Depuy Rodilla PFC Sigma Tecnica Quirurgica
Depuy Rodilla PFC Sigma Tecnica Quirurgica
®
P. F. C. S IGMA ™ K NEE S YSTEMS
SPECIALIST ®
INSTRUMENTS
CRUCIATE-RETAINING PROSTHESIS DESIGNED BY
CHITRANJAN S. RANAWAT, MD
Introduction 1
INTRODUCTION
Total knee replacement is performed on a range The P.F.C.® Total Knee Systems were designed
of patients, of all ages, with various pathologies as comprehensive approaches allowing intraop-
and anatomical anomalies. As no single arthro- erative transition from PCL retention to PCL
plastic approach is appropriate for every knee, substitution. The major difference in the design
the surgeon must be prepared, as the situation for the two prostheses is the incorporation of an
indicates, to preserve or substitute for the intercondylar post in the PCL substituting tibial
posterior cruciate ligament. PCL sacrifice is insert and its corresponding intercondylar
indicated in patients with severe deformity, receptacle in the femoral component, to com-
pronounced flexion contracture and in the pensate for the stabilizing restraint of the PCL.
greater number of revision cases. Most primary They were also designed to provide greater
and some relatively uncomplicated revision restraint in cases of revision surgery, and to
cases are suitable for cruciate-sparing proce- meet the most demanding clinical and institu-
dures. Where the ligament is to be preserved, tional requirements.
it is essential that its balance in flexion be
confirmed. A single integrated set of instruments, the
Specialist® 2 Instruments, was designed to
make fully accurate bone resection and to
accommodate most surgical techniques
and contingencies.
1
CRITERIA FOR SUCCESSFUL TKR BALANCING THE KNEE
Appropriate Sizing of Components The appropriate level of prosthetic constraint is
This is attained through critical approximation determined through preoperative evaluation
of the A/P dimension of the femoral compo- subject to intraoperative confirmation. Where
nent to the lateral femoral profile. Undersizing soft-tissue constraint is identified, the system is
will create looseness in flexion and possible designed to effectively address it.
notching of the femoral cortex. Oversizing will
create tightness in flexion and increased excur- Primary Cruciate-Retaining TKR
sion of the quadriceps mechanism. employs a posteriorly lipped insert, designed
for situations where the PCL is functionally
Accurate Component Alignment intact. Where there is tightness in the PCL, a
This is accomplished by resection of the distal posterior cruciate recession is indicated (see
femur in the appropriate degree of valgus as Appendix I).
determined by preoperative evaluation, and
resection of the proximal tibia at 90˚ to its Primary Cruciate-Supplementing TKR
longitudinal axis. uses a curved insert with improved contact area
to supplement the PCL where the ligament has
Soft-Tissue Balance sufficient functional laxity to accommodate the
This is realized through the careful sequential greater conformity.
release of medial constraining elements in
varus deformity and lateral structures Primary Cruciate-Substituting TKR
in valgus. incorporates a central polyethylene eminence in
the tibial insert to perform the function of an
Accurate Patellar Tracking absent PCL. The corresponding femoral compo-
This is effected through accurate positioning nent uses A/P cuts and chamfers identical to
of the femoral and tibial components, precise those of the PCL-retaining component, allowing
resurfacing of the patella, careful trial evalua- ready transition without revision of the pre-
tion and, where indicated, lateral retinacular pared implantation site.
release.
Revision TKR
Dependable Cement Fixation The geometry of the tibial insert allows for
This is achieved through controlled technique substitution of the PCL and/or MCL in revision
that ensures the establishment of comprehen- and complex primary situations. The selection
sive bone/cement/prosthesis interlock. of modular tibial and femoral stems and wedges
will accommodate virtually any revision con-
sideration. The system offers three levels of
constraint to meet the varied requirements of
revision cases: stabilized, constrained or TC3.
