INDIVIDUALLY
CUSTOMIZED
Surgical procedure, Episealer® Knee Trochlea resurfacing implant
UNIQUE
Episealer® Knee Trochlea resurfacing implant
Each Episealer® Knee Trochlea implant is uniquely designed to fit each patient’s individual size and
location of cartilage damage.
Description of Episealer® Knee Trochlea
Episealer® Knee Trochlea is an implant consisting of both peg and hat in one piece. The implant is
made of Cobalt Chrome alloy with Titanium and Hydroxyapatite coated surfaces and a polished top
surface. The Episealer® Knee Trochlea is available in different circular sizes, whereas the topography and
thickness of the articular surface have a patient unique design.
It does not matter where in the trochlea the injury
is located since the Episealer® is a customized device
tailored to each patient’s individual anatomy.
The Episealer® Knee Trochlea is available in three diameter sizes; 20, 25 and 29 mm. The instruments
in the Tool kit used for guiding the implant placement are adapted to the implant size.
All individually unique parts are delivered sterile.
1
Episealer® Knee Trochlea implant placed in the knee trochlea groove
2
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
EPISEALER® KNEE TROCHLEA
Patient unique design
Cobalt Chrome
Titanium undercoating
Hydroxyapatite outer coating
Name
Article number
Diameter implant hat
Episealer® Knee Trochlea D20
31120
20 mm
Episealer® Knee Trochlea D25
31125
25 mm
Episealer® Knee Trochlea D29
31129
29 mm
3
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
INTENDED USE
Intended use Episealer® Knee Trochlea
The Episealer® Knee Trochlea is a resurfacing implant, intended to be used as a cartilage replacement for
knee trochlea cartilage defects, covering a part of the joint. It is intended to give the patient improved knee
function and relief of pain.
It is applicable:
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on the knee trochlea,
for different lesion sizes,
on lesions of degenerative or traumatic etiology.
Indications and Intended Patient Population
The device is intended for patients with a focal knee trochlea cartilage lesion, causing pain and/or disability.
The patient has a history of failed conservative treatments and has a lesion requiring surgical treatment.
The following should be considered in selection of the device as a treatment for localized cartilage lesions:
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need of pain relief and improved knee function,
patient’s condition motivate consideration of an early-aged total joint arthroplasty,
patella tracking is substantially normal,
tibiofemoral joint condition is substantially normal,
overall well-being of the patient including the ability or willingness to follow
instructions.
Contraindications
Absolute contraindications include:
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non-focal defects,
on-going infection in the tibiofemoral joint,
inflammatory arthritis or radiographic osteoarthritis,
patellofemoral instability or malalignment that is uncorrectable at the time of
treatment,
sensitivity to materials typically used in orthopedic prosthetics,
inadequate bone stock where the implant is to be inserted,
existing prosthesis in knee trochlea or patella,
severe lesion (ICRS 3-4) on opposing patellar surface.
Relative contraindications include:
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patella maltracking or instability,
pain of unknown etiology,
other diseases or medication that may affect the bone anchoring of the implant,
uncooperative patient that is not willing to follow instructions,
muscular insufficiency,
vascular insufficiency,
intern medical, hormonal, hematological, immunological and metabolic illnesses,
demineralized bone.
Possible adverse effects
General surgical complications:
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Implant treatments always involve certain risks such as local swelling, temporary soreness,
joint exudate, hematoma, thrombosis, inflammation, infection in the operation area and bleeding.
Complications related to anaesthetization.
Adverse effects related to the implant:
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early or late post-operative infection,
intra operative or postoperative bone fracture,
allergic reaction,
loosening, migration or loss of fixation of implant,
no pain alleviation,
incomplete range of motion,
wear and damage to the opposed articular cartilage surface or meniscus.
4
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
KNEE TROCHLEA TOOL KIT
The Episealer® Knee Trochlea implant is delivered together with the Knee Trochlea Tool kit.
Both the implant and the Tool kit are for single use only.
Name
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4.
