t2anklearthrodesis_optech_b1000044d0710

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Operative Technique

T2Ankle Arthrodesis Nail


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Ankle Arthrodesis Nailing System

Contributing Surgeons

Joseph D. DiCicco D.O.

Chief Orthopedic TraumaGood Samaritan HospitalChairman, Dept of Orthopaedic SurgeryGrandview Hospital, Dayton, OhioClinical Professor Orthopaedic SurgeryOhio University & Wright State UniversityDayton, Ohio

Thomas Mckley, M.D.

Department of Trauma, Hand andReconstructive Surgery

University Hospital JenaGermany

Anthony T. Sorkin, M.D.

Rockford Orthopaedic Associates, LLPClinical Instructor, Department of SurgeryUniversity of Illinois, College of MedicineDirector, Orthopaedic TraumatologyRockford Memorial HospitalRockford, Illinois, USA

This publication sets forth detailedrecommended procedures for usingStryker Osteosynthesis devices andinstruments.

It offers guidance that you shouldheed, but, as with any such technicalguide, each surgeon must consider

the particular needs of each patientand make appropriate adjustmentswhen and as required.

A workshop training is required priorto first surgery.

All non-sterile devices must becleaned and sterilized before use.Follow the instructions provided inour reprocessing guide (L24002000).Multi-component instruments mustbe disassembled for cleaning. Pleaserefer to the corresponding assembly/disassembly instructions.

See package insert (L22000007) fora complete list of potential adverseeffects, contraindications, warningsand precautions. The surgeon mustdiscuss al l relevant risks, including thefinite lifetime of the device, with thepatient, when necessary.

Warning:

All bone screws referenced inthis document here are notapproved for screw attachment orfixation to the posterior elements(pedicles) of the cervical, thoracicor lumbar spine.

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Contents

Page

1. Introduction 4

2. Implant Feature and Design Rationale 4 Implant Feature 5

Design Rationale 5

3. Features 6

Technical Details - T2 Ankle Arthrodesis Nail 6

Instrument Features 7

4. Indications, Precautions & Contraindications 8

Indications 8

Precautions 8

Relative Contraindications 8

Pre-operative Planning 8 Locking Options 8

5. Operative Technique 9

Patient Positioning and Joint Surface Preparation 9

Incision and Entry Point 10

Reaming 12

Target Device Assembly 14

Nail Length Determination 15

Nail Insertion 15

Guided Locking via Target Device 16

Static Locking Mode 22

Freehand Proximal Locking of Long Nails 25

End Cap Insertion 26

Nail Removal 27

Case Resport 28

References 29

Ordering Information Implants 30

Ordering Information Instruments 31

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The T2 Nailing SystemrepresentsStrykers latest and mostcomprehensive development of theoriginal intramedullary principlespresented by Prof. Gerhard Kntscherin 1940. With a new generation ofT2 Nails (e.g. T2 Proximal HumeralNail, T2 Supracondylar Nail, T2Recon Nail), the indications haveextended from shaft fractures tofractures of the metaphyseal regions.

In addition to the T2 Nailing systemsfor Femoral, Tibial, and Humeralfractures, Stryker Osteosynthesis has

developed the T2 Knee ArthrodesisNail and, more recently, the T2 AnkleArthrodesis Nailto provide theoption for tibiotalocalcaneal fusionwith a retrograde intramedullary nail.

Introduction

The main advantages of the techniqueare limited soft tissue damage in theankle area, high primary stabilityallowing early weight bearing,(3) as well as compression of thesubtalar and tibiotalar joints (5).

Severe arthrosis and deformityof the ankle and subtalar jointsare debilitating problems thatcan be difficult to treat. Thetibiotalocalcaneal fusion with aretrograde intramedullary nail canbe considered a salvage procedurefor severe arthrosis and deformity of

the ankle and subtalar joints (1).Ankle arthrodesis is a challengingprocedure due to poor host conditions(e.g. bad skin, deformity, avascularnecrosis), inability to get adequatefixation for this slow healing process,and the inability to get adequatecompression across the fusion.

Like other nails in the T2 family,the T2 Ankle Arthrodesis Nail

enables the surgeon to create aninherently stable construct byproviding internal compression tothe fusion mass and distal crosslockholes within the nail to generate anintramedullary fixed-angle device.Performing an ankle arthrodesis canbe technically demanding because ofthe shape and small size of the talus.Therefore, preoperative planning isan absolute necessity to determineplacement and number of screws (2).

The T2 Ankle Arthrodesis NailingSystem is based on the establishedT2 instrument platform and lockingscrews. It offers the advantages of aunique locking configuration al lowingfor tibiotalocalcaneal fixation.

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Implant Feature and Design Rationale

Design RationaleThe T2 Ankle Arthrodesis Nail offersstrong biomechanical* intramedullarystabilization using cannulatedimplants for the tibiotalocalcanealfusion.

All implants of the T2 Ankle Arthro-desis Nailing System are made of TypeII anodized titanium alloy (Ti6Al4V)for enhanced biomechanical andbiomedical performance*.

Standard 5mm cortical screwssimplify the surgical procedure andoffer the advantages of both reduced

insertion torque and low profileheads*. Fully Threaded LockingScrewsare available for standardlocking procedures. PartiallyThreaded Locking Screws (ShaftScrews) are designed for use ifapposition/compression is applied.

The proximal locking configurationfeatures a round and an oblong hole toallow for static or dynamic locking.Controlled apposition/compression

up to 5mm can be applied at thetibio-talar joint by introducing aCompression Screw from the drivingend of the nail against the 5mmShaft Screw placed in the talus. TheCompression Screw is cannulatedtherefore allowing nail insertion overthe guide-wire with the compressionscrew pre-loaded.

T2 Ankle Arthrodesis Nails come in10, 11 and 12mm diameters and 150,200 and 300mm lengths. The driving

end diameter is 12mm for all nails.

The design of the T2 AnkleArthrodesis Nail features a 5lateral (valgus) bendproviding ananatomical fit with better purchasethrough the calacaneal bone.

