Mako Total Hip Direct anterior approach Mako Robotic-Arm Assisted Surgery
Table of contents Implant compatibility...................... 4... 6 Acetabular shell planning... 6 Femoral stem planning... 8 Reduced implant planning... 9 Recommended operating room layout... 9 Express distal and proximal landmark placement. 10 Pelvic array placement...10 Express landmark and initial checkpoint capture. 11 Acetabular registration...12 Acetabular reaming...13 Acetabular shell impaction..................13 Femoral preparation...14 Trial reduction...14 Implant insertion...15 reduction results...15 Enhanced femoral workflow...16 Femoral array screw placement and checkpoint. 17 Initial femoral landmarks...18 Femoral bone registration and verification...18 Guided femoral neck resection...19 Femoral preparation...19 Broach tracking...20 Enhanced femoral workflow reduction results..21 This publication sets forth detailed recommended procedures for using Stryker s devices and instruments. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required. Note: the information provided in this document is not to be used as the surgical technique when completing a Mako Total Hip procedure. Please refer to the Mako THA surgical guide (PN 210558) for detailed intended use, contraindications, and other essential product information. 2
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Implant compatibility Accolade II Anato Femoral implant compatibility Neck options Sizes Part number Approaches Broach tracking Stem tracking 127 0-11 6721-XXXX Anterolateral Posterolateral 132 0-11 6720-XXXX DAA Right anteverted 1-8 4845-7-10X Right neutral 1-8 4845-7-11X Left anteverted 1-8 4845-7-20X Left neutral 1-8 4845-7-21X Anterolateral Posterolateral DAA AL and PLdivots or array; DAA-divots AL and PLdivots or array; DAA-divots AL and PL-array; DAA-n/a AL and PL-array; DAA-n/a Acetabular shell compatibility Shell Trident PSL HA solidback Trident PSL HA cluster Trident hemi solidback Trident hemi HA solidback Trident hemi cluster Trident hemi HA cluster Trident hemi multihole Tritanium solidback Sizes (mm) 40-72mm 40-72mm 42-74mm 42-74mm 42-74mm 42-74mm 42-74mm 44-66mm Part number 540-11-XXX 542-11-XXX 500-01-XXX 500-11-XXX 502-01-XXX 502-11-XXX 508-11-XXX 500-03-XXX Tritanium cluster 44-66mm 502-03-XXX Tritanium multihole 54-80mm 509-02-XXX Liner compatibility Liner Trident X3 0 Trident X3 10 Trident X3 Eccentric 0 Trident X3 Eccentric 10 Trident X3 Elevated rim Trident 0 constrained Trident 10 constrained MDM liner MDM X3 insert Part number 623-00-XXX 623-10-XXX 663-00-XXX 663-10-XXX 643-00-XXX 690-00-XXX 690-10-XXX 626-00-XXX 1236-2-XXX Femoral head compatibility Part Femoral head number V40 CoCr (non LFIT) LFIT V40 CoCr V40 BIOLOX delta ceramic Universal BIOLOX delta ceramic V40 Universal adapter sleeves for delta universal heads 6260-X-XXX 6260-9-XXX 6570-0-XXX 6519-1-XXX 6519-T-XXX 4
Femoral head, X3 liner, and cup compatibility chart Shell size, liner alpha code, and head size (mm) Trident PSL shell 40 42 44 46, 48 50, 52 54, 56 58, 60 62, 64 66, 68 70,72 Trident hemispherical shell 42 44 46 48, 50 52, 54 56, 58 60, 62 64, 66 68, 70 72,74 Tritanium hemispherical shell* 44 46 48 50, 52 54, 56 58, 60 62, 64 66, 68 70, 72 74-80 Liner alpha code A B C D E F G H I J Liner thickness 44mm - - - - - 3.8 5.4 7.1 8.6 10.6 Anatomic femoral heads 40mm - - - - 3.8 5.8 7.4 9.1 10.6 12.6 36mm - - - 3.9 5.9 7.9 9.4 11.2 12.7 14.7 32mm - 3.9 4.9 5.9 7.9 9.9 11.4 13.2 14.7 16.7 Femoral 28mm 4.9 5.9 6.9 7.9 9.9 11.9 13.4 15.2 16.7 18.7 heads 26mm - - 7.9 8.9 10.9 12.9 14.4 16.2 17.7 19.7 22mm 7.8 8.8 9.8 10.8 12.8 14.8 16.3 18.1 19.6 21.6 MDM liner and insert compatibility Shell size (mm), liner alpha code Trident PSL shell 44 46, 48 50, 52 54, 56 58, 60 62, 64 66, 68 70, 72 Trident hemispherical shell 46 48, 50 52, 54 56, 58 60, 62 64, 66 68, 70 72, 74 Tritanium hemispherical shell* 48 50, 52 54, 56 58, 60 62, 64 66, 68 70, 72 74-80 Liner alpha code C D E F G H I J MDM CoCr liner 36C 38D 42E 46F 48G 52H 54I 58J Poly insert OD (mm) 36 38 42 46 48 52 54 58 Poly insert ID (mm) 22.2 22.2 28 28 28 28 28 28 Nominal poly thickness (mm) 6.7 7.7 6.8 8.8 9.8 11.8 12.8 14.8 *Tritanium solidback and clusterhole acetabular shells (500-03-XXX and 502-03-XXX) are available in sizes 44mm-66mm Tritanium multihole acetabular shells (509-02-XXX) are available in sizes 54mm-80mm 5
