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From the «BioBall® Company»
OsteoBridge® IKAIntramedullary Knee Arthrodesis Fixation System
OsteoBridge® Family
The modular system for the fixation of the knee joint
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OsteoBridge® IKA
01. OsteoBridge® IKA
Failed total knee arthroplasty
Limb salvage
Oncology surgery
Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treat-ment of choice
Indications include:
The OsteoBridge® IKA serves as a custom implant to fixate the knee after failed primary
knee arthroplasty. Based on the OsteoBridge® IDSF system, the OsteoBridge® IKA modu-
lar segments are designed to be attached together to form a complete fixed knee implant
using specially designed semicircular attachement shells that are clamped together to
create a firm bridge at the joint.
All components are manufactured from Ti-6Al-4V Titanium Alloy conforming to ASTM
F-136. The intramedullary rods can be fixed with interlocking screws without or with bone
cement.
Nail without Collar
Angled Spacer
Clamping Screws
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OsteoBridge® IKA
Merete Medical Inc. · 49 Purchase Street · Rye, New York 10580 · USA · Phone: (914)9671532 · Fax: (914)9671542 · Mail: [email protected] · www.merete-medical.com
Advantages and System Structure
Interlocking Screws
Clamping Screws
Nail with Collar
Cementless and cemented implantation possible
Primary stability is achieved by pressfit
Distal interlocking screws provide rotational stability
Secondary stability is achieved with biological integration of the stems into the bone structure (osseointegration) stimulated by a brushed titanium surface
By rotating the angled spacer, the surgeon may adjust both the extension/flexion and valgus/varus positioning of the joint
Trial nails and a trial spacer for an intraoperative selection of implant components
Hollow spacer shells can be used as a carrier of antibiotics as well as bone graft
The custom modularity of the system enables intraoperative adaption to the bone defect by using variable nail diameters and lengths
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OsteoBridge® IKA
02. Case Studies
preoperative
postoperative
• Axial knee replacement after meniscal resection with infection
• Fall resulting in patellectomy with arthrolysis
• Arthrodesis with chronic pain syndrome using OsteoBridge® IKA
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OsteoBridge® IKA
Merete Medical Inc. · 49 Purchase Street · Rye, New York 10580 · USA · Phone: (914)9671532 · Fax: (914)9671542 · Mail: [email protected] · www.merete-medical.com
preoperative postoperative
Condition after failed TKR with infectionTemporary prosthesis
••
Treatment with OsteoBridge® IKA•
preoperative postoperative
Merete Medical GmbH likes to thank Dr. med. I. Flesch, Berufsgenossenschaftliche Unfallklinik Tübingen, Germany; Prof. Dr. med. L. Rabenseifner, Stadt-klinik Baden-Baden, Germany and Prof. Dr. med. A. H. Tiemann, Bergmannstrost Berufsgenossenschaftliche Kliniken Halle, Germany for the kind supply of the x-ray images.
• Condition after infection
• Temporary prosthesis using a carbon fiber rod
• Treatment with OsteoBridge® IKA
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OsteoBridge® IKA
Prepare the intramedullary canal by opening it with
the manual awl or by drilling with flexible or rigid
reamers (not included) to the desired diameter.
The diameter varies depending on nail form and
the principle of anchoring.
Most often after failed TKA the defect is trumpet
shaped. In this case the nail with collar fits per-
fectly into the bone. The reamer (GA90021) can
be used to shape the bone. The line on the reamer
indicates the correct depth.
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Preparation of the Intramedullary Canal and Implant Selection
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04. OsteoBridge® IKA Surgical Technique
Nail without Collar
Nail ØReamer Size
CementedReamer SizeCementless
Ø 14 mm 16 mm 12 mm
Ø 16 mm 18 mm 14 mm
Ø 18 mm 20 mm 16 mm
Nail ØReamer Size
CementedReamer SizeCementless
Ø 10 mm 14 mm 10 mm
Ø 12 mm 16 mm 12 mm
Ø 14 mm 18 mm 14 mm
Ø 16 mm 20 mm 16 mm
Nail with Collar
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OsteoBridge® IKA
Merete Medical Inc. · 49 Purchase Street · Rye, New York 10580 · USA · Phone: (914)9671532 · Fax: (914)9671542 · Mail: [email protected] · www.merete-medical.com
Under fluoroscopy use the trial nails to check the
adequate length and diameter. Different nails can be used for tibia and femur. For checking the total
length, the trial spacer has to be assembled. The
upper spacer half-shell is guided by two pins and fastened by two screws. Remove the trial compo-
nents when the leg length is accurate.