Proximal locking is performedfrom medial to lateral in order to:

Avoid damage of muscular andneuro-vascular stuctures locatedon the lateral side of the tibia

Avoid interference with the bula.

The low profile design of T2Locking Screws helps reduceprominence under the soft tissueon the medial cortex of the tibia.

Two 5mm Fully Threaded LockingScrews can be placed in thecalcaneus: the proximal one in aL/M directionthrough a threadedlocking hole, and the distal one inP/A direction with a 10 angle frompostero-medial to antero-lateral

(Fig. 1). This design dictates theneed for left and right nails.Internal compression techniques arepreferred because of higher unionrates, shorter fusion times, and fewercomplications (2).

End Caps in different sizes areavailable to provide the improvedfit for every indication and lockdown on the PA calcaneal screw.This feature creates a fixed anglebetween the nail and Locking

Screw.

See the detailed chart on the nextpage for the design specificationsand size offerings of the implants.

Implant Features

* Data on file at Stryker:

- Test Report No 130505CG1 Strength calculation

(FEA) of 10mm T2 Ankle Arthrodesis Nail

- White Paper: Ti6Al4V with Anodization Type II

Biological Behavior and Biomechanical EffectsAxel Baumann, Dipl.-Ing. DOT GmbH, Rostock,

Germany, Nils Zander, Dipl.-Ing. Stryker Trauma

GmbH, Schnkirchen / Kiel, Germany

- Test Report 080103HK1 T2 / S2: Modified screw

head design of cross screws 4 / 5mm

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Fig. 1View from distal

5.0mm Partially Threaded

Locking Screws (Shaft Screws)

L=25mm 120mm

Note:Screw length is measuredfrom top of head to tip.

5.0mm Fully Threaded

Locking Screws

L=25mm 120mm

Compression Screw

(cannulated)

End Caps

Features

Diameter 10, 11 and 12mm (Left and Right)Sizes 150, 200 and 300mm

Note:Driving end diameter is 12mmfor all nails.

Technical Details - T2 Ankle Arthrodesis Nail

6

10anterior

Standard +5mm +10mm +15mm

lateral medial

Endcap

Compression Screw

lateral medial

5mm

47

mm

19.5mm

7.5mm

5mm

40mm

15mm


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The major advantage of theinstrument system is the integrationof acore instrument platformwhich can be used not only for thecomplete T2 Nailing System, butalso represent the platform for allfuture Stryker Osteosynthesis nailingand fur ther reduces complexityand inventory. The T2 instrumentplatform offers advanced precisionand usability, as well as ergonomicallystyled targeting devices. Exceptfor the addition of a small numberof dedicated instruments, the T2Femoral Instrument platform is used

for the T2 Ankle Arthrodesis Nail.

Dedicated instruments for theT2 Ankle Arthrodesis Nail in-clude the Ankle ArthrodesisTargeting Device and a specialCompression Screwdriver.

A pre-assembled Apposition Handleand Ring/Sleeve allow for applyingadditional external compression.

As with all T2 Nailing Systems, the T2Ankle Ar throdesis Targeting Deviceis made of carbon fiber and featuresa friction locking mechanism to lockthe Tissue Protection Sleeves in place.

Both proximal and distal holes ofthe 150mm and 200mm nails can belocked with the Targeting Device. Forproximal locking of the 300mm nails,free hand technique must be applied.

An additional Aiming Adaptercanbe attached to the Targeting Deviceto help achieve the appropriaterotation based on the position ofthe PA calcaneal screw aligned withthe anatomic calcaneal body axis.

Features

Instrument Features

Aiming Adapter

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Apposition Handle

Apposition Ring

Apposition Sleeve

Targeting Device


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Indications, Precautions & Contraindications

RelativeContraindications

Indications

The T2 Ankle Arthrodesis Nail shouldNOT be used if following conditionsare present:

Tibial malalignment of > 10 in any

plane Severe vascular deciency Osteomyelitis or soft tissue

infection

Note:

Please see package insert forwarnings, precautions, adverseeffects and other essential productinformation.

The T2 Ankle Arthrodesis Nailmay be used for:

Posttraumatic and primaryArthrosis

Neuromuscular deformity Revision of Failed Ankle

Arthrodesis Failed Total Ankle Replacement Avascular Necrosis of the

Talus (requiring tibiocalcanealarthrodesis)

Neuroarthropathy (Charcot) Rheumatoid Arthritis with severe

deformity

Osteoarthritis Pseudarthrosis

Pre-operative PlanningPreoperative clinical and radiologicalassessments are very important for thesurgical outcome.

Clinical assessment comprises:

evaluation of pain, quality andviability of soft tissue at thesurgical site, neurological andvascular status.

Radiological assessment of theankle includes: weight bearinganteroposterior and lateral views.A lateral hindfoot and Brodensview are useful in evaluating thesubtalar and transverse tarsaljoints.

Appropriate implant size can be

selected with the T2 Ankle X-RayTemplate (1806-3217).

Locking OptionsBased on the clinical and radiologicalassessment, different lockingoptions can be used to obtainthe Tibiotalocalcaneal fusion:

Apposition/CompressionLocking Mode:

- Tibio-talo internal compression

with or without additional talo-calcaneal external compression(static locking proximal)

- Tibio-talo-calcaneal externalcompression (static lockingproximal and distal)

Static Locking Mode:

- Talo-calcaneal static lockingwith proximal static locking

Dynamic Locking Mode:

- The proximal oblong hole allowsfor secondary dynamization

PrecautionsThe T2 System has not been evaluatedfor safety and compatibility in the MR

environment.The T2 System has not been testedfor heating or migration in the MRenvironment.

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Operative Technique

Positioning

Place the patient supine on aradiolucent table (Fig. 2). Care shouldbe taken to assure neutral al ignmentof the knee and ankle. Prepare theentire foot and ankle and drapethe limb free from above the kneeto allow intraoperative assessmentof lower limb alignment to avoidmalalignment later in the procedure.

The lower limbs should hang over theoperating table about 1520cm andthe affected l imb should be elevated

by placing a bolster under the calf.

