OptiLock Periarticular Plating System For Distal Femoral ...€¦ · The 5.5mm self-drilling...

Pre-Launch Surgical Technique

OptiLock® PeriarticularPlating System ForDistal Femoral Fractures

Introduction ................................................. Page 1

Indications And Fracture Classification ........ Page 6

Design Features ........................................... Page 7

Surgical Technique....................................... Page 8

Ordering Information ................................... Page 17

Further Information...................................... 1

Contents

Lateral Plates

The anatomically contoured distal lateral femoral plate is

available in 3-hole increments from 3 to 18 holes, ranging

from 122 – 386mm in length for right and left distal femurs.

For easy recognition, the left distal lateral plates are colored

light blue and the right plates are colored gold.

1

The OptiLock Periarticular Plating System (OPPS) utilizes

unique patent pending SphereLock™ technology. This

advanced implant/instrumentation design allows for effective

and efficient anatomic fixation of distal femoral fractures. The

OptiLock Periarticular Plating System offers both left and

right distal lateral femoral pre-contoured, titanium alloy plates

for optimizing fixation of simple and complex condylar

fractures of the femur.

Complete anatomic restoration is facilitated through

precise anatomic contouring, multiple bone screw

options, and proper plate positioning on the lateral

aspect of the distal femur.

Introduction

2

Locking Bone Screws

A unique, patent pending aspect of the OptiLock Periarticular

Plating System is application of either locking or non-locking

bone screws through any threaded hole of the plates. By

design, the screw head for each diameter screw is seated

virtually flush to the plate surface. This allows for maximum

flexibility in choice of screw diameter with minimal hardware

prominence, which minimizes potential for irritation or

impingement of soft tissue.

The 3.5mm locking bone screws range in lengths from

10mm – 95mm.

• 10-20mm in 2.0mm increments



The 4.5mm locking bone screws range in lengths from

14mm – 95mm.




The 5.0mm self-drilling locking bone screws are available

in 14mm, 18mm, 26mm, 40mm and 55 – 85mm

in 10mm increments.

• 14mm (Flat nose only)

• 18mm (Flat nose and self-drilling)

• 26mm

• 40mm

• 55-85 in 10mm increments

The 5.5mm self-drilling cannulated locking bone screws range

in length from 25 – 95mm in 5.0mm increments for precise

application over a 2.0mm x 25cm K-wire. The 5.5mm outer

diameter size may be considered ideal for a metaphyseal

application in the distal femur.

Introduction (Continued)

3

Non-Locking Bone Screws

The 3.5mm non-locking bone screws range in lengths

from 8.0mm – 95mm.


• 60–95mm in 5.0mm increments

The 4.5mm non-locking bone screws range in lengths

from 14mm – 95mm.



The 5.5mm self-drilling cannulated non-locking bone screws

range in length from 40 – 95mm in 5.0mm increments for

precise application over a 2.0mm x 25cm K-wire.

With a wide variety of sizes of locking and non-locking bone

screws and locking bone screw trajectories, the OptiLock

Periarticular Plating System sets a new standard for internal

fixation of distal femoral fractures, effectively meeting the

discriminating preferences of surgeons to produce desired

patient outcomes.

5.5mm Non-locking

5.5mm Locking

5.0mm Locking, Self-Drilling

4.5mm Non-Locking

4.5mm Locking

3.5mm Locking

3.5mm Non-Locking

4

Outer Diameter Drill Bit Size Suggested Application

5.5mm Self-Drilling, Cat. # 27555: 4.5mm Used in the condyles of the distal femur. Cannulated over a 2.0mm guideCannulated Non-Locking Cat. # 27585: 5.5mm (Lag) wire. A 5.5mm drill bit allows for a lag technique to be used with the plate

5.5mm Self-Drilling, Cat. # 27550: 4.8mm Used in the condyles of the distal femur. Cannulated over a 2.0mm guideCannulated Locking wire. Can be used in larger patients as truss load sharing screws for support

of subchondral bone

5.0mm Self-drilling Locking Cat. # 27557: 4.3mm Used in the condyles of the distal femur or in diaphyseal bone for a locked,unicortical approach

