mm (femoral component) Note: Ligaments can be released to achieve desired ligament balance (value of 0 on balancer). Press the blue unlock button to remove the balancer from the joint. Important: remove the 2 headless pins left in anterior part

15 Read femoral rotation here OPTION 2 : Ligament Balancer + 4-in- Pin Positioner Transfer of gap into flexion Flex the knee. Insert the balancer and apply the desired tension (same procedure as with knee extended). Read the flexion gap value and femur rotation value (induced by ligament laxity) relative to the tibia. Make sure the flexion gap is equal to the extension gap (8 mm must be subtracted from the extension gap value). Read flexion gap here (Subtract 8 mm from extension gap) On the back table: Read femoral component size here } 2 ML positions of probe Anterior cut height by Femur size (Verify with resection gauge) Set femoral rotation here Set the femoral rotation based on the measurement taken with the balancer. If the flexion gap is equal to the extension gap, set the posterior plate position to 0 mm. If the flexion gap is larger than the extension gap, set the posterior plate position to -2 mm to reduce the posterior gap by 2 mm. If the flexion gap is smaller than the extension gap, set the posterior plate position to +2 mm to increase the posterior gap by 2 mm. Note: The pin positioner uses a posterior reference point. Mount the femoral probe. The distal pins can be offset by +2 mm or -2 mm in the anteroposterior direction 28 29

16 OPTION 2 : Ligament Balancer + 4-in- Pin Positioner Distal pin insertion On the patient: Remove the balancer and place the pin positioner while making sure: - it is flush with the distal cut and - it rests against the posterior condyles Place the probe tip against the anterior cortex and determine the femoral component size. Verify the size by placing the resection gauge into the slots to preview the anterior cut position. If the femoral size shown is between two sizes, the distal pins can be offset: - Position +2 mm: Femoral component position will be offset by 2 mm anteriorly (posterior gap is 2 mm larger, anterior cut is 2 mm higher) - Position -2 mm: Femoral component position will be offset by 2 mm posteriorly (posterior gap is 2 mm smaller, anterior cut is 2 mm lower) Insert the distal pins (diameter 3,2 mm, length 65 mm). Remove the pin positioner. 30 3

17 OPTION 2 : Ligament Balancer + 4-in- Pin Positioner Femoral cuts using the 4-in- instrumentation Set the 4-in- resection guide that corresponds to the measured size on the distal pins in the middle holes (neutral position). Make sure side of the resection guide is flush with the distal cut. Use the resection gauge to check the anterior cut will not notch the femoral cortex is intact. If the femoral cuts need to be adjusted in the anteroposterior direction, set the 4-in- resection guide on the distal pins in either the lower holes (flexion gap increased by +mm) or the upper holes (flexion gap decreased by - mm). Optional pin into intercondylar notch Secure the sides of the resection guide with headless pins or collared threaded pins. In patients with osteoporosis, better fixation can be achieved by adding a pin in the intercondylar notch, connect the two handles on the cutting guide for better hold while inserting the pins. Make the anterior and posterior cuts using a medium AMPLITUDE saw blade that matches the instrumentation set and motorized handpiece. - mm Remove the distal pins using the pin extractor. Make the 2 chamfer cuts. + mm 0 Reference mark 32 33

18 Mediolateral femoral adjustment Impact the trial femoral using the femoral impactor (trial position), by choosing a mediolateral position. Drill the first anchorage peg with the stop drill. Insert the trial peg. Drill the second peg. Insert the second trial peg. Trochlear groove preparation Prepare the intercondylar notch using the cutting end of the rasp that corresponds to the size of the selected femoral component. The rasp is constrained on two sides. Finalise the preparation with the roughened end. Use the verification gauge to ensure the intercondylar notch has been prepared correctly. Resect any posterior osteophytes with the osteotome 34 35

19 Tibial plateau preparation Position the appropriate sized trial baseplate. A smaller or larger size as compared to the femur may be selected. Fix the baseplate with two 30 mm headed pins In case of a sclerotic bone, drill at 3.2 mm before fixing the nails. Position the mobile trial insert of a size corresponding to the femur. The insert size must always be identical to the femur size. Important: remove the 2 headless pins left in the tibia. Position the appropriate sized routing guide onto the trial baseplate. Ream using the tibial reamer to the stop(same for all sizes). Impact the appropriate sized tibial stem punch. (In case of a sclerotic bone or after osteotomy, prepare first with an osteotome)