2
PREOPERATIVE PLANNING INSTRUMENTATION RATIONALE
Full-length extremity roentgenograms are Specialist 2 instrumentation was designed to
obtained and the mechanical and anatomic axes address the requirements of all total-knee
identified. Where the intramedullary alignment replacement procedures, to fully assure precise
system is selected, the angle of the anatomic and dependable resection of the recipient bone
and mechanical axes indicates the appropriate and to serve a variety of surgical options. The
angle to be used in conjunction with the intra- instruments can be customized to meet any spe-
medullary rod and the femoral locating device, cial requirements of the individual surgeon.
thereby assuring that the distal femoral cut will
be perpendicular to the mechanical axis. It is Preparation may be initiated at either the femur
helpful to draw the femoral and tibial resection or the tibia. The instruments may be employed
lines on the film as an intraoperative reference. with either the intra- or extramedullary align-
ment approach. Bone resection is made at the
Radiographic templates are overlaid on the appropriate level as determined through a cali-
films to estimate the appropriate size of the brated stylus assembly. A selection is offered of
prosthesis. The femoral component is sized on slotted and surface-cutting blocks. Spacer blocks
the lateral view. The A/P size is critical to the are provided for extension and flexion gap eval-
restoration of normal kinematics and quadri- uation. Patellar instrumentation is available for
ceps function. compatible preparation of either resurfaced or
inset patellar implants.
3
PRIMARY CRUCIATE-RETAINING PROCEDURE
RICHARD D. SCOTT, MD
Boston, Mass.
THOMAS S. THORNHILL, MD
Orthopaedist-in-chief
Brigham and Women’s Hospital
Boston, Mass.
4
THE SURGICAL APPROACH
The skin incision is longitudinal and, where The joint is entered through a medial para-
possible, straight. It is initiated proximally from patellar capsular approach, extended proximally
the midshaft of the femur and carried over the to the inferior margin of the rectus femoris
medial third of the patella to the medial margin and distally to the medial margin of the tibial
of the tibial tubercle. tubercle.
N.B. Where indicated, the subvastus or the lateral approach may be used.
5
EXPOSURE
6
A 90˚ Hohmann retractor is positioned
between the everted patella and the distolat-
eral femur, exposing the lateral patellofem-
oral ligament, which is incised with
electrocautery.
7
ENTERING THE MEDULLARY CANAL
8
THE INTRAMEDULLARY ROD
9
THE EXTERNAL ALIGNMENT SYSTEM
10
ROTATIONAL CORRECTION
11
THE DISTAL FEMORAL CUTTING BLOCK
The cutting block is assembled onto the cali- The base block is slotted; however, if used
brated outrigger by depressing the button without the slot and the resection is initiated
located on the right proximal end. The resection from the top of the block, 4 mm is added to the
of the more prominent condyle, inclusive of resection level. For example, if 9 mm is the
residual cartilage, will correspond to the distal desired resection level, add 4 mm to this and
dimension of the femoral prosthesis. set the block at 13 mm and cut from the surface
Where the femoral locating device rests of the block. Note the top of the block is
on eburnated bone, resection is engraved “4 mm offset.”
2 mm less than the distal
dimension of the femoral
prosthesis to allow for
absent cartilage and to
avoid elevation of the
joint line.
The scale for the numbers on the outrigger is The outrigger and cutting block is lowered onto
even on the left and odd on the right. The the anterior cortex by depressing the button on
number corresponding to the appropriate resec- the left-hand side of the locating device. Either
tion level is aligned with the inscribed line in 1/8" drill bits or Steinmann pins are
the center of the window of the distal femoral introduced through the holes desig-
cutting block. nated zero and enclosed in ■ ’s. They
are advanced into the anterior cortex.
12
THE DISTAL FEMORAL CUT
aa
The locating device and intramedullary rod are disengaged from the cut-
ting block by depressing the right button on the cutting block. The holes
on the block are designated -2, 0, and +2, indicating in millimeters the
amount of bone resection each will yield supplemental to that indicated
The oscillating saw blade is positioned through the slot, or, where applic-
able, the blade is positioned flush to the top cutting surface of the block.