5.0mm Self-drilling Locking, Cat. # 27557: 4.3mm For use through the distal femoral plate’s threaded screw holes

Flat Nose Used for periprosthetic fractures

4.5mm Non-locking Cat. # 27565: 3.2mm Used in cortical bone of the distal femur through any plate threaded bonescrew hole for lagging fixation; may be applied in metaphysis or diaphysis ofdistal femur through any plate threaded bone screw hole for lagging fixation

4.5mm Locking Cat. # 27560: 3.8mm Primarily used in cortical bone. May be used in distal femoral metaphysealbone in smaller patients

3.5mm Non-Locking Cat. # 27575: 2.5mm May be used for fragment capture, manipulation, and lagging

Cat. # 27562: 3.5mm (Lag) Primarily used in proximal/distal tibial plate applications

3.5mm Locking Cat. # 27570: 2.7mm Used in cortical bone

2.7mm Non-Locking Cat. # 27580: 2.0mm Primarily used in distal tibial plate applications

Used for lagging fragments

2.7mm Locking Cat. # 27580: 2.0mm Primarily used in distal tibial plate applications

2.0mm Non-Locking Cat. # 27582: 1.5mm Apply through K-wire holes for additional lagging fixation

While Biomet suggests specific bone screw sizes for specific applications, the surgeon is the ultimate decision maker for applying

appropriate bone screw sizes and types based on clinical need.

Introduction (Continued)

5

2.0mm Non-Lock; thread pitch is .020mm

5.5mm Cannulated Non-Lock; thread pitch is 1.75mm

5.5mm Cannulated Lock; thread pitch is 1.25mm

5.0mm Self-Drilling Lock; thread pitch is 1.0mm

5.0mm Self-Drilling Lock, Flat Nose; thread pitch is 1.0mm

4.5mm Non- Lock; thread pitch is 1.75mm

4.5mm Lock; thread pitch is .080mm


3.5mm Lock; thread pitch is .080mm


2.7mm Lock; thread pitch is 1.0mm

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Indications And Fracture Classification

Supracondylar FemoralFractures

Supracondylar FemoralFractures

Distal Femoral Shaft Fracture

Indications For Use

• Split fractures of the femoral condyle

• Split fractures with shaft involvement

• Distal shaft fractures

Extra Articular Unicondylar

Bicondylar Hoffa Fragment

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Design Features

• Staggered plateholes promoteincreased stabilityand greaterprotection againstscrew pullout.

Providing Optimized Solutions For A Variety Of Distal Femoral Fractures

• Lateral plates are composed of titanium alloyand offer strength and anatomic contouringfor application to the distal femur.

• Color-coded implants and instruments make theOptiLock® Periarticular Plating System easy touse, which enable intraoperative efficiencies.

• Locking bonescrew trajectoriesproduce raftingsupport ofsubchondralbone withcombined“Truss” loadsharing bonescrews toprotect fromvarus collapse

• Patent pending slotted carbon figer jig may beused independent of its head for an accurate,intraoperatively efficient minimal invasiveapproach to distal femoral plate application.

• Double radius ofcurvature –r1 =2.41m and at hole#11, r2 =.76m–incorporated into15 and 18-hole platedesigns to aid inproper anatomicrestoration

Patent PendingSphereLock™

Technology

• Wide variety of bone screw sizes(2.0, 2.7, 3.5, 4.5, 5.0 and 5.5mm)

• Locking and non-locking bone screw types

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Surgical Technique

STEP 1: Patient Positioning—Standard Approach

The patient should be placed in the supine position on a

radiolucent table. A wedge pillow or prop of the surgeon’s

choice will suffice to raise the affected leg above the

contralateral side, providing a position for a good lateral

x-ray. Confirm that unobstructed anterior-posterior and

lateral radiographic images are obtainable. Prep and drape

in the usual orthopedic fashion with the appropriate lower

extremity exposed.