5.
6.
7.
8.
9.
Available sizes
Pin clamp
Adjustment socket
Drilling socket
Epidrill
Epiguide
Epidummy
Epimandrel
Epicut
Episealer®
One size
Art.nr. ref
Art.nr. ref
Art.nr. ref
Art.nr. ref
Art.nr. ref
Art.nr. ref
Art.nr. ref
Art.nr. ref
size
size
size
size
size
size
size
size
20/25/29
20/25/29
20/25/29
20/25/29
20/25/29
20/25/29
20/25/29
20/25/29
Art.Nr.
33600
33420/33425/33429
33120/33125/33129
32120/32125/32129
33720/33725/33729
34120/34125/34129
37120/37125/37129
35220/35225/35229
31120/31125/31129
mm
mm
mm
mm
mm
mm
mm
mm
1.
2.
3.
4.
5.
6.
7.
8.
9.
5
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
SURGICAL PROCEDURE
1 - PLACING THE EPIGUIDE
Place the Epiguide on the articular surface by inserting it
under the joint capsule. See the markings A (anterior) and P
(posterior) at the Epiguide to find correct orientation and
find its unique position on the Knee Trochlea groove.
Often the lesion itself serves as the primary
positioning indicator.
Look through the circular opening of the Epiguide to make
sure it covers the lesion. Make sure the Epiguide is in
contact with the cartilage all the way around the
circular opening. This is important to achieve correct
drilling angle and depth.
If the circular opening of the Epiguide does
not cover the lesion, do not proceed with the
surgery.
2 - SECURING THE EPIGUIDE AND ASSEMBLING THE DRILLING SOCKET
Use three pins to attach and secure the Epiguide to the
bone. Use the drilling machine to insert the pins. After
inserting the first pin; check that the Epiguide hasn’t moved
out of its unique position. Then insert the remaining two
pins. Last mount the Pin clamps over the pins and push them
into contact with the Epiguide.
The Drilling socket guides the pre-cutting of cartilage and
the first drill step.
Mount the Drilling socket to the Epiguide. Check that
the Drilling socket has bottomed onto the Epiguide. Check
that the Drilling socket is set in its start position; the
arrow at the top of the Epiguide shall be in line with the
marking on the Drilling socket.
Make sure the Epiguide is securely fastened
to the bone.
Ensure that the Drilling socket is in a correct
position before drilling. Incorrect positions
may result in an incorrect drilled depth and
incorrect implant placement.
Start position
7
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
3 - PRE-CUTTING THE CARTILAGE
A sharp cartilage edge is imperative in order to get a precise
fit between cartilage and Episealer® implant. To get a sharp
cartilage edge the Epicut is used to pre-cut the cartilage
before drilling.
Insert the Epicut into the Drilling socket. Use one hand to
hold the Drilling socket steady in the Epiguide and use the
other hand to rotate the Epicut 1 - 2 turns clockwise pushing
it slightly downwards. Remove the Epicut.
Pay attention to cut through the cartilage down to the
bone.
4 - CREATING THE STEERING HOLE
To get a proper steering of the Epidrill the first step is to
pre-drill a small steering hole using the Epidrill.
Attach the Epidrill to the assigned drilling machine. Check
that the drilling machine is adjusted for drilling clockwise.
Insert the Epidrill into the Drilling socket. Use one hand to
hold the Drilling socket steady in the Epiguide and use the
other hand to handle the drilling machine.
Make sure the Drilling socket has bottomed and is
securely fastened into the Epiguide.
When the Epidrill is inserted into contact with the cartilage
surface, start drilling. Then drill until the drill stops at the
top of the Drilling socket.
Use moderate speed and keep the drilling machine steady
while applying only moderate force. Use vigorous lavage
through the openings at the Epiguide during drilling to minimize heat effects to adjacent bone and cartilage tissues and
to rinse away bone and tissue debris.
Make sure that the drill is not misaligned and that the
drill does not load the drill guide in any direction.