The condyles are resected and the surface checked for accuracy.
a 13
THE FEMORAL SIZING GUIDE
14
ROTATIONAL ALIGNMENT
15
Where the guide is pinned in neutral rotation using
the posterior holes, it will position the A/P cutting
block such that 8 mm will be resected from the pos-
terior condyle, corresponding to the posterior
dimension of the prosthesis.
3º External Rotation
16
aa a
ANTERIOR, POSTERIOR AND CHAMFER CUTS
17
a
The chamfers are made through the slotted A/P block.
18
TIBIAL ALIGNMENT
19
THE UPPER PLATFORM
20
THE TIBIAL STYLUS
The level of 0
is selected where
resection is based
on the more
involved condyle and does not
result in excessive contralateral
resection. The cutting block is secured
by the large anterior setscrew.
21
LOWER ALIGNMENT
22
THE TIBIAL ALIGNMENT
The distal portion of the long arm of the tibial Lateral alignment is similarly confirmed.
alignment device should align with the center
of the talus. N.B. Where indicated, varus/valgus corrections are made
by sliding the distal portion of the tibial alignment to the
appropriate location.
a 23
a
SECURING THE PLATFORM AND TIBIAL RESECTION
anterior cortex.
60
70
80
90
110 100
25
THE PATELLAR CUTTING GUIDE
26
RESECTION AND DRILLING
a a
Alternatively, the saw blade is inserted into the
well of the cutting surface of either of the jaws.
The insert is lifted and the blade thereby con-
fined within the slot created, ensuring that the
cut will remain flush to the cutting surface. A
1.19 mm saw blade is recommended.
27
a
THE TRIAL TIBIAL COMPONENT
a a
Assemble the quick connect slaphammer onto the femoral inserter.
With the knee in full flexion, the femoral trial is assembled to the
femoral inserter and positioned onto the prepared surface. The leading
edges are advanced equally, parallel to the distal femoral cut,
preserving its precisely prepared configuration.
Where there is a tendency for the trial to rock posteriorly (into flexion),
the most common cause is upward sloping or failure to resect adequately
at the anterior aspect. Less commonly, the posterior condyles have been
under-resected. The A/P chamfer cutting block
is repositioned onto the distal surface and the
deficient cut appropriately revised.
29
TRIAL REDUCTION
30
OVERALL ALIGNMENT
31
PLATEAU PREPARATION
a
a
With the knee in full flexion and the tibia sub-
a
luxed anteriorly, the trial tibial tray is assem-
bled to the alignment handle and placed onto
the resected tibial surface. Care is taken that
proper rotational alignment with the electro-
cautery marks be established.
Remove the alignment handle from the tray trial and assemble the appro-
priately sized cruciform keel punch guide to the tray trial.
Assemble the appropriately sized non-cemented keel punch onto the slap-
hammer and insert the punch through the guide and impact until the
shoulder of the punch is in contact with the guide. The stem punch is sub-
sequently freed, taking care that the punch configuration be preserved.
33
P.F.C.® MODULAR TRAY & UHMWPE* TIBIA PREPARATION
Select the appropriate punch guide, drill bushing, drill and modular keel
punch system. Remove the alignment handle from the tray trial and as-
semble the appropriately sized modular tray punch guide to the tray trial.
Seat the appropriately sized drill bushing into the modular tray
punch guide.
*UHMWPE (ALL-POLY)
34
THE FEMORAL LUG DRILL
35
a
36
a
IMPLANTING THE COMPONENTS
38
THE PATELLAR COMPONENT
The patellar implant may be cemented at the over the articular surface of the implant and the
surgeon’s convenience with either of the other metal backing plate against the anterior cortex,
components. The cut surface is thoroughly avoiding skin entrapment. When snug, the han-
cleansed with pulsatile lavage. Cement is dles are closed and held by the ratchet until
applied to the surface and the component polymerization is complete. Excessive compres-
inserted. sion is avoided as it can fracture osteopenic
bone. All extruded cement is removed with a
The patellar clamp is designed to fully seat and curette. To release the clamp, place the locking
stabilize the implant as the cement polymerizes. knob in the unlocked position and squeeze the
It is positioned with the silicon O-ring centered handles together to release the pawl.