Acetabular shell planning Plan the acetabular shell in the transverse view and coronal view in the cup plan mode (figure 1). Figure 1 The ideal component size will evenly fit between the anterior and posterior columns in the transverse view. This view also provides a visual for how much cup overhang there may be beyond the anterior or posterior rim of the acetabulum. The shell should be medialized to the bottom of the acetabulum. Using the cortical rim (represented by the magenta line) as a guide, the shell should be just medial of the acetabular wall but not buried past it (figure 2). Figure 2 The coronal view can be used to plan inclination and the superior/inferior position of the cup (figure 3). The default settings are 40º of inclination and 20º of version but may be changed based on surgeon preference. Figure 3 6
Acetabular shell planning The coronal view can also be shown in x-ray mode by selecting x-ray view in the software (figure 4). Figure 4 While in reaming view, the surgeon is able to visualize the surface of the planned bone resection. The surgeon should confirm that sufficient bone is resected for cup fixation and that the amount of resected bone is evenly distributed anterior/posterior and superior/inferior within the acetabular rim. The transverse view is helpful with the assessment of the bone stock in the anterior/posterior columns for reaming. Planned bone resection is illustrated with green (figure 5). Figure 5 Note: While a cup-first approach is shown in the following steps, the surgeon may elect to prepare the femur prior to acetabular preparation. Note 7
Femoral stem planning Femoral stem size, femoral stem offset, and femoral head lengths can be adjusted on the right side of the screen. The coronal view will allow the surgeon to select the optimal stem size. The implant should be centered in the femoral canal just inside the bone cortices. Picture-in-picture views allow surgeons to scroll through segmented slices in the sagittal view (figure 6) and the transverse view (figure 7). Figure 6 In the coronal view for femoral stem planning, the magenta sphere represents the pre-surgical, or native head center. The blue sphere represents the head center of the femoral implant, and the green sphere represents the planned cup center of rotation. This will help the surgeon plan the optimal neck cut, represented by the green line superior to the lesser trochanter. The transverse view may be helpful to assess proximal and distal fit of the implant in the femoral canal and give visualization of any abnormalities with the canal (figures 6 and 7). Figure 7 The surgeon may prefer to measure the planned neck resection level relative to the top of the lesser trochanter using the measurement tool in x-ray view or the coronal CT view (figure 8). Figure 8 8
Reduced implant planning The reduced mode shows the entire plan (acetabular shell, femoral stem, acetabular liner and neck length) and gives the surgeon data on changes to the operative hip and how it compares to the contralateral side (figure 9). Figure 9 The reduced mode can also be viewed in x-ray view, giving the surgeon the opportunity to see the plan from a more familiar perspective (figure 10). Figure 10 Recommended operating room layout O.R. setup is important to the success of a Mako Total Hip procedure. The ideal position for camera placement is at the head of the table. As this may interfere with anesthesia, optimal results can be achieved by placing the camera between 11:00 and 1:00 o clock. The camera may be moved intra-operatively, and this will not impact the case. The robotic-arm should be located on the operative side of the patient and should be aligned with the ASIS and acetabulum of the patient for a direct anterior approach. The approach angle of the robotic-arm to the operating table should be at 45 degrees (figure 11). Figure 11 Note: Although placing the robotic-arm at 45 degrees to the table is recommended, sometimes reorientation of the robotic-arm and camera are needed to accommodate surgeon stance, table height, patient size, and other O.R. equipment. 9
