t2 kids pediatricflexiblenail · 2 contents 1. introduction&rationale 3 2....

Operative Technique

T2 KidsPediatric Flexible Nail

2

Contents

1. Introduction & Rationale 3

2. Indications and Contraindications 4

3. Features & Benefits 5

Nails 5

Instruments 5

Trays 5

Material Advantages 6

All Fractures 7

Nail Bending 8

Determining the Incision and Insertion Points 9

Femoral Midshaft 12

1 - Cortical Opening 12

2 - First Nail Insertion and Progression 12

3 - Crossing the Fracture Site with the First Nail 13

4 - Crossing the Fracture Site with the Second Nail 14

5 - Impacting the Nail Tips 15

6 - Bending the Nails Prior to Cutting 15

7 - Cutting the Nail Ends 16

8 - Impacting the Cut Nail Ends 16

Forearm Mid-Shaft 17

1 - Incision and Insertion Points for Radial Shaft Fracture 17

2 - Radial Nail Insertion 17

3 - Crossing the Fracture Site with the Radial Nail 18

4 - Cortical Opening for the Ulnar Nail 19

5 - Insertion of Ulnar Nial 19

6 - Crossing the Fracture Site with the Ulnar Nail 20

7 - Impacting the Nail Tips 21

8 - Bending the Nail Ends Prior to Cutting 21

9 - Cutting the Nail Ends 22

10 - Impacting the Nail Ends 22

Removing the Nails 23

Care and Maintenance 24

4. Ordering Information - Implants 25

5. Ordering Information - Instruments 26

6. References 28

3

Introduction & Rationale

In 1979, Professor Jean Prévot and hisyoung team of surgeons -Dr Métaizeau, Dr Ligier andDr Lascombes of the CentreHospitalier Universitaire of Nancy,France, developed and introduced atechnique for the treatment of longbone fractures in children usingflexible IM nailing. The goal was toimprove cumbersome surgicaltechniques that required long hospitalstays and sometimes substantial scarsthat were badly perceived by both thechildren and their parents. At the sametime, the system needed to provideadequate stability for the healing bone.

In 1994, Professor Prévot passed historch of pediatric orthopaedicleadership of the University Hospitalin Nancy to Professor PierreLascombes, who has continued toperfect and teach the flexibleintramedullary nailing techniquearound the world.

In order to share the expertiseacquired over more than 30 years inNancy and with the intention to unitethe culmination of experience of manyrenowned surgeons, ProfessorLascombes published one of the mostcomplete books about this flexible nailtechnique to date. The book, entitledEmbrochage centromédullaire élastiquestable 1 describes the technique for allbones and provides numerousillustrated tips and tricks. Theillustrations found in this documentare used with the permission of thepublisher.1

Introduction

Rationale

What is the concept behind flexiblenailing which makes it not onlybiomechanically advantageous to morerigid fixations but also moredemanding to learn as a technique?

The technique consists of bendingnails of appropriate diameters in sucha manner that, when inserted into afractured bone, the nails may reducethe fracture, splint the cortices withoptimal force at the fracture site andmaintain the elastic energy tocontinually brace against rotationaland angular forces of the muscles.

An effort is required of the surgeon toconsider not only the choice of

implant but also the manner in whichthe frame is to be constructed in his orher hands, according to the indication.It is the aim of Stryker to providesurgeons with the best possiblematerials and instruments to ease thetask of reducing and stabilizingfractures in children. Much consultinghas been done, drawings made andexplained in detail, surgeries observed,laboratory studies and testingperformed to determine the optimalmaterials, the dimensions and theshape of the nails as well as theeffectiveness, ergonomics and necessityof each instrument. The operating

room staff ’s needs have not beenforgotten, as we have also consideredthe practicalities of the cleaning,storage and easy identification of ourproducts.

It is our desire that the T2 KidsPediatric Flexible Nail system helpseach surgeon gain not only confidencebut also joy in his or her ability tobring children back to good health.

4

Indications and Contraindications

The physician’s education, training andprofessional judgment must be reliedupon to choose the most appropriatedevice and treatment.

Conditions presenting an increasedrisk of implant failure include:

• Open fractures Gustilo grade III.

• Comminuted fractures

• Epiphyseal fractures

• Obese patients with lower limbfractures

• Any active or suspected latentinfection or marked localinflammation in or about theaffected area.