This position will allow:

- Easy exposure to the C-Armfor the X-Ray control

- Proximal locking from medial sideand distal locking from lateral side

- Convenient access for posteriorlocking of the PA calcaneal screw.

Place the C-Arm on the opposite

side and make sure that both lateraland anterioposterior views of thelower limb can be obtained.

Exposure

Make a 56 cm lateral incision in linewith the distal lateral malleolus.

To gain access to the tibiotalar joint,resection of the most distal portionof the fibula just above the tibiotalarjoint might be required (Fig. 3).

This allows adequate exposure of thetibiotalar joint and may provide sourceof bone graft if required. Resect thedistal fibula at an angle superolateralto inferomedial to preventprominence after healing (Fig. 4).

Any exposure (lateral or medial) maybe used as long as it allows adequateaccess to the tibiotalar and subtalarjoints. In complex cases, exposureof both sides might be required.

Patient Positioning and Joint Surface Preparation

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Fig. 3

Fig. 2

Fig. 4


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Joint Preparation

Correction of any deformity shouldbe addressed at this time. Generally,the contours of the tibiotalar andsubtalar joints are maintained withdenuding of any articular car tilage.

Sometimes a flat on flat surfacecan be used depending on surgeonpreference. Tibiotalar jointpreparation may be aided by alaminar spreader or distraction ofsome kind. Care should be takento avoid excessive bony resection

which may later result in limbshortening or loss of talar fixation.

Ankle positioning for fusion

Several authors have attemptedto define the optimal position forankle arthrodesis without objectivemultiplanar radiographic analysisand consistent reference points (4).Position the foot with neutral ankle

dorsi-plantar flexion, 510 externalrotation in relation to the tibial crestand 5 of hindfoot valgus seems to bethe most accepted.(Fig. 5). An assistant shouldmaintain this position for properentry point determination.

Incision and Entry PointIncision

After joint preparation andconfirmatory X-Ray evaluationof fusion position, the incisionpoint is determined as follows:

Place a K-Wire (1806-0050S) on theplantar surface (1/3 lateral) and takean axial heel viewto align it withthe longitudinal axis of the calcaneus(Fig. 6). Mark this line with a pen onthe skin. Next, place the K-Wire onthe lateral side of the ankle aligningthe wire along the tibial axis on a

lateral fluoroscopic view. Mark thisline with a pen on the skin extendingthe line onto the plantar surface(Fig. 7).

The starting point for the incisionis determined by the intersection ofthe two lines on the plantar surface.

The line marked on the plantarsurface which is aligned with thelongitudinal axis of the calcaneus

will also help align the AimingAdapter after Nail insertion.

A longitudinal incision approximately23cm should be made at thisintersection. Careful dissection isthen utilized to gain access to theplantar surface of calcaneus.

510

5

Operative Technique

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Fig. 5

Fig. 6

Fig. 7


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Operative Technique

The entry point is made under lateraland axial heel fluoroscopy control(Fig. 8) by using one of the followingoptions:

- A center-tipped Dril l 4.2340mm(1806-4260S).

- A Stepped Reamer, 812mm(1806-2013), over a 3285mm(1806-0050) K-Wire.

The Wire should be inserted to thelevel of the superior aspect of the ta lar

cut or prepared surface. Once thisposition has been verified as center/center in the talus, the Stepped reameris inserted over the wire.

It is recommended in this case touse the Protection Sleeve Retrograde(703165).

Note:Do not use bent K-Wires.

The axial heel view can help centerand assure good position within thecalcaneal body.

Stop the Drill or Stepped Reamer afterpassing through the tibial articularsurface gaining access into the tibialcanal.

Entry Point

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Fig. 8


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Operative Technique

ReamingInsert the 3800mm Ball TippedGuide Wire (1806-0080S) with theGuide Wire Handle (1806-1095 and1806-1096) through the talocalcanealand tibiotalar joints. Reaming is thenperformed with the Bixcut Reamersin 0.5mm increments until corticalcontact is made within the tibia. Foreasier nail insertion, the medullarycanal should be reamed 0.51.0mmmore than the nail diameter selected(Fig. 9).

The Ball Tip at the end of the GuideWire will stop the Bixcut Reamer

(Fig. 10).

Note:Prior to reaming, it is impor-tant to check the centered intra-medullary position of the GuideWire with image intensifier.

Prior to nail insertion, the3800mm Ball Tip Guide Wiremust be exchanged for a 3800mmSmooth Tip Guide Wire (1806-0090S).

Note:The Ball Tip at the end of theGuide Wire will stop the reamerhead.

Reaming (Fig. 9) is commenced in0.5mm increments until corticalcontact is appreciated. Final reamingshould be 1mm-1.5mm larger than thediameter of the nail to be used.

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Fig. 9

Fig. 10


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Operative Technique

The Guide Wire Pusher can be used tohelp keep the Guide Wire in position

during reamer shaft extraction. Themetal cavity at the end of the handlepushed on the end of the power toolfacilitates to hold the Guide Wire inplace when starting to pull the powertool (Fig. 11). When close to the GuideWire end place the Guide Wire Pusherwith its funnel tip to the end of thepower tool cannulation (Fig. 12).While removing the power tool theGuide Wire Pusher will keep theGuide Wire in place.

Caution:The diameter of the driving endof the 10mm11mm diameternails is 11.5mm. Additionalmetaphyseal reaming maybe required to facilitate nailinsertion. 12mm nails have aconstant diameter.

Note: The Ball Tip Guide wire must

be exchanged for the 3 800mm

Smooth Tip Guide Wire (1806-0090S) prior to nail insertion.

Use the Teflon Tube (1806-0073S)for the Guide Wire exchange.

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Fig.11

Fig. 12


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Operative Technique

Pre-load the Compression Screw(1818-0001S).Use the Compression Screwdriver(1806-3210) to insert the CompressionScrew into the nail (Fig. 13a).Make sure the screw is set betweenthe round and the oblong hole.

Prior to nail insertion, the Ball TipGuide Wire must be exchanged for aSmooth Tip Guide Wire.