If temporary external fixation was not previously applied, then

use manual traction or skeletal distraction (ligamentotaxis) to

obtain gross metaphyseal alignment.

Minimal invasive Approach: Lateral Plate

Full Jig Application: A minimal invasive approach is made

possible with provision of a radiolucent targeting jig.

The head of the jig seats and locks to the metaphyseal head

of the plate with soft tissue and drill guides, which can be

affixed to both the head and tail of the jig for optimized and

reproducible bone screw targeting accuracy.

NOTE: Make sure all connections are all hand tight with

screwdriver after initial alignment has been obtained.

C

F ED

H

G

BA

TrussLocking BoneScrew Holes

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I. After removing cap from the lock wire guide jig

(Cat. # 26928), thread the shaft into screw hole D,

which has three dimples surrounding it.

II. Insert lock wire guide jig into the corresponding

jig head hole identified in he middle of the jig head

pins (hole D).

III. Thread cap of lock wire guide jig back on to the

shaft and tighten down using the butt end of the

drill guide’s long handle (Cat. # 26935).

IV. To complete the assembly, align the jig tail pins

with the dimples on the jig head.

Jig head Pins

Jig tail Pins

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STEP 2: Skin Incision—Standard Approach

A curved or straight anterolateral incision is recommended.

The initial skin incision is made mid-line at the knee, lateral

parapatellar region and then perform a lateral parapatellar

arthrotomy. Coagulation of any bleeders may be necessary.

Proximal Jig Head Application: A less invasive approach can

be performed for those cases amenable to this technique. A

short, oblique incision is made just slightly distal to the lateral

condyle and extended proximally 8cm. Exposure of the lateral

surface of the distal femur is performed with a periosteal

elevator. The knee joint can be exposed, if needed, via a

minimal dissection and sub-meniscal arthrotomy where

needed. The proximal targeting is minimally invasive with the

use of the OptiLock jig in a periosteal sparing approach. The

distal aspect of the jig locks to the metaphyseal head of the

plate. With this setup preoperatively and under fluoroscopic

image guidance, the outrigger locking guide can be

percutaneously inserted and locked with minimal soft tissue

dissection for proximal interlocking.

Low profiling jig head allows surgeons to easily identify

locked screw trajectories for efficient locked drill guide

application to plate.

NOTE: The low profile jig head is designed to be slightly loose,

even after the tightening the constrained bolt to the plate. This

does not adversely affect application.

STEP 3: Standard Approach—Reduction And External

Fixation

Prior to reducing the articular surface, external fixation may be

applied to help facilitate visualization and reduction of the

joint. In the case of open fractures, external fixation - such as

a Pin-to-Bar fixator – may already have been applied to allow

for treatment of soft tissue trauma.

Surgical Technique (Continued)

11

Articular Reduction

In displaced intraarticular fractures, the priority of reducing

the articular surface must occur before periarticular plate

application. This may be accomplished by temporarily

securing articular fragments with reduction forceps and/or by

applying K-wires (2.0mm x 250mm) – Cat. # 27590 threaded

or Cat. # 27591 Non-threaded.

Once temporarily reduced, 3.5mm, 4.5mm or 5.5mm

non-locking bone screws may be utilized for compression

independently outside of the plate as needed or be utilized

within the metaphyseal head of the periarticular plate. These

lag screws may be inserted through any of the threaded plate

holes. Regardless of the approach, the placement of a lag

screw should be based upon a preoperative plan, so that

locking bone screw trajectories are avoided.

Standard Approach—Reduction

Reduce the fracture using manual traction or skeletal

distraction (ligamentotaxis) to obtain gross metaphyseal

alignment. For holding reduction, apply K-wires and clamp

and verify under fluoroscopic imaging.