Express distal and proximal landmark placement Prior to sterile preparation of the patient s leg, flex the knee so that the patella is stabilized, then place an EKG lead on the distal pole of the patella. In order to improve stability of the lead, it is recommended to secure the EKG lead with a sterile film dressing, followed by a self-adherent wrap. Continue with patient draping in the surgeon s preferred manner. It is important to ensure that the leg remains in the same position while capturing the proximal and distal checkpoints (figures 12a and 12b). Figure 12a Pelvic array placement Figure 12b Prior to the operative incision, the surgeon should make a stab incision along the lateral aspect of the non-operative iliac crest. Array placement on the contralateral iliac crest improves array visibility with a direct anterior approach. Insert a bone pin 1-2 finger breadths superior to the most prominent point of the ASIS. Use the pin clamp to make the subsequent stab incisions and place the remaining bone pins (figure 13). Figure 13 10
Express landmark and initial checkpoint capture Figure 14 Note: While a cup-first approach is shown in the following steps, the surgeon may elect to prepare the femur prior to acetabular preparation. Perform incision and exposure. Insert the pelvic checkpoint superior to the acetabulum, angled away from the joint to avoid violating the acetabular wall and incidental reaming. Capture and verify the pelvic checkpoint at this time. The surgeon should place the proximal femoral checkpoint on the lateral portion of the greater trochanter. Flex the knee at 90 degrees and capture the proximal and distal femoral landmarks for the express femoral workflow (figure 14). Figure 15 Next, capture the pelvic checkpoint (figure 15). Once the checkpoint is captured, the surgeon resects the femoral neck and removes the femoral head. Note: If the surgeon prefers, it is also acceptable to dislocate prior to placing the pelvic check-point. Extreme care must be taken not to bump the pelvic array during dislocation. If the array is bumped, reduction values at the end of the case may be compromised. 11
Acetabular registration Capture the first three landmarks in the posterior acetabulum, anterior acetabulum, and superior rim of the acetabulum (figure 16). It is important to match the registration points as close as possible to the virtual model, because these initial landmarks align the patient s bone with the patient s virtual model. Figure 16 The system will automatically continue through the registration process for the next 32 registration points (figure 17). If there is difficulty in capturing the posterior rim points, the captured pattern may be shifted more anteriorly than displayed on the monitor. Ensure that the points are properly spaced and outside the acetabular rim. Figure 17 Once registration is completed, the surgeon will confirm eight verification spheres. This will conclude acetabular registration (figure 18). Registration technique is very important. The surgeon should spread registration points out as much as possible, ensuring peripheral points are outside of the acetabular rim and that the probe is against the bone rather than on soft tissue. Figure 18 12
Acetabular reaming Attach the reamer, reamer handle, adapter, and power equipment to the end effector. Make sure that the current size reamer is consistent with the size selected in the software. In free arm mode, move the reamer into the acetabulum and into the planned orientation. Once the robotic-arm is in range, take the arm out of free arm mode to engage the robotic-arm guidance and begin reaming. In the stereotactic boundaries, the surgeon has 10 degrees of freedom from the planned cup axis of inclination and version. Acetabular shell impaction Figure 19 The surgeon should ream until the superior, lateral, and posterior values read 0. On the bone model, green indicates more bone should be resected, white indicates bone resection is to plan, and red indicates resection has exceeded 1mm of plan (figure 19). Once reaming is satisfactory, remove the power equipment and reamer handle from the robotic-arm. Attach the acetabular shell to the impactor handle. Place the impactor shaft into the end effector and attach the impactor platform. Figure 20 In free arm mode, move the shell into the acetabulum and into the planned orientation. Once the robotic-arm is in range, take the arm out of free arm mode to engage the robotic-arm guidance. Ensure that the end effector is fully seated on the impactor handle and begin impaction. Capture the current inclination, version and impaction depth by selecting capture values. It is important to perform a final capture values assessment when the cup is seated for the express femoral workflow (figure 20). When the acetabular shell is seated, disassemble the impactor handle while the robotic-arm is engaged. Once it has been removed, free the robotic-arm and disassemble the impaction shaft. Figure 21 The surgeon may want to check the shell orientation results at this time, especially if they inserted acetabular screws. He or she may do so by using the surgical results feature under the final results tab (figure 21). Surgeons may implant the final acetabular liner at this time, if they so choose. 13
