Exeter x3 Rimfit Surgical Technique

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Exeter X3 RimFit Acetabular Cup

Table of Contents Indications


Indications and Contraindications.................................. IFC The indications for use for total hip arthroplasty include:
Introduction.......................................................................... 1 • Painful, disabling joint disease of the hip resulting from:
degenerative arthritis, rheumatoid arthritis, post-traumatic
Surgical Protocol
arthritis or late stage avascular necrosis.
Step 1 – Pre-Operative Planning...................................... 2
• Revision of previous unsuccessful femoral head
Step 2 – Acetabular Preparation...................................... 3 replacement, cup arthroplasty or other procedure.
Step 3 – Socket Preparation.............................................. 4 • Clinical management problems where arthrodesis or
Step 4 – Trialing................................................................ 5 alternative reconstructive techniques are less likely to
Step 5 – Cement Fixation Bone Preparation................... 6 achieve satisfactory results.
Step 6 – Cement Introduction.......................................... 7 • Where bone stock is of poor quality or inadequate for other
Step 7 – Cup Implantation............................................... 8 reconstructive techniques, such as cementless fixation, as
indicated by deficiencies of the acetabulum.
Step 8 – Final Step............................................................. 9
The Exeter X3 RimFit Acetabular cup is intended for
Catalog Information
Cemented use only.
Instrument Listing.......................................................... 10
Implant Listing................................................................ 12
Contraindications
• Any active or suspected latent infection in or about the hip
joint.
• Any mental or neuromuscular disorder which would create
an unacceptable risk of prosthesis instability, prosthesis
fixation failure, or complications in postoperative care.
• Bone stock compromised by disease, infection or prior
implantation which cannot provide adequate support and/
or fixation to the cement mantle around the prosthesis.
• Skeletal immaturity.
• Obesity. An overweight or obese patient can produce loads
on the prosthesis which can lead to failure of the fixation of
the device or to failure of the device itself.

Warnings and Precautions


See implant package insert for warnings, precautions, adverse
effects and other essential product information.
Before using instrumentation, verify:
• Instruments have been properly disassembled prior to
cleaning and sterilization
• Instruments have been properly assembled post sterilization
• Instruments have maintained design integrity
• Proper size configuration is available

This publication sets forth detailed recommended procedures for using Stryker Orthopaedics devices and instruments. It offers guidance 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.
INTRODUCTION
This surgical protocol is a guide to preparing the
acetabulum for the Exeter X3 RimFit cup utilizing Exeter
Contemporary instrumentation.
The Exeter X3 RimFit cup is a highly cross-linked poly­
ethylene cemented cup with 4 PMMA cement spacers
and a mini flange design, with X-ray wire to help easily
identify the cup position on an X-ray. Exeter X3 RimFit
cups are available with an ID 22.2 – 40mm and an OD
40 – 60mm.
For sizing purposes the final Exeter X3 RimFit cup used is
to be 2mm smaller than the final reamer.
The chart below shows the sizes and the polyethylene
thickness for the Exeter X3 RimFit cup. All Exeter X3
RimFit cups are neutral. All cup sizes (OD) include the
cement spacers.

Catalog ID OD* Cement Spacer Nominal Polyethylene


Number (mm) (mm) Size (mm) Thickness** (mm)
6309-2-240 22.2 40 2 6.8
6309-2-242 22.2 42 2 7.8
6309-2-244 22.2 44 2 8.8
6309-2-844 28 44 2 5.9
6309-2-846 28 46 2 6.9
6309-2-848 28 48 3 6.9
6309-2-850 28 50 3 7.9
6309-2-852 28 52 3 8.9
6309-2-854 28 54 3 9.9
6309-2-856 28 56 3 10.9
6309-2-858 28 58 3 11.9
6309-2-860 28 60 3 12.9
6309-3-248 32 48 2 5.9
6309-3-250 32 50 2 6.9
6309-3-252 32 52 3 6.9
6309-3-254 32 54 3 7.9
6309-3-256 32 56 3 8.9
6309-3-258 32 58 3 9.9
6309-3-260 32 60 3 10.9
6309-3-652 36 52 2 5.9
6309-3-654 36 54 2 6.9
6309-3-656 36 56 3 6.9
6309-3-658 36 58 3 7.9
6309-3-660 36 60 3 8.9
6309-4-056 40 56 2 5.9
6309-4-058 40 58 2 6.9 * OD = Diameter at the top of the cement spacers
6309-4-060 40 60 3 6.9 ** Thickness between dome diameter and inner diameter