The leg should be shortened to facilitate walking.
3
Check the position of the nails inside the spacer.
The nails have to be flush with the window in the
upper half-shell.
For a better recognition of the trial components
and implants, the trial nails are labeled with dia-
grams of dice indicating the diameter of the nail.
The diagram with the corresponding number of the
dice can also be found on the product label.
To remove the trial nails use the extractor and slot-
ted hammer. Insert the extractor into the proximal
thread of the nail.5
4
6
Ø 10 mm Ø 18 mmØ 12 mm Ø 14 mm Ø 16 mm
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OsteoBridge® IKA
Insertion of the Nails
When using interlocking screws the drill holes in
the nail have to be positioned in the frontal plane,
for medial insertion of the screws. To insert the nail
correctly into the bone, the nail guiding/impacting
instrument has to be fitted into the slot and the
locking screw screwed down until the nail is tigh-
tened to the nail guiding/impacting instrument.
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1
20 mm
Attention: Clamping length of 20 mm minimumIf the surgeon prefers to not use interlocking
screws, the nails may be inserted and pressfit into
the bone with the impactor. At least 20 mm clam-
ping range has to remain outside the bone.
For cemented indications, cover sleeves must be
placed over the nails before starting to insert the
nail. The sleeves are removed once the insertion of
the nails has been completed. The diameter of the intramedullary canal should be 4 mm larger than for cementless insertion (refer to the table on page
6). If the nail guiding/impacting instrument is not
used, the covers GA90002 must be used when ce-
menting the nails.
2Locking Non-locking
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OsteoBridge® IKA
Merete Medical Inc. · 49 Purchase Street · Rye, New York 10580 · USA · Phone: (914)9671532 · Fax: (914)9671542 · Mail: [email protected] · www.merete-medical.com
Use the Ø 4.5 mm drill bit to drill the interlocking
hole. Then remove the drill sleeve. The depth gauge must be positioned to the bone through
the protection sleeve. Push the small depth gauge
measuring hook through the bone and hook the
opposite cortical bone. Now the required length
of the interlocking screw can be determined at the
end of the depth gauge. Always measure up to the
next available screw size.
5
Insert the interlocking screw through the pro-
tection sleeve and tighten with the Merete
screwdriver. All nails are provided with two drill
holes for double interlocking. After inserting
the screws remove the nail guiding/impacting
instrument. Do not start locking the second nail
until the first nail has been completely locked into
position.
Additional Information: To achieve dynamic com-
pression of the nail postoperatively, the surgeon
may remove the static interlocking screw after
a few weeks. Please contact Merete for surgical
guidance when the indication requires dynamic
screw compression postoperatively.
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Dynamic interlocking
Static interlocking
Interlocking the nails: The length of the nail and
corresponding drill hole alignment is indicated on
the side of the nail guiding/impacting instrument.
The protection sleeve must be inserted into the
corresponding drill hole of the guiding/impacting
instrument, indicating the same length as the nail.
The trocar peak center-punches a percutaneous
drill hole. The trocar is removed and the drill sleeve
inserted.
4
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OsteoBridge® IKA
Position the lower half-shell carefully underneath
the nails. Distract the leg to allow enough space to
insert and position the spacer. A minimal clamping length of 20 mm must be maintained! The colored
area must be entirely positioned inside the spacer.
4 guiding pins are then inserted into the four out-
side holes. Guided by the pins the upper half-shell
can correctly be adjusted onto the lower half-shell.
Support the knee bend to facilitate the correct po-sitioning of the spacer.
Between the spacer and each collared nail a dis-
tance holder is inserted. The distance holder de-
fines the minimal distance needed for secure im-
plantation. The dot on the distance holder must face the end of the nail, away from the spacer. Clamping screws must be screwed into the four
vacant threaded holes, but not entirely tightened.
The half-shells must always have the same dis-tance to each other on both sides.
1
2
Inserting and Fastening the Spacer
20 mm
Dot
Parallel alignment
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OsteoBridge® IKA
Merete Medical Inc. · 49 Purchase Street · Rye, New York 10580 · USA · Phone: (914)9671532 · Fax: (914)9671542 · Mail: [email protected] · www.merete-medical.com
Replace the guiding pins with four more clam-
ping screws that are tightened down slightly. Next
tighten the screws firmly with the torque limiting
screwdriver. The torque limiting screwdriver con-
sists of two pieces that must be assembled before
use (picture A).
