Sirius
Cemented Femoral Hip Stem
Surgical Technique
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Sirius Cemented Femoral Hip Stem
Table of Contents
Indications and Contraindications....................................................................................................................................................2
Preoperative Planning .......................................................................................................................................................................3
Templating Procedure ........................................................................................................................................................................4
Surgical Exposure ...............................................................................................................................................................................4
Femoral Neck Resection......................................................................................................................................................................5
Preparation of the Acetabulum and Insertion of the Acetabular Component.........................................................................5
Femoral Canal Opening......................................................................................................................................................................6
Femoral Canal Reaming......................................................................................................................................................................7
Femoral Canal Broaching....................................................................................................................................................................8
Stem Trial Reduction...........................................................................................................................................................................9
Femoral Canal Final Preparation.....................................................................................................................................................10
Cement Preparation
Femoral Cementing ..........................................................................................................................................................................10
Cement Delivery
Pressurization
Femoral Stem Insertion.....................................................................................................................................................................12
Final Reduction..................................................................................................................................................................................13
Component Removal.......................................................................................................................................................................14
Cement-in-Cement Revision Procedure........................................................................................................................................14
Cement Mantle Preparation
Trial Insertion and Reduction
Cement Insertion
Final Implant Insertion
Ordering Information.......................................................................................................................................................................17
Acknowledgment
The Biomet Sirius system and subsequent operative technique were developed in conjunction with Mr. Peter Brydon (Melbourne, Australia), Mr. Alun John (Cardiff, UK), Prof.
Azhar Merican (Kuala Lumpur, Malaysia) and Dr. Gary Nielsen (Brisbane, Australia).
Biomet, as the manufacturer, does not practice medicine and does not recommend specific products or techniques for individual patients.
This brochure represents the surgical technique utilized by the developing surgeons of
the Sirius femoral stem. Acetabular components are selected, as appropriate for each
patient, by each individual surgeon. The acetabular components included in this brochure
are examples of available technology that are compatible with the Sirius femoral stem
and are not necessarily utilized by the Sirius development team. Please see the Sirius
product labelling and alternative acetabular components available through Biomet at
www.biomet.com
1
Indications For Use
Contraindications
1. Non-inflammatory degenerative joint disease including
osteoarthritis and avascular necrosis
Absolute contraindications include: infection, sepsis,
and osteomyelitis.
2. Rheumatoid arthritis
Relative contraindications include:
3. Correction of functional deformity
1.
Uncooperative patient or patient with neurologic
disorders who are incapable of following directions
4. Treatment of non-union, femoral neck fracture, and
trochanteric fractures of the proximal femur with head
involvement, unmanageable by other techniques
2.
Osteoporosis
3.
Metabolic disorders which may impair
bone formation
4.
Osteomalacia
5.
Distant foci of infections which may spread to the
implant site
6.
Rapid joint destruction, marked bone loss or bone
resorption apparent on roentgenogram
7.
Vascular insufficiency, muscular atrophy,
or neuromuscular disease
5. Revision procedures where other treatment or devices
have failed
The Sirius Femoral Hip Stem is intended for cemented use only
and may be used in partial and total hip arthroplasties.
Sirius Cemented Femoral Hip Stem
Figure 1
Figure 2
Preoperative Planning
Digital Preoperative Planning
Selection of the appropriate femoral component is attained
through careful preoperative planning. This can be achieved
either manually by means of X-ray templates or using a digital
templating system (Figures 1 and 2).
Sirius digital templates are available from various digital
template providers. When using digital templates, it is
necessary to use a magnification marker with a known
dimension to calibrate the image.
Manual Preoperative Planning
Once the correct magnification has been determined, the digital
templating system can be used to best decide the correct
implant required to help restore the patient’s natural anatomy.
The Sirius femoral templates are overlaid onto the Anterior
Posterior radiograph to best decide the correct resection
level, adequate implant size and cement mantle thickness.
X-ray magnification should be taken into consideration when
selecting templates.
