Johnson & Johnson Depuy Synthes Trumatch User manual

Pin Guide System
SURGICAL TECHNIQUE
TRUMATCH®
PERSONALIZED
SOLUTIONS
with the SIGMA®High
Performance Instruments

PIN GUIDE SURGICAL TECHNIQUE
The following steps are an addendum to the SIGMA®
High Performance (HP) Instruments, Fixed Reference
Surgical Technique (Cat. No. 0612-87-510).
This surgical technique provides instructions on how to
incorporate the use of the TRUMATCH®Solutions Femoral
and Tibial Pin Guides into the broader SIGMA HP
Instruments Fixed Reference Surgical Technique. The
surgeon must be familiar with the proper use of the
appropriate instruments that are necessary to complete
the operation following the use of the TRUMATCH
Solutions Femoral and Tibial Pin Guides.
It is strongly recommended that the surgeon carefully
review the TRUMATCH Solutions Patient Proposal prior to
proceeding with the surgical procedure. The Patient
Proposal is available through the web-based, password
protected, TRUMATCH Personalized Solutions Web Portal
(www.depuysynthes.com/trumatch). The Patient Proposal
contains in-depth information utilized in the design of the
patient specific guides including, as necessary, case
specific remarks that are listed in the Notes/Comments
section.
Note: Pin Guides are only cleared for the use with
SIGMA and ATTUNE®Knee Fixed Bearing Total
Knee Implants.

BASIC TRUMATCH®SOLUTIONS PIN GUIDE
SURGICAL STEPS
Femoral Preparation
Step 1: Insert drill guides
and twist clockwise to
tighten
Step 6:
Distal femoral resection
Step 2: Femoral pin
guide placement
Step 7: Use of fixed
reference guide to
position the 4-in-1
femoral cutting block
Step 3: Drill anterior and
distal pin holes, remove
drill pins and pin guide
Step 8: Use of angel wing
to verify anterior resection
Step 9: Fixation of
4-in-1 femoral cutting
block to complete femoral
resection
Step 4: Position the distal
femoral cutting block with
anterior reference guide
Step 5: Use of angel wing
to verify distal resection
level
Tibial Preparation
SIGMA®Total Knee System steps shown.
Step 1: Insert drill guides
and twist clockwise to
tighten.
Step 5: Twist
counterclockwise and
remove drill guide and pin
guides. Anterior pins left
in place
Step 4: Placement of
anterior pins. Use of HP
uprod and rod extension
Step 6: Proximal tibial
resection using HP Knee
Tibial Cutting Block
Step 2A: Tibial guide
placement
Step 2B: Tibial guide
alignment
Step 3: Use of uprod
extension. Verification of
V/V alignment
Surgical Technique TRUMATCH Personalized Solutions Pin Guides DePuy Synthes Joint Reconstruction 3

The tibial pin guide (in addition to the product packaging
label) will have patient specific identifiers: Patient Name,
Lot No., Size and Patient Anatomy (R/L). Verify the
accuracy of these identifiers prior to opening the sterile
package (Figure 1).
Note: The size information was selected pre-
operatively based on the Patient Proposal. Final
implant sizing may change due to intra-operative
assessment of implant fit and/or joint gap balance.
Prior to use, insert the TRUMATCH Solutions Drill Guides
(Part Number (P/N) 2004-20-925) into the two anterior
openings of the plastic tibial pin guide by twisting in a
clockwise direction until tightened (Figure 2).
Note: The TRUMATCH Solutions Drill Guides (P/N
2004-20-925) are reusable after sterilization. A
minimum of four (4) drill guides should be on hand
for a case. They are shipped separately from the
TRUMATCH Solutions Pin Guides.
For optimal handling and placement stability of the tibial
pin guide, first insert the HP Extra Medullary Tibial Uprod
(P/N 9505-01-228) into the anterior holes of the tibial pin
guide. Then slide the Rod Extension (P/N 2004-20-923)
over the distal end of the uprod. This will lengthen it to
reach the patient’s ankle. Grasp the guide using the
medial and lateral finger pads (Figure 3A). Do not grasp
the uprod or the area on which the metal drill guides are
located. (Figure 3B).
Figure 2
Figure 1
Figure 3A Figure 3B
PROXIMAL TIBIAL RESECTION
4 DePuy Synthes Joint Reconstruction TRUMATCH Personalized Solutions Pin Guides Surgical Technique

