Transcript
Page 1: OsteoBridge IKA - Activizeactivize.com/wp-content/uploads/2014/05/IKA-Knee-Surgical-Protocol.pdf · 2 OsteoBridge® IKA 01. OsteoBridge® IKA Failed total knee arthroplasty Limb salvage

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.

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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.

3

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.

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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

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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

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

12

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