1
STEP 1
PRE-OPERATIVE PLANNING AND X-RAY EVALUATION

Pre-operative templating and X-ray evaluation using


X-rays that have been suitably scaled for magnification
allows the surgeon to predict the optimal size of implant
for the patient’s anatomy and hip pathology.
Check all instruments and implants for any damage or
defects before beginning the procedure.

Surgical Templates
Scale 1 – 6309-4-100
Scale 1.2 – 6309-4-120

2 EXETER X3 RIMFIT ACETABULAR CUP SURGICAL TECHNIQUE


STEP 2
ACETABULAR PREPARATION

The acetabulum is prepared by the release and removal of


soft tissue using the surgeon’s preferred technique to gain
adequate exposure for reaming. Excision of the labrum
and osteophytes allows for proper visualization of the
bony anatomy, and improves ease of reaming (Figure 1).

NOTE

Careful identification and removal of osteophytes


can help reduce the possibility of bone-to-bone or
component-to-bone impingement.

With the acetabulum exposed, bony defects can be


identified. If necessary, bone grafting options may be
considered prior to reaming.

Figure 1

EXETER DESIGNER SURGEON


GROUP
“For potentially improved exposure, a knife can be
introduced between the labrum and capsule to release
the reflected head of rectus femoris and the illio­
femoral ligament from the wing of the ilium” (Figure 2).

Figure 2

3
STEP 3
SOCKET PREPARATION

A. Spherical Reaming
To obtain optimal component positioning in the
reaming process the reamer handle should normally be
at approximately 45º of abduction and 25º of anteversion
(Figure 3).
Medial wall osteophyte should be removed prior to
concentric reaming. The aim is for the inferior edge of
the cup to be positioned at the level of the transverse
ligament.
It is recommended that the initial reaming begin with a
Reamer that is 4mm smaller than the templated or gauged
size. Continue to ream up in 2mm increments (Figure 4). Figure 3

B. Final Reaming
The full profile of the Stryker Spherical Reamer
necessitates reaming to the full depth.
Care should be taken so as not to enlarge or distort the
acetabulum by eccentric reaming. After final reaming to
the correct depth all cartilage will have been removed and
the subchondral bone may have been breached leaving
cancellous bone which is an ideal surface for cement
application. When the subchondral bone remains intact
multiple holes should be drilled through this to allow
cement interdigitation.
Particular attention is paid to clear the rim of the
acetabulum of cartilage and soft tissue and expose
trabecular bone by drilling, since it is important to achieve
interdigitation of cement with bone in this area.
Figure 4

EXETER DESIGNER SURGEON


GROUP
“After final reaming, it is useful to leave the final
reamer in the socket in the correct orientation.
The edge acts as a guide for the removal of excess
osteophytes with an osteotome” (Figure 5).

Figure 5

Contemporary Retractor
Instrument Tray Aspirator
6304-4-080 6781-8-560

4 EXETER X3 RIMFIT ACETABULAR CUP SURGICAL TECHNIQUE


STEP 4
TRIALING

Following the reaming procedure, the appropriate cup


trial of the same diameter as the final implant size is
inserted into the reamed cavity. The appropriate diameter
of cup to be inserted is normally a size 2mm less than Posterior Wall
Blowhole
the diameter of the last reamer used. The trial is used to
assess fit, contact, and congruency of the trial with the
O.D.
acetabulum. Hole for Cup Reference
Introducer Line
After choosing the appropriate size acetabular
component, the cup is mounted on the cup introducer.
The flange is trimmed appropriately so that the rim of
the flange lies just within the mouth of the acetabulum.
Specific trimming scissors are available to cut out the
flange. The flange has a line marked. This line corresponds
to the diameter of the cup at the top of the cement spacers Chamfer Inner Surface
(I.D.)
and surgeons may cut up to this line if necessary (Figure
8). A further rehearsal is made to ensure that the cup can
be introduced through the soft tissues into the desired Figure 8
position without difficulty.

