Distal Femoral Growing Prosthesis: Surgical Protocol
Distal Femoral Growing Prosthesis: Surgical Protocol
Growing
Prosthesis
Surgical Protocol
Table of Contents
Section 1: Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Section 2: Indications and Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Section 3: Stryker Distal Femoral Growing Prosthesis Components
and System Offerings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Distal Femoral Growing Prosthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Stem Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Extension Pieces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Total Femur. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Tibial Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Instrumentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Section 4: Primary Surgical Technique. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Pre-Operative Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Exposure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Planning the Resection Length. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Rotational Alignment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Femoral Osteotomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Femoral Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Proximal Tibial Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Tibial Resection Level. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Proximal Tibial Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Tibial Preparation for the Pediatric All Poly Tibial Component. . . . . . . . . . . . . 20
Trial Reduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Assembly of the Femoral Prosthesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Implantation and Orientation of the Femoral and Tibial Components. . . . . . . 27
Appendix I: Expansion of the Stryker Distal Femoral Growing Prosthesis. . . . . . . 30
Incision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Unlock Prosthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Expansion of the Prosthesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Re-lock the Prosthesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Appendix II: Taper Disassembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Appendix III: Growing Prosthesis Sterilization Instructions . . . . . . . . . . . . . . . . . . 33
Catalog. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Distal Femoral Growing Prosthesis
Surgical Protocol
Section 1: Introduction
The Stryker Distal Femoral Growing Prosthesis provides a means to reconstruct
large bone defects resulting from bone resection in skeletally immature patients.
The device can be expanded as a patient grows so that leg-length equality can
be achieved. The device utilizes a rotating hinge design. The expansion process
is mechanical and is conducted with subsequent minimally invasive procedures
following the initial implantation surgery.
The system consists of distal femoral components, extension pieces, and stems.
It also includes a complete set of trial components and instrumentation.
The devices are single use implants intended only for implantation with bone
cement.
The contraindications for use of the Stryker Distal Femoral Growing Prosthesis
include:
Polyethylene
Bearing
Axis
Circlip
Tibial Bearing
Component Wedge
The Distal Femoral Growing Prosthesis is available in left and right configurations,
and replacement lengths from 150mm to 200mm in 10mm increments. The Distal
Femoral Growing Prosthesis measures 43.5mm in the A/P and 45mm in the M/L.
Caution:
Not all sizes are readily available. Please contact your Stryker sales representative
regarding availability at the beginning of the treatment cycle to ensure device
availability.
3
Distal Femoral Growing Prosthesis
Surgical Protocol
Stem Components
The GMRS cemented stems are available in six styles: straight, curved and long
curved; each style with or without extra-cortical porous-coated body sections.
The extra-cortical porous-coated body section has a 40mm replacement length.
The stems are also available without the extra-cortical porous-coated body section,
with an 11mm replacement length.
All stems are available in 8, 9 , 10, 11, 13, 15 and 17mm diameters. Their respective
seat diameters at the resection level are as follows:
GMRS Cemented Stem Options Available for the Growing Distal Femur
Stem Diameter Seat Diameter Straight Stem Length Bowed Stem Length
The stems are designed to be cemented into the medullary canal. Optional stem
centralizers are available for the 10-17mm diameter (for the straight and
short-curved stems only).
Extension Pieces
The extension pieces are used to customize the replacement length and are
available in 30, 40, 50, 60, 70, 80, 100, 120, 140, 160, 180, 200, and 220mm lengths.
This component features a male and female taper, which attaches a stem to a
distal femoral component.
4
Total Femur
The Growing Prosthesis can also be assembled to a connection piece and proximal
femoral component to reconstruct the entire femur.
The proximal femoral components are available in two styles, standard and
trochanteric. The components are available in three different configurations but
only the neutral configuration should be used for total femoral replacement. All
components have a replacement length of 70mm, which is measured to the center
of the standard length (zero offset) femoral head. The components accept Stryker
femoral head implants with the 5°40’ taper (V40 femoral heads). The proximal
femoral components have a 135° neck angle and fixation holes to re-attach the
abductor mechanism.
The connection pieces are available in 80 or 90mm replacement lengths and left
and right configurations. This component features a double male taper design
to connect the Distal Femoral Growing Prosthesis to either a proximal femoral
component or an extension piece if additional replacement length is required.
Tibial Components
There are three tibial component options for use with the Distal Femoral Growing
Prosthesis: the Pediatric All-Polyethylene Tibial Component, the Modular Rotating
Hinge Tibial Baseplate, and the GMRS Small Proximal Tibia. Each tibial component
option requires a different Tibial Bearing Component:
5
Distal Femoral Growing Prosthesis
Surgical Protocol
If the bone quality is suspect or the component cannot be properly supported, the
Modular Rotating Hinge (MRH) tibial baseplate is recommended.
The MRH Tibial Baseplate is available in four sizes (Small 1, Small 2, Medium 2
and Large 2), with modular stem options (80 and 155mm lengths, 10-23mm
diameter). The tibial inserts are available in two sizes (Small 1 / Small 2 and Medium
2 / Large 2), each in 5 thicknesses (10, 13, 16, 20, and 24mm) and are made from
DURATION Stabilized Ultra High Molecular Weight Polyethylene (UHMWPE).
A comprehensive range of modular stem extensions are available to be assembled
with these Tibial Baseplates.
The GMRS Proximal Tibial Component is available in two sizes (Small and
Standard) and has a replacement length of 80mm, measured to the sulcus of the
thinnest, 10mm, tibial insert. The Proximal Tibial Component has fixation holes
in the Anterior-Posterior (A/P) and Medial-Lateral (M/L) direction to re-attach
soft tissues. The Proximal Tibial Component accepts the small GMRS Tibial Inserts
(6495-3-0XX). The tibial inserts are available in five thicknesses (10, 13, 16, 20, and
24mm) and are made from DURATION Stabilized Ultra High Molecular Weight
Polyethylene (UHMWPE). The GMRS Small Proximal Tibial Component accepts
the GMRS cemented stems.
Instrumentation
6
Section 4: Primary Surgical Technique
Pre-Operative Plan
Caution:
Not all sizes are readily available. Please contact your Stryker sales representative
regarding availability at the beginning of the treatment cycle to ensure device
availability.
Exposure
> Biopsy tracts are incorporated into the incision and elipsed out.
> Tumor and any soft tissue extension is exposed through careful dissection.
> Collateral and cruciate ligaments are dissected from the tibia.
> Bone segment is measured and resected en bloc based on pre-operative plan.
7
Distal Femoral Growing Prosthesis
Surgical Protocol
> If the surgeon intends to use the Proximal Tibia, please
refer to the GMRS Proximal Tibial Surgical Protocol
(LSPK39) for instructions on planning the tibial
resection.
Figure 2: MRH/All-Poly Tibial Template
8
Instrument Bar
6496-9-069
Distal Femoral Template
The anterior
cortex of the
femur is marked
with a Bovie or 6496-9-071
similar device MRH/All Poly Tibial Template
to indicate the
resection level.
Measurement
Note:
Tech Tip:
Caution:
Rotational Alignment
10
Instrument Bar
6496-9-069
Distal Femoral Template
6496-9-071
MRH/All Poly Tibial Template
Figure 5: Osteotomy
Femoral Osteotomy
Tech Tip:
Note:
11
Distal Femoral Growing Prosthesis
Surgical Protocol
Femoral Preparation
Note:
PMMA
Flexible Reamer Distal Centralizer > Optional stem centralizers are available for the
10-17mm diameter stems (for the 102 and 127mm
length stems only). The last size reamer used
corresponds to the diameter of the distal centralizer
necessary for correct positioning of the stem tip.
15mm 15mm
Figure 7
12
Instrument Bar
13
Distal Femoral Growing Prosthesis
Surgical Protocol
Fixation Pins > With the knee flexed, place the EM Tibial Alignment
Guide on the tibial shaft. Place the Ankle Clamp
EM Tibial around the distal tibia just above the malleoli.
Alignment Guide
> Place the Fixation Pins of the instrument over the
tibial eminence. There should be a finger’s breadth
clearance between the proximal shaft of the Alignment
Guide and the anterior cortex when the Fixation Pins
are positioned properly. Center the Proximal Fixation
Pins over the tibial eminence and tap in the most
posterior pin first to fix the anterior/posterior location
of the head. Rotation is now adjusted and then set by
Proximal anchoring the second pin. Tighten the vertical screw to
Shaft secure the proximal shaft of the guide.
Figure 9
Vertical
Screw
Medial/Lateral
Adjustment Screw
Ankle
Figure 8 Clamp
Anterior/Posterior
Adjustment Screw
14
Instrument Bar
8000-1040
EM Tibial Ankle Clamp
8000-1056
EM Tibial Spiked Proximal Rod
Alignment Guide
Figure 10
15
Distal Femoral Growing Prosthesis
Surgical Protocol
Anterior/
Posterior
Adjustment Tibial Resection Level
Screw
> If templates were used to plan the tibial resection level
earlier in the procedure, this marking can be used as
Medial/ a guide.
Lateral > Alternatively, a tibial stylus can be utilized to set the
Adjustment tibial resection level. Assemble the Tibial Stylus to the
Screw Tibial Resection Guide by depressing the locking button
on the top of the Tibial Stylus, inserting the stylus into
either the medial or lateral holes on the top of the Tibial
Figure 12 Resection Guide and releasing the button to lock the
Stylus into place (Figure 13).
> The Stylus has two depth setting options for the Tibial
Resection Guide (12 or 18mm), depending on which
Locking Button end of the stylus is used. An 18mm resection from the
medial tibial sulcus is required from the tibia if the
distal most aspect of the femoral replacement is placed
at the same level of the original anatomy. Typically, a
12mm resection from the medial tibial sulcus would
Tibial Stylus be preferred, which requires resecting an additional
Tibial
Resection Guide 6mm from the femur. However if the tibial growth plate
is still open, a 2mm resection from the medial tibial
sulcus of the proximal tibia preserves the growth plate,
allows for continued tibial growth and requires less
expansion of the prosthesis. The joint line corrects over
time as prosthesis expansion exceeds tibial growth.
8000-1040
EM Tibial Ankle Clamp
8000-1056
Spiked Proximal Rod
Proximal
Shaft
7650-1072
Tibial Stylus
6496-9-051/052
Tibial Cutting Block
Figure 14
17
Distal Femoral Growing Prosthesis
Surgical Protocol
> Extract the two headed Fixation Pins on the top of the
Alignment Guide from the proximal tibia. Remove the
proximal shaft of the Alignment Guide by sliding it up
through the top of the Resection Guide (Figure 15).
Tibial > Slide the Tibial Resection Guide posteriorly until it
Resection comes in contact with the anterior tibia. Placing a 1/8”
Guide Drill Pin through the “X” pin hole will further secure
the Resection Guide to the tibia.
Vertical
Thumb
Screw
Figure 15
Figure 16
18
Instrument Bar
8000-1040
EM Tibial Ankle Clamp
8000-1056
Spiked Proximal Rod
Tibial
Resection
Guide
6496-9-051/052
Tibial Cutting Block
Figure 17
7650-1035
> If desired, 2mm or 4mm of additional bone may be Headless Pin Driver
resected by repositioning the guide over the pins
through the -2 or -4 holes respectively
7650-1038
Note: Headless Pins
If the “X” Pin hole is used, this pin must be removed prior to
repositioning the Tibial Resection Guide.
6633-7-250
> The Tibial Resection Guide is removed by first Alignment Handle
removing the “X” pin, then sliding the guide off over
the two 1/8” drill pins.
6838-7-220/230
Alignment Pin
6633-7-605
Pin Puller
19
Distal Femoral Growing Prosthesis
Surgical Protocol
Figure 18
Note:
Figure 19
> Using the Pediatric Stem Drill, prepare for the central
tibial stem by drilling through the raised central hole in
the Pediatric Tibial Template (Figure 20).
> The Pediatric Stem Drill has a stop and will bottom out
on the Pediatric Tibial Template.
Figure 20
20
Instrument Bar
6737-8-500/505
Pediatric Tibial Template
6633-7-250
Alignment Handle
6838-7-220/230
Alignment Pin
7650-1038
Headless Pins
6737-8-510
Pediatric Stem Drill
Figure 21
8000-7845
Counter Sink Drill
> Then complete the tibial preparation by using the
Counter Sink Drill to prepare for the tibial pegs
through the two posterior raised holes in the Pediatric
Tibial Template (Figure 21). 7650-1035
Headless Pin Driver
> Both drills have a stop and each drill should bottom out
on the Pediatric Tibial Template.
6633-7-610
Headed Nail Impactor Extractor
6633-7-600/615
Headed Nails
21
Distal Femoral Growing Prosthesis
Surgical Protocol
Trial Reduction
2. Distal pulses
Femoral
Component Equivalent GMRS Trial Construct
Length
Caution:
Figure 22
22
Instrument Bar
6496-2-010/020
Distal Femoral Trial - Small
6496-6-0X0
Trial Extension Piece
See Catalog
Cemented Stem Trial
Figure 23
23
Distal Femoral Growing Prosthesis
Surgical Protocol
> Insert the Trial Tibial Bearing Component into the tibial trial. Bring the
Trial Tibial Bearing Component up between the femoral condyles and
insert the Trial Axle. Then insert the Trial Bumper through the anterior
hole of the Trial Tibial Bearing Component (Figure 24). Hold the trial
Trial Cemented
femoral assembly in one hand to prevent rotation and fully extend the
Stem
leg. Palpate the femoral vessels to determine the status of the pulse. If
the pulse is diminished, flex the knee to determine if it increases. This
will indicate the need for either modifying the length of the prosthesis
or for removing additional bone from the distal femur or proximal tibia.
Tech Tip:
Trial Extension > A final test of the range of motion of the knee with the patella tracking
Piece in place is then performed. A full range of motion should be obtained.
Note whether the capsular mechanism can be closed. These factors,
taken together, will determine the adequacy of the length of the
Trial Distal resection.
Femoral
Component > If it is determined that the prosthetic construct is too long, the length
of the distal femoral bone resected should be rechecked against the
length of the assembled prosthesis. The primary means to address a
construct that is too long should be to remove additional bone from the
femur. Other alternatives include shortening the prosthesis (if it has
been expanded), selecting a shorter extension piece (if applicable), or
evaluation of a thinner tibial construct if possible.
Trial Axle
> If it is determined that the prosthetic construct is too short, expand the
prosthesis to the appropriate length (See Expansion of the Stryker Distal
Femoral Growing Prosthesis on pages 30 through 32).
The replacement length should err on the side of being too short rather
Trial Tibial than too long. A reconstruction that is too long can lead to challenges
Bearing with wound closure. Additionally, with children maintaining motion is
Component critical. Children have the potential to lose motion over time as they are
not as disciplined as adults in following their physical therapy regimen.
> The decision can now be made if a gastrocnemius flap or muscle transfer
Pediatric All Poly will be required, dependent upon the presence or absence of the capsule
Tibial Trial Figure 24 or portions of the quadriceps.
24
Instrument Bar
See Catalog
Cemented Stem Trial
6496-6-0X0
Trial Extension Piece
6496-2-010/020
Distal Femoral Trial - Small
6496-2-115
Figure 25
Trial Axle
6486-8-0XX
Trial Pediatric All Poly Tibia
25
Distal Femoral Growing Prosthesis
Surgical Protocol
Figure 26
Figure 27
Figure 28
26
Instrument Bar
Tech Tip:
6496-9-064
If a stem centralizer is not being used, plug the hole in Impaction Support Block
the stem with bone cement.
Tech Tip:
27
Distal Femoral Growing Prosthesis
Surgical Protocol
Note:
Tech Tip:
6497-2-300
2mm Hex Screwdriver for Distal Femoral
Growing Prosthesis
Figure 32
Clockwise
Figure 33
29
Distal Femoral Growing Prosthesis
Surgical Protocol
Figure 34
Incision
> A lateral approach is utilized. For the initial
expansion, a 1-2cm incision is made as close to the
locking and expansion screws as possible
(Figure 35). For subsequent expansions, the incision
should be made along the original incision site.
The locking and expansion screws can be located
by palpation or fluoroscopic imaging.
Note:
Unlock Prosthesis
> Once exposure to the device has been gained on the
Counter-Clockwise lateral side, to unlock the expandable prosthesis, insert
the smaller hex screwdriver into the hole indicated and
turn counter-clockwise (Figure 36). Do not bend the
screwdriver. Ensure that the smaller hex screwdriver is
fully seated in the hole prior to unlocking the device.
Caution:
6497-2-300
2mm Hex Screwdriver for Distal Femoral
Growing Prosthesis
Counter-Clockwise
702429
Teardrop Handle Large w/AO Quick Fitting
1806-0292
Screwdriver Shaft, 3.5 x 85mm
Figure 37
Tech Tip:
0.5cm 5
1.0cm 11
1.5cm 17
2.0cm 22
31
Distal Femoral Growing Prosthesis
Surgical Protocol
Figure 39
Method 1
> The wedges are initially advanced by hand to bring
them in contact with the implant at the joint to be
disengaged. The wedges are advanced by turning the
Figure 40 nut in a clockwise direction, until resistance is felt
(Figure 39). The wedges are then further advanced,
using the wrench end of the 5-in-1 impactor provided,
until the tapers disengage.
Method 2
> The wedges of the separator are advanced until they are Method 3
sufficiently tight against the taper junction to be separated
using the wrench end of the 5-in-1 impactor. A mallet > The separator can be disassembled and the chisel
can then be used to impact the chisel component of the component of the assembly can be used by itself to
separator. The separator is designed to allow the nut and separate a taper junction (Figure 40). The chisel is
chisel to travel a small distance when impacted to ease inserted anteriorly at the location to be separated and
separation. impacted with a mallet until separation is achieved.
Caution should be taken when disengaging any taper-
locked joint. The high forces that hold a taper-locked
32 joint together may result in a sudden and forceful action
upon disengagement along the axis of the tapers.
Instrument Bar
33
Distal Femoral Growing Prosthesis
Surgical Protocol
34
Catalog # Description GMRS Kit Number
35
Distal Femoral Growing Prosthesis
Surgical Protocol
Catalog # Description
36
Catalog # Description
37
Distal Femoral Growing Prosthesis
Surgical Protocol
Catalog # Description
38
Catalog # Description
39
325 Corporate Drive
Mahwah, NJ 07430
t: 201 831 5000
[Link]
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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 product offerings.
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