After pre-drilling
Before pre-drilling
8
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
5 - ASSEMBLING THE ADJUSTMENT SOCKET
Remove the Drilling socket and insert the Adjustment socket
into start position. Make sure that Adjustment socket is
inserted all the way to the bottom. It shall be in contact
with the Epiguide.
Check that the drilling machine is adjusted for drilling
clockwise. Insert the Epidrill into the Adjustment socket. Use
one hand to hold the Adjustment socket steady in the
Epiguide and use the other hand to handle the drilling
machine.
Make sure the Adjustment socket has bottomed and is
securely fastened into the Epiguide.
Ensure that the Adjustment socket is in a
correct position before drilling. Incorrect
positions may result in an incorrect drilled
depth and incorrect implant placement.
Start position
6 - DRILLING
Make sure that the tip of the Epidrill is inserted into the
pre-drilled hole but that the large drill body does not contact
the cartilage surface when the drilling procedure starts.
Drill until the Epidrill stops at the top of the Adjustment
socket.
Use moderate speed and keep the drilling machine
steady while applying only moderate force. Use vigorous
lavage through the openings in the Epiguide during drilling
to minimize heat effects to adjacent bone and cartilage
tissues and to rinse away bone and tissue debris.
Remove the Epidrill.
If the drilling gets harder during the drilling process
residues might be stuck in the drilling channels. Then
stop drilling, remove the Epidrill and cleanse the
Epidrill from residues. Handle the Epidrill with care
since it contains sharp edges.
Epidrill at start position
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Epidrill bottoming
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
7 - REMOVAL OF DEBRIS AND LOOSE CARTILAGE
Note the Adjustment socket position and then remove the Adjustment socket from the Epiguide. Use the flushing device
and suction device to cleanse the drilled hole.
Check that all residues are removed from the drilled hole.
Ensure that there are no fringes on the
cartilage edge after cutting the cartilage.
Fringes on the cartilage edge should be
removed using standard tweezers. If
residues of bone and/or cartilage are left
in the osteotomy, the implant may be
prevented from becoming osseointegrated
with the bone.
8 - EVALUATE THE DRILLED DEPTH
Insert the Epidummy into the drilled hole. Rotate the
Epidummy so that its rotation mark is aligned with the
rotation mark of the Epiguide, facing anterior direction.
Compare the depth of the Epidummy top surface with the
surrounding cartilage edge and note the height difference.
Use the openings in the Epiguide to evaluate the depth.
When the Epidummy top surface is positioned
approximately 1 mm below the adjacent articular
cartilage surface the drilling is finished, proceed to step 10,
if not continue to step 9.
The initial drilling, with the Adjustment socket in the start
position, will always result in a too shallow drill hole.
Ensure that the implant articular surface is
positioned approximately 1 mm below
the adjacent cartilage surface. If the implant
is placed protruding or too deep it may
damage surrounding and opposing soft
tissues.
Not deep enough
10
OK
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
9 - ADJUSTING DRILL DEPTH
If the Epidummy shows that the drilled hole has not reached
appropriate depth; Re-assemble the Adjustment socket in
the Epiguide. Adjust the drilling depth by turning the
Adjustment socket to desired position. The drilling depth is
increased by 0.2 mm in each step. Proceed and iterate step
6-8 until the Epidummy bottoms with its top surface approximately 1 mm below the surrounding cartilage.
It is recommended that the additional drilling should
be performed incrementally, increasing the drill
depth by small increments at a time.
Note the increase of drill depth. In case of removal of
the Adjustment socket it needs to be replaced at the
correct depth to avoid too deep drilling
unintentionally. One step is equal to an increase of
0.2mm.
Ensure that the Adjustment socket is in a
correct position before drilling. Incorrect
positions may result in an incorrect drilled
depth and incorrect implant placement.
Each step here adjusts depth 0.2 mm
10 - MARKING DIRECTION OF IMPLANT POSITION
The next step after a correct drill depth is achieved and
verified with the Epidummy in step 8, is preparation of the
implant insertion.