39
THE TIBIAL INSERT
The trial insert is removed and the perma-
nent insert introduced into the implanted
tibial tray and seated posteriorly, its
anterior margin resting on the lip.
CLOSURE
The tourniquet is released and bleeding controlled
by electrocautery. A closed-wound suction drain
is placed in the suprapatellar pouch and brought
out through the lateral retinaculum. The fat pad,
quadriceps mechanism, patella tendon, and medial
retinaculum are reapproximated with interrupted
sutures.
40
CRUCIATE SUBSTITUTING PROCEDURE
CHITRANJAN S. RANAWAT, MD
41
THE SURGICAL APPROACH
The extremity is appropriately prepared and The incision is developed at the deep fascial
draped. A tourniquet is applied and, following level to the tendon of the rectus femoris and the
application of an Esmarch bandage, inflated. patellar tendon. Undermining of the bilateral
skin flaps is avoided. The tendon of the rectus
A long straight incision is initiated 12 cm proxi- femoris is incised and the incision carried
mal to the superior margin of the patella and an 2–3 mm medial to the medial margin of the
equivalent distance distal to its inferior margin. patella, the patellar tendon and, subperios-
Reducing, thereby, the degree of skin retraction teally, 5 cm distal to the superior margin of the
and lowering the risk of subsequent adipose tis- tibial tubercle.
sue necrosis.
42
EXPOSURE
43
TIBIAL ALIGNMENT
44
THE UPPER PLATFORM
45
THE TIBIAL STYLUS
The level of 0
is selected where
resection is based
on the more
involved condyle and does not
result in excessive contralateral
resection. The cutting block is secured
by the large anterior setscrew.
46
LOWER ALIGNMENT
47
THE TIBIAL ALIGNMENT
The distal portion of the long arm of the tibial Lateral alignment is similarly confirmed.
alignment device should align with the center
of the talus. N.B. Where indicated, varus/valgus corrections are made
by sliding the distal portion of the tibial alignment to the
appropriate location.
48
a
SECURING THE PLATFORM AND TIBIAL RESECTION
49
ENTERING THE MEDULLARY CANAL
50
THE INTRAMEDULLARY ROD
51
THE EXTERNAL ALIGNMENT SYSTEM
52
ROTATIONAL CORRECTION
53
THE DISTAL FEMORAL CUTTING BLOCK
The cutting block is assembled onto the cali- The base block is slotted; however, if used
brated outrigger by depressing the button without the slot and the resection is initiated
located on the right proximal end. The resection from the top of the block, 4 mm is added to the
of the more prominent condyle, inclusive of resection level. For example, if 9 mm is the
residual cartilage, will correspond to the distal desired resection level, add 4 mm to this and
dimension of the femoral prosthesis. set the block at 13 mm and cut from the surface
Where the femoral locating device rests of the block. Note the top of the block is
on eburnated bone, resection is engraved “4 mm offset.”
2 mm less than the distal
dimension of the femoral
prosthesis to allow for
absent cartilage and to
avoid elevation of the
joint line.
The scale for the numbers on the outrigger The outrigger and cutting block is lowered onto
is even on the left and odd on the right. The the anterior cortex by depressing the button on
number corresponding to the appropriate the left-hand side of the locating device. Either
resection level is aligned with the inscribed 1/8" drill bits or Steinmann pins are
line in the center of the window of the distal introduced through the holes desig-
femoral cutting block. nated zero and enclosed in ■ ’s. They
are advanced into the anterior cortex.