The pre-loaded Compression Screw iscannulated but does not allow the balltip to pass through.

Assemble the Apposition Handle(1806-3215) onto the Nail Adapter(1806-3211). Turn the AppositionHandle until the end of the threadsin order not to influence the insertiondepth of the nail (Fig. 13b).

Attach the selected nail to theNail Adapter (Fig. 13c) until its 3connection teeth engage into thecorresponding slots of the Nail.

The Nail Holding Screw (1806-3203)is placed through the Nail Adapterand tightened securely with theInsertion Wrench (1806-0135) andWrench 8/10mm (1806-0130) to avoidloosening during Nail insertion.Engravings on the Nail Adapter willindicate lateral direction.

Insert the Target Arm(1806-3212)over the Nail Adapter and lock itin the Lateral Locking position.

Attach the Aiming Adapter (1806-3216) and secure the whole assemblyby tightening the Nut (1806-3213)(Fig. 14).

Prior to nail insertion please checkcorrect alignment of the TargetingDevice by inserting a 4.2340mmDrill (1806-4260S) through theassembled Tissue Protection (1806-0185) and Drill Sleeve, Long, (1806-0215) placed into the Targeting Arm

and targeting all Lateral Lockingholes of the implant.

Target Device Assembly

Note: If the Apposition Sleeve (1806-

3214) is to be used, slide itover the nail and Nail Adapterprior to nail insertion.

The Aiming Adapter shouldbe attached only when theTarget Arm is mounted on theNail Adapter in the LateralLocking position. Checkalignment of the P/A calcanealhole by passing a K-Wire

through the Aiming Adapter.

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Fig. 13a

Fig. 13c

Fig. 13b

Fig. 14

AppositionSleeve

Nut


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Operative Technique

Insert the nail over the Smooth TipGuide Wire (Fig. 15) to the desireddepth.

A chamfer is located on the medial side

of the nail driving end to avoid softtissue impingement af ter insertion.

Verify correct position of the nailby checking the correct depth androtation.

Depth of insertionis determined bycorrect placement of the distal oblonghole in the center of the talar body.This should be approximately themid-talar region to ensure satisfactorypurchase of the locking screw

(Fig. 15a).

Two circumferential grooves arelocated on the insertion post at 2mmand 7mm from the driving end of thenail (Fig. 15b). Depth of insertionmay be visualized with the aid offluoroscopy.Additionally, the 3285mm K-Wirecan be inserted through the TargetingDevice to identify the junction of thenail and insertion post (Fig. 15).

Rotational alignmentis determinedby a K-Wire placed into the AimingAdapter. This indicates the positionof the P/A calcaneal screw and al ignsthe screw with the anatomic calcanealbody axis (Fig. 16).

Correct position is achieved whenthe K-Wire is in line with the verticalline marked on the plantar surface(used for determining the entry point)(Fig. 16a).

The K-Wire may be inserted 1cminto the calcaneus to help maintainposition.

Remove the Guide Wire and proceedwith locking screw placement.

The nail length can be determinedpre-operatively by the X-Ray Templateor intra-operatively after a correctplacement of the Guide Wire andmeasurement by the Guide Wire Ruler.

Nail Insertion

Nail Length Determination

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Fig. 15a

Fig. 15b

Fig. 15

Fig. 16 Fig. 16a

7mm

2mm


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Operative Technique

Guided Locking via Target DeviceApposition/Compression

Locking Mode

The T2 Ankle Arthrodesis Nailprovides the option to achieve activemechanical apposition/compression.

Note:Proximal static locking with twoFully Threaded Locking Screwsmust be performed prior toapplying active, controlled tibio-talar apposition/compression.

Step 1:

Guided Dynamic Locking

of the Talar Screw

If clinical and radiological assessmentallow for applying tibio-talarcompression, a 5mm Shaft Screwshould be placed in the Dynamicposition of the oblong hole. Thiswill a llow for a maximum of 5mmof active, controlled apposition/compression. Make sure the Target

Arm is locked in the LateralLockingposition to place the screwfrom the lateral side of the talus.

Insert the Tissue Protection Sleeve,Long, (1806-0185) together with theDrill Sleeve, Long, (1806-0215) andthe Trocar, Long, (1806-0315) intothe Talus Dyn./Compr. hole ofthe Targeting Arm by pressing theSafety Clip (Fig. 17a). This mechanismwill keep the sleeve in place and

prevent it from fal ling out. It wil lalso prevent the sleeve from slidingduring screw measurement. To releasethe Tissue Protection Sleeve, theSafety Clip must be pressed again.

Advance the assembly through theskin incision that was used for jointpreparation until it is in contact withthe lateral cortex of the Talus (Fig. 17).

The Trocar is removed, with the TissueProtection Sleeve and the Drill Sleeveremaining in position (Fig. 18).

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Fig. 17a

Fig. 17


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Operative Technique

To ensure accurate drilling anddetermination of the screw length,use the centered tipped 4.2340mmcalibrated Dril l (1806-4260S). Afterdrilling both cortices, the screwlength may be read directly from thecalibrated Drill at the end of the DrillSleeve (Fig. 18a).

Next, drill the near cortex only, withthe 5230mm Drill (1806-5000S).

If measurement with the Screw Gauge,Long, (1806- 0325) is preferred, firstremove the Drill Sleeve and read the

screw length directly at the end of theTissue Protection Sleeve.

The position of the tip of the Drill asit relates to the far cortex is equal towhere the tip of the screw will end.Therefore, if the tip of the Drill is 3mmbeyond the far cortex, the tip of thescrew will a lso be 3mm beyond.

The Screw Gauge is calibrated so thatwhen the bend at the end is pulled

back flush with the far cortex, thescrew tip will end 3mm beyond the farcortex.

Note:Make sure the Tissue ProtectionSleeve/Drill Sleeve Assembly isseated on bone prior to selectingfinal screw length. (according tothis picture)

Remove the Drill Sleeve and insertthe appropriate Shaft Screw length

through the Tissue Protection Sleeveusing the Self-Holding Screwdriver,Long, (1806-0233) (Fig. 19). The screwis advanced through both cortices.The screw is near its proper seatedposition when the groove around theshaft of the screwdriver is approachingthe end of the Tissue Protection Sleeve(Fig. 19a).

