osteobridge® knee arthrodesis

From the «BioBall® Company»

OsteoBridge® Knee ArthrodesisThe modular system for the fusion of the knee joint

OsteoBridge® Family

2

Failed surgery (total knee replacement)

Arthrodesis or knee prostheses infections

Periprothetic fractures

Posttraumatic condition preventing an implantationof a knee prosthesis

Tumors in the proximity of the knee

Loosening or impairment of the pulley

01. OsteoBridge® Knee Arthrodesis

Advantages of the OsteoBridge® Knee Arthrodesis

Modularity of the system ensures flexible supply

Cementless and cemented implantation possible

Immediate mobility and analgesia possible

Simple handling, short time surgery

Indications

OsteoBridge® Knee Arthrodesis System

The OsteoBridge® Knee Arthrodesis serves as an implant to fuse the knee after failed

primary knee arthroplasty. The implant can also be used for bridging large bone defects

and the resection of the metaphysis of femur and tibia.

The System is available in three different variations:

I. Standard System II. Extended System III. Extended System PLUS

The Standard System consists of an angled spacer for bridging the damaged joint as well

as nails with a collar in different lengths and diameters to anchor the implant in the femur

and tibia. The nails are trumpet-shaped to optimize their stability into the damaged bone.

The Extended System contains additional nails that do not have a collar. These nails are

tapered and ribbed for a better anchorage in the bone. To bridge medium sized bone

defects spacers in the length of 20 mm without a collar and 30 mm with collar can be

clamped onto the nails.

The Extended System PLUS includes spacers in the lengths from 40 to 70 mm to bridge

particulary large bone defects. They can be connected with a spacer connector.

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Merete Medical GmbH · Alt-Lankwitz 102 · 12247 Berlin · Germany · Phone: +49 (0)30-77 99 80-0 · Fax: +49 (0)30-77 99 80-177 · Mail: [email protected] · www.merete.de 3

Service package for the surgical assistance

Preoperative Planning

On the basis of the patient’s x-rays the sur-

geon will be provided with a preoperative

planning. Necessary implants will be selec-

ted and a graphical exposition of the propo-

sed provision can be drawn.

Supply

For the first surgeries all necessary implants

and instruments will be provided on a loan

basis.

In-House Training

Before the Surgery our product specialist

demonstrates the use of the instruments

and implants and performs saw bone trai-

ning for your staff.

Surgical Assistance

A Merete product specialist attends the sur-

gery and assists the assembly and instru-

mentation of the implants.

02. Service Package for Surgical Assistance

4

03. Properties and System Structure

Cementless and cemented implantation possible•

Primary stability is achieved by pressfit and a partly tapered, wedge-shaped nail de-sign with radiating ribs

•

Rotational stability by distal interlocking screws, static or dynamic•

Secure secondary stability due to biological integration of the prosthesis stem into the bone structure (osseointegration) stimulated by a roughened titanium surface

•

All implant components are made of titanium alloy (TiAl6V4)•

Adjustment of the extension/flexion and valgus/varus positioning of the joint by ro-tation of the angled spacer

•

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 for an active stimulation of bone growth

•

The modularity of the system enables intraoperative adaption to the particular bone defect by using variable spacer lengths and spacer combinations.

•


Spacer in den Längen 20 und 30 mm

Nail with Collar

Angled Spacer

Interlocking Screws

Standard System

I. Standard System – Basic Supply

Clamping Screws



Interlocking Screws

Clamping ScrewsSpacer Connector

Extended spacer

II. Extended System – Flexible Supply

Nail without Collar

Spacer with/without Collar

Extended SystemExtended System

PLUS

III. Extended System PLUS – Complete Supply

6

I. Standard System – Basic Supply

Angled Spacer

Nail with Collar

Interlocking Screws

x-ray templates are available for the preoperative planning.

Intraoperatively the surgeon can select the appropriate im-

plant sizes with the aid of trial components.

Interlocking screws with a diameter of 5 mm (lengths: 20 mm

to 56 mm) are provided in this package. They ensure a secure

fixation of the nails into the bone. The intruments are provi-

ded in two trays.

OsteoBridge® Knee Arthrodesis Standard System

Ref. GA04041

Spacer, sterileNails 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*

(mm

)

*Special lengths on request.

Diameter 5 mm

Interlocking screws

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

Diameter 40 mm, Angle 10°

The implant is used for the fusion of the knee joint. Due to

the implant design of the OsteoBridge® Knee Arthrodesis

Standard System small and medium bone defects can be

treated. The system consists of an angled spacer for bridging

the damaged joint as well as a set of nails with collar in dif-

ferent lengths and diameters to anchor the implant in femur

and tibia. Due to previous TKRs the bone ends have become

trumpet shaped openings. The nails with collar adapt to this

anatomy very well.

The angled spacer enables a flexion of 10°. By rotating the

spacer the valgus-varus position of the joint can be adjusted.