3
Sirius Cemented Femoral Hip Stem
Figure 3
Figure 4
Templating Procedure
Surgical Exposure
The aim of templating is to plan for correct size and position
of the implants, to restore the hip center, femoral offset and
leg length.
The Sirius stem can be implanted using any of the standard
approaches for total hip arthroplasty. Irrespective of which
approach is used, the goal is to gain adequate exposure of
the proximal femur (Figure 4). This is essential for effective
preparation of the endosteal surface of the bone, cementation
and correct alignment of the prosthesis.
Templating typically begins on the contralateral hip with a true
A/P radiograph (Figure 3). First the correct cup size is chosen,
and then the center of rotation of the femoral head is identified.
On the operative side, mark the anatomic center of the femoral
head. Using the appropriate template, align the midline of
the implant with the anatomical axis of the femoral canal.
Move the template vertically so the selected head level mark
overlays the planned center of the femoral head. Select the
stem size by choosing the stem which will allow an adequate
cement mantle. The dotted line on the templates represents
the width of a 1.5 mm cement mantle for stem size B, and a 2
mm cement mantle for stem sizes C–G. Stem oversizing should
be avoided. It is recommended that a sufficient bed of proximal
cancellous bone be preserved for bone cement interlock. Once
the appropriate stem size has been chosen, note the resection
level and corresponding stem depth mark.
4
Figure 5
Femoral Neck Resection
Once the hip has been dislocated, complete the femoral neck
resection. As the Sirius stem is a non-collared implant, the
resection angle and level are not critical. However, if needed,
a femoral neck resection guide is available. Place the guide
over the neck, parallel to the longitudinal axis of the femur
(Figure 5). Then, move the guide along this axis to match the
resection level determined by preoperative templating and
make the appropriate neck resection (Figure 6).
Figure 6
Preparation of the
Acetabulum and Insertion
of the Acetabular Component
Biomet cemented or cementless acetabular components
can be used with the Sirius cemented femoral hip stem.
Insertion of the chosen prosthesis must be carried out
as instructed in the relevant operative technique for the
chosen acetabular component.
5
Sirius Cemented Femoral Hip Stem
Figure 7
Figure 8
Femoral Canal Opening
It is important to enter the femoral canal at the piriformis
fossa to prevent malpositioning and or undersizing of the
femoral component. The modular box chisel (Figure 7) or
starter drill (Figure 8) may be used, according to the preferred
technique. Either method helps to clear the femoral canal
postero-laterally and to line-up the starter reamer without
impingement on the greater trochanter.
•
The modular box chisel is attached onto the clamping
broach handle.
•
The starter drill is connected to the reamer T-handle.
6
The curved starter rasp can then be utilized to further open
the proximal femoral canal and remove some cancellous
bone from the calcar. Retain a layer of strong trabecular bone
for optimal cement interdigitation.
Figure 9
Femoral Canal Reaming
Insert a single starter reamer on a T-handle (Figure 9) into the
distal femoral canal to a level appropriate for the component
templated on the preoperative X-rays. Care should be taken
to insert the reamer straight into the medullary canal. Correct
reaming will allow the broaches and subsequent femoral
component to be inserted in the correct position.
Note: Power reamers should not be used to prepare the
femoral canal as damage to the endosteal surface of the femur
compromises cement interdigitation into cancellous bone.
7
Sirius Cemented Femoral Hip Stem
Not a depth
indication hole
Figure 10
Figure 11
Femoral Canal Broaching
When preparing the proximal femur, insert and remove the
broaches carefully to control the anteversion of the femoral
stem. A version rod can be threaded onto the clamping
broach handle to guide broach insertion.
Connect the broaches to the clamping broach handle
(Figure 10). Use them in a sequential manner starting with the
smallest broach (i.e. size A). Continue to insert progressively
larger broaches until the planned size is achieved.
Note: Do not strike the threaded version rod. Impaction should
only occur on the clamping broach handle strike plate.