• Bone stock compromised bydisease, infection or priorimplantation that can not provideadequate support and/or fixationof the devices.

• Material sensitivity documented orsuspected.

• Malignant bone tumors.

• Implant utilization that wouldinterfere with anatomicalstructures or physiologicalperformance.

• Other medical or surgicalconditions which would precludethe potential benefit of surgery.

Detailed information is included in theinstructions for use being providedwith each implant.

See package insert for a complete listof potential adverse effects andcontraindications.

The surgeon must discuss all relevantrisks, including the service life of thedevice, with the child’s parents orguardian.

Contraindications

Indications

The Stryker T2 Kids nail is intendedfor the fixation of fractures whereflexibility of the implant is desired.This includes the following fractures:

• Lower extremity diaphysealfractures of children and small-statured adults.

• Upper extremity diaphysealfractures in both adults andchildren.

• Some metaphyseal fractures, suchas radial neck, proximal humerusand supracondylar humerusfractures.

Nails

Materials

The T2 Kids nail is offered in twomaterials:16-19

Titanium: Grade 5 Ti6Al4V ELIconforming with ASTM F136, type IIanodized with laser-etched rings foreasy identification of nail diameter.

Stainless Steel: 1.4441 (316 LVM)conforming with DIN ISO 5832-1 withlaser-etched rings for easyidentification of nail diameters.

Diameters

Diameters: Ø1.5; Ø1.75; Ø2.0; Ø2.25mmwith length 300mm.

Diameters: Ø2.5; Ø3.0; Ø3.5; Ø4.0mmwith length 450mm.

We offer an extensive diameter rangefor optimal patient treatment.

Packaging

All nails are offered with 2 nails of thesame diameter in sterile as well as innon sterile packaging, for theconvenience of the hospital policiesand practices.

Curved Tip

Curved nail tip with optimized lengthto allow maximal guidance withoutblocking in intramedullary canal.

IF the selected nail diameter (d) is 2/5or 40% of the IM canal diameter (D)AND the nail tip height is a factor of2.2d - THEN there remains a clearancebetween the IM canal and the nail tip.

Example: D=10mm

d =0.4x10=4mm

Nail tip height =8.8<10mm

Tapered Tips and Concave Side

Tapered tip and concave inner side foranchoring in metaphyseal bone andcapturing fracture fragments.

Smooth Convex Side

Smooth and broad outer convex sideimproves gliding during insertion and

helps to prevent second cortexpenetration.

Pre-curved Shaft

The T2 Kids nail features an additionalinsertion bend to assure the maximumease of insertion. This bend saves onestep during the surgical procedure as

such a curved shaft is added in mostcases to ease insertion.

Note:

This pre-curved proximal shaftdoes not preclude the need for thesurgeon to bend the nail to createthe three point cortical contact.

Instruments

The Stryker T2 Kids instruments arebased on the T2 IM Nailing instrumentplatform.

More than that, the T2 Kids systeminstruments are designed for besttreatment outcome by distinguishingbetween small and large bonetreatment characteristic to pediatricorthopaedics.

This optimizes the instrument-to-patient precision maneuvering whilemaintaining the Stryker signatureergonomic handles.

Trays

Tray Layout According to OperativeSteps

1) Nail bending: Bending Instrument

2) Bone opening: Awl (Large andSmall) and Tissue Protective Sleeve(opt.)

3) Nail Insertion and Tip Impaction:Inserter, Slotted Hammer

4) Nail Cutting: Cutters

5) Nail End Impaction: FinalImpactors (Large and Small) andSlotted Hammer

6) Nail Removal: Forceps, UniversalRod (top tray insert) and SlottedHammer

5

Features and Benefits

Nail end (Driving end)

Straight shaftportion

Pre-curved shaftportion

Nail tip

Inner curve(concave)

Taperedextremity

Outer curve(convex)

Curved Nail tip ornail tip curvature

Figure 1.

Image 1.

Ti 6AI 4V Type III anodizedTi 6AI 4V non anodized Ti 6AI 4V Type II anodized

115%100%100%

23.70g 0.05g3.29g

Fatigue Strength

Wear rates

NON ANODIZED TITANIUM TYPE II ANODIZED TITANIUMTYPE III ANODIZED TITANIUM

6

Features and Benefits

Material Advantages

All Stryker T2 implants are made of Type II anodized titanium alloy (Ti6AL4V) for enhanced biomechanical performance19.