Standard Approach—Reduction Holding

Once in good position, prepare to apply a lag screw (3.5mm

non-locking screw recommended) through the very distal

posterior aspect of the distal femur and verify with

fluoroscopic imaging. Be certain to verify that the position

does not encroach on the intracondylar notch. Over-drill the

near cortex to the fracture site, then use the appropriate core

diameter calibrated drill bit to drill through the opposite side

of the fracture to the contralateral cortex. Apply the selected

non-locking bone screw for intrafragmentary fixation. At this

time, a second reduction may be applied via ligamentotaxis

and provisional external fixation applied.

STEP 4: Preliminary Plate Position

Determine the appropriate length of the distal femoral plate via

x-ray measurement or by inserting the plate up the lateral side

of the femur, using it as a template and checking length

radiographically. Provisionally apply a K-wire through the

distal hole in the center of the head of the plate, parallel to the

knee joint.

NOTE: By using the jig head attached to the plate, this will

give you a true trajectory across the condyle for the K-wire.

Use the Z-1 hole.

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STEP 5: Plate Position

Using specific anatomic benchmarks, mount the plate on the

intact or reconstructed distal femur. Do not yet attempt to

reduce the distal portion of the plate to the femoral diaphysis.

If this is done, the trajectories for the proximal screws may be

altered. On the lateral C-arm position (posterior aspect of the

medial and lateral femoral condyles overlapping), the proper

position for the plate is such that the anterior border of the

plate parallels the anterior border of the femoral diaphysis.

The proximal/distal location of the plate is such that the

posterior proximal hole should be at the level of the lateral

joint line.

Based on the preoperative plan, a free hand technique can be

used by taking the selected lateral distal femoral plate (usual

length is 3-4 cortical screws distal to the fracture) and affix

the locking drill guides into the five most proximal threaded

plate holes and the truss hole. When this is done prior to

insertion, the threading of the sleeves is much easier without

soft tissue interference.

Under power and fluoroscopic image guidance, insert a

2.0mm x 250mm K-wire through both proximal holes making

sure on the lateral view the plate is aligned appropriately.

Once the proximal aspect of the plate is secured, secure the

distal aspect of the plate to prevent rotation. Because the

OptiLock Periarticular Plating System is a multiplanar locked

plate, the positioning is paramount prior to locking.


Prior to proceeding, confirm the placement of the plate head

to the metaphysis. The following should be confirmed under

fluoroscopy.

• K-wires are inserted in the subchondral bone and areconfirmed extra articular in planar fluoroscopy and clinicalinspection (sub-meniscal arthrotomy)

• The plate is positioned correctly on the lateral femur byusing bi-planar fluoroscopy

• The plate shaft is aligned with the diaphysis according toAP and lateral radiographs, which ultimately determinesfinal flexion/extension reduction

• The plate is correctly positioned on the femur and is affixedto the bone using K-wires distally and proximally to keepalignment during bone screw insertion

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STEP 6: Reducing Proximal Shaft To Femur

Reduce the distal femoral component to the diaphysis by

temporarily securing the plate to the femoral shaft with bone

forceps. At this point, rotation of the extremity must be

confirmed via clinical examination.

Once acceptable rotation has been achieved, the plate must be

maneuvered for compressing or distracting to the acceptable

anatomic length. For complex intraarticular fracture patterns,

it may not be desired or possible to anatomically reduce the

fracture. Additionally, the OptiLock temporary fixation device

may be used to reduce fragments.

STEP 7: Insert Distal Bone Screws

I. The plate position must be secured on the lateral aspect

of the distal femur with the K-wires, prior to inserting the

first bone screw.

II. Advance the K-wire until it reaches the medial cortex when

inserting convergent bone screws.

III. If the plate inadvertently shifts from the desired position

during bone screw insertion, then all guide wires must be

removed and reinserted using the locking drill guides.

This countermeasure enables the bone screw to easily

lock into the plate threaded screw hole.

Care must be taken to ensure that the distal bone screws are

out of the joint. Visual inspection of multi/planar fluoroscopy

is performed to ensure that locked bone screws do not angle

toward or penetrate the joint.

