Insignia Surgical Protocol
Insignia Surgical Protocol
Hip Stem
Surgical protocol
Insignia Hip Stem | Table of contents Home Table of contents
Table of contents
Introduction..................................................................................................................................................4
Step 4: Broaching.......................................................................................................................................8
Implant information.................................................................................................................................15
Catalog information..................................................................................................................................17
This publication sets forth detailed validated procedures for using the Insignia Hip Stem. It offers instructions 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.
Insignia Hip Stem | Indications and contraindications Home Table of contents
Additional indication specific to use of Insignia Hip Stems For Instructions for Cleaning, Sterilization, Inspection
with compatible Howmedica Osteonics Constrained Liners: and Maintenance of Orthopaedic Medical Devices, refer to
LSTPI-B, QIN 4310, 4330, 4333, 4350, 4383, 4441, 0090-9-621,
• When the stem is to be used with compatible Howmedica 0095-3-200, and SLI001.
Osteonics Constrained Liners, the device is intended for
use in primary or revision patients at high risk of hip
dislocation due to a history of prior dislocation, bone
loss, soft tissue laxity, neuromuscular disease, or intra-
operative instability.
Additional indication specific to use of Insignia Hip Stems
with compatible ADM and MDM Acetabular Components:
• When the stem is to be used with compatible Howmedica
Osteonics ADM and MDM Acetabular Components, the device
is indicated for Dislocation risks.
Insignia Hip Stems are intended for cementless use only and
are intended for total and hemiarthroplasty procedures.
Contraindications
1. Any active or suspected latent infection in or about the hip
joint.
2. Any mental or neuromuscular disorder which would create
an unacceptable risk of prosthesis instability, prosthesis
fixation failure, or complications in post-operative care.
3. Bone stock compromised by disease, infection or prior
implantation which cannot provide adequate support and/
or fixation to the prosthesis
4. Skeletal immaturity
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Insignia Hip Stem | Introduction Home Table of contents
Introduction
This surgical protocol is a guide to preparing the femur for
an Insignia Hip Stem. The total system includes 12 body sizes
ranging from size 0 to size 11.
Insignia is a broach only, fully HA coated stem designed for
muscle-sparing surgical approaches in addition to traditional
approaches. Designed using Stryker’s proprietary SOMA
database, it features a size specific collar and size specific
medial curvature.
The stem is designed for use with Stryker V40 femoral heads,
sleeves and their compatible acetabular components.
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Preoperative planning
Step 1
Pre-operative planning aids in the determination of
probable implant style and size. The pre-operative planning
process should take qualitative and quantitative factors
(including patient bone quality, density, and morphology) into
consideration in order to evaluate and select the appropriate
implant system for the patient. Digital templates are available
for use.
Determining leg length
With the templates provided, determine the desired
postoperative leg length, taking into consideration
radiographic leg length inequality and patient clinical
assessment.
Figure 1
For example, if 8mm of leg lengthening is required to equalize
the leg lengths, make a new mark 8mm superior to the center
of rotation marked during templating of the acetabular shell.
Tips: This new mark will be your target when templating the
• Templating is an important aspect of pre-operative femoral stem (described below).
planning, but it should only serve as a guide. Final decision In this example, if this plan is properly executed at the time of
making concerning fit, size, and soft tissue tensioning surgery, there will be 8mm of leg lengthening.
should take place intra-operatively at the surgeon’s
Similarly, the predicted change in offset is also considered by
discretion.
comparing the relative medial/ lateral position of the center of
• The templated stem size and neck resection level may have rotation marking of the acetabular component and new mark
to be adjusted if leg length cannot be managed solely by used to plan the femoral component. The digital templates
changing the head offset. should be used to estimate the final components that most
• Patient positioning is key to obtaining adequate hip closely restore the normal offset of the patient’s hip.
stability and acetabular placement. Acetabular cup position and sizing
• Standing pre-operative x-rays are recommended. Both an Utilize the acetabular templates to determine the optimal
A/P and lateral x-ray are preferred to assess stem size. position and size for the acetabular component. Be sure the
cup is well centered in the acetabulum and the size fills
• To help facilitate correct placement of final implants, take
between the tear drop and the superior rim (Figure 1). After
into account any pelvic tilt observed.
templating, mark the center of rotation.
Femoral stem selection
Insignia has two offset options for each size: Standard and
High Offset. Refer to page 15 for more information on sizing
options. High Offset is designed to provide 5mm of direct
lateralization, increasing offset without changing leg length.
Choose the template for which the stem size achieves medio-
lateral cortical engagement at the proximal two- thirds of the
stem and recreates the desired leg length and offset. For both
Standard and High Offset options, the template has markings
that indicate the center of the femoral head for a range of head
offset options.
Through templating and trialing, determine which option
restores proper offset and center of rotation by matching
the cup’s center of rotation with the desired head center of
rotation of either the Standard or High Offset stem.
Templates Once the final estimated stem size and position is determined,
the neck resection level should be noted. This will be used as
Insignia Digital Templates
a reference during intra-operative neck resection.
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Insignia Hip Stem | Surgical protocol Home Table of contents
Figure 2
Instruments
Neck Resection Guide
1020-1100
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Insignia Hip Stem | Surgical protocol Home Table of contents
Tips:
• Remove the lateral cortical bone at the piriformis fossa
to help obtain ideal proximal fit and to minimize the risk
of undersizing and/or varus placement of the femoral
component.
• The Axial Starter Reamer (1020-1200) may be used with
the T-Handle (1101-2200) or power to open the femoral
canal and to aid in determining the orientation of the
femoral axis.
Note: Care should be taken not to sink the Axial Starter
Reamer below the first graduation mark to allow for proper
press fit of the implant.
Figure 3
Instruments
Modular Box Osteotome Orthonomic Modular Handle Mallet
1601-1210 1020-2900 1120-1000
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Broaching
Step 4
Insignia is designed to be compatible with several broach
handle designs to ease insertion in various surgical
approaches.
Broaching is performed beginning with the size 0 broach.
The broach should be inserted via canal access by
positioning the broach laterally and posteriorly. Insignia
was designed to be inserted parallel to the posterior
cortical bone of the femoral neck although adjustments can
be made by the surgeon during insertion based on patient
need.
Sequentially broach upward in size until the proper fit is
achieved. The surgeon’s clues to a firm fit and final size
Figure 4
include 1.) increased resistance to forward advancement;
2.) changing pitch of sound that results from mallet blows
to the broach handle; 3.) lack of further motion, and 4.)
rotational stability as assessed with broach handle in place.
Upon reaching the final size and depth of the broach, detach
the broach handle from the broach, leaving the broach fully
seated in the femoral canal (Figure 4, Figure 5).
Tips:
• The neck resection should be about 1-2 mm above the
final broach height. This will allow for calcar planing
prior to final implant placement enhancing collar contact
with medial bone.
• Relying only on the neck resection height alone for
final seating height may lead to improper sizing and
inadequate component fixation.
Figure 5 • For good fixation of the implant, it is important to
maintain rotational alignment throughout the broaching
process.
• For broach handles featuring a lever design, close the
Broach handle styles Insignia is
lever arm until the broach is secured onto the Broach
compatible with:
Handle.
1. Extra Offset Broach Handle – Lever • For broach handles featuring a lever design, to open the
(7000-5529) lever with one hand place your thumb on the top edge
of the impaction pad and your index finger in the notch
2. Straight Broach Handle – Lever
under the end of the lever. Use your index finger to pull
(7000-5525)
up on the lever.
3. Offset Broach Handle – Lever Note: Insignia broaches can be properly identified through
(7000-5526) the following:
4. Straight Broach Handle 1) The size is marked on the top of the broach post.
(1440-1460) 2) The size is marked in the tab slot.
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Insignia Hip Stem | Surgical protocol Home Table of contents
Trial reduction
Step 5
Select a Neck Trial that corresponds to the color shown on
top of the final broach and matches the planned Standard
or High Offset implant size (Figure 6). The High Offset
option is designed to provide 5mm of direct offset without
changing leg length.
The table below indicates the correct neck trial color code
for each stem size. The High Offset neck trials feature a
gold TiN coating (Figure 7).
Assemble the Neck Trial onto the broach. Next, assemble
a V40 Head Trial onto the Neck Trial. Femoral heads come
in multiple options and are different for each femoral head
implant material (see table below). For this reason, final
head material should be chosen prior to trial reduction.
Offsets add or subtract from the base neck length of the
implant and help to achieve the desired leg length and
offset.
Perform a trial reduction of the hip. The final broach size
facilitates determination of the correct implant size. Upon
confirmation of the selected components, note selected neck
offset, femoral head, and broach size.
Figure 7
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Insignia Hip Stem | Surgical protocol Home Table of contents
28 -4, -2.7, 0, +4
BIOLOX delta V40 6570-0-XXX 32 -4, 0, +4
36 -5, -2.5, 0, +2.5, +5, +7.5
28 -2.5, 0, +4
32 -2.5, 0, +4
BIOLOX delta Universal Taper
6519-1-XXX 36 -2.5, 0, +4
(must be used with Universal Taper Sleeve #6519-T-XX)
40 -2.5, 0, +4
44 -2.5, 0, +4
18-28XX 28 -2.5, 0, +2.5, +5
BIOLOX delta C-Taper
18-32XX 32 -2.5, 0, +2.5, +5
(must be used with a C-Taper Sleeve #17-0000E)
18-36XX 36 -5, -2.5, 0, +2.5, +5, +7.5
28 -2.7, 0, +4
Alumina V40 6565-0-XXX 32 -4, 0, +4
36 -5, 0, +5
17-28XXX 28 -2.5, 0, +5
Alumina C-Taper
17-32XXX 32 -2.5, 0, +5
(must be used with a C-Taper Sleeve #17-0000E)
17-36XXX 36 -5, 0, +5
22 0, +3, +8
26 -3, 0, +4, +8, +12
28 -4, 0, +4, +6, +8, +12
LFIT CoCr V40 6260-9-XXX 32 -4, 0, +4, +8, +12
36 -5, 0, +5, +10
40 -4, +0, +4, +8, +12
44 -4, +0, +4, +8, +12
6260-4-XXX 22 0, +3, +8
26 -3, 0, +4, +8, +12
CoCr V40
6260-5-XXX 28 -4, 0, +4, +6, +8, +12
32 -4, 0, +4, +8, +12
Tips:
• Neck trials are collarless, designed to allow trialing of the construct prior to calcar planning. Trialing should be done prior to
planing the calcar to allow for stem size adjustments.
• During the trial reduction, an x-ray may be used to verify proper broach size and position, leg length and offset.
• After trialing, check broach rotational stability again.
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Insignia Hip Stem | Surgical protocol Home Table of contents
Calcar preparation
Step 6
Assemble the Calcar Planer to the reamer power adaptor.
With the final broach in place, guide the Calcar Planer
over the broach post ensuring the Calcar Planer is axially
aligned with the post and is stable. Initiate power prior
to contacting the femur and slowly advance the Calcar
Planer toward the broach using continuous power until the
positive stop on the Calcar Planer contacts the broach face
and the bone is removed (Figure 8). Failure to operate the
Calcar Planer in accordance with these instructions may
result in damage to the femur.
In the event that the Calcar Planer cannot fully engage the
Figure 8 broach post, remove the broach and perform a new neck
resection at a lower level. Alternatively, a larger broach size
could also be considered.
Upon confirmation of the selected components, reassemble
the broach handle to the broach. Remove the broach from
the femoral canal.
Instruments
Calcar Planer – Standard Calcar Planer – Large
1020-1111 1020-1112
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Insignia Hip Stem | Surgical protocol Home Table of contents
Instruments
Modular Offset Quick Connect Modular Stem Impactor
Stem Inserter 1020-1870
1020-1860
Modular Threaded Stem Inserter
1020-1800
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Insignia Hip Stem | Surgical protocol Home Table of contents
A mallet is then used to gently seat the stem into the canal,
following the central axis of the femur, ideally when the
collar is just above or rests on the calcar (Figure 10). If
the collar is sitting proud, do not attempt to continue
impacting the stem if visual and auditory clues indicate
that it is firmly seated in the canal. These clues, rather than
the collar seating level, should be used to determine the
final seating height of the implant. Continued aggressive
impaction could lead to femoral fracture.
In the event that dense bone is encountered intra-
operatively and compounding anatomical factors are
present, the seating of the implant may not be consistent
with the level of the broach due to the viscoelastic nature of
the femoral bone.* If the final seating height is undesirable,
the implant can be removed and additional broaching can
be performed.
Figure 10
Tip: Use moderate mallet strikes/blows to seat the stem
until it is stable.
If the stem hangs up due to impingement of the Modular
Threaded Stem Inserter against the overhanging tip of
the greater trochanter, remove the threaded stem inserter
leaving the stem in place and use the Modular Stem
Impactor to fully seat the stem.
Warning:
• If any intra-operative stem extraction is required, utilize
the Modular Threaded Stem Inserter (1020-1800).
• If the stem inserter is contacting the greater trochanter
during insertion, continued impaction could lead to a
fracture.
Instruments
Orthonomic Modular Handle Mallet
1020-2900 1120-1000
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Insignia Hip Stem | Surgical protocol Home Table of contents
Final reduction
Step 8
Prior to final head assembly, femoral head selection may be
re-evaluated using a V40 Head Trial. Place the Head Trial
onto the stem neck taper and reduce the hip.
Leg length equality and proper soft tissue tension are
evaluated. Remove the Head Trial and dry the implant
trunnion with a sponge or sterile towel.
Select the appropriate corresponding V40 Femoral Head
(BIOLOX delta Ceramic, CoCr, Alumina Ceramic) or sleeve
and place it onto the dry trunnion of the femoral stem
with a slight twist. Impact the head with two moderate
impactions using the Modular Head Impactor (1601-1700)
Figure 11 (Figure 11).
Verify the head is secure on the trunnion after head
impaction by applying traction to the head and confirming
stability on the trunnion. If necessary, the head can be
removed utilizing a head disassembly instrument
(6059-9-505).*
Relocate the femoral head into the acetabular cup and
re-check the hip biomechanics. The surgical site is then
closed according to surgeon preference.
*If a ceramic head is placed on the trunnion and then removed, it must be
replaced with a V40 cobalt chrome head or a V40 Titanium Adapter Sleeve
(17-0000E) and a C-Taper ceramic head.
If the stem must be removed, utilize the Modular Threaded Stem Inserter
(1020-1800).
Warning:
• Following trial reduction and prior to final head assembly, After completing the trialing process, intra-operatively
clean and dry the implant to ensure the taper is free of assemble the adaptor sleeve to the femoral stem manually.
debris. Finally, clean the bearing surfaces and reduce the The Universal Adaptor Sleeve must be fully seated on the
hip. stem taper before the head is assembled.
• Any debris that is potentially generated must be fully Note: In no instance should any attempt be made to
lavaged prior to wound closure. pre-assemble the adaptor sleeve inside the BIOLOX delta
Universal Ceramic Head.
Optional:
Intra-operatively assemble the BIOLOX delta Universal Taper
When selecting a BIOLOX delta Universal Taper Ceramic Ceramic Head onto the sleeved femoral stem and set with
Femoral Head (6519-1-0XX) for implantation, use of a two moderate strikes using the Stem Head Impactor (1104-
Universal Adaptor Sleeve (below) is necessary. 1000). Care must be taken to avoid excessive impact forces
when assembling the Ceramic Head to the sleeved femoral
Catalog no. Offset (mm) Taper component.
6519-T-025 -2.5 V40
6519-T-100 +0 V40
6519-T-204 +4 V40
Instruments
Orthonomic Modular Handle Modular Head Impactor V40 Head Trial
1020-2900 1601-1700 6264-x-xxxR
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Insignia Hip Stem | Implant information Home Table of contents
(FO)
Femoral offset
Implant information
(NL)
Neck
Length
Leg
Length
48˚
(SL)
Stem Length Center axis
Distal
Dimension
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Insignia Hip Stem | Implant information Home Table of contents
Implants
7000-5500 Size 0 Insignia Collared Standard Size 0 7000-6600 Size 0 Insignia Collared High Size 0
7000-5501 Size 1 Insignia Collared Standard Size 1 7000-6601 Size 1 Insignia Collared High Size 1
7000-5502 Size 2 Insignia Collared Standard Size 2 7000-6602 Size 2 Insignia Collared High Size 2
7000-5503 Size 3 Insignia Collared Standard Size 3 7000-6603 Size 3 Insignia Collared High Size 3
7000-5504 Size 4 Insignia Collared Standard Size 4 7000-6604 Size 4 Insignia Collared High Size 4
7000-5505 Size 5 Insignia Collared Standard Size 5 7000-6605 Size 5 Insignia Collared High Size 5
7000-5506 Size 6 Insignia Collared Standard Size 6 7000-6606 Size 6 Insignia Collared High Size 6
7000-5507 Size 7 Insignia Collared Standard Size 7 7000-6607 Size 7 Insignia Collared High Size 7
7000-5508 Size 8 Insignia Collared Standard Size 8 7000-6608 Size 8 Insignia Collared High Size 8
7000-5509 Size 9 Insignia Collared Standard Size 9 7000-6609 Size 9 Insignia Collared High Size 9
7000-5510 Size 10 Insignia Collared Standard Size 10 7000-6610 Size 10 Insignia Collared High Size 10
7000-5511 Size 11 Insignia Collared Standard Size 11 7000-6611 Size 11 Insignia Collared High Size 11
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Insignia Hip Stem | Catalog information Home Table of contents
Catalog information
Femoral head implants & trials: BIOLOX delta Ceramic
Universal Taper BIOLOX delta Universal Adapter V40 Additional Universal V40
Ceramic Heads* Sleeves - Titanium Trial Heads
Diameter Offset Offset Diameter Offset
Catalog no. Catalog no. Catalog no.
(mm) (mm) (mm) (mm) (mm)
6519-1-028 28 -2.5, 0, +4 6519-T-025 -2.5 6264-8-728R 28 -2.5
6519-1-032 32 -2.5, 0, +4 6519-T-100 +0 6264-8-632R 32 -2.5
6519-1-036 36 -2.5, 0, +4 6519-T-204 +4 6264-8-236R 36 +5.0
6519-1-040 40 -2.5, 0, +4 6264-8-940R 40 -2.5
6519-1-044 44 -2.5, 0, +4 6264-8-944R 44 -2.5
*Must be used with Universal Adapter Sleeve,
catalog # 6519-T-XXX
C-Taper BIOLOX delta Ceramic Heads** C-Taper BIOLOX delta Ceramic Anatomic Heads**
18-3205 32 +5
**Must be used with a C-Taper Sleeve catalog #17-0000E.
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Insignia Hip Stem | Catalog information Home Table of contents
Catalog information
Femoral head implants & trials: Alumina Ceramic
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Insignia Hip Stem | Catalog information Home Table of contents
Catalog information
Femoral head implants & trials: CoCr
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Insignia Hip Stem | Catalog information Home Table of contents
Catalog information
Femoral head implants & trials: Modular Endo head
Unitrax Unipolar
(For full list of Unitrax instruments and trials, refer to UHT Instrument System surgical protocol)
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Insignia Hip Stem | Catalog information Home Table of contents
Catalog information
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Insignia Hip Stem | Catalog information Home Table of contents
Catalog information
22
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when Howmedica Osteonics Corp.
treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular 325 Corporate Drive
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The information presented is intended to demonstrate the breadth of Stryker’s product offerings. A surgeon must always refer to the package
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