Large band marking = 1mmSmall band marking = .25mm

All Stryker T2 Kids nail ends are laser-marked with bands for easy diameter identification. Thick bands indicate 1mmdiameter and thin bands indicate .25mm diameter. Verify the nail diameter by inserting the nail end into the designated holein the tray insert.

4m 3.5 3m 2.5m 2.25 2m 1.75 1.5

Diagram 1.

Diagram 2.

7

Operative Technique

All Fractures

Nail Selection

Instrument: X-Ray Ruler

The diameter of the implants shouldbe about 40% of the diameter of theintramedullary canal measured on theX-ray.

The formula is therefore:

Ø nail = 0.4 x Ø IM canal.

Some individual adaptations aretolerated but experience has shownthat when hesitating between twodiameters, the greater diameter shouldalways be preferred over the lesserdiameter, which may lead to adeformation caused by a less stableconstruct.

In the majority of cases, the two nailsshould have matching diameters toprevent iatrogenic valgus or varusdeformities. Verify the selected naildiameter in at least one of the fourpossible ways:

• Packaging information

• Laser band markings on the nail

• Measuring holes on the metal trayinsert

• X-Ray Ruler

ø Nail = 0.4 x IM canal

Alternatively the nail diameter can bedetermined using the X-Ray Ruler.Place the X-Ray Ruler on the skinabove the IM canal to be measured.Take a fluroscopic pictureperpendicular to the X-Ray Ruler.Adjust the ruler now so that the IMcanal outer line lies in between the cutout. The recommended nail diameteris displayed above the cut out.

Fracture Reduction

Instrument: Reduction Instrument

Check if the fracture can be reduced ina closed manner prior to setting up thesterile field.

Assemble the Reduction Instrument bythreading the two bars into the handleat the appropriate levels according tothe limb to be treated and the patient’ssize. Slide the Reduction Instrumentover the limb with a bar on each sideand reduce the fracture bymaneuvering the handle of the tool.Verify the reduction through bi-planarfluoroscopy over the radiolucentreduction bars.

Figure 2.

Image 3.

Image 2.

Image 4.

Image 5.

8

Nail Bending

Instrument: Bending Instrument

The Bending Instrument is a multi-purpose instrument with specificallydesigned bending slots and through-holes. The following possibilities areprovided:

• creating identical fracture bends fortwo nails

• increasing or decreasing the radius ofthe pre-manufactured curved shaft

The fracture bend is created by thesurgeon to ensure a continuedcorrectional force within theintramedullary canal at the fracturelevel. This correctional force is a resultof the characteristic memory of themetal (found in titanium and to alesser degree in stainless steel). Thismetal memory, called elasticity, is apotential energy which causes the nailto strain against the cortex in an effortto regain the pre-operative bend whichwas produced by the surgeon andwhich afterwards is contained in anarea too narrow to permit the bend tobe physically expressed.

Engage the nail into the appropriateslot or through-holes.

Bend the nails according to thesituation with the apex at the fracturelevel. Bending both nails identicallypermits an optimal stability of theframe by ensuring matching curves.

Caution: Avoid both over-bending thenail and creating any notches on thenail surface.

Operative Technique

Image 9. Increasing the pre-curvedshaft

Image 6. Creating the fracture bendusing the slots

Image 7. Creating the fracture bendusing the through-holes

Image 8. Decreasing the pre-curvedshaft

Figure 3.

Tibial/Fibial Antegrade

Opening Construct

Femoral Antegrade

Opening Construct

9

Operative Technique

All Fractures

Determining the Incision andInsertion Points

The insertion site can be determinedby placing the Awl perpendicular to thebone and above the skin then taking afluoroscopy image in the frontal viewto confirm. The skin is incised wherethe cortex will be opened, allowing forextra space to permit maneuvering ofthe nail upon insertion withoutirritating the skin.

To fully benefit from the flexibleintramedullary nailing technique,respect the following guidelines:

1) The apex of the (40°) bend issituated at the fracture level

2) The two nails are aligned face-to-face in the canal

3) The two nails cross each otherabove and below the fracture site.

See the diagrams on the followingpages which depict the opening andfinal constructs for several procedures.

