06.01205.012 REV08 Allofit - Allofit S Cup System Surgical Technique

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Allofit®/Allofit®-S

Alloclassic®
Acetabular System
Surgical Technique
Table of Contents

Preoperative Planning............................................................................................... 2

Surgical Approach.....................................................................................................3

Acetabular Exposure...........................................................................................3

Acetabular Reaming............................................................................................3

Cleaning the Reamer Handle ...............................................................................4

Provisional Shell Insertion....................................................................................5

Final Implant Insertion - Allofit Shell Without Screw Holes....................................6

Final Implant Insertion - Allofit-S Shell With Screw Holes......................................7

Allofit-S Screw Fixation ........................................................................................9

Liner Insertion................................................................................................... 11

Changing the Shell Liner.................................................................................... 13


2 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 1

Preoperative Planning
X-ray templates are available for pre­ operative In cases of acetabular dysplasia, pre­operative planning
planning of an Allofit shell. Together with a current helps in deciding whether the implant bed must be
X-ray overview of the pelvis, these are a practical aid sup­ported by using bone grafts. The center of rotation
for planning the surgical procedure. should approximate phys­iological conditions as closely
as pos­sible.
The aim of preoperative planning is to help determine
the size, desired location and position of the acetabular The inclination of the shell should form an angle of 40°
shell and is an essential part of the surgical process. A – 45° to the pelvic horizontal line. A shell template of
load-bearing, stable acetabular floor and solid lateral appropriate size is placed between the acetabular root
bony tissue are desirable. An extensively preserved and teardrop (Figure 1), which serve as a reference
osseous circumfer­ ence of the acetabulum is a to determine the shell diameter. The shell should be
prerequisite for primary stability of the shell. placed in an anteversion of 10° – 15° interoperatively.
However, it should be kept in mind that the correct
shell orientation also depends on the femoral implant
position.
3 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 2a Figure 2b

Surgical Approach
The Allofit acetabular shell can be implanted using a Important: Reaming must be minimal to preserve
variety of surgical approaches. The specific approach bone stock and the morphology of the acetabulum.
depends on the surgeon’s preference and therefore
may differ from the procedure shown below. In case of flat acetabular cavity, start with reaming the
central acetabular floor with a relatively small reamer
Acetabular Exposure and then deepen according to the preoperative
A clean and clear exposure of the acetabulum is a planning (Figure 2a). In case of a normal acetabular
prerequisite for successful implantation. Introduce cavity, deepening is not required. Once the neces­
the reamers after excising the capsule in its entire sary depth has been reached, incline the reamer at
circumference and removing all fibrous, cartilaginous around 40° to the lon­gitudinal axis of the body and
and bony structures. form a hemispherical implant bed using the next
largest reamer (Figure 2b). Maintain the reamer
Acetabular Reaming towards cranial direction until:
Ream the acetabulum, starting with a small reamer size 1. Reaching necessary depth and
and gradually progress to larger size until reaching the
preoperatively planned final size. The aim is to create 2. Reaming 50 to 60% of the acetabular roof to
an anatomically shaped acetabular implant bed so that vascularized bone
the cup is gripped by bone on all sides and anchored in
well-vascularized bone.
4 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 3a Figure 3b

Acetabular Reaming (cont.) Cleaning the Reamer Handle


The anterior and posterior acetabular roof must remain To clean the reamer handle, remove the white tissue
stable and solid. protector from the reamer handle. Then push the
locking sleeve up and turn it to the right (Figure 3a).
The reaming process is completed when these
conditions are met. Next, pull the coupling apart (Figure 3b). After cleaning,
reassemble the locking sleeve in reverse order.
Perform final reaming manually to obtain an implant
bed being as symmetrical as possible and to avoid
thermal necrosis. Insert the reamer to a depth where
its equator is entirely covered by bone. This does not
apply to dysplastic acetabulum, for which an additional
im­plant bed must be created.
5 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Anterior