8
The final broach used indicates the size of the femoral stem
to be implanted (Figure 11). The Sirius broaches have a
1.5mm thick cement mantle built-in for stem size B, and a
2mm cement mantle for sizes C–G. Take care not to over-rasp
the femoral canal and remove too much cancellous bone. A
proximal layer of 2–3 mm of strong cancellous bone should
be preserved.
The broaches have depth indicator holes corresponding to the
depth marks on the definitive implants and X-ray templates.
These depth marks are 3.5 mm apart, vertically.
Figure 12
Stem Trial Reduction
With the final broach left in situ, select the appropriate trial
neck size, corresponding to the stem body size (view table
below), and attach it to the broach trunnion.
Neck Size
32
34
38
44
50
Stem body Size
B
B,C
C,D,E
D,E,F
F,G
The trial neck replicates the exact neck geometry of the
femoral stem.
Biomet Type 1 taper heads are available in a wide array of
diameters and neck lengths. This allows for the adjustment
of femoral offset, leg length, good joint stability and large
range of motion. Attach the desired modular trial head to
the trial neck (Figure 12). Perform a trial reduction using the
head pusher. Assess range of motion, soft tissue tension, joint
stability and leg length. Repeat the trial reduction procedure
with different neck and head offsets and, if needed, different
broach implantation depths until joint stability and desired leg
length have been achieved.
The broach insertion depth can be adjusted and held in
position by placing a trial pin through the corresponding
depth indication hole. If the leg is too long but the offset is
correct, the broach can be impacted further. If the leg is too
short but the offset is correct, the broach can be disimpacted
and held out to length by placing the provided trial pin
through the depth insertion hole that lies at the level of the
neck cut.
Once the trial reduction has been completed, note the
insertion depth and medial/lateral position of the final broach
implanted by marking the position of the depth hole closest
to the neck cut.
Carefully remove the trial modular head from the rasp. Reattach
the rasp handle to the broach and remove the broach from the
canal. Care must be taken to avoid damaging the cancellous
bone in the proximal femoral canal.
9
Sirius Cemented Femoral Hip Stem
Figure 13
Figure 14
Femoral Canal Final Preparation
Femoral Cementing
Bone Bed Preparation
Cement Preparation
Measure the distal plug size by using the plug sizers or by
measuring the intramedullary canal diameter on the preoperative
radiographs. The distal plug must be tight within the canal to
create an adequate seal and allow for cement pressurization.
The Optivac cartridge mixing system allows cement mixing
and collection under vacuum. This minimizes the risk of
exposure to monomer fumes and contact with cement. The
Optivac system provides a reproducible high quality cement
with reduced porosity and improved fatigue strength. Once
the cement is mixed and collected under vacuum, load the
cement cartridge into the cement gun.
Mount the appropriate plug size onto the plug inserter. The
plug inserter is designed to place the plug approximately 14
mm distal to the tip of the final prosthesis (Figure 13). Once
tightly seated in the femoral canal, the plug will detach itself
from the inserter upon removal.
Thoroughly clean the femoral shaft using a pulse lavage, and
dry the femoral shaft to remove any loose debris from the
cancellous surface of the canal (Figure 14). This final preparation
is essential to maximize cement penetration into the cancellous
bone, and therefore achieve a strong bone/cement microinterlock.1,2 Utilizing a pulse lavage may also minimize the risk
of embolism during cement insertion.3
10
Figure 15
Figure 16
Cement Delivery
Pressurization
Introduce cement into the plugged femoral canal in a
retrograde fashion, moving the cement gun nozzle out as the
canal fills with cement (Figure 15).
Once the femoral canal is filled with cement, snap off the
redundant nozzle and apply the proximal pressurizer and
support plate against the resected femoral neck to pressurize
the cement (Figure 16). A positive sign of pressurization
is marrow extrusion from the proximal femur. Cement
pressurization has been shown to achieve greater penetration
into the cancellous bone, thereby improving the bonecement interlock and enhancing cement strength.4,5
Note: Delivery of cement to the bone, should never be done
when the cement is in low viscosity stage.