Exeter X3 Trimmer
RimFit Trials Scissors
6304-7-XXX 6304-4-140

5
STEP 5
CEMENT FIXATION BONE PREPARATION

After completion of reaming, multiple fixation holes


should be made in the trabecular bone or through the
subchondral plate using the acetabular step drill. Smaller
holes are made around the rim of the acetabulum using
the distal end of the step drill (Figure 9). Care should be
taken not to perforate the inner table of the acetabulum.
The wall is thinnest medially and anteriorly. If the cortex
is breached, then bone graft should be used to fill the hole.
Thorough lavage of the socket is carried out to clean the
interstices of the trabecular bone of bone debris, marrow
and fat (Figure 10). Fluid is sucked out of the wing of the
ilium by the sucker aspirator (Figure 11).
When the bone is clean, dry gauze swabs are packed into
the acetabulum to further clean the bone and promote
hemostasis. Figure 9

EXETER DESIGNER SURGEON


GROUP
“At this stage bone graft reamings may be compacted
onto the transverse ligament (to prevent cement
egress through the acetabular notch) and against
the smooth cortical medial wall since the cement
cannot adequately gain fixation against this surface.
The bone graft is covered by a folded small swab
and compressed during lavage of the acetabulum to
prevent it from being washed out of the acetabulum.”

Figure 10

Figure 11

Contemporary Acetabular
Instrument Tray (2 Level) Step Drill
6304-4-090 6781-8-750

6 EXETER X3 RIMFIT ACETABULAR CUP SURGICAL TECHNIQUE


STEP 6
CEMENT INTRODUCTION

Cement mixing is commenced during the final bony


preparation of the acetabulum. The cement may be
handled approximately 3.5 minutes after commencement
of mixing (Simplex cement at 20° C.). After introduction
of the cement bolus, excess material is removed so the
surface of the cement lies with a slightly concave surface
within the mouth of the acetabulum. This step prevents
escape of surplus cement into the soft tissues when the
acetabular pressurizer is used.
Pressurization of the cement is carried out using a
disposable acetabular pressurizer on a handle (Figure 12).
Three diameters are available so that an adequate
seal can always be established at the socket rim. The
pressurizing technique entails applying significant force
onto the device to drive the cement into the bone and, by Figure 12
maintaining pressure, protect the bone cement interface
from backbleeding from the host bone. The pressurizer
is applied as soon as the cement has been placed in the
acetabulum and full pressure is maintained until the
cement viscosity has risen to a level suitable for cup
insertion (Figure 13), usually about 5 minutes after the
commencement of mixing. In the elderly, or where a large
surface area of open trabecular bone has been exposed,
a significant volume of cement is pressurized into the
acetabulum and a further bolus is required on top of
the initial cement. This will become apparent when the
pressurizer is removed. If more cement is to be used, then
the existing cement should be clean and dry before it is
applied.

Figure 13

Acetabular Cement Acetabular


Pressurizer Handle Cement Seal
Straight-0935-0-001 0935-0-0XX
Curved-0935-0-002

7
STEP 7
CUP IMPLANTATION

Care should be taken to ensure the cup orientation is


appropriately maintained and that the final position of
the flange is at the pre-rehearsed position just within
the mouth of the acetabulum. (Figure 14). The flanged
cup is inserted using the Lateral Cup Introducer (Figure
15) and an axial Cup Pusher with head diameter
corresponding to the cup ID is used to drive the cup into
a stable seated position. Insertion is complete after the
flange is positioned in the pre-rehearsed position just
within the acetabular rim and it becomes impossible to
advance the cup further into the viscous cement
(Figure 16).
Figure 14

NOTE

Cup has to be assembled on the appropriate size of


lateral cup introducer:
• For cups I.D. 36/40mm, use cup introducer
identified as I.D. 36/40
• For cups O.D. 40/42mm, use cup introducer
identified as O.D. 40/42
• For all other cups, use the standard cup introducer

NOTE
Figure 15
The posterior wall of the cup has to be placed on
the side of the cup introducer plate with the identifi­
cation corresponding to the side of the operated hip
(« POST RIGHT » or « POST LEFT ») (Figure17).