Cranial Caudal

Posterior

Figure 4

Provisional Shell Insertion


Insert the provisional shell (Figure 4) with a 40°–45° Note: To protect the acetabulum, the provisional
inclination and 10°–15° anteversion. Confirm stability shell is slightly larger (1 mm) than the reamer of the
under pulling, tilting and rotating loads. Unscrew nominal size due to its lack of surface structure. The
the shell inserter from the provisional shell and definitive implant is 2 mm larger, and will therefore
check contact between the acetabular floor and the fit even more tightly.
provisional shell with the control hook.
If there is an “onlay effect” despite this, perform
If the provisional shell does not have a sufficient fixation an additional primary anchoring with at least two
base, proceed to further deepening of the acetabulum cancellous bone screws.
and check stability again. If the provisional shell is not
seated firmly enough even with sufficient osseous The provisional shell can be removed by tipping out.
enclosure, choose the next largest provisional implant.
6 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 6

Figure 7a

Figure 5 Figure 7

Final Implant Insertion Allofit Shell


Without Screw Holes
Important: The nominal size of the definitive shell Use the control hook to confirm proper seating of the
must match the last ream­er used; the excess of shell on the acetabular floor and check stability under
2 mm has been taken into account. Oversizing and pulling, rotating and tipping loads.
selection of a larger implant than prereamed is only
advisable for soft bone, as the risk of pelvic fracture If a trial reduction with the provisional liner is needed,
would be increased. it is possible to seat the provisional liner into the
shell with a fixation screw using the pole plug setting
Connect the inserter to the final implant and seat the instrument (Figure 6).
shell into the acetabulum with a 40 – 45° inclination
Connect the pole plug to the pole plug setting
and 10 – 15° anterversion (Figure 5).
instrument, making sure to align the slot of plug
Any soft tissue which remains between the bone and with the line mark on the tip of the pole plug setting
the implant must be resected. instrument (Figure 7a). Screw the pole plug into the
shell dome hole.
It is absolutely essential to align the shell before
tapping in and maintain the selected setting direction. In addition to tapping the dome hole, the plug also
helps centering the liner into the shell.
7 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 8

Final Implant Insertion Allofit-S Shell


With Screw Holes
Important: The nominal size of the definitive shell
must match the last reamer used; the excess of
2 mm has been taken into account. Oversizing
and selection of a larger implant than prereamed is
only advisable for soft bone, as the risk of a pelvic
fracture would be increased.

Connect the inserter to the final implant and seat the


shell into the acetabulum with a 40 – 45° inclination
and 10 – 15° anterversion (Figure 8).
8 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 10a

Figure 9 Figure 10

Final Implant Insertion Allofit-S Shell


With Screw Holes (cont.)
Any soft tissue which remains between the bone and Use the control hook to confirm proper seating of the
the implant must be resected. It is absolutely essential to shell on the acetabular floor.
align the shell correctly before tapping in, as its position
cannot be changed after tapping in. If a trial reduction with the provisional liner is needed,
it is possible to seat the provisional liner into the
The Allofit-S shell has an orientation groove at shell with a fixation screw using the pole plug setting
the equator of the shell indicating the position of instrument (Figure 9).
the screw holes in the shell. The holes must be
placed correctly in the direction of the load transfer. Connect the pole plug to the pole plug setting
A deviating orientation may not be biomechanically instrument, making sure to align the slot of plug
suitable and could lead to vascular and nerve lesions with the line mark on the tip of the pole plug setting
caused by the screws. instrument (Figure 10a). Screw the pole plug into the
shell dome hole (Figure 10).

In addition to tapping the dome hole, the plug also


helps centering the liner into the shell.
9 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 11 Figure 12

Allofit-S Screw Fixation


Drill 3.2 mm holes into the subchondral bone to
simplify initial insertion of the self-tapping cancellous
bone screws (Figure 11). This step is recommended
in cases of sclerotic bone, to break through the hard
osseous parts.

Since screws are only to be anchored in cancellous


bone, lengths of up to 30 mm are normally sufficient.
The screws should not penetrate the opposite cortex.

The geometry of the screw holes allows the screws in


all cup sizes to be orientated within a range of around
10° in all directions (Figure 12).
10 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 13

Allofit-S Screw Fixation (cont.)


The screws must be screwed-in fully as projecting
screw heads would prevent proper seating of the liner.
Unused screw holes in the titanium shell can be capped
(not mandatory) with a screw hole plug (Figure 13)
using the appropriate setting instrument and a light
tap. The screw hole plugs are intended for single use
only.

Note: Zimmer 6.5 mm countersunk screws must


be used in combination with the Allofit-S acetabular
shell.