Remove the Tissue Protection Sleeveand proceed with proximal locking.

Note:The Adapter and K-Wire mustbe removed before turning theTarget Arm to the medial side forproximal locking.

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Fig. 18

Fig. 18a

Fig. 19a

Fig. 19


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Step 2:

Guided Locking of the

Proximal Screws

Note:Guided Locking of the ProximalScrews must be performed withthe Target Arm locked in theMedial Locking position.

Do not attempt to use the TargetArm in the Lateral Lockingposition for proximal locking asthis will lead to miss-drilling.

The 300mm Nails can be lockedproximally only with thefree-hand technique.

Release the Nut and turn the TargetArm around the Nail Adapter until itcan be locked in the Medial Lockingposition (Fig. 20).

Before locking the proximal screws,check with the image intensifierthe gap between the tibial and talarsurface. If this is more than 5mm, tryto reduce the gap by applying gentlepressure on the Nail Adapter.

Insert the Tissue Protection Sleeve,Long, together with the Drill Sleeve,Long, and the Trocar, Long, into theappropriate hole for locking the staticproximal hole of the selected Naillength (150mm or 200mm are markedon the Target Arm).

Make a small skin incision in front

of the Trocar and push the assemblyuntil the Tissue Protection Sleeve is incontact with the medial cortex of thetibia (Fig. 21).

Before starting to drill for the firstproximal locking screw, check correctrotational position for the fusion; animaginary sagital line drawn downfrom the tibia tuberosity, along thetibial crest, should align with thesecond ray of the foot (Fig. 21).

Operative Technique

18

Fig. 20

Fig. 21


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Operative Technique

The Trocar is removed, with the TissueProtection Sleeve and the Drill Sleeveremaining in position (Fig. 22).

To ensure accurate drilling,it is recommended to use the4.2250, Drill oblique (1806-8018)to open the first cortex.

Use the centered tipped 4.2340mmcalibrated Drill (1806-4260S).After dril ling both cortices, thescrew length may be read directlyfrom the calibrated Drill at theend of the Drill Sleeve (Fig. 22a).

The position of the tip of the Drill, asit relates to the far cortex, is equal towhere the tip of the screw will end.

When the Drill Sleeve is removed,the correct Fully Threaded LockingScrew is inserted through theTissue Protection Sleeve using theScrewdriver, Long. The screw isadvanced through both cortices.The screw is near its proper seating

position when the groove aroundthe shaft of the screwdriver isapproaching the end of the TissueProtection Sleeve (Fig. 23).

The countersink (1806-2015) can beused through the Tissue ProtectionSleeve to help sinking the proximalscrew head. If this is used, undersizethe screw length by 5mm.

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Fig. 22

Fig. 23

Fig. 22a


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Operative Technique

Repeat the locking procedure for thesecond Locking Screw (Fig. 24). Thisone can only be placed in the dynamicposition of the proximal oblong hole.

Remove the Tissue Protection Sleeveand proceed with the tibio-talarcompression.

Step 3:

Tibio-talar apposition/

compression

Insert the Compression Screwdriver(1806-3210) through Nail Holdingscrew until the tip of the Screwdriverengages into the Compression Screw.

Start turning the CompressionScrewdriver clockwise. As the Com-pression Screw is advanced against the5.0mm Partially Threaded LockingScrew (Shaft Screw), it draws thetalus towards the proximal tibialsegment, employing active apposition/compression (Fig. 25).

Note:Caution should be taken whenactively compressing acrossthe tibiotalar fusion site inosteoporotic bone to avoidiatrogenic talus fractures dueto overcompression. Tibio-talaractive compression must becarried out under fluoroscopycontrol.

Before proceeding with the guidedlocking of the Lateral Calcaneal Screw,external talo-calcaneal apposition/compression can be applied, if needed.

20

Fig. 24

Fig. 25


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Operative Technique

Step 4 (optional):

Talo-calcaneal external

compression

External compressionis achievedby inserting the Apposition Ring(1806-3204) over the AppositionHandle (1806-3215). This will pro-tect the soft tissues by applying com-pression forces on a larger surface.Turn the Apposition Handle Clock-wise until the Apposition Ring is incontact with the soft t issues. Continueturning the Apposition Handle to

apply talo-calcaneal apposition/compression(Fig. 26).

Alternatively, the Apposition Sleeve(1806-3214) can be used to applyexternal compression directly on thecalcaneal cortex in case of poor softtissue condition.

Note:The Apposition Sleeve must beinserted over the Nail Adapterbefore nail insertion.

Step 5:


Lateral Calcaneal Screw

Release the Nut and turn the TargetArm around the Nail Adapter untilit can be locked again in the LateralLocking position (Fig. 27).

Insert the Tissue Protection Sleeve,Long, together with the Drill Sleeve,Long, and the Trocar, Long, into theCalcaneus hole of the Target Armby pressing the Safety Clip.

Make a small skin incision in frontof the Trocar and push the assemblyuntil the Tissue Protection Sleeve isin contact with the lateral calcanealcortex.

The Trocar is removed, with the Tissue

Protection Sleeve and the Drill Sleeveremaining in position.

Use the centered tipped 4.2340mmcalibrated Dril l (1806-4260S). After

drilling both cortices, the screwlength may be read directly from thecalibrated Drill at the end of the DrillSleeve.

When the Drill Sleeve is removed,the correct Fully Threaded LockingScrew is inserted through theTissue Protection Sleeve using theScrewdriver, Long (Fig. 28).

Step 6:


Posterior Calcaneal Screw

Release the external compression.

Release the Nut and turn the TargetArm around the Nail Adapter until

it can be locked in the PosteriorLockingposition.

Insert the Tissue Protection Sleeve,Long, together with the Drill Sleeve,Long, and the Trocar, Long, into theCalcaneushole of the Targeting Armby pressing the Safety Clip (Fig. 29).