20 After clearing the area around the patella Patellar preparation Patellar reaming option Trim away any peripheral osteophytes. Center the trial inset patella on the central ridge of the articular surface of the native patella. The appropriate size (Ø 23, 26 or 29 mm) is determined based on the following criteria: - Superior-to-inferior length of the articular surface - Width of the patella s medial articular facet - The size must be slightly smaller (by about 2 mm) than the superior-to-inferior length of the articular surface and must be slightly inside the medial edge of the medial articular facet Assemble the clamp corresponding to the chosen patellar implant size onto the locking patellar reaming forceps and lock it into place. Position the forceps. The inferior jaw on the reaming forceps must rest against the anterior side of the patella. The clamp must rest against at least one of the patella s two articular facets. Use the thumb knob to tighten the reaming forceps. Assemble the reamer for inset patella of the same size as the chosen clamp onto the power tool. Ream the patella until the stop is reached. Use the clamp for trial patella to place the trial cemented patellar implant or the trial uncemented patellar implant of the selected size into the native patella. Test the articulation of the patella in the trochlea. Assemble the patella binding clamp onto the locking patellar reaming forceps and lock it into place. Insert the chosen patellar component. Patellar preparation Patellar resection option Place the clamp so the two lugs are on the anterior side of the patella. With the clamp jaws open, bring the 8 mm probe into contact with the articular surface using the adjustment knob. Lock the clamp. Evaluate remaining bone. Push the saw blade into the slot to perform the cut. Use the drilling templates to determine the size of patellar component needed: 30, 33 or 36 mm. Centre and impact the drilling template. Make the pilot holes for the three pegs. Set the trial patellar component into place using the patellar clamping forceps. Test the articulation in the trochlea. Insert the chosen patellar component

21 Placing definitive implants On the selected tibial baseplate (with or without cement), tighten the stem or, if required, the extension stem using the wrench. Position the baseplate with the tibial baseplate impactor. Place the polyethylene insert with the size corresponding to the femur and the thickness validated during testing. Assemble the femoral implant (with or without cement) of the selected size on the femoral holder (anterior position). Place the femoral implant, and complete the impaction using the femoral impactor. Warning: if a cemented femoral implant is used, it is recommended to apply little cement on the posterior condyles and no cement on the posterior area of the notch, due to the implant design. 40 4

22 Optional: tibial half-wedge, tibial extension stem and offset connector Tibial preparation Intramedullary tibial aiming Make a hole in the medullary canal with the step drill bit. Gradually ream the medullary canal using reamers mounted on the universal T-handle. The graduated reamers are used to estimate the most appropriate extension stem length. Use progressively larger reamers (0/2/4/6 mm) until contact is made with the bone cortex. Leave the last reamer used in place. Tibial instrumentation positioning Assemble the sleeve and revision tibial resection guide onto the bracket. Put the entire unit onto the reamer or IM rod left in the tibia. If combined aiming is preferred, assemble the malleolar clamp with the extramedullary alignment rod and attach it around the ankle. Set the rotation of the extramedullary alignment guide and its position in the sagittal plane before locking it into place with the H5 screwdriver. Set the resection height with the stylus as follows: - On the healthy side: stylus positioned at 0 mm (0 mm cut relative to this reference) - On the worn side: stylus positioned at 0 mm (exit level of saw blade) - For other resection heights, use the 2 mm markings on the alignment rod Determine if a tibial half-wedge is needed (resection guide placed in the half-slots labelled 5/0/5 mm)

