Download Mako™ Total Hip Direct anterior approach

Mako Total Hip
Direct anterior
approach
™
Surgical reference guide
Mako
Robotic-Arm
Assisted Surgery
Mako Total Hip - direct anterior approach
Surgical reference guide
Table of contents
Implant compatibility. . . . . . . . . . . . . . . . . . . . . . 4
Express femoral workflow . . . . . . . . . . . . . . . . . . 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
Express femoral workflow 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.
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Mako Total Hip - direct anterior approach
Surgical reference guide
3
Mako Total Hip - direct anterior approach
Surgical reference guide
Implant compatibility
Femoral implant compatibility
Neck options
Sizes
Part number
Approaches
Broach tracking
Stem tracking
127°
0-11
6721-XXXX
132°
0-11
6720-XXXX
Anterolateral
Posterolateral
DAA
AL and PLdivots or array;
DAA-divots
AL and PL-array;
DAA-n/a
Right anteverted
1-8
4845-7-10X
Right neutral
1-8
4845-7-11X
Left anteverted
1-8
4845-7-20X
1-8
4845-7-21X
AL and PLdivots or array;
DAA-divots
AL and PL-array;
DAA-n/a
Left neutral
Anterolateral
Posterolateral
DAA
Accolade II
Anato
Acetabular shell compatibility
Shell
4
Sizes
(mm)
Part
number
Trident PSL HA
solidback
40-72mm 540-11-XXX
Trident PSL HA
cluster
40-72mm 542-11-XXX
Trident hemi
solidback
42-74mm 500-01-XXX
Trident hemi HA
solidback
42-74mm 500-11-XXX
Trident hemi
cluster
42-74mm 502-01-XXX
Trident hemi
HA cluster
42-74mm 502-11-XXX
Liner compatibility
Liner
Trident X3 0°
Part
number
Femoral head
compatibility
Femoral head
Part
number
V40 CoCr
(non LFIT)
6260-X-XXX
LFIT V40 CoCr
6260-9-XXX
V40 BIOLOX
delta
ceramic
6570-0-XXX
Universal
BIOLOX delta
ceramic
6519-1-XXX
V40 Universal
adapter sleeves
for delta
universal heads
6519-T-XXX
623-00-XXX
Trident X3 10°
623-10-XXX
Trident X3
Eccentric 0°
663-00-XXX
Trident X3
Eccentric 10°
663-10-XXX
Trident X3
Elevated rim
643-00-XXX
690-00-XXX
Trident hemi
multihole
42-74mm 508-11-XXX
Trident 0°
constrained
Tritanium
solidback
44-66mm 500-03-XXX
Trident 10°
constrained
690-10-XXX
Tritanium cluster
44-66mm 502-03-XXX
MDM liner
626-00-XXX
Tritanium
multihole
54-80mm 509-02-XXX
MDM X3 insert
1236-2-XXX
Mako Total Hip - direct anterior approach
Surgical reference guide
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
A
B
C
D
E
F
G
H
I
J
Liner alpha code
Anatomic femoral
heads
Femoral
heads
Liner thickness
44mm
-
-
-
-
-
3.8
5.4
7.1
8.6
10.6
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
28mm
4.9
5.9
6.9
7.9
9.9
11.9
13.4
15.2
16.7
18.7
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
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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).
Note: While a “cup-first” approach is shown in the
following steps, the surgeon may elect to prepare the
femur prior to acetabular preparation.
Figure 5
Note
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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.
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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
Figure 12b
Pelvic array placement
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
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
Express landmark and initial checkpoint capture
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 14
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.
Figure 15
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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.
Figure 19
Acetabular shell impaction
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.
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.
Figure 21
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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.
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.
Figure 23
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.
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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.
Femoral workflow
Required steps
Express
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
Femoral workflow
Express
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.
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Table 1
Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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).
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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).
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Figure 31
Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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.
Note: If the surgeon chooses to adjust the broach
Note
position, remove the
femoral array, broach, and then
reattach the array to capture the new position as
outlined above.
Figure 35
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
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Mako Total Hip - direct anterior approach
Surgical reference guide
Express femoral workflow
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
8 Herbert Street St Leonards
NSW 2065 Australia
Ph: +61 2 9467 1000
www.stryker.com.au
Stryker New Zealand Limited
515 Mt. Wellington Highway
Auckland 1060 New Zealand
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
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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.
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