Repeat the locking procedure asdescribed for the Lateral CalcanealLocking.

The countersink (1806-2015) can beused through the Tissue ProtectionSleeve to assist in sinking the P/ACalcaneus screw head. If this is used,undersize the screw length by 5mm.

21

Fig. 26

Fig. 27

Fig. 29

Fig. 28


22/36

Operative Technique

Step 1:

Guided Static Locking of the

Talar Screw

If clinical and radiological assess-ment does not allow for applyingtibio-talar compression, a 5mmShaft Screw should be placed inthe Static position of the oblonghole.Make sure the Target Armis locked in the Lateral Lockingposition to place the screw fromthe lateral side of the talus.

Insert the Tissue Protection Sleeve,Long, together with the Drill Sleeve,Long, and the Trocar, Long, into theTalus Statichole of the Target Armby pressing the Safety Clip (Fig. 30).

Follow the same locking procedureas described on page 16 and 17for the insertion of the TalarScrew in dynamic position.

Static Locking Mode

22

Fig. 30


23/36

Operative Technique

After the Talar Screw is inserted,remove the Tissue ProtectionSleeve and proceed with advancingthe compression screw againstthe Talar Screw (Fig. 31).

Insert the Compression Screwdriver(1806-3210) through Nail Holdingscrew until the tip of the Screwdriverengages into the Compression Screw.

Start turning the CompressionScrewdriver clockwise. TheCompression Screw will advanceuntil it locks down onto the

Talar Screw providing axialstability of the construct.

Caution:The coupling of Elastosil Handlescontains a mechanism withone or multiple ball bearings.In case of applied axial stresson the Elastosil handle, thosecomponents are pressed into thesurrounding cylinder resulting ina complete blockage of the device

and possible bending.

To avoid intra-operativecomplications and secure long-term functionality, we mandatethat Elastosil handles be used onlyfor their intended use.DO NOT HIT hit on them.

Step 2:


Lateral Calcaneal Screw

After locking the Talar screw inplace with the compression screw,leave the Target Arm in the LateralLocking position and proceed withthe Lateral Calcaneal screw insertion.

Follow the locking procedureas described on page 21 for theLateral Calcaneal Screw.

23

Fig. 31

Fig. 32


24/36

Operative Technique

Step 4:


Posterior Calcaneal Screw

Release the Nut and turn the TargetArm around the Nail Adapter untilit can be locked in the PosteriorLockingposition (Fig. 34).

Insert the Tissue Protection Sleeve,

Long, together with the Drill Sleeve,Long, and the Trocar, Long, into theCalcaneus hole of the Target Armbypressing the Safety Clip.

Repeat the locking procedure asdescribed on page 21.

Step 3:


Proximal Screws

Note:Guided Locking of the ProximalScrews must be performedwith t he Target Arm locked inthe Medial Locking position(Fig. 32).The 300mm Nails can be lockedproximally only with the free-hand technique.

Proceed with the locking procedureas described on pages18-19 for theApposition/Compression LockingMode.

24

Fig. 33

Fig. 34


25/36

Operative Technique

Freehand Proximal Locking of Long NailsThe freehand technique is used toinsert locking screws into both M/Lproximal holes of the T2 AnkleArthrodesis Long Nails (300mm).

Multiple locking techniques andradiolucent drill devices are availablefor freehand locking. The criticalstep with any freehand lockingtechnique, proximal or distal,is to visualize a perfectly roundlocking hole or perfecty oblonglocking hole with the C-Arm.

Hold the center-tipped 4.2130mm

Drill (1806-4280) at an obliqueangle to the center of the lockinghole (Fig. 35). Upon fluoroscopicverification, the Drill is placedperpendicular to the nail anddrilled through the medial andlateral cortex of the tibia. Confirmthat the Drill passes through thehole in the nail in both the A/Pand M/L fluoroscopy views.

After dri lling both cortices, the screw

length may be read directly fromScrew Scale, Short, (1806-0360) atthe green ring on the center-tipped4.2130mm Drill(Fig. 36).Alternatively, the Screw Gauge (1806-0480) can be used instead of the ScrewScale to determine the screw length.

Routine locking screw insertionis employed with the assembledScrewdriver Shaft, Short, (1806-0294)and the Teardrop Handle (702429).

Repeat the locking procedure to insertthe second proximal locking screw.

green ring

25

Fig. 35

Fig. 36


26/36

Operative Technique

End Cap InsertionThe End Cap (1826-0003S) can beinserted

Either through the Nail Adapter, withthe Screwdriver, Long, (after removalof the Nail Holding Screw)

or

With the Screwdriver Shaft, Short, andthe Teardrop Handle (Fig. 37), afterremoval of the Target Device (Fig. 37).

Note:

This is the same End Cap usedfor the T2 SCN. The End Cap wil llock on the distal P/A calcanealscrew providing additional ax ialstability.

Extension End Caps of +5, +10 and+15mm are also available to adjustnail length and lock down on thedistal P/A calcaneal screw. These EndCaps cannot be inserted throughthe Nail Adapter due to the largerdiameter of the head.

Extension End Caps are notcannulated.

+5mm +10mm +15mm

26

Fig.37


27/36

Nail RemovalNail removal is an elective procedure.

If used, remove first the End Capand the most distal Screw with theScrewdriver, Long (Fig. 38).

Remove the Lateral Calcaneal Screw.

Release the Compression Screw toallow removal of the Talar screw.

Insert the Universal Rod into thedriving end of the nail.

Remove all other Locking Screws and

use the Slottet Hammer (1806-0170) toextract the nail in a controlled manner(Fig. 39).

Operative Technique

27

Fig. 38

Fig. 39


28/36

Operative Technique

Case ReportsProvided by Anthony

T. Sorkin, M.D.

The patient is a 58 year old malewith a pilon fracture 30 yearsprior to her first visit to theoffice, complaining of severepain. Advanced post-traumaticarthritis of both sub-talar andtibio-talar joints can be seen on thepreoperative X-Rays (Fig. 40 andFig. 41).

Incisions were made both laterallyand medially to fully debride the

tibiotalar and subtalar joints.

The T2 Ankle Arthrodesis Nailused as definitive treatment.

Tibio-talar compression wasapplied with a preloadedcompression screw. Additional talo-calcaneal compression was achievedwith the external compressiondevice. Axially stable locking ofthe transverse calcaneal screw

(passing through a threaded holeof the T2 AAN) and P/A calcanealscrew (locked in place by the endcap) providing increased stability.

Postoperative X-Rays (Fig.43a, 43b, 43c) show perfectalignment sustained by the5 valgus of the T2 AAN.

Patient weight bearing at 8 weeks without any pain.

Fig. 40

Fig. 41

Fig. 43cFig. 43a Fig. 43b

28


29/36

References

1. Tibiotalocalcaneal fusion with aretrograde intramedullary nail:

clinical and functional outcomes. Millett PJ, OMalley MJ, Tolo ET,

Gallina J, Fealy S, Helfet DL. Harvard Medical School, Brigham

& Womens Hospital, Boston, Massachusetts, USA. Am J Orthop.

2002 Sep; 31(9):531-6.

2. The effect of bone quality on thestability of ankle arthrodesis.

A finite element study. Alonso-Vazquez A, Lauge-Pedersen

H, Lidgren L, Taylor M. Bioengineering Sciences Research

Group, School of EngineeringSciences, University ofSouthampton, Southampton SO171BJ, UK. Foot Ankle Int.

2004 Nov; 25(11):840-50.

3. Ankle arthrodesis with intra-medullary compression nailing

Muckley T, Schutz T, SrivastavaS, Goebel M, Gonschorek O,Bhren V.

BerufsgenossenschaftlicheUnfallklinik, Murnau.Unfallchirurg. 2003 Sep;106(9):732-40.

4. Realignment arthrodesisof the rearfoot and ankle: a

comprehensive evaluation. Mendicino RW, Lamm BM,

Catanzariti AR, Statler TK, Paley D. Division of Foot and Ankle

Surgery, Western PennsylvaniaHospital, Pittsburgh, PA 15224,USA.

5. Primary stiffness of differentarthrodesis techniques for theupper ankle joint considering thecompression nail: a biomechanicalstudy

Muckley T, Eichhorn S, SteinhauserE, von Oldenburg G, Speitling A,Hofmann G.O., J. Ortop. Trauma2004 #18,

6. Intramedullary nailing intibiocalcaneal arthrodesis

Goebel M, Muckley T, GerdesmeyerL, Militz M, Bhren V.Unfallchirurg. 2003 Aug;106(8):633-41

29


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Ordering Information Implants

ANKLE ARTHRODESIS NAIL, RIGHTANKLE ARTHRODESIS NAIL, LEFT

REF Diameter Length mm mm

1818-1015S 10 150

1818-1020S 10 2001818-1030S 10 300

1818-1115S 11 1501818-1120S 11 2001818-1130S 11 300

1818-1215S 12 1501818-1220S 12 2001818-1230S 12 300

END CAPS


1818-0001S 8.0 14.5

COMPRESSION SCREW (CANNULATED)



1819-1015S 10 150

1819-1020S 10 2001819-1030S 10 300

1819-1115S 11 1501819-1120S 11 2001819-1130S 11 300

1819-1215S 12 1501819-1220S 12 2001819-1230S 12 300

1826-0003S 8.0 4.01818-0005S 12.0 +5mm

1818-0010S 12.0 +10mm1818-0015S 12.0 +15mm

+5mm

+10mm

+15mm

30


31/36

Ordering Information Instruments

REF Description

T2 Basic Long

702429 Teardrop Handle, AOCoupling

703165 Protection Sleeve,Retrograde

1806-0022 Guide Wire Ruler

1806-0032 Awl Plug

1806-0041 Awl

1806-0110 Universal Rod

1806-0125 Reduction Spoon

1806-0130 Wrench 8mm/10mm

1806-0135 Insert ion Wrench, 10mm

1806-0150 Strike Plate

1806-0170 Slotted Hammer

1806-0185 Tissue Protection Sleeve,Long

1806-0203 Screwdriver, Self-Holding,Extra Short (3.5)

1806-0215 Dril l Sleeve, Long

1806-0227 Screwdriver Shaft AO,Long

1806-0233 Screwdriver, Self-Holding,Long (3.5)

1806-0268 Screwdriver Shaft,Compression (hex3.5)

1806-0271 Guide Wire Pusher

1806-0315 Trocar, Long

1806-0325 Screw Gauge, Long

1806-0331 Screw Gauge (20-120mm)

1806-0350 Extraction Rod,Conical (8mm)

1806-0365 Screw Scale, Long

1806-1095 Guide Wire Handle

1806-1096 Guide Wire HandleChuck

1806-2014 Rigid Reamer 12mm

1806-9900 T2 Basic LongInstrument Tray

REF Description

T2 Ankle Art hrodesis

1806-0050 K-Wire 3x285mm

1806-0073 Teflon Tube

1806-0360 Screw Scale , Short

1806-2015 Countersink for Cortica l Screw

1806-3203 Nail Holding Screw

1806-3204 Apposition Ring

1806-3210 Compression Screwdriver

1806-3211 Nail Adapter

1806-3212 Target Arm

1806-3213 Nut

1806-3214 Apposition Sleeve

1806-3215 Apposition Handle

1806-3216 Aiming Adapter

1806-3218 Nut Tightening Pin

1806-4260* Dril l 4.2340mm, AO

1806-4280* Dril l 4.2130mm, AO

1806-5000* Dril l 5.0230mm, AO

1806-8018 Dril l 4.2250mm, Oblique AO

1806-9960 T2 Ankle Instrument Tray

* Instruments designated Outside of the U. S. may not

be ordered for the U. S. market.

Caution:8mm Nails require 4mm FullyThreaded Screws for locking at thenon-driving end.

Optional Instruments

1806-9975 T2 Ankle Dril l Rack

1806-9982 Silicon Mat

1806-3217 X-Ray Template

REF Description

31


32/36

Complete range of modular andfixed-head reamers to matchsurgeon preference and optimizeO. R. efficiency, presented in f ullysterilizable cases.

Studies1have demonstrated thatthe pressures developed withinthe medullary cavity through the

introduction of unreamed IMnails canbe far greater than those developedduring reaming but this dependsvery much upon the design of thereamer.

After a three year development study2involving several universities, thefactors that determine the pressuresand temperatures developed duringreaming were clearly established.These factors were applied to the de-

velopment of advanced reamers thatdemonstrate significantly better per-formance than the best of previousdesigns3.

1 Jan Paul M. Frolke, et al. ;

Intramedullary Pressure in Reamed Femoral

Nailing with Two Different Reamer Designs.,

Eur. J. of Trauma, 2001 #5

2 Medhi Moussavi, et al.;

Pressure Changes During Reaming with Different

Parameters and Reamer Designs,

Clinical Orthopaedics and Related ResearchNumber 373, pp. 295-303, 2000

3 Andreas Speitling;

Intramedullary Reamers, commented slides of

internal test report, Sep 1999

Large clearance rate resulting from reduced number

of reamer blades coupled with reduced length of

reamer head to allow for effective relief of pressure

and efficient removal of material3.

Cutting flute geometry optimized to lower pressure

generation3.

Forward- and side-cutting face combination produces

efficient material removal and rapid clearance3.

Double-wound shaft transmits torque effectively and

with high reliability. Low-friction surface finish aids

rapid debris clearance3.

Smaller, 6 and 8mm shaft diameters are designed to

reduce IM pressure.Typical Standard

Reamer 14mm

Clearance area :

32% of cross section

Bixcut

Reamer 14mm

Clearance area :

59% of cross section


Bixcut

Bixcut

32


33/36

REF Description Diameter mm

BIXCUT MODULAR HEAD


BIXCUT FIXED HEAD AO FITTING**

REF Description Length mm

BIXCUT SHAFTS (STERILE)1,2,3, 4

REF Description

SHAFT ACCESSORIES

REF Description

BIXCUT TRAYS EMPTY


REF Description

OPTIONAL INSTRUMENTS

0227-0060 Hand Reamer 6 mmw/Mod Trinkle connection




1806-6520 Curved Reduction Rod 8.5 mmw/Mod Trinkle connection

1806-6500 T-Handle w/Mod Trinkle connection

0226-3090

0226-3095

0226-3100

0226-3105

0226-3110

0226-3115

0226-3120

0226-3125

0226-3130

0226-3135

0226-3140

0226-3145

0226-3150

0226-3155

0226-3160

0226-3165

0226-3170

0226-3175

0226-3180

0226-41850226-4190

0226-4195

0226-4200

0226-4205

0226-4210

0226-4215

0226-4220

0226-4225

0226-4230

0226-4235

0226-4240

0226-4245

0226-4250

0226-4255

0226-4260

0226-4265

0226-4270

0226-4275

0226-4280

Bixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut Head

Bixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut HeadBixcut Head

9.09.5

10.010.511.011.512.012.513.013.514.014.515.015.516.016.517.017.518.0

18.519.019.520.020.521.021.522.022.523.023.524.024.525.025.526.026.527.027.528.0

0227-8240S Mod. Trinkle 2840227-3000S Mod. Trinkle 4480227-8510S Mod. Trinkle 5100227-8885S Mod. Trinkle 8850226-8240S AO 2840226-3000S AO 448

0225-6000 Tray, Modular Head

(up to size 22.0mm)0225-6001 Tray, Modular Head (up to size 28.0mm)0225-8000 Tray, Fixed Head (up to size 18.0mm)0225-6040 Mini Trauma Tray (for modular heads 9-18)0225-6050 Mini Revision Tray (for modular heads 9-28)

0225-50600225-50650225-50700225-60750225-60800225-60850225-60900225-60950225-61000225-61050225-61100225-81150225-81200225-81250225-81300225-81350225-81400225-81450225-8150

0225-81550225-81600225-81650225-81700225-81750225-8180

6.0*6.5*7.0*7.58.08.59.09.5

10.010.511.011.512.012.513.013.514.014.515.0

15.516.016.517.017.518.0

400400400480480480480480480480480480480480480480480480480

480480480480480480

3212-0-210 Grommet (pack of 25)3212-0-220 Grommet inser ter/extractor0225-6010 Grommet Case

Note:

Bixcut Fixed Head Modifed Trinkle fttingavailable in same diameters and

length as the AO Fitting (REF No: 0227-xxxx)* Use with 2.2mm 800mm Smooth Tip and 2.5mm 800mm Bal l Tip Guide Wires only.**Use with Stryker Power Equipment.

1. Non-Sterile shafts supplied without grommet. Use new grommet for each surgery. See ShaftAccessories.

2. Sterile shafts supplied with grommet pre-assembled.

3. For Non-Sterile leave S off the REF Number when ordering (510 and 885mm available only steril e

Modified Trinkle Fitting).

4. Non-Sterile, AO Fitting Shafts in 510 and 885mm are available as build to order items:

CM810921 AO Fitting Shaft, length 510mm

CM810923 AO Fitting Shaft, length 885mm.

33


34/36


35/36

Notes

35


36/36

This document is intended solely for the use of healthcare professionals.A surgeon must always rely on his or herown professional clinical judgment when deciding whether to use a particular product when treating a particularpatient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particularproduct before using it in surgery. The information presented in this brochure is intended to demonstrate a Strykerproduct. Always refer to the package insert, product label and/or user instructions including the instructions forCleaning and Sterilization (if applicable) before using any Stryker products. Products may not be available in allmarkets. Product availability is subject to the regulatory or medical practices that govern individual markets. Pleasecontact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the followingtrademarks or service marks: Stryker, T2 and Bixcut.

All other trademarks are trademarks of their respective owners or holders

Stryker Trauma GmbHProf.-Kntscher-Strae 15D - 24232 SchnkirchenGermany

www.osteosynthesis.stryker.com

t2anklearthrodesis_optech_b1000044d0710

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