54
THE DISTAL FEMORAL CUT
aa
The locating device and intramedullary rod are disengaged from the cut-
ting block by depressing the right button on the cutting block. The holes
on the block are designated -2, 0, and +2, indicating in millimeters the
amount of bone resection each will yield supplemental to that indicated
The oscillating saw blade is positioned through the slot, or, where applic-
able, the blade is positioned flush to the top cutting surface of the block.
The condyles are resected and the surface checked for accuracy.
a 55
EVALUATING THE EXTENSION GAP
Balanced
56
SIZING THE FEMORAL COMPONENT
The appropriate
rod is selected
and assembled to
the femoral A/P
cutting block, the
appropriate
RIGHT/LEFT desig-
nation to the ante-
rior. The pins are
retracted.
57
POSITIONING THE CUTTING BLOCK
ROTATIONAL ADJUSTMENT
58
a
EVALUATING THE FLEXION GAP
Medial
tightness
Balanced
59
a
a
ANTERIOR AND POSTERIOR FEMORAL CUTS
a
a
a
60
The chamfer cuts can be made through
the slotted A/P block at this time.
a
flexion. When using blocks
to assess flexion and exten-
sion gaps, a 1 mm shim
should be used for the exten-
sion gap and removed when
assessing the flexion gap.
This will compensate for the
1 mm difference between the
distal and posterior resection
levels.
a
Place the trial femoral component onto the prepared
femur and position it such that the lateral flange of the
trial component meets the lateral margin of the femur.
Overhang of the flange is avoided where possible.
a
to the distal femur, seated flush upon the cut
anterior and distal surfaces. It is centered about
the two lines, previously made, within the
intercondylar notch.
a a
The notch is created with
an oscillating saw and an
osteotome.
63
Alternatively, the femoral notch/chamfer
guide may be employed for the notch and
chamfer cuts.
The chamfers are fashioned with the oscillating saw using the
appropriate slots. A 1.19 mm saw blade is recommended.
65
PATELLAR RESURFACING
anterior cortex.
60
70
80
90
110 100
66
THE PATELLAR CUTTING GUIDE
67
RESECTION AND DRILLING
a a
Alternatively, the saw blade is inserted into the
well of the cutting surface of either of the jaws.
The insert is lifted and the blade thereby con-
fined within the slot created, ensuring that the
cut will remain flush to the cutting surface. A
1.19 mm saw blade is recommended.
68
Resection is performed with an oscillating saw,
maintaining the blade flush to the cutting sur-
face. The guide is subsequently removed and
the residual dimension checked with calipers,
laterally, medially, proximally and distally. All
measurements should be equivalent. Asymme-
try is addressed with the saw or a bone rasp.
a
THE TRIAL TIBIAL COMPONENT
a
70
➀
➂
THE FEMORAL COMPONENT BOX
ASSEMBLY
a
1) Place the two outrigger tabs of the box trial into
the recesses of the posterior condyles.
71
OVERALL ALIGNMENT
72
PLATEAU PREPARATION
a
a
With the knee in full flexion and the tibia sub-
a
luxed anteriorly, the trial tibial tray is assem-
bled to the alignment handle and placed onto
the resected tibial surface. Care is taken that
proper rotational alignment with the electro-
cautery marks be established.
Remove the alignment handle from the tray trial and assemble the appro-
priately sized cruciform keel punch guide to the tray trial.
Assemble the appropriately sized non-cemented keel punch onto the slap-
hammer and insert the punch through the guide and impact until the
shoulder of the punch is in contact with the guide. The stem punch is sub-
sequently freed, taking care that the punch configuration be preserved.
74
P.F.C.® MODULAR TRAY & UHMWPE* TIBIA PREPARATION
Select the appropriate punch guide, drill bushing, drill and modular keel
punch system. Remove the alignment handle from the tray trial and as-
semble the appropriately sized modular tray punch guide to the tray trial.
Seat the appropriately sized drill bushing into the modular tray
punch guide.