Note: The specified Ti-6AI-4V screws have a lower


shearing resistance than screws made of steel or
CoCrMo alloys.
11 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 14 Figure 15

Liner Insertion
Once final cup implantation and trial reduction are The size of the liner is indicated by a letter code, which
complete, decide between a neutral or hooded liner. matches the size on the corresponding titanium shell.
Remove the provisional liner and cover the apical hole
of the shell with a pole plug (see page 8). Clean and dry the inner surface of the shell, connect the
liner to the setting instrument, position the liner over
The pole plug allows appropriate fitting with the the entrance plane of the shell and rotate clockwise. The
polyethylene liner peg. peg of the polyethylene liner must be inserted into the
pole plug hole (Figures 14 and 15). Complete seating of
Bone or soft tissue remnants must not overlap the
the liner with a light hammer blow.
edge of the titanium shell as they may prevent the
insert from snapping into position. The shell edge
must be free from any tissue and particular attention
must be paid to the posterior inferior bony edge of the
acetabulum.
12 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 16 Figure 17

Liner Insertion (cont.)


If the liner can still be rotated after light impaction, If the insert has snapped into place correctly, the edge
this indicates mispositionning, nonconcentric, or soft is protruding around 1.5 mm over the equator of the
tissues interference between the liner and the shell titanium shell (Figure 17).
surfaces.
Note: If unsure, the seating can be checked using a
In such situation, remove the liner, clean both surfaces raspatory. If the fitting of the insert is faulty, a new
and introduce the liner back into the shell, making insert must be used. If the polar peg is deformed,
sure it is properly centered and repeat the seating it will not be possible to anchor the insert correctly.
procedure.

Once the liner remains steady after light hammer


blows, finalize seating with final impaction
(Figure 16).

Where necessary, a tap plastic impactor provides


confirmation that the connection is reliable.
13 | Allofit/Allofit-S Alloclassic Acetabular System Surgical Technique

Figure 18

Changing the Shell Liner


Should the removal of a firmly seated liner be needed,
start drilling a small pilot drill hole at the center of the
polyethylene rim, and insert a cancellous bone screw
(Figure 18).

Another approach is to lever out the liner with an


osteotome.

If the goal is to seat another liner into the same shell,


make sure to protect the inner surface of the shell. Any
minor damage to the shell surface may prevent the
new liner from a proper seating. In such situation the
shell must be removed and replaced.
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intellectual property rights, as applicable, owned by or licensed to
Zimmer Biomet or its affiliates unless otherwise indicated, and must not
be redistributed, duplicated or disclosed, in whole or in part, without the
express written consent of Zimmer Biomet.
This material is intended for health care professionals. Distribution to any
other recipient is prohibited.
For indications, contraindications, warnings, precautions, potential
adverse effects and patient counselling information, see the package
insert or contact your local representative; visit www.zimmerbiomet.com
for additional product information.
Document not for distribution in France.
Check for country product clearances and reference product specific
instructions for use.
Zimmer Biomet does not practice medicine. This technique was
developed in conjunction with health care professionals. This document
is intended for surgeons and is not intended for laypersons.
Each surgeon should exercise his or her own independent judgment in
the diagnosis and treatment of an individual patient, and this information
does not purport to replace the comprehensive training surgeons have
received. As with all surgical procedures, the technique used in each case
will depend on the surgeon’s medical judgment as the best treatment
for each patient. Results will vary based on health, weight, activity and
other variables. Not all patients are candidates for this product and/or
procedure. Caution: Federal (USA) law restricts this device to sale by or
on the order of a surgeon. Rx only.
©2019 Zimmer Biomet.
For ordering information please refer to document N° 0754

Legal Manufacturer
Biomet Orthopedics
P.O. Box 587
56 E. Bell Drive
Warsaw, Indiana 46581-0587
USA

Legal Manufacturer
Zimmer GmbH
Product with this system are
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8404 Winterthur, Switzerland under the design control 2797
of various manufacturers.
Telephone +41/ (0)52 262 60 70
Refer to the product labeling CE mark on a surgical technique
Fax +41/ (0)52 262 01 39
of each device for the legal is not valid unless there is a CE
06.01205.012-REV08-0819 www.zimmerbiomet.com manufacturer. mark on the product label.

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