The locking threaded screw holes in the central proximal

aspect of the periarticular plate generate converging bone

screw trajectories for improved pullout strength. When using

locking bone screws longer than 60mm, it is possible that the

converging bone screws may meet in the subchondral bone.

Therefore, accurate determination of bone screw length is

crucial. This is accomplished by sliding the depth gauge over

the K-wire that extends beyond the locked drill guide.

All locking bone screws should be tightened for a secure fit

into the periarticular plate. A power drill combined with the

torque-limiting device provided in the set may also be utilized

to definitively set the screws in the plate.

Multi-angular locking trajectoriesin the OptiLock distal femoralperiarticular plate, offers a uniqueelement of stability to the fractureconstruct. The effective “pull out”forces are well countered by thesemulti-planar locked screws

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STEP 8: Insert 4.5mm Bi-cortical Or 5.0mm Uni-Cortical

Locking Bone Screws

According to clinical requirement or to surgeon preference,

4.5mm or 5.5mm locking bone screws may be inserted into

the distal threaded holes along the plate shaft. After drilling,

bone screw length may be measured off of the drill bit, with

the assistance of fluoroscopy and/or depth gauge.

The 5.0mm self-drilling, locking bone screws may be used in

diaphyseal bone, if desired or required. No drilling prior to

insertion is necessary.

An irrigation method requiring a Trocar, Cat. # 26929,

a Soft Tissue Sleeve, Cat. # 26910, and an irrigation Cooling

Cap, Cat. # 26950. Then an IV extension tubing with the end

cut off and a 60cc syringe can be attached to the Cooling Cap.

This can be used to irrigate the bone surface while drilling

the 5.0mm screws to prevent overheating.


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STEP 9: Insert Truss Locking Bone Screws

Affix desired locking drill guide to the two oblique angled

threaded plate holes (J&K) and drill with the corresponding

4.0mm drill bit. Measure the appropriate bone screw length

under fluoroscopic image guidance, directly off of the

calibrated drill bit and/or depth gauge. The purpose of the

Truss bone screw is:

1. To aid in load sharing on the medial side of the metaphysis;

2. To protect from varus collapse; and

3. To resist “pull out” of the plate bone construct.

Alternatively, the 4.5mm, 5.0mm, or 5.5mm locking bone

screws may be used as Truss bone screws.

Optional: Distal Femoral Jig Tail Only Application

“Retro Targeting”

The OptiLock Periarticular Plating System offers a retro

targeting approach, whereby the carbon fiber jig tail can be

used independent of the jig head. This allows for unobstructed

visualization of the distal femur with freehand locking and

percutaneous “retro jig” use for bone screw locking. Once a

stab incision is made, at least two drill guides and two soft

tissue guides are locked into the plate. The carbon fiber jig tail

is then attached and locked into place by the soft tissue

guides. Proceed with drilling and insertion of screws.

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STEP 10: Standard Approach—Fluoroscopic Image

Confirmation

Confirm fixation under fluoroscopic image guidance in both

the AP and lateral planes. Close incision.

2.5 Months Post Op

Post Op

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OPPS Complete Set Catalog Numbers

Catalog # Description Qty.