*UHMWPE (ALL-POLY)
75
a
76
a
IMPLANTING THE COMPONENTS
78
THE PATELLAR COMPONENT
The patellar implant may be cemented at the over the articular surface of the implant and the
surgeon’s convenience with either of the other metal backing plate against the anterior cortex,
components. The cut surface is thoroughly avoiding skin entrapment. When snug, the han-
cleansed with pulsatile lavage. Cement is dles are closed and held by the ratchet until
applied to the surface and the component polymerization is complete. Excessive compres-
inserted. sion is avoided as it can fracture osteopenic
bone. All extruded cement is removed with a
The patellar clamp is designed to fully seat and curette. To release the clamp, place the locking
stabilize the implant as the cement polymerizes. knob in the unlocked position and squeeze the
It is positioned with the silicon O-ring centered handles together to release the pawl.
79
THE TIBIAL INSERT
The trial insert is removed and the perma-
nent insert introduced into the implanted
tibial tray and seated posteriorly, its
anterior margin resting on the lip.
CLOSURE
The tourniquet is released and bleeding controlled
by electrocautery. A closed-wound suction drain
is placed in the suprapatellar pouch and brought
out through the lateral retinaculum. The fat pad,
quadriceps mechanism, patella tendon and medial
retinaculum are reapproximated with interrupted
sutures.
80
LIGAMENTOUS BALANCE IN TOTAL KNEE ARTHROPLASTY
I
Following removal of
peripheral osteophytes, the
medial meniscus (1) and
the meniscotibial ligament
(2) are excised. In rheuma-
toid arthritis and minimal
deformity, this is often
sufficient.
81
a
Where further release is indicated, the posterior
expansion of the deep medial collateral liga-
ment is released from its tibial attachment (3)
using a curved osteotome.
83
a
a
Where still further release is indicated, the
lateral collateral ligament and popliteus tendon
are released from the femoral epicondyle and
allowed to slide posteriorly (5).
a
N.B. Priority of steps 5 and 6 is a matter
of preference.
a
84
Where balance requires still further release,
dissection is extended posteriorly, freeing
the intermuscular septum (7) and the lateral
head of the gastrocnemius (8).
85
Where the surgeon elects to increase the poste- PCL recession is possible at either the tibial or
rior slope, it should not exceed a total of 7˚, as femoral attachments, but as the anterior and
excessive posterior slope will complicate liga- posterior fibers at the femoral attachment differ
mentous balance in flexion and extension. It is in tension in transition from extension to flexion
preferable, therefore, that the PCL be recessed. and as compromising this attachment increases
the likelihood of evulsion, preliminary recession
at the tibial attachment is recommended.
In extension, the bulk of the PCL is relaxed and only the posterior band is tight.
In flexion, the bulk of the PCL becomes tight and the small posterior band is loose.
86
The tibial attachment is elevated subper-
iosteally along the entire proximal margin such
that the ligament is allowed to recede incre-
mentally until flexion tension in trial reduction
is satisfactory with normal patellar tracking.
87
BALANCING FLEXION AND EXTENSION GAPS
Where the joint line is maintained, flexion and RESIDUAL FLEXION CONTRACTURE
extension gaps are usually found to be bal-
anced at trial reduction, but where there is pre- Where there is restriction in extension but not
operative deformity and contracture, imbalance in flexion, additional bone is removed from the
may be present. distal femur. This affects the extension gap but
not the flexion gap. Where contracture persists
following appropriate retinacular release
and removal of posterior osteophytes and scar
tissue, depending on severity, removal of an
additional 2–4 mm of distal femur is indicated.
88
RESIDUAL TIGHTNESS IN FLEXION
AND EXTENSION
89
II
THE EXTERNAL FEMORAL ALIGNMENT SYSTEM
P P E N D I X
90
III
INTRAMEDULLARY ALIGNMENT DEVICE
PREOPERATIVE PLANNING
P P E N D I X
91
ENTERING THE MEDULLARY CANAL
92
a THE I.M. TIBIAL ALIGNMENT GUIDE
a
POSITIONING THE GUIDE
The handle is removed and the I.M. tibial alignment guide is positioned
on the I.M. rod. The I.M. guide should sit flush to the resected tibial spine.