Use a sterile pen to mark the direction of rotation of the
Episealer® implant. Make the mark on the cartilage surface
aligning the rotation mark of the Epiguide. Make sure it is
aligned in the anterior direction.
Mark here
11
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
11 - PLACING THE IMPLANT
Remove the Epiguide. Gently place the Episealer® Knee
Trochlea implant into the drilled hole. Check that the
rotation mark on the Episealer® implant is aligned to the
rotation mark on the cartilage (see figure below). If the
rotation mark on the Episealer® implant is not correctly
aligned, use your hand to gently turn it into the correct
rotational direction.
Use your hand to gently press the implant down into the
drilled hole while keeping it in the correct rotational
direction.
Rotation mark
12 - DRIVING DOWN THE IMPLANT
Use the Epimandrel and a hammer to gently tap down the
Episealer® implant into bone until bottomed. The top
surface of the Episealer® implant shall be approximately 1
mm below the adjacent articular cartilage surface
(during insertion, carefully check that the rotational
alignment is not changed).
Make sure to gently tap the implant until bottomed.
This is indicated by a more distinct sound.
During insertion, carefully check that the
rotational alignment of the implant is not
changed.
Improper handling of the implants can cause
scratches, nicks or dents that may have
adverse clinical effects on opposing
joint surfaces.
12
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
RESULT
13
WARNINGS
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
EPISEALER
INTENDED USE
TOOL KIT
5 - ADJUSTMENT SOCKET | 6 - DRILLING
11 - PLACEMENT | 12 - DRIVING DOWN
1 - POSITIONING | 2 - SECURING
7 - DEBRIS | 8 - DRILLED DEPTH
RESULT
3 - PRE-CUTTING | 4 - STEERING HOLE
9 - DRILL DEPTH | 10 - MARKING
WARNINGS
WARNINGS
Warnings
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For insertion of the implant the surgeon is advised to contact Episurf Operations or
their local representatives for more information about the surgical technique. The
user instructions are not sufficient to enable usage of the Episurf products.
Expected results may not be accomplished if the Knee Trochlea Tool Kit which is
intended for guidance and control when inserting implant is not used.
Improper positioning and implantation of the implant may reduce the effective
lifetime of the implant.
The implant, Epiguide and Epidummy may not be re-sterilized.
The implant and Knee Trochlea Tool Kit may not be re-used.
Implants and instruments that have been damaged, mishandled or removed from
the sterile field shall not be used.
Epicut and Epidrill contain sharp edges and should be handled with care.
If implantation isn’t performed within 6 months from MR scan the physician shall
judge if the MR still is valid to ensure the customized fit.
Improper handling of the implants can cause scratches, nicks or dents that may have
adverse clinical effects on opposing joint surfaces.
Ensure that there are no fringes on the cartilage edge after cutting the cartilage.
Fringes on the cartilage edge should be removed using standard tweezers. If
residues of bone and/or cartilage are left in the osteotomy, the implant may be
prevented from becoming osseointegrated with the bone.
Ensure that the implant articular surface is positioned approximately 1 mm
below the adjacent cartilage surface. If the implant is placed proud or too deep it
may damage surrounding and opposing soft tissues.
If the circular opening of the Epiguide does not cover the lesion, do not proceed
with the surgery.
Do not proceed with surgery if the Epiguide is not securely fastened to the bone. A
loosely fastened Epiguide may cause improper implantation and incorrect implant
placement.
Ensure that the Drilling socket and Adjustment socket are in a correct position before
drilling. Incorrect positions may result in an incorrect drilled depth and incorrect
implant placement.
During insertion, carefully check that the rotational alignment of the implant is not
changed.
14
BECAUSE YOU ARE UNIQUE
INFORMATION
The Episealer® implant is also available for the following joints:
- Femoral Condyle
For more information, visit our website
www.episurf.com
Stora Skuggans Väg 11 | 115 42 Stockholm | [email protected]
1764-5MA003-01