Standard System

Length 50 mm


Merete Medical GmbH likes to thank Prof. Dr. med. L. Rabenseifner, Stadtklinik Baden-Baden, Germany for the kind supply of the x-ray images.

Interlocking Screws

OsteoBridge® Knee Arthrodesis Standard System

Trial Implant Tray with 2 Trial Nails per Size

Case Study Standard System

Ref. GA91003

preoperative postoperative

Condition after failed TKR with infectionTemporary interim prosthesis

••

Treatment with OsteoBridge® Standard System•

Standard System

8

II. Extended System – Flexible Supply

The Extended System provides a second set of nails without

a collar. The taper shaped nails fit perfectly into the intra-

medullary canal. Ribs provide firm anchorage in the bone.

Spacers in the length 20 mm without collar and 30 mm with

collar can optionally be clamped onto these nails. A treat-

ment of defects up to 70 mm can be achieved.

Ref. GA04020 Ref. GA04030

Length 20 mm Length 30 mm

Nail without Collar

Spacer with Collar

Spacer without Collar

Ribs

Example of use: Application of a nail without collar and without additional spacer

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*

(mm

)

Diameter (mm) Diameter 40 mm, Angle 0°

Spacer without/with Collar, sterile

OsteoBridge® Knee Arthrodesis Extended System

*Special lengths on request.

Extended System


Trial Implant Tray with 2 Trial Nails per size

OsteoBridge® Knee Arthrodesis Extended System

Ref. GA91004

Case Study Extended System


Condition after failed TKR with infectionTemporary treatment with bone cement spacer

••

Treatment with OsteoBridge® Extended System•

Merete Medical GmbH likes to thank Dr. med. A. H. Tiemann, Berufsgenossenschaftliche Kliniken Bergmannstrost, Halle, Germany for the kind supply of the x-ray images.

Extended System

10

III. Extended System PLUS – Complete Supply

Spacer 70/60/50/40 mm, sterile

Large bone defects can be treated with the Extended System PLUS. Spacers in the lengths of 40 to 70 mm are

provided. These Spacers can be connected with a spacer

connector.

Spacer 70mm

60 mm

50 mm

40 mm

Spacer Connector

Spacer Connector, sterile

Diameter 40 mm, Angle 0˚

Ref. Length

GA04070 Spacer 70 mm




Ref. GA40040

OsteoBridge® Knee Arthrodesis Extended System PLUS

Merete Medical GmbH likes to thank Prof. Dr. med. L. Rabenseifner Stadtklinik Baden-Baden, Germany for the kind supply of the x-ray images.

Case Study Extension PLUS


Condition after failed TKR with infectionTemporary interim prosthesis

••

Treatment with OsteoBridge® Extended System PLUS•

EXTENS

ION

PLUS

Extended System PLU

S


OsteoBridge® Knee Arthrodesis Instruments

Item Ref.

Arthrodesis Nail Guiding/Impacting Instrument

GA90100

Protection Sleeve GB90101

4x Guiding Pins GA90003

Drill Sleeve Ø 4.5 mm GB90145

Trocar GB90102

Extractor GB90203

Ruler 300 mm AI90300

1

2

3

4

5

6

7

Item Ref.

Slotted Hammer AI00048

Screwdriver, hex. 5 (for clamping screws) GA90009

Screwdriver, hex. 3.5(for interlocking screws)

AI00135

Screwdriver, hex. 3.5 with AO-connector (for interlocking screws)

GA90023

Screwdriver, hex. 5.0 with ¼‘‘-connector (for clamping screws)

GA90024

15

16

17

18

19

Instruments

Instrument Tray 1 Ref. GA91001

12

3

4

5

6

8

9

10

1112

13

14

Instrument Tray 2 Ref. GA91002

15

16

17

18

19

20 21

22

23

24

25

Item Ref.

Depth Gauge AI00200

Bradawl 6/10 GA90020

Reamer GA90021

2x Cover Sleeve (cement protection for nail) GA90002

2x Cover Sleeve (cement protection for nail to use with Nail Guiding/Impacting Instrument )

GA90025

2x Distance Holder GA90007

Drill Bit Ø 4.5 mm GB90245

8

9

10

11

12

13

14

Item Ref.

Torque Limiter with ¼˝-connector GA90026

Impactor GA90008

Spacer Measuring Gauge GA90022

Trial Spacer Connector GA50040

Trial Spacer GA54041

4 Interlocking Screws apiece Ø 5 mmLänge 20 - 56 mm

GB35020-GB35056

20

21

22

23

24

25

12

Prepare the intramedullary canal by opening it with

the bradawl or by drilling with an intramedullary

drill to the desired diameter. The diameter varies

depending on nail form and the principle of ancho-

ring.

Use the reamer and shape the bone in the proximal

area to implant a nail with collar.

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 components when the leg length

is accurate.

OsteoBridge® Knee Arthrodesis surgical technique

04.

2

3

Preparation of the Intramedullary Canal and Implant Selection

11

Nail with Collar Nail without Collar

Cemented2 to 4 mm larger than nominal diameter

2 mm larger than nominal diameter

Cementlessnominal diameter 2 mm smaller than

nominal diameter

OsteoBridge® Knee Arthrodesis Surgical Technique


Check the position of the nails inside the spacer.

The nails have to be flush with the window in the

upper half-shell.

If the angled spacer ist not long enough to bridge

the defect, the length of an additional spacer can

be determined with the Spacer Measuring Gauge.

For a better allocation of trial components and im-

plants the trial nails are labeled with pictograms

of a dice indicating the diameter of the nail. The

pictogram 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

7

6

Ø 10 mm Ø 18 mmØ 12 mm Ø 14 mm Ø 16 mm

4

14

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 plugged into the slot and the

locking screw screwed down until the nail is tighte-

ned to the nail guiding/impacting instrument.

Interlocking the nails: The length of the nails who-

se drill holes align is indicated on the nail guiding/

impacting instrument. The protection sleeve must

be inserted into the corresponding hole of the gui-

ding/impacting instrument, indicating the same

length as the nail, . The trocar peak center-punches

the drill hole. The trocar is removed and the drill

sleeve inserted.


1

Insertion of the Nails

2

3

20 mm

Attention: Clamping length of 20 mm minimumIf no interlocking screws are used the nails can be

inserted into the bone with the impactor. At least 20 mm clamping range has to remain outside the

bone.


Use the drill bit Ø 4.5 mm to drill the interlocking

hole. Afterwards remove the drill sleeve. The depth gauge must be positioned onto the bone through

the protection sleeve. Push the small measuring

pole through the bone and hook to the opposite

cortical bone. Now the required length of the in-

terlocking screw can be read out at the end of the

measure.

Insert the interlocking screw of the correct length

into the protection sleeve and tighten with the

enclosed screwdriver. All nails are provided with

two drill holes for double interlocking. Remove

the static interlocking screw to achieve a dynami-

sation of the nail via the long hole. After insertion

of the screws remove the nail guiding/impacting

instrument. Do not start locking the second nail

before the locking of the first nail has been com-

pleted.

In case of a cemented insertion the cover sleeves

have to be placed onto the nails before starting to

insert the nail. The sleeves are removed once the

insertion of the nails has been completed. The dia-meter of the intramedullary canal should be 2 to 4 mm larger than for cementless insertion (Refering

to the table on page 12, picture 1). If the nail gui-

ding/impacting instrument is not used the covers

GA90002 must be used when cementing the nails.


4

5

6Locking Non-locking

Dynamic interlocking

Static interlocking

16

Position the lower half-shell carefully underneath

the nails. Always respect the minimal clamping length of 20 mm! The colored area must be entirely

positioned inside the spacer. Thereafter 4 guiding

pins must be inserted into the four outside holes.

Guided by the pins the upper half-shell can cor-

rectly be adjusted onto the lower half-shell.

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.

When using the Extended System PLUS, on one

side of the spacer a spacer connector must be

used instead of a nail. The spacer connector has to be pushed up against the side of the spacer.


1

3

2

Inserting and Screwing the Spacer

20 mm

20 mm

Dot


Replace the guiding pins by four more clamping

screws which are tightened down slightly. There-

after tighten the screws firmly with the torque li-

miting screwdriver. The torque limiting screwdriver

consists of two pieces that must be assembled

before use.

IMPORTANT! Follow the steps to tighten exactly! (see figure 5) Follow the instructions for the connection of the

spacer with 8 clamping screws carefully. The exact execution 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!

Repeat the whole procedure 3 times!


1. 4.

3. 2.

7. 6.

5. 8.

5

4

! All screws have to be tightened with the torque limiting screwdriver in the given order.

IMPORTANT! Repeat this precedure 3 times to re-tighten the screws!!

18

When using a spacer with the length of 40 mm to

70 mm of the Extended System PLUS this spacer

has to be assembled between the spacer connec-

tor and the nail only after the angled spacer is fully

mounted.

When using a spacer with the length of 20 mm or

30 mm of the Extended System it has to be posi-

tioned onto the clamping area of the nail without

collar and screwed in place. Do not clamp the spa-

cer onto the tapered part of the nail.

ATTENTION: The part of the nail left outside of the bone has to have a length of 40 - 50 mm!


6

5

40 - 50 mm

20 mm




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Product Forecast – Development in Progress

OsteoBridge® Metaphysic Supply

OsteoBridge® Diaphysis The modular diaphyseal endoprosthesis for the

long term stabilisation of segmental bone de-

fects and bone resections in humerus, femur and tibia

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Merete Medical GmbHAlt-Lankwitz 102

12247 Berlin · Germany

Phone: +49 (0)30 77 99 80-0

Fax: +49 (0)30 76 68 03 61

[email protected]

www.merete.de

osteobridge® knee arthrodesis

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