Femoral preparation For femoral preparation and sequential broaching, please refer to the surgical technique for the planned femoral implant. Figure 22 Trial reduction Select the appropriate size neck trial, head diameter, and acetabular liner and reduce (figure 23). Confirm implant sizes and placement in Reduction Results. Confirm joint stability by taking the hip through a range of motion assessment. Figure 23 Any adjustments made from the initial plan must be changed in the software to reflect the updated values. Return to the original operative position and capture the proximal and distal landmarks to confirm the planned offset and leg length have been achieved. Surgeons may take intra-operative x-rays, if so desired. Once the desired reduction results are achieved, remove the trials and prepare the femur for the final implants. Note: Depending on the patient setup, for the direct anterior approach, it may not be possible to obtain 90 degrees of knee flexion. Keeping the femur parallel to the table, flex the knee as much as possible. 14
Implant insertion Insert the appropriate acetabular liner. Introduce the femoral stem into the canal by hand and fully seat the stem with the selected stem insertion instrument. Clean and dry the neck taper, place the femoral head onto the taper and firmly impact the head with a mallet and femoral head impactor. Reduce the joint and assess range of motion, stability, and leg length (figure 24). Figure 24 Reduction results In the express femoral workflow, the surgeon can capture the final values after implantation in the reduction results page by capturing the proximal and distal femoral checkpoints (figure 25). Remove all of the arrays, checkpoints and bone pins. Pulse lavage the surgical site. The surgeon should then close the surgical site using his/her preferred method. Figure 25 15
Enhanced workflow features The enhanced femoral workflow of Mako Total Hip requires additional steps. However, the surgeon may derive certain benefits using the enhanced femoral workflow. The features that are included in the enhanced femoral workflow are guided neck resection, broach version, combined anteversion and reduced leg length and combined offset. Table 1 outlines the differences between the express and enhanced femoral workflows. Required steps Express Femoral workflow Enhanced Proximal checkpoint Yes Yes Distal checkpoint Yes No Cortical array screw No Yes Femoral array No Yes Femoral registration No Yes Reduced hip center capture No No** Available features Express Femoral workflow Enhanced Guided neck resection No Yes Broach and/or stem* version and COR No Yes Combined anteversion display No Yes Reduced HL and OS Yes Yes * Stem tracking is not available with the direct anterior approach ** Hip center capture is not required for the enhanced femoral workflow as the hip center is obtained during final impaction. However, it may be captured manually based on surgeon preference. Table 1 16
Femoral array screw placement and checkpoint Locate the proper placement for the femoral cortical screw and prepare the surface by clearing all soft tissues. Next, create a pilot hole for the femoral array cortical screw. If the surgeon is using the standard screw (p/n 116240) use a 2.5mm drill. If the surgeon is using the variable angle cortical screw (p/n 111655) use a 3.0mm drill. Thread in the screw until snug, but avoid over-tightening. Confirm that the teeth are anchored into the bone to make certain that the screw will not toggle and compromise femoral registration (figure 26b). Figure 26a Figure 26b Insert the femoral array into the cortical screw and gently toggle the array to make certain that there is no motion between the flange and the bone. If so, the screw must be re-tightened (figure 27). Place the femoral array into the screw and position the array so that it is visible in the dislocated and reduced position. Hand-tighten the array while assembled to the cortical screw to ensure visibility. Next, remove the array and use the square driver to tighten the array. Do not tighten the array while it is attached to the cortical screw. Figure 27 Insert the checkpoint into the anterolateral aspect of the proximal femur. Next, capture and verify the checkpoint by placing the probe tip in the divot of the femoral checkpoint (figure 26a). 17