Figure 16

Posterior Wall

Post Right

Figure 17

Contemporary Lateral Cup Cup Pusher


Instrument Tray (2 Level) Introducer Straight – 6304-4-110
6304-4-090 6304-4-022 Curved – 6304-4-120

8 EXETER X3 RIMFIT ACETABULAR CUP SURGICAL TECHNIQUE


STEP 8
FINAL STEP

Clear any excess cement with a small curette (Figure 18).


The post-operative radiograph should show good cement
penetration and no radiolucent lines in any zone. The
X-ray wire will allow the surgeon to see the correct
position of the cup (Figure 19).

Figure 18

Figure 19

9
INSTRUMENT AND
IMPLANTS LISTING

Implant & Instrument Listing


ID OD Exeter X3 Trial
(mm) (mm) RimFit Cups Cups
22.2 40* 6309-2-240 6304-7-240
22.2 42* 6309-2-242 6304-7-242
22.2 44* 6309-2-244 6304-7-244
28 44* 6309-2-844 6304-7-844
28 46* 6309-2-846 6304-7-846
28 48 6309-2-848 6304-7-848
28 50 6309-2-850 6304-7-850
28 52 6309-2-852 6304-7-852
28 54 6309-2-854 6304-7-854
28 56 6309-2-856 6304-7-856
28 58 6309-2-858 6304-7-858
28 60 6309-2-860 6304-7-860
32 48* 6309-3-248 6304-7-348
32 50* 6309-3-250 6304-7-350
32 52 6309-3-252 6304-7-352
32 54 6309-3-254 6304-7-354
32 56 6309-3-256 6304-7-356
32 58 6309-3-258 6304-7-358
32 60 6309-3-260 6304-7-360
36 52* 6309-3-652 6304-7-952
36 54* 6309-3-654 6304-7-954
36 56 6309-3-656 6304-7-956
36 58 6309-3-658 6304-7-958
36 60 6309-3-660 6304-7-960
40 56* 6309-4-056 6304-7-456
40 58* 6309-4-058 6304-7-458
40 60 6309-4-060 6304-7-460

* These cups have 2mm high cement spacers. All other cups have 3mm
high cement spacers. 1

Retractor Aspirator 1
6781-8-560 1
Contemporary Instrument Tray 1
6304-4-080

Contemporary Instrument Tray (2 level) 1


6304-4-090

Surgical Templates (5 pack)


Scale 1 6309-4-100
Scale 1.2 6309-4-120

10 EXETER X3 RIMFIT ACETABULAR CUP SURGICAL TECHNIQUE


INSTRUMENT LISTING

Acetabular Step Drill


Ø 9mm 6781-8-750

Trimming Scissors
6304-4-140

Lateral Cup Introducer


For cup O.D. 40/42 6304-4-022
For cup I.D. 36/40 6304-4-024
For other cups 6304-4-060

Cup Pusher Straight


6304-4-110

Cup Pusher Curved


6304-4-120

Heads for Cup Pusher


Ø 22.2mm 6304-4-122
Ø 28mm 6304-4-128
Ø 32mm 6304-4-132
Ø 36mm 6304-4-136
Ø 40mm 6304-4-240

Straight Handle (for acetabular cement pressurization)


0935-0-001

Curved Handle (for acetabular cement pressurization)


0935-0-002

Acetabular Cement Seal (5 pack)


Ø 54mm 0935-0-054
Ø 60mm 0935-0-060
Ø 66mm 0935-0-066

11
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to 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. A surgeon must
always refer to the package insert, product label and/or instructions for use before using any Stryker product.
The products depicted are CE marked according to the Medical Device Directive 93/42/EEC. Products may
not be available in all markets because product availability is subject to the regulatory and/or medical practices
in individual markets. Please contact your Stryker representative if you have questions about the availability of
Stryker products in your area.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the
following trademarks or service marks: Exeter, RimFit, Simplex, Stryker, X3. All other trademarks are
trademarks of their respective owners or holders.
EXETER-SP-3 Rev. 1 Copyright © 2015 Stryker

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