23 Tibial cut Use a motorised handpiece and the universal or AO quick-release connector to drive 2 headless pins into the 0 landmarks on the tibial resection guide. Loosen the screw on the tibial bracket with the H5 screwdriver. Use the slaphammer to remove the intramedullary (and extramedullary) alignment rod. Set the resection guide against the bone. Stabilize the resection guide with 3 headed pins; the pin holes can be predrilled with a 3.2 mm drill bit. Use a medium saw blade (AMPLITUDE) to make the tibial cuts and those of the tibial half-wedges (slots at 5/0/5 mm) if needed. Remove the headed pins with the pin extractor. Slide the resection guide off the pins, but make sure the pins stay in place in case recutting is required; if so, the +2 and +4 marks will be used. Make the cut, then assess the gaps and ligament tension with the knee flexed and extended. Positioning of trial tibial baseplate Important: remove the two pins that were left in the tibia (after the tibial cut is completed). Select the trial tibial baseplate that provides the best possible bone coverage. Reposition the reamer selected during the tibial resection onto the universal T-handle. Assemble the 0 mm offset positioner onto the trial tibial baseplate. Place these two components onto the reamer, against the previously-made tibial cut; if needed, a tibial half-wedge of the same size of the baseplate can be used 44 45

24 Positioning of trial tibial baseplate If the trial baseplate does not fully cover the tibial cut surface when it is centred on the reamer, use the 2, 4 or 6 mm offset positioner instead. Turn the offset positioner until the trial tibial baseplate covers the cut surface completely. Make note of the connector size and its position using the graduations on the connector and the mark on the trial baseplate. This information will be used when the trial and final components are assembled. Secure the unit with 2 headed pins; the appropriate pin length (30, 50 or 70 mm) depends on the thickness of any tibial half-wedge that is used. Remove the reamer and offset positioner. Preparing the trial tibial baseplate Screw the trial extension stem (length and diameter correspond to final reamer used) to the trial offset connector corresponding to the selected tibial offset positioner. These components are assembled using the chuck key for offset connector and extension stem wrench. With the H5 screwdriver, tightly screw this unit to the delta wing for tibial trials while making sure the position of the trial offset connector previously determined from the trial tibial baseplate is maintained. Impact the delta wing/connector (if used)/extension stem unit through the tibial baseplate into the tibia until it stops. Secure the entire unit to the trial baseplate using the thumb knob that connects the baseplate and delta wing. Tests can now be carried out in the same configuration as the final implants. Note: If no connector is used, screw the trial extension stem directly into the delta wing for tibial trials 46 47

25 Assembly and placement of final implants Assembly of tibial implant Screw the tibial extension stem to the offset connector that corresponds to the validated tibial offset positioner. These components are assembled using the chuck key for offset connector, extension stem wrench and the screwdriver H3.5. If no offset connector is used, screw the extension stem directly into the tibial baseplate using the extension stem wrench and the screwdriver H3.5. Impact the whole unit into the tibial baseplate while matching the position determined during tibial preparation (laser markings can be found on the edge of the delta wing). Place the tibial baseplate impactor into the female side of the baseplate taper. Finish impacting by firmly tightening the screw in the tibial baseplate impactor with the H5 screwdriver. Placement of tibial implants Lengths Diameters Carefully lavage the implantation site to clean it out. Prepare the bone cement and apply it to the tibial cut surface or under the tibial baseplate. If using a tibial half-wedge, apply a thin layer of cement between the half-wedge and tibial baseplate. Impact the final components into the tibia using the trial baseplate impactor and make sure the half-wedge is perfectly positioned relative to the tibial baseplate and tibial cut. 35 mm 25 mm 25 mm Examples with 00 mm long extension stem 00 mm 35 mm Tighten the tibial impactor with offset connector one last time before removing it completely. Remove any excess cement with a curette. Place a tibial insert of the size corresponding to the femur and thickness validated during the trials 48 49