Initital femoral landmarks Next, the surgeon must complete the initial femoral registration. The first landmark is located on the anterior side of the femoral neck (figure 28). Figure 28 With a direct anterior approach, the second landmark is distal to the greater trochanter on the anterior side of the femur (figure 29). Figure 29 The third landmark is the lateral side of the greater trochanter (figure 30). It is important to match these three points as close to the model as possible. Figure 30 Femoral bone registration and verification The system will auto-proceed into the femoral bone registration mode (figure 31). 18 Figure 31
Femoral bone registration and verification (continued) Next, the surgeon will collect 32 points on the femur. When this process is complete, the surgeon must collect the six femoral verification spheres (figure 32). Figure 32 Guided femoral neck resection In the enhanced femoral workflow, the surgeon has access to a guided neck resection. With the femoral array attached to the cortical screw, use a surgical marker or electrocautery to mark two points with the probe tip on the neck resection line (figure 33). Next, connect the two points to mark the neck resection line. Resect the neck and remove the femoral head. Figure 33 Femoral preparation For femoral preparation and sequential broaching, please refer to the surgical technique for the planned femoral implant. Figure 34 19
Broach tracking Attach the appropriate divoted neck trial that corresponds to the planned femoral implant and selected neck option, reattach the femoral array and collect the three points on the neck trial in the order shown on the screen (figure 35). The surgeon can make intra-operative adjustments by selecting different head lengths or offsets within the drop down menus located in the software. Figure 35 Note: If the surgeon chooses to adjust the broach position, remove the Note femoral array, broach, and then reattach the array to capture the new position as outlined above. Once broach version has been established, the surgeon has the opportunity to change the planned acetabular orientation to the desired combined anteversion values (figures 36a and 36b). Figure 36A Figure 36B 20
Enhanced femoral workflow reduction results Once the hip is reduced, reattach the femoral array. Ensure that both the femoral array and pelvic array are visible to the camera. Leg length and offset will automatically be calculated based on the impacted hip center data. If the cup position was adjusted manually after robotic-arm assisted impaction, press capture hip center and articulate the hip until the progress bar on the screen reaches 100% for leg length and offset measurements (figure 37). Figure 37 Final reduction results will be displayed (figure 38). When the results are satisfactory, the surgeon may implant the final components. Figure 38 21
Stryker Australia Pty Ltd Stryker New Zealand Limited 8 Herbert Street St Leonards 515 Mt. Wellington Highway NSW 2065 Australia Auckland 1060 New Zealand Ph: +61 2 9467 1000 www.stryker.com.au Ph: +64 9 573 1890 www.stryker.com 325 Corporate Drive Mahwah, NJ 07430 t: 201.831.5000 www.stryker.com A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker s product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any of Stryker s products. The products depicted are CE marked according to the Medical Device Directive 93/42/EEC. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your sales representative if you have questions about the availability of Stryker s products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Accolade, Anato, LFIT, Mako, MDM, PSL, Stryker, Trident, Tritanium, V40, X3. All other trademarks are trademarks of their respective owners or holders. BIOLOX delta is a registered trademark of Ceramtec Ag. MKOTHA-PG-5 Copyright 2016 Stryker.