Pressure needs to be maintained until the cement is sufficiently
doughy to withstand bleeding from the endosteal surface of the
femoral canal. The cement polymerization time varies depending
on the type of cement used, temperature and humidity.
11
Sirius Cemented Femoral Hip Stem
Figure 17
Figure 18
Femoral Stem Insertion
Select the appropriate Sirius stem. Hollow winged and
wingless distal stem centralizers are supplied with the
definitive implant. The wingless centralizer is used in femoral
canals of 10 mm diameter or under. The centralizer has a
hollow cavity to prevent tip loading and allow for controlled
subsidence within the cement mantle.
Mount the prosthesis onto the stem inserter by pulling
on the T-handle which depresses the ball bearing locking
mechanism. Place the tip of the inserter into the slot on the
stem shoulder. Release the T-handle and the stem is locked
(Figure 17).
Note: The stem can also be inserted into the femoral canal
using the stem pusher.
When the cement is at the appropriate consistency, introduce
the Sirius stem into the center of the femoral canal. The
T-handle can be used as a visual aid to control the version of
the stem during insertion and cement polymerization.
12
To facilitate cement pressurization during insertion, occlude
the medial aspect of the femur between the calcar and the
stem with your thumb whilst the stem is slowly introduced.
The stem must be inserted to the predetermined depth
mark (Figure 18). When the final implant position is achieved,
remove all excess cement from the resected femoral neck with
a curette. Maintain pressurization and stem position until the
cement has fully hardened, ensuring that the stem does not
back out during cement polymerization.
Note: The stem inserter is designed to allow for a small degree
of rotation in relation to the stem. A small movement of the
inserter or leg during the polymerization process does not
result in unwanted stem rotation within the cement mantle.
Note: The stem inserter should not be hit during implant
insertion. If impaction is required, utilize the stem pusher.
Figure 19
Final Reduction
If desired, once the cement has cured, complete a further trial
reduction using the appropriate trial heads. Check the range of
motion, joint stability, soft tissue tension and leg length.
Note: Modular heads should never be heavily impacted onto
the trunnion as this may cause damage to the surface of the
modular head.
After fully seating the femoral component (Figure 19), position
the modular femoral head onto a dry and clean surface of the
trunnion with hand pressure only. Fully seat the modular head
by means of a gentle tap utilizing the femoral head pusher
and mallet.
Once the definitive modular femoral head has been attached to
the femoral stem, reduce the hip joint.
13
Sirius Cemented Femoral Hip Stem
Figure 20
Femoral Stem Removal
Should a Sirius femoral component ever require removal, a
stem removal instrument and slide hammer are available in the
universal head/stem removal tray.
Position the stem removal instrument on either side of the
trunnion and use the slide hammer to exert sufficient force to
remove the femoral stem (Figure 20).
Clear the proximal cement, paying special attention to the
trochanteric area.
Cement-in-Cement
Revision Procedure
Cement-in-cement revision of the femoral component can be
performed in cases where the femoral cement mantle appears
intact at the time of revision surgery. It is an attractive option
as removal of well fixed cement can be difficult and as such
increases the risk of excessive bone stock loss, fracture or shaft
perforation.6 Indications for such a surgical technique include: 6
• femoral stem removal for improved access
to the acetabulum
• exchange of a monoblock stem with
a damaged head
• exchange of a modular stem with a damaged
or incompatible trunnion
• change of version, length or offset for the treatment
of instability or leg length discrepancy
• stem fracture
• aseptic loosening at the prosthesis / cement interface
Note: Due to its small dimensions, the Biomet Sirius stem is
ideally suited to perform cement-in-cement revisions. In many
cases, the Sirius stem can be inserted into the cemented cavity
left after removal of primary implants without requiring any
distal cement removal.
14
Figure 21
Cement Mantle Preparation
Trial Insertion and Reduction
After removal of the existing stem, take care to avoid debris or
soft tissues entering the femoral canal that could compromise
the cement-in-cement technique. Once the revised stem is
extracted, should there be any concerns about the integrity of
bone cement interface, resect the femoral neck 2–3 mm below
the existing resection.