26560A/B Instrument/Screw Tray-Fully Packed 1

26562A/B Distal Femoral Tray-Fully Packed 1

Total Sets Required For Distal Femoral Plate Applications 2

OPPS Instruments


26550 Instrument/Screw Tray 1

26552 Distal Femoral Tray 1

26910 Soft Tissue Guide 4

26914 2.7mm Lock Drill Guide Long 2



26919 2.0mm Wire Sleeve Long Lock 2

26921 2.5mm Drill Guide Long 2







26928 Lock Wire Guide Jig 2

26929 Trocar 2

26930 Depth Gage (10mm To 110mm Range) 1

26935 Drill Guide Long Handle 2

26939 2.0mm Wire Guide Non Lock 2

26940 Wire Depth Gage Long 1

26950 Cooling Cap 2

26960 1.5/2.0mm Drill Guide 2

26970 AO Torque Limiting Coupler 1

26980 TF Sleeve 2

27505 3.5mm Hex Driver Shaft AO 2

27510 3.5mm Hex Driver Shaft AO Cannulated 2

27561 Tap 4.5mm Lock Screw 2

27566 Tap 4.5mm Non-Lock Screw 2

27571 Tap 3.5mm Lock Screw 2

27576 Tap 3.5mm Non-Lock Screw 2

22875 Fixed AO Handle 1

22880 Ratcheting AO Handle 1

22842 AO Driver For 2.0mm Screw 2

22855 AO Drill Adaptor 1

26245-01 Femoral Plate Left LD Jig Head 1

26245-02 Femoral Plate Left LD Jig Tail 1

26246 Femoral Plate Left LP Jig ?

27245-01 Femoral Plate Right LD Jig Head 1

27245-02 Femoral Plate Right LD Jig Tail 1

Total Instrumentation 71

OPPS Distal Femoral Plates


26232 Left, Lateral Distal Femur 3H-122mm 2






27246 Femoral Plate Right LP Jig ?

27232 Right, Lateral Distal Femur 3H-122mm 2






Total Plates 24

Ordering Information

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Ordering Information (Continued)

OPPS Bone Screws


26510 2.0mm x 10mm Non-Locking Screws 3
















27710 3.5mm x 10mm Locking Screws 3















































19

































































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25914 5.0mm x 14mm SD Locking Screw, Flat Nose 3

25918 5.0mm x 18mm SD Locking Screw, Flat Nose 3

25818 5.0mm x 18mm SD Locking Screw 4
























26460 5.5mm x 60mm Cannulated Lag Screw 2








Total Bone Screws 547

OPPS Disposable Instruments


26981 Unicortical TF Shaft 3.5mm 2

26982 Bicortical TF Shaft 3.5mm 2

27550 4.8mm Cannulated Drill Bit AO (5.5 Lock) 2

27555 4.5mm Drill Bit AO (5.5 Non- Lock) 2

27557 4.3mm Drill Bit AO (5.0 Lock Self-Drilling) 2

27560 3.8mm Drill Bit AO (4.5 Lock) 2

27562 3.5mm Drill Bit AO (3.5 Non-Lock) 2


27570 2.7mm Drill Bit AO (3.5 Lock) 2



27585 5.5mm Cannulated Drill Bit AO (5.5 Lag) 2

27590 2.0mm x 250mm Threaded Guide Wire, 5Single

27591 2.0mm x 250mm Non-Threaded Guide Wire, 5Single

Total Disposables 36

Ordering Information (Continued)

Further Information

For further information, please contact the Customer Service

Department at:

Biomet Trauma

100 Interpace Parkway

Parsippany, NJ 07054

(973) 299-9300 - (800) 526-2579

www.biomettrauma.com

Biomet Trauma, as the manufacturer of this device, and their

surgical consultants do not recommend this or any other

surgical technique for use on a specific patient. The surgeon

who performs any implant procedure is responsible for

determining and utilizing the appropriate techniques for

implanting the device in each individual patient. Biomet and

their surgical consultants are not responsible for selection

of the appropriate surgical technique to be utilized for an

individual patient.

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Notes:

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Notes:

Notes:

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Copyright 2007 Biomet, Inc. All rights reserved. P/N 215067L 07/07

100 Interpace ParkwayParsippany, NJ 07054www.biomettrauma.com800-526-2579

Unless otherwise indicated, ™ denotes a trademark, and ® denotes a registered trademark, ofone of the following companies: Biomet Manufacturing Corp.; Electro-Biology, Inc.; EBI, L.P.;Biolectron, Inc.; Interpore Cross International, Inc., Cross Medical Products, Inc.; or InterporeOrthopaedics, Inc. Rx Only.

OptiLock Periarticular Plating System For Distal Femoral ...€¦ · The 5.5mm self-drilling...

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Transcript of OptiLock Periarticular Plating System For Distal Femoral ...€¦ · The 5.5mm self-drilling...