N.B. For a full explanation of the stylus, refer to page 21 of this manual.
93
ROTATIONAL ALIGNMENT
When the level of resection has been determined, the alignment tower,
tibial side, is inserted into the tibial cutting block and rotated such that the
center of the block is aligned with the medial third of the tibial tubercle.
The long alignment rod is passed through the appropriate hole to the
ankle. It should align with the center of the talus. Lateral alignment is
similarly confirmed.
94
a
a SECURING THE CUTTING BLOCK
TIBIAL RESECTION
Steinmann pins or 1/8" drill bits are introduced
through the central holes, marked with a ■, into
the tibia stopping well short of the posterior cor-
tex. The intramedullary alignment device is
removed from the cutting block and the I.M. rod
is subsequently removed.
95
IV
P P E N D I X
a
A
EXTRAMEDULLARY TIBIAL ALIGNMENT DEVICE
WITH PROXIMAL FIXATION SPIKE
96
Adjustable Head
Set Knob
a a
A level of 0 mm or 2 mm is selected where
resection is based on the more involved
condyle and does not result in excessive
contralateral resection. The block is adjusted
such that the stylus rests on the center of the
condyle and the block is secured by the large
lateral knob.
97
Steinmann pins or 1/8" drill bits are intro-
duced through the central holes into the tibia,
stopping well short of the posterior cortex.
The cutting block is unlocked, the black lat-
eral knob loosened and the set knob securing
the head loosened. The uprod is pulled and
disengaged from the cutting block. Connect
the quick connect slap hammer to the head
and disengage the spikes from the proximal
tibia. The tibial alignment device is removed
and the appropriate resection performed.
a
Appendix IV, Extramedullary Tibial Alignment Device
with Proximal Fixation Spike Surgical Technique,
edited by William L. Healy, MD, Chairman,
Department of Orthopaedic Surgery, Lahey Hitchcock
Medical Center, Burlington, Mass.
98
a
CRUCIATE RETAINING—
V
CR FEMORAL COMPONENT
SIZE 1.5 SIZE 2 SIZE 2.5 SIZE 3 SIZE 4 SIZE 5 SIZE 6
53AP/57ML 56AP/60ML 59AP/63ML 61AP/66ML 65AP/71ML 69AP/73ML 74AP/78ML
TIBIAL INSERTS
SIZE 1.5
41AP/61ML PLI ■ ■ ■
AP
CVD, CVD+XLK ■ ■
SIZE 2
43AP/64ML PLI ■ ■ ■ ■ ■
CVD, CVD+XLK ■ ■ ■ ■
SIZE 2.5
45AP/67ML PLI ■ ■ ■ ■ ■
CVD, CVD+XLK ■ ■ ■
SIZE 3
47AP/71ML PLI ■ ■ ■ ■ ■
CVD, CVD+XLK ■ ■ ■ ■
SIZE 4
51AP/76ML PLI ■ ■ ■ ■ ■ ■
CVD, CVD+XLK ■ ■ ■
SIZE 5
55AP/83ML PLI ■ ■ ■ ■
CVD, CVD+XLK ■ ■ ■
SIZE 6
59AP/89ML PLI ■ ■ ■
CVD, CVD+XLK ■ ■
POSTERIOR LIPPED
8, 10, 12.5, 15, 17.5, 20 (mm)
CURVED
8, 10, 12.5, 15, 17.5, 20 (mm)
99
CRUCIATE SUBSTITUTING PRIMARY AND REVISION—
FEMORAL AND TIBIAL INSERT COMPATIBILITY
TIBIAL INSERTS
SIZE 1.5
41AP/61ML PS SP ■ ■ ■ ■
TC3 ■ ■
SIZE 2
43AP/64ML PS SP ■ ■ ■ ■ ■ ■ ■ ■
TC3 ■ ■ ■ ■
SIZE 2.5
45AP/67ML PS SP ■ ■ ■ ■ ■ ■
TC3 ■ ■ ■
SIZE 3
47AP/71ML PS SP ■ ■ ■ ■ ■ ■ ■ ■
TC3 ■ ■ ■ ■
SIZE 4
51AP/76ML PS SP ■ ■ ■ ■ ■ ■
TC3 ■ ■ ■
SIZE 5
55AP/83ML PS SP ■ ■ ■ ■ ■
TC3 ■ ■
SIZE 6
59AP/89ML PS SP ■ ■ ■
PS POSTERIOR STABILIZED
8, 10, 12.5, 15, 17.5, 20, 22.5, 25 (mm)
SP STABILIZED PLUS
10, 12.5, 15, 17.5, 20, 22.5, 25, 30 (mm)
TC3 TC3
10, 12.5, 15, 17.5, 20, 22.5, 25, 30 (mm)
100
NOTES
NOTES
LCS® Complete™ – P.F.C.® Sigma™ RP Mobile Bearing Total Knee System
Important:
This essential product information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all
necessary information.
Indications
Cemented Use:
The LCS® Complete™ – P.F.C.® Sigma™ RP Mobile Bearing Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid
arthritis. The RPF insert and femoral component are indicated where a higher than normal degree of post-operative flexion is required. The rotating
platform prosthesis and modular revision components are indicated for revision of failed knee prostheses.
Uncemented Use:
The porous coated Keeled and Non-Keeled M.B.T.™ (Mobile Bearing Tibial) Tray configurations of the LCS Total Knee System are indicated for
noncemented use in skeletally mature individuals undergoing primary surgery for reconstructing knees damaged as a result of noninflammatory
degenerative joint disease (NIDJD) or either of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies. The Rotating Plat-
form device configuration is indicated for use in knees whose anterior and posterior cruciate ligaments are absent or are in such condition as to justify
their sacrifice. The P.F.C. Sigma RP Curved bearings when used with the P.F.C. Sigma Cruciate Retaining Femoral Component can be used in
posterior cruciate ligament retaining procedures.
Contraindications:
The use of the LCS Complete – P.F.C. Sigma RP Mobile Bearing Total Knee System is contraindicated in:
• the presence of osteomyelitis, pyrogenic infection or other overt infection of the knee joint;
• patients with any active infection at sites such as the genitourinary tract, pulmonary system, skin or any other site. Should a patient have any
infection prior to implantation, the foci of the infection must be treated prior to, during and after implantation.
• patients with loss of musculature or neuromuscular compromise leading to loss of function in the involved limb or in whom the requirements
for its use would affect recommended rehabilitation procedures.
• patients with severe osteoporosis or other metabolic bone diseases of the knee.
• patients with any of the following conditions:
• lesions of the supporting bone structures (e.g. aneurysmal or simple bone cysts, giant cell tumor or any malignant tumor),
• systemic and metabolic disorders leading to progressive deterioration of solid bone support,
• the presence of severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity, fixed
deformities greater than 60° of flexion, 45° of genu varus or valgus,
• known drug or alcohol addiction,
• skeletally immature individuals and the presence of allergic reaction to implant metals or polyethylene are also contraindications for the non-
cemented, porous coated, M.B.T. and LCS Complete – P.F.C. Sigma RP Mobile Bearing device configurations, and for the cemented use of
all device configurations of the LCS Complete – P.F.C. Sigma RP Mobile Bearing Total Knee System.
In the presence of any of the above conditions the components should be fixed with cement.
Adverse Events:
The following are the most frequent adverse events after knee arthroplasty: change in position of the components, loosening, bending, cracking,
fracture, deformation or wear of one or more of the components, infection, tissue reaction to implant materials or wear debris; pain, dislocation, sub-
luxation, flexion contracture, decreased range of motion, lengthening or shortening of leg caused by improper positioning, looseness or wear of compo-
nents; fractures of the femur or tibia.
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