2
1
Rod is parallel
in all cases.
Pins include
tibial slope.
With the knee flexed at 90 degrees, place the tibial resection
guide with uprod assembly onto the proximal anterior
medial aspect of the tibia and both plateaus. Avoid using
excessive force to seat the guide. Apply most of the force
anterior to posterior while holding the guide as described.
To assist in the medial/lateral positioning of the tibial pin
guide, refer to the last page of the Patient Proposal which
contains a top view of the patient’s tibial surface. It is
recommended to visualize the red line shown in the
Patient Proposal to the patient’s bone and to check
alignment with the raised line on the lateral aspect of the
tibial pin guide (Figure 4).
The planned Varus/Valgus (V/V) alignment can be confirmed
by verifying the alignment of the rod to the patient’s tibial
crest and center of the ankle (Figure 5). The rod is designed
to be parallel to the mechanical axis of the tibia regardless of
the planned tibial slope, when viewed laterally.
Note: The position of the line in the Patient Proposal
is intended to reference the medial one-third of the
tibial tubercle and not the middle of the tibial crest
(Figure 4).
Note: It is recommended to clear extraneous tissue
along the anterior medial aspect of the tibia. Soft
tissue impingement can impact the fit of the guide
and overall alignment or slope. Visualization in
assessing proper fit observed from a sagittal or side
view is helpful.
Note: To position the guide, apply most of the
pressure to the anterior aspect and the remaining
pressure to the proximal aspect of the guide. This
will help assure proper seating of the guide at the
appropriate resection level. The correct position is
found when there is minimal or no toggling/rocking
of the tibial pin guide.
Once the tibia pin guide and uprod assembly is in the
desired position, hold it in place, and secure it to the bone
by drilling two (recommended P/N 9505-02-302) pins, first
through the lateral and then the medial, drill guide pin
holes (Figure 6).
Figure 4
Figure 5
Figure 6
0 degree block
should be used as
slope has been
planned in the pin
placement.
Surgical Technique TRUMATCH Personalized Solutions Pin Guides DePuy Synthes Joint Reconstruction 5

Figure 8
Figure 7
After drilling the two anterior pins, the TRUMATCH
Solutions Drill Guides are removed by twisting in a
counter-clockwise direction, while leaving the two
anterior pins in place (Figure 7). Remove the tibial pin
guide by moving it up and pulling it away from the
anterior fixation pins. Check to verify that the spikes of
the fixed reference guide are in the middle holes of the
bottom hole cluster. It is possible to position the spike
through the top hole and opposite bottom hole (vice-
versa). This will result in an incorrect rotation placement
of the cutting block.
Slide the appropriate L/R 0 degree HP Proximal Tibial
Cutting Block over the anterior fixation pins through the
“0” mm holes marked with a square. (Figure 8) If desired,
confirm the cut orientation with the angel wing. If
necessary, the block may be shifted 2 mm proximally or
distally by selecting the appropriate offset holes adjacent
to the “0”mm hole. Perform the proximal resection with
a 1.19 mm whale tail saw blade.
Remove the HP tibial cutting block and make sure bone
cuts are clean and void of any under-cut bone fragments.
Note: The arthritic disease process can cause
adaptive bone changes that result in hard, sclerotic
bone in the affected tibial condyle, thus making
resection difficult. A solution is to start the tibial
cut on the “least affected” or the side opposite to the
more involved tibial condyle. This will provide an
easier entry cut in the intended orientation and sets
the path for the continued saw blade sweep through
the hard, sclerotic bone of the involved plateau.
PROXIMAL TIBIAL RESECTION
6 DePuy Synthes Joint Reconstruction TRUMATCH Personalized Solutions Pin Guides Surgical Technique

The femoral pin guide (in addition to the product
packaging label) will have patient specific identifiers:
Patient Name, Lot No., Size and Patient Anatomy (R/L).
Verify the accuracy of these identifiers prior to opening
the sterile package (Figure 9).
Note: The size information was selected pre-
operatively based on the Patient Proposal. Final
implant sizing may change due to intra-operative
assessment of implant fit and/or joint gap balance.
Prior to use, insert the TRUMATCH Solutions Drill Guides
(P/N 2004-20-925) into the two anterior and two distal
openings of the plastic femoral pin guide by twisting in a
clockwise direction until tightened (Figure 10).
With the knee flexed to at least 90 degrees, place the
femoral pin guide over on the anterior aspect of the
femur and position the “feet” of the guide over the distal
femoral condyles (Figure 11A). Avoid using excessive force
to seat the guide. Care should be taken to avoid
squeezing the block and causing the legs to deform while
pins are being placed (Figure 11B).
The majority of the finger pressure (~75%) should be
applied on the anterior aspect of the guide while applying
less pressure (~25%) over the distal aspect of the guide.
Note: Soft tissue impingement may cause difficulty
in seating the femoral pin guide on the femur and
could impact the overall alignment of the guide. It
is recommended to clear extraneous soft tissue from
the anterior aspect of the femur to facilitate proper
placement of the guide. Visualization for proper
seating may be enhanced when the guide is observed
from a sagittal or side view.
Figure 9
Figure 11A
Figure 11B
DISTAL FEMORAL RESECTION
Figure 10
Surgical Technique TRUMATCH Personalized Solutions Pin Guides DePuy Synthes Joint Reconstruction 7

Evaluate the lack of toggling or rocking of the femoral pin
guide to confirm the optimum placement of the guide. It
is not uncommon to see a 1 to 2 mm gap around the
periphery of the guide. Next drill two anterior pins and
two distal pins through the drill guides (Figure 12).
The anterior holes will be used to place the HP distal
femoral cutting block to perform the distal femoral cut.
The distal holes set the femoral rotation and match the
fixed reference pin placement of the SIGMA HP Femoral
4-in-1 Cutting Block.
Extract the two anterior and two distal pins and remove
femoral pin guide by flexing the guide from posterior to
anterior.
Note: The TRUMATCH Solutions Drill Guides (P/N
2004-20-925) are reusable after sterilization. A
minimum of four (4) drill guides should be on hand
for a case. They are shipped separately from the
TRUMATCH Solutions Pin Guides.
Attach the H/P Universal Handle to the Anterior Reference
Guide (P/N 2004-20-926) and position the guide’s spikes
through the “0” mm holes, marked with a square, in the
SIGMA HP Distal Femoral Resection Block (Figure 13).
Using the handle, place the Anterior Reference Guide
spikes located through the SIGMA HP Distal Femoral
Resection Block into the anterior femoral holes.
Figure 12
Figure 13
DISTAL FEMORAL RESECTION
8 DePuy Synthes Joint Reconstruction TRUMATCH Personalized Solutions Pin Guides Surgical Technique

Evaluate the distal cut using the reference guide or angel
wing (Figure 14A). If needed, the block may be shifted 2
mm proximally or distally by selecting the appropriate
offset holes adjacent to the “0” mm hole.
For additional stability during the cut, an optional third,
fixation pin can be placed through the cutting block in
either the lower medial or lateral holes. Perform the distal
femoral resection using a 1.19 mm whale tail thick saw
blade (Figure 14B).
Remove the HP Distal Femoral cutting block and confirm
the bone cuts are clean and without any under-cut bone
fragments.
Note: In order to address gap assessment and
ligament tension, it may be necessary to re-cut
additional bone from the distal femur or the
proximal tibia. The HP spacer block and alignment
rod are useful in assessing leg alignment and gap
balance.
Figure 14A
Figure 14B
Surgical Technique TRUMATCH Personalized Solutions Pin Guides DePuy Synthes Joint Reconstruction 9

Figure 17
Figure 15
FEMORAL PREPARATION - A/P AND CHAMFER CUTS
Figure 16
Attach the HP Universal Handle to the Femoral Fixed
Reference Guide (P/N 2004-20-920) and position the
guide’s spikes through the “0” mm holes marked with a
square located at the bottom of the SIGMA Femoral Fixed
Reference Femoral 4-in-1 Cutting Block (Figure 15). Insert
the construct spikes into the previously drilled holes
located on the distal femoral bone cut. Check to verify
that the spikes of the fixed reference guide are in the
middle holes of the bottom hole cluster. It is possible to
position the spike through the top hole and opposite
bottom hole (vice-versa). This will result in an incorrect
rotation placement of the cutting block.
Evaluate the anterior cut with the angel wing (Figure 16). If
desired, the block may be shifted 2 mm anteriorly or
posteriorly by selecting the appropriate offset holes
adjacent to the “0” mm hole marked with the square. (See
notes section on page 11 for additional detail).
Secure the block’s location by inserting threaded headed
pins into the convergent pin holes on the medial and
lateral aspect of the femoral 4-in-1 cutting block. Remove
the handle/fixed reference guide assembly and perform
the femoral resections (Figure 17). After performing all
cuts, remove the pins and cutting block, making sure
bone cuts are clean and void of any under-cut bone
fragments.
10 DePuy Synthes Joint Reconstruction TRUMATCH Personalized Solutions Pin Guides Surgical Technique

Note: If the Femoral Fixed Reference Guide (P/N
2004-20-920) is unavailable, two fixation pins can be
inserted in the previously drilled distal femoral holes
and used to set the location of the HP Femoral 4-in-1
Cutting Block. The TRUMATCH Solutions Femoral
Pin Guide is designed to position the pin holes
posteriorly on the femur which maintains the ability
to move the block to resect 2 mm more bone anterior
or 2 mm more bone posterior with the same size
block regardless if the surgeon preference is anterior-
down or posterior-up. However, if it is necessary to
downsize the femoral component, the pin placement
references a posterior-up preference and the smaller
femoral block can be inserted over the posterior
placed pins. This will keep the posterior resection
in the same plane and take additional anterior
femoral bone. In order to address an anterior-
down preference and the ability to downsize the
component, drill two fixation pins through the “0”
mm holes, marked with a square with the planned
femoral block. Remove the femoral block and use
these anterior placed pins with the smaller block
when downsizing. This will keep the anterior femoral
resection in the same plane and take additional
posterior femoral condylar bone. In addition,
regarding the SIGMA Knee System, the HP SIGMA
RP-F, SIGMA CR-150 and the standard SIGMA Fixed
Reference Femoral 4-in-1 Cutting Blocks look very
similar. Care should be taken to use the appropriate
block as this could result in under or over resection
of the posterior femoral condyles with use of the
wrong cutting block.
Surgical Technique TRUMATCH Personalized Solutions Pin Guides DePuy Synthes Joint Reconstruction 11

Figure 19
SURGICAL TIPS AND PEARLS
Date of Consult:
Patient Name:
Gender: Male Female
Patient Profile: Varus Valgus
Estimated Joint Space Loss: 0% Medial 25% Medial 50% Medial 75% Medial 100% Medial
0% Lateral 25% Lateral 50% Lateral 75% Lateral 100% Lateral
Femoral Comp. Type: CR PS
Poly Comp. Type: Curved Curved+ Stabilized Stabilized+
Special Comments:
Height:
Flexion Contracture: Yes No
D.O.B.:
Weight:
Affected Side: Left Right
Tibial Comp. Type: Fixed Bearing Rotating Platform
OPTIONAL: COMPLETE IF USING DIFFERENT IMPLANTS FROM STATED SURGEON PREFERENCES
0612-03-510
HEALTHY BONE BONE-ON-BONE
Order Form
®
Figure 18
PRE-OPERATIVE CONSIDERATIONS
Order Submission
Evaluate the M/L Joint Space Loss by utilizing weight-
bearing knee joint radiographs and provide the values with
the order submission. These values are an important part of
the algorithm used to design the cartilage offset for proper
positioning of the guides. For ease of assessment, it is
sufficient to select from “0”, “50” or “100” % of Joint
Space Loss, without affecting the guide design accuracy.
The optional Order Form (Figure 18) can be utilized to
record all the necessary information required to submit the
TRUMATCH Solutions order online.
Patient Proposal
a. Review in detail prior to the surgery.
b. Review the Notes/Comments section for important
information from the TRUMATCH Solutions Design Team
regarding the design of the guides.
c. Print in Color! All Notes/Comments will be shown
in red.
d. For intra-operative reference, display the wall chart
summary page (Figure 19) at an easy to read location in
the OR, such as the light box or back wall.
Intra-operative Check-List
Review the Wall Chart Summary (last page), which
contains bone resection information and the tibial guide
orientation line.
The bone resection information can be used to verify if
bone cuts within 2 mm of the planned values shown. In
particular, the relationship between the medial and lateral
cuts should be noted. If both cut measurements are
proportionally similar (i.e. deviate by a similar amount),
then the varus/valgus alignment is preserved. Otherwise,
it is an indication that the guide placement and/ or bone
resection(s) should be re-visited.
For clarity, the tibial resection thickness, shown for each
condyle, is measured from the lowest point on the middle
third of the respective condyle.
12 DePuy Synthes Joint Reconstruction TRUMATCH Personalized Solutions Pin Guides Surgical Technique

Fixation Pins and Saw Blades
a. The SIGMA HP Threaded Headless Sterile Pins (P/N
9505-02-302), combined with the HP driver (P/N 9505-
02-071) are recommended for firmly securing the
guides, especially when used in soft bone.
b. For efficient resection of large bones, select the longest
blade possible, such as 12.7 mm wide x 1.19 mm
thick (The blade is 13 mm wide and 21 mm wide at
teeth.).
Femoral Resection Guide
a. The femoral guide’s primary reference surface is the
anterior cortex of the femur (Figure 20). The most
upper portion of the guide should clear the anterior
femoral flange and sit flush on the cortical surface. It is
recommended to remove the thin soft tissue to expose
the underlying bone.
b. Distally, the guide should be in contact with distal
femoral condyles, although a slight gap may exist
along the periphery.
If the femoral pin guide does not fit, verify the
following:
1. Was the tissue in the anterior surface of the femur
removed and is the proximal portion of the guide
sitting on bone?
2. Did the upper guide portion clear the anterior femoral
flange and is it sitting on the anterior cortex?
3. Is the incision preventing the placement of the guide
on the bone? The incision must be large enough to
provide access of the guide onto the anterior and a
clear view of the guide fit to bone.
Figure 20
INTRA-OPERATIVE CONSIDERATIONS
Surgical Technique TRUMATCH Personalized Solutions Pin Guides DePuy Synthes Joint Reconstruction 13

Figure 21
Tibial Resection Guide
a. The tibial guide’s primary reference surface is the
anterior/medial aspect of the tibia. This area, roughly
triangular in shape, matches the guide’s largest surface
contact area (Figure 21). When positioning the guide,
apply most of the pressure (~75%) against the anterior
aspect of the tibia. It is recommended to remove the
thin soft tissue to expose the underlying bone.
b. While applying force anteriorly, apply light downward
force (~25%) on the guide’s proximal arms to hold the
guide stable while drilling the anterior pins.
If the tibial guide does not fit, verify the following:
1. Is the incision preventing placement of the guide on
the bone? The incision must provide access for guide
placement and a clear view of the guide fit on the
bone.
2. Check for interference of the lateral aspect of the
guide with the patellar ligament.
3. Confirm that both of the guide’s proximal arms are not
impinging by tissue close to the tibial spine.
4. Check the Patient Proposal; was the Joint Space Loss
reported to be 100% for either of the condyles and
the actual patient has little to no joint space loss? If so,
scrape the condyle where full joint loss was requested.
SURGICAL TIPS AND PEARLS
14 DePuy Synthes Joint Reconstruction TRUMATCH Personalized Solutions Pin Guides Surgical Technique

Indications For Use:
The TRUMATCH Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement
component intra-operatively and in guiding the marking of bone before cutting.
The anatomical landmarks necessary for the creation of the TRUMATCH Patient Specific Instruments must be present and identifiable on CT.
The TRUMATCH Patient Specific Instruments are intended for use with SIGMA®Total Knee Implants and ATTUNE®Total Knee Implants and their cleared indications for use.
The TRUMATCH Patient Specific Instruments are intended for single use only.
Contraindication:
The following conditions are not compatible with TRUMATCH Personalized Solutions:
• Previous knee replacement of the same knee.
Cautions:
• Any metal device that will cause scatter in the CT through the knee.
• Angular deformities greater than 15 degrees of fixed varus, valgus, flexion, or tibial slope exceeding 15 degrees.
• Moderate to severe bony deformities, Charcot knee, or patients with severe patella tendon calcification that may prevent patella eversion.
For instruments produced by another manufacturer, reference the manufacturer’s instructions for use.
Limited Warranty and Disclaimer: DePuy Synthes Joint Reconstruction products are sold with a limited warranty to the original purchaser against defects
in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.
WARNING: In the USA, this product has labeling limitations. See package insert for complete information.
CAUTION: USA Law restricts these devices to sale by or on the order of a physician.
Not all products are currently available in all markets.
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46582
T. [phone]
www.depuysynthes.com/trumatch
© DePuy Synthes Joint Reconstruction, a division of DOI 2014. All rights reserved.
0612-88-511 (Rev. 2) 04/14 1M