26 Composition of the instrumentation i.m.a.g.e. 4-in- kit for TKA The i.m.a.g.e. 4-in- instrumentation for the SCORE TKA requires: An i.m.a.g.e. 4-in- kit for TKA The additional set - i.m.a.g.e. 4-in- for TKA The 4-in- SCORE conventional instrumentation composed of 5 trays: - One common - One for tibial resection - One for tibial trials - One for 4-in- femoral resections - One for femoral trials And either of: - One for patellar resection - One for patellar reaming In addition: - One for tibial revision - Sterile large saw blades - Sterile medium saw blades Item Name Product No Qty i.m.a.g.e. F and T Pin Positioning Guides with Phantoms, TKA 4-in-, MRI Version Non Sterile i.m.a.g.e. Femoral Pin Positioning Guide, TKA 4-in-, MRI Version NS - 2 i.m.a.g.e. Tibial Pin Positioning Guide, TKA 4-in-, MRI Version NS - 3 i.m.a.g.e. Femur Phantom, TKA - 4 i.m.a.g.e. Tibia Phantom, TKA - i.m.a.g.e. F and T Pin Positioning Guides with Phantoms, TKA 4-in-, CT Scan Version Non Sterile i.m.a.g.e. Femoral Pin Positioning Guide, TKA 4-in-, CT scan Version NS - 2 i.m.a.g.e. Tibial Pin Positioning Guide, TKA 4-in-, CT scan Version NS - 3 i.m.a.g.e. Femur Phantom, TKA - 4 i.m.a.g.e. Tibia Phantom, TKA - 2 i.m.a.g.e. F and T Pin Positioning Guides TKA 4-in-, MRI Version Non Sterile i.m.a.g.e. Femoral Pin Positioning Guide, TKA 4-in-, MRI Version NS i.m.a.g.e. Tibial Pin Positioning Guide, TKA 4-in-, MRI Version NS i.m.a.g.e. F and T Pin Positioning Guides, TKA 4-in-, CT scan Version Non Sterile i.m.a.g.e. Femoral Pin Positioning Guide, TKA 4-in-, CT scan Version NS i.m.a.g.e. Tibial Pin Positioning Guide, TKA 4-in-, CT scan Version NS

27 Additional set - i.m.a.g.e. 4-in- for TKA Common Set Item Name Product No. Qty Removable Tibial and 4-in- Distal Femoral Pin Guide i.m.a.g.e Removable 4-in- Femoral Pin Guide +0 Rotation i.m.a.g.e Removable 4-in- Femoral Pin Guide +.5 Rotation i.m.a.g.e Removable 4-in- Femoral Pin Guide +3 Rotation i.m.a.g.e Removable 4-in- Femoral Pin Guide +4.5 Rotation i.m.a.g.e Item Name Product No. Qty Intramedullary drill bit Intramedullary rod length 250 mm Intramedullary rod length 400 mm T wrench Navigated Universal handle Extramedullary alignment rod Spacer thickness 7 mm Spacer thickness 0 mm Spacer thickness 8 mm Spacer thickness 2 mm for spacer Spacer thickness 4 mm for spacer H5 screwdriver Resection gauge Ø 2 headless pin Alignment gauge Universal quick release adaptor for pin AO quick release adaptor for pin Pin extractor Wrench for tibial stem Drill bit Ø 3.2 lenght 45 mm Slap hammer Flat rasp Hohmann retractor 240 mm 8 mm Hohmann retractor 265 mm 24 mm

28 Tibial Resection Set Tibial Trial Set Item Name Product No. Qty Malleolar clamp Extramedullary alignment guide Wheel for extramedullary aiming column Tibial slide bar Tibial bracket Thumb knob for tibial bracket Headed pin lenght 30 mm Headed pin lenght 70 mm Headless pin lenght 80 mm Tibial resection guide Right Tibial resection guide Left Thumb knob for resection guide Tibial stylus Punch guide for tibial baseplate size / Punch guide for tibial baseplate size 3/4/ Punch guide for tibial baseplate size 6/ Removable handle for punch guide Reamer for tibial extension stem Punch for tibial extension stem - size / Punch for tibial extension stem - size 3/4/ Punch for tibial extension stem - size 6/ Standard trial stem Item Name Product No. Qty Trial baseplate navigated Size Trial baseplate navigated Size Trial baseplate navigated Size Trial baseplate navigated Size Trial baseplate navigated Size Trial baseplate navigated Size Trial baseplate navigated Size Trial insert size thick. 0 mm Trial insert size thick. 2 mm Trial insert size thick. 4 mm Trial insert size thick. 6 mm Trial insert size thick. 20 mm Trial insert size 2 thick. 0 mm Trial insert size 2 thick. 2 mm Trial insert size 2 thick. 4 mm Trial insert size 2 thick. 6 mm Trial insert size 2 thick. 20 mm Trial insert size 3 thick. 0 mm Trial insert size 3 thick. 2 mm Trial insert size 3 thick. 4 mm Trial insert size 3 thick. 6 mm Trial insert size 3 thick. 20 mm