Femoral Retrograde

Opening ConstructWarning: When opening the medial site, be careful not to let the Awl or Drill Bit slip posteriorlyinto the region of the femoral artery.

Construct

Figure 4.

Figure 5.

Figure 6.

10

Tibial Retrograde

Operative Technique

All Fractures

Proximal Humerus

Opening Construct

Humerus Midshaft

Opening Construct

Construct

Warning: Avoid the radial nerve.

Figure 7.

Figure 9.

Figure 8.

11

All Fractures Humerus Supracondylar

Radial Neck

Opening Construct

Forearm

Ulnar Opening Construct

Opening Construct

Radial Opening

Warning: Avoid the extensor tendons and superficial radial nerve.

Figure 12.

Figure 11.

Figure 10.

12

Operative Technique

Femoral Mid-Shaft

1 - Cortical Opening

Instruments: Large ø5.0mmAwl orø5.0mmDrill bit, Tissue ProtectionSleeve

The Tissue Protection Sleeve acceptsboth the large ø5.0mm and smallø3.2mm drill bit as well as the Largeø5.0mm Awl. The front is serrated for abetter grip on bone.

The length of the Tissue ProtectionSleeve limits the functional length ofthe Drill Bits and the Large Awl to20mm. This avoids penetration of thefar cortex by the Drill Bit or Awl aswell as protecting the adjacent softtissues.

The Large ø5.0mm Awl or largeø5.0mm Drill Bit is reccommendedwhen nails of the following diametersare used:

ø2.5mm; ø3.0mm; ø3.5mm andø4.0mm.

The cortical insertion hole is madewith the Awl or Drill Bit which is firstapplied at a 90° angle (perpendicular)to the cortex. Once the first cortex ispenetrated, the instrument-to-boneangle is lowered to shape an obliqueopening in the direction of thefracture.

Optional Curved Awls are available tofurther enlarge the insertion hole.

Warning:

Do not use the Curved Awl forthe initial opening of thebone as a sharp curvedinstrument is difficult toprevent from damagingsoft tissues.

2 - First Nail Insertion andProgression

Instrument: Inserter

Engage the selected nail with theInserter by sliding its end into the frontthrough the designated opening. Fororientation of the curved nail tip alignthe nail tip with the handle of theInserter.

Squeeze and hold the handle of theInserter to firmly grip the nail.

Introduce the nail into the boneopening with the hook facing awayfrom the fracture. When the oppositecortex is felt, rotate the nail 180° sothat the hook now faces the fractureand is ready to be glided progressivelythrough the intramedullary canal.

The nail is pushed forward in the canalusing slight rotational movements toavoid blockage in the intramedullarycanal.

Figure 13. Cortical opening

Figure 14. Nail insertion

Operative Technique

Femoral Mid-Shaft

3 - Crossing the Fracture Sitewith the First Nail

Instruments: Inserter,

Slotted Hammer

The Slotted Hammer is designed to fitover the nail and slide along it to tapwith controlled blows on the Inserterand drive the nail forward in theintramedullary canal. Make sure toonly tap on the strike surface on thefront and backside of the Inserter foran insertion force in line with the nail.

Check the progression of the nail withfluroscopy to ensure that the tip isadvancing with each blow.

When the fracture site is reached, thenail tip must be rotated 180° so that itis oriented just below the oppositefragment in both frontal and lateralfluoroscopic views. The fracture isreduced and reduction is checkedusing fluoroscopy once again. Drivethe nail across the fracture site usingthe Slotted Hammer.

How far up the fragment should thefirst nail be inserted?

Option 1: Verify the reduction and nailposition with frontal and lateralfluoroscopy. Advance the nail a fewcentimeters further in the far fragment.

By advancing the first nail just slightlyinto the second fragment there is lessstability but more reduction potential,given that the communication betweenthe two fragments is with only oneunanchored nail. This also facilitatespassage of the second nail.

Option 2: If the first nail is advancedmuch further up the canal, there is aheightened stability of the primaryreduction but the passage of thesecond nail is not as simple, as thespace in the intramedullary canal hasbeen reduced. In this case, more spacecan be gained by rotating the nail.

13

Figure 16. Crossing the fracture site

Figure 15. Crossing the fracture site

14

Operative Technique

Femoral Mid-Shaft

4 - Crossing the Fracture Sitewith the Second Nