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