Insert a stem trial with the appropriate trial neck to ensure the
correct stem size can be implanted. The Sirius stem and neck
trials replicate the exact stem geometry of the real prosthesis.
The trial stem insertion depth can be adjusted and held in
position by placing a pin through the corresponding depth
indication hole. The thickness of the future cement mantle
and distal centralizer must be taken into account when
trialling. If need be, further cement mantle reaming may be
carried-out, using the cement reamer, until the desired stem
position is achieved.
If inspection of the cement cavity reveals loose cement
particles, soft tissue at the bone cement interface or any other
visible damage distal to the lesser trochanter, the cement-incement method should be abandoned and a different revision
technique should be used.
Following removal of the original stem, if the cement cavity is not
large enough to accommodate the Sirius stem, and providing
the cement is thick enough, the excess cement mantle can be
removed using cement reamers or high speed burs.
Perform a trial reduction to assess the range of motion, soft
tissue tension, leg length and joint stability.
Note the insertion depth mark of the trial stem to facilitate the
future insertion of the definitive implant (Figure 21).
Note: Irrigation whilst reaming the cement mantle is
highly recommended.
15
Sirius Cemented Femoral Hip Stem
Figure 22
Cement-in-Cement
Revision Procedure (cont.)
Cement Insertion
Final Implant Insertion
Thoroughly clean the new cement cavity using a pulse lavage
and dry the cavity to remove any remaining debris. Optivac
is mixed and collected under vacuum. Insert the cement in a
retrograde fashion with a cement gun using a revision nozzle
and pressurized as described on page 11. The cement cavity
must be completely filled.
Select the final implant matching the size and offset of the last
trial stem used. Fit the hollow wingless distal stem centralizer
onto the implant. Mount the assembly onto the stem inserter
and carefully insert it into the femoral canal to the required
depth (Figure 22). It is essential to maintain the desired stem
anteversion during stem insertion and pressurization.
Once the cement has set, perform a final trial reduction before
implanting the definitive modular femoral head.
16
Sirius Sizing Chart
Femoral
size
Horizontal
Offset
Vertical
Offset
Stem
Length
* Measured from resection level to the distal tip.
Stem
Horizontal
Length*
Offset
Vertical
Offset
CCD
Angle
32-B
B
100
32
16
125
34-B
B
100
34
18
125
34-C
C
110
34
18
125
38-C
C
110
38
20
125
38-D
D
110
38
20
125
38-E
E
110
38
20
125
44-D
D
110
44
24
125
44-E
E
110
44
24
125
44-F
F
130
44
24
125
50-F
F
130
50
27
125
50-G
G
130
50
27
125
17
Sirius Cemented Femoral Stem
Implants
Sirius Stems and Centralizers
Product
Part Number
Description
Size
51-199332
51-199333
51-199334
51-199335
51-199336
51-199337
51-199341
51-199342
51-199343
51-199351
51-199352
Sirius Femoral Hip Stem
32-B
34-B
34-C
38-C
38-D
38-E
44-D
44-E
44-F
50-F
50-G
51-199300
Sirius Winged Centralizer
51-199301
Sirius Wingless Centralizer
Note: The Sirius stem is packaged with the winged and wingless centralizer options.
Product
18
Part Number
Description
XRAY31-149100
Sirius Acetate X-ray Template Set
Instruments
Sirius Broach Tray
Product
Part Number
Description
Size
597044
Sirius Broach Tray
–
596044
Sirius Broach Instrument Case (Empty)
–
Sirius Broach
B
C
D
E
F
G
31-149122
31-149123
31-149127
31-149124
31-149125
31-149126
Sirius Trunnion
32
34-B
34-C
38
44
50
31-149160
Sirius Hip T-Handle Inserter
–
31-555408
Sirius Straight Clamping Broach Handle
–
31-149163
Sirius Standard Plug Inserter
–
4197
Support Plate for Femural Pressurizer II
–
31-149164
Sirius Stem Pusher (Optional Instrument)
–
31-149110
Sirius Stem Trial Pin
–
31-149102
31-149103
31-149104
31-149105
31-149106
31-149107
19
Sirius Cemented Femoral Stem
Optional Instruments
Sirius Trial Tray
Product
Part Number
Description
Size
597045
Sirius Trial Tray
–
596045
Sirius Trial Instrument Case (Empty)
–
31-149101
31-149132
31-149133
31-149134
31-149135
31-149136
31-149137
31-149115
20
Sirius Trial Stem
Sirius Cement Reamer
A
B
C
D
E
F
G
–
Femoral Stem Removal Instruments
Product
Part Number
Description
X31-400061
Extended Stroke Slap Hammer
X31-400059
J-Hook Stem Extractor
General Instrumentation
Product
Part Number
Description
Size
31-601565
Taperloc Complete General Instrument Case
—
31-399999
Ergonomic Head Driver
—
31-473620
Reamer T–Handle
—
X31-400003
Exact Femoral Resection Guide Alliance
—
428195
Starter Reamer
—
51-222221
Initial Starter Rasp
—
466365
Pilot Tipped Twist Drill
—
31-473794
Exact Modular Calcar Planer
42 mm
31-400000
Exact Bone Plug Inserter
—
31-400100
Exact I-M Plug Inserter
—
31-473678
Gibbs Hollow Chisel
—
21
Sirius Cemented Femoral Stem
Cement Accessories
Product
22
Part Number
Description
430900
Femoral Pressurizer II
Notes
23
References
1. Miller, J. and Johnson, J. Advances in Cementing Techniques in Total
Hip Arthroplasty in The Art of Total Hip Arthroplasty. Grune & Stratton
Inc, 1987.
2. Breusch S.J., Lavage Technique in Total Hip Arthroplasty: Jet Lavage
Produces Better Cement Penetration than Syringe Lavage in the
Proximal Femur. Journal of Arthroplasty. 15(7):921-7, 2000.
3. Christie, J. et al. Medullary Lavage during Cemented Hemiarthroplasty,
Journal of Bone and Joint Surgery [Br]. 77- B:456-9, 1995.
4. Reading A.D., et al. A Comparison of 2 Modern Femoral Cementing
Techniques: Analysis by Cement-bone Interface Pressure Measurements,
Computerized Image Analysis, and Static Mechanical Testing. Journal of
Arthroplasty. 15(4):479-87, 2000.
5. Breusch, S. Cementing Techniques in Total Hip Replacement: Factors
Influencing Survival of Femoral Components, In Bone cements and
Cementing Technique. ed by Walenkamp, G. and Murray, D. Springer
Verlag, 2001.
6. Duncan, W. et al. Revision of the Cemented Femoral Stem using a
Cement-in-Cement Technique: A Five to 15 Year Review. Journal of Bone
and Joint Surgery [Br]. 91-B(5): 577-82, 2009.
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This publication is intended for health care professionals and is not for
redistribution.
Biomet does not practice medicine and does not recommend any particular
orthopaedic implant or surgical technique and is not responsible for the kind of
treatment selected for a specific patient. The surgeon who performs any implant
procedure is responsible for determining and utilizing the appropriate techniques
for implanting prosthesis in each individual patient.
For complete product information regarding indications, contraindications,
precautions, warnings and sterilization, see the instructions for use packaged with
the device, and on which can also be located on www.biomet.com.
Please check for local product clearances and reference product specific
instructions for use.
Biomet Orthopedics
P.O. Box 587
56 E. Bell Drive
Warsaw, Indiana 46581-0587
USA
Note: The Legal Manufacturer
for the instruments and bone
cement listed in this operative
technique is shown on the
individual labels, packaging or
instrument set labels. Further
refer to the labeling or package
inserts of the instruments and
bone cement for reference
to the CE mark and Notified
Body Number.
©2014 Biomet Orthopedics • Form No. BMET0240.0 • REV0614
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