IMPORTANT! Follow the steps to tighten correctly! Follow the instructions for the connection of the
spacer with 8 clamping screws. The exact executi-on of these steps is required to achieve a sufficient clamping and the necessary rotational stability.
First the 4 inner clam-ping screws must be tightened in the defi-ned order.
Inside
Then the 4 outer clam-ping screws have to be tightened in the defi-ned order.
Outside
ATTENTION!
The tightening sequence must be performed at least 3 times!
1. 4.
3. 2.
7. 6.
5. 8.
4
3
! All screws have to be tightened with the torque limiting screwdriver in the order as shown.
IMPORTANT! Perform this sequence 3 times to tighten the screws!
!
A
Before wound closure we strongly recommend co-
vering the spacer with bone graft to enhance callus
formation.
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OsteoBridge® IKA
Diameter 5 mm
Interlocking Screws, non-sterile
Ref. Length
GB35020 20 mm
GB35022 22 mm
GB35024 24 mm
GB35026 26 mm
GB35028 28 mm
Ref. Length
GB35030 30 mm
GB35032 32 mm
GB35034 34 mm
GB35036 36 mm
GB35038 38 mm
GB35040 40 mm
GB35042 42 mm
Ref. Length
GB35044 44 mm
GB35046 46 mm
GB35048 48 mm
GB35050 50 mm
GB35052 52 mm
GB35054 54 mm
GB35056 56 mm
Intramedullary Nails without Collar, sterile
Ø =14 Ø =16 Ø =18
L = 130 GA21413 GA21613 GA21813
L = 150 GA21415 GA21615 GA21815
L = 200 GA21420 GA21620 GA21820
Leng
th (m
m)
Diameter (mm)
Intramedullary Nails with Collar, sterile
Ø =10 Ø =12 Ø =14 Ø =16
L = 110 GA11011 GA11211 GA11411 GA11611
L = 130 GA11013 GA11213 GA11413 GA11613
L = 150 GA11015 GA11215 GA11415 GA11615
Diameter (mm)
Leng
th (m
m)
Custom angled Spacer, sterile
Ref. Length
GA04041 50 mm
Diameter 40 mm, Angle 10˚
Components of OsteoBridge® IKA
13
OsteoBridge® IKA
Merete Medical Inc. · 49 Purchase Street · Rye, New York 10580 · USA · Phone: (914)9671532 · Fax: (914)9671542 · Mail: [email protected] · www.merete-medical.com
Ø =14 Ø =16 Ø =18
L = 130 GA21413 GA21613 GA21813
L = 150 GA21415 GA21615 GA21815
L = 200 GA21420 GA21620 GA21820
Item Ref.
IKA Nail Guiding / Impacting Instrument GA90100
Protection Sleeve GB90101
Guiding Pins GA90003
Ø 4.5 mm Drill Sleeve GB90145
Trocar GB90102
Extractor GB90203
300 mm Ruler AI90300
1
2
3
4
5
6
7
Item Ref.
Slotted Hammer AI00048
Hex. 5.0 Screwdriver (for Clamping Screws) GA90009
Hex. 3.5 Screwdriver(for Interlocking Screws)
AI00135
Hex. 3.5 Screwdriver with AO-coupling (for Interlocking Screws)
GA90023
Hex. 5.0 Screwdriver with ¼˝-coupling (for Clamping Screws)
GA90024
15
16
17
18
19
InstrumentsInstrument Tray 1 Ref. GA91006
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3
4
5
6
8
9
10
1112
13
14
Instrument Tray 2 Ref. GA91005
15
16
17
18
19
20 21
22
23
Item Ref.
Depth Gauge AI00200
Manual awl 6/10 GA90020
Reamer GA90021
Cover Sleeve (cement protection for nail) GA90002
Cover Sleeve (cement protection for nail to use with Nail Guiding/Impacting Instrument )
GA90025
Distance Holder GA90007
Ø 4.5 mm Drill Bit GB90245
8
9
10
11
12
13
14
Item Ref.
Torque Limiter with ¼˝-coupling GA90026
Impactor GA90008
Trial Spacer GA54041
Ø 5 mm Interlocking Screws length: 20 - 56 mm
GB35020-GB35056
20
21
22
23
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OsteoBridge® IKA
Trial Implant Tray with 2 Trial Nails per size
Ref. GA91004
Trial Implant Tray with 2 Trial Nails per Size
Ref. GA91003
Implants