29 Tibial Trial Set 4-in- Femoral Resecıon Set Item Name Product No. Qty Trial insert size 4 thick. 0 mm Trial insert size 4 thick. 2 mm Trial insert size 4 thick. 4 mm Trial insert size 4 thick. 6 mm Trial insert size 4 thick. 20 mm Trial insert size 5 thick. 0 mm Trial insert size 5 thick. 2 mm Trial insert size 5 thick. 4 mm Trial insert size 5 thick. 6 mm Trial insert size 5 thick. 20 mm Trial insert size 6 thick. 0 mm Trial insert size 6 thick. 2 mm Trial insert size 6 thick. 4 mm Trial insert size 6 thick. 6 mm Trial insert size 6 thick. 20 mm Trial insert size 7 thick. 0 mm Trial insert size 7 thick. 2 mm Trial insert size 7 thick. 4 mm Trial insert size 7 thick. 6 mm Trial insert size 7 thick. 20 mm Baseplate impator Item Name Product No. Qty 4-in- Femoral resection guide - Size in- Femoral resection guide - Size in- Femoral resection guide - Size in- Femoral resection guide - Size in- Femoral resection guide - Size in- Femoral resection guide - Size in- Femoral resection guide - Size Removable hand holds V2 Extra-articular ligament balancer Screwdriver H Femoral condyle holder Headless pin, Ø 3.2 length 65 mm in- probe in- pin positioner Distal resection guide - 8 mm Distal resection guide - 0 mm Distal slide bar Adjustable varus-valgus barrel Adjustable varus-valgus barrel Adjustable varus-valgus barrel Wrench H Snap screwdriver H Collared threaded pin, Ø3.2 lenght 57 mm

30 Femoral Trials Set Patellar Resection Set 7D 6D 5D 4D 3D 2D D G 4 2G 3G 4G 5G 9 6G 8 7G Item Name Product No. Qty Trial openwork femoral component -Navigated - Right Size Trial openwork femoral component -Navigated - Right Size Trial openwork femoral component -Navigated - Right Size Trial openwork femoral component -Navigated - Right Size Trial openwork femoral component -Navigated - Right Size Trial openwork femoral component -Navigated - Right Size Trial openwork femoral component -Navigated - Right Size Trial openwork femoral component -Navigated - Left Size Trial openwork femoral component -Navigated - Left Size Trial openwork femoral component -Navigated - Left Size Trial openwork femoral component -Navigated - Left Size Trial openwork femoral component -Navigated - Left Size Trial openwork femoral component -Navigated - Left Size Trial openwork femoral component -Navigated - Left Size Trial peg for trial femoral component Drill for peg holes Femoral rasp size /2/ Femoral rasp size 4/5/6/ Cutting gauge Femoral component impactor Intercondylar control gauge Item Name Product No. Qty Patellar resection forceps Patellar resection gauge Drilling template Ø Drilling template Ø 33 and Ø Drill bit for resurfacing patella Trial resurfacing patella Ø Trial resurfacing patella Ø Trial resurfacing patella Ø Clamp for trial patella or locking ring Patellar clamping forceps

31 Patellar Reaming Set Tibial revision set TIBIA 4 TIBIA 2 TIBIA 0 TIBIA /5 2/9 4/2 6/ Item Name Product No. Qty Stop reaming patellar forceps Reamer for inset cementless patellar Ø Reamer for inset cementless patellar Ø Reamer for inset cementless patellar Ø Binding clamp for stop reaming patellar forceps Clamp for stop reaming patellar forceps Ø Clamp for stop reaming patellar forceps Ø Clamp for stop reaming patellar forceps Ø Trial inset patellar implant - cemented Ø 23 mm Trial inset patellar implant - cemented Ø 26 mm Trial inset patellar implant - cemented Ø 29 mm Clamp for trial patella or locking ring Trial inset patellar implant - cementless Ø Trial inset patellar implant - cementless Ø Trial inset patellar implant - cementless Ø Item Name Produc No Qty Reamer Ø Reamer Ø Reamer Ø Reamer Ø Sleeve 0/ Sleeve 2/ Sleeve 4/ Sleeve 6/ Revision tibial bracket Revision tibial resection guide Thumb knob for resection guide Trial tibial half-wedge - Size /2 thickness 5 mm Trial tibial half-wedge - Size /2 thickness 0 mm MED.R / LAT.L Trial tibial half-wedge - Size /2 thickness 5 mm MED.R / LAT.L Trial tibial half-wedge - Size /2 thickness 0 mm LAT.R./.MED.L Trial tibial half-wedge - Size /2 thickness 5 mm LAT.R./.MED.L Trial tibial half-wedge Size 3/4/5 thickness 5 mm Trial tibial half-wedge - Size 3/4/5 thickness 0 mm MED.R / LAT.L Trial tibial half-wedge - Size 3/4/5 thickness 5 mm MED.R / LAT.L Trial tibial half-wedge - Size 3/4/5 thickness 0 mm LAT.R./.MED.L Trial tibial half-wedge - Size 3/4/5 thickness 5 mm LAT.R./.MED.L Trial tibial half-wedge - Size 6/7 thickness 5 mm Trial tibial half-wedge - Size 6/7 thickness 0 mm MED.R / LAT.L Trial tibial half-wedge - Size 6/7 thickness 5 mm MED.R / LAT.L Trial tibial half-wedge - Size 6/7 thickness 0 mm LAT.R./.MED.L Trial tibial half-wedge - Size 6/7 thickness 5 mm LAT.R./.MED.L Offset positioner for trial tibial baseplate - 0 mm Offset positioner for trial tibial baseplate - 2 mm Offset positioner for trial tibial baseplate - 4 mm Offset positioner for trial tibial baseplate - 6 mm

32 Tibial revision set Large saw blades 6 TIBIA 4 TIBIA 2 TIBIA 0 TIBIA SYNTHES AO / SODEM large saw blade Sterile Product No STRYKER large saw blade Sterile Product No /5 2/9 4/2 6/ ZIMMER / HALL / LINVATEC large saw blade Sterile Product No Item Name Produc No Qty 8 Trial extension stem - Ø 0 length Trial extension stem - Ø 2 length Trial extension stem - Ø 4 length Trial extension stem - Ø 0 length Trial extension stem - Ø 2 length Trial extension stem - Ø 4 length Trial extension stem - Ø 6 length Trial extension stem - Ø 0 length Trial extension stem - Ø 2 length Trial extension stem - Ø 4 length Trial extension stem - Ø 6 length Trial extension stem - Ø 2 length Trial extension stem - Ø 4 length Trial extension stem - Ø 6 length Trial offset connector 2 mm Trial offset connector 4 mm Trial offset connector 6 mm Chuck key for offset connector Delta wing for tibial trials Thumb knob to connect baseplate / delta wing Tibial impactor with offset connector Extractor for offset connector Headed pin - length 50 mm SYNTHES AO / SODEM medium saw blade Sterile Product No STRYKER medium saw blade Sterile Product No ZIMMER / HALL / LINVATEC medium saw blade Sterile Product No Medium saw blades 62 63

33 Assembly and Disassembly of Balancer Assembly and Disassembly of Pin Positioner Disassembly of Pin Positioner - Unscrew the indexing thumb knob ( ). 2 - Remove the dowel ( ). 3 - Take the H2.5 wrench ( ). 4 - Unscrew the pan-head screw. Assembly of Balancer - Pick up the removable handle ( ). 2 - Screw the removable handle onto the tibial housing ( ). 3 - Place the gear wheel ( ) into the lateral opening on the tibial housing. 5 - Remove the saw blade guide. Assembly of Pin Positioner Repeat the above steps in the reverse order. 4 - Press the blue button and insert the femoral housing ( ) on top of the tibial housing. Disassembly of Balancer Repeat the above steps in the reverse order

34 Notes Notes 66 67

35 Reference: TO.G.GB.02/.0 Customer Service France : Porte du Grand Lyon, 0700 Neyron France Tel. : +33 (0) Fax : +33 (0) amplitude@amplitude-ortho.com Customer Service Export :, cours Jacques Offenbach, Zone Mozart 2, Valence France Tel. : +33 (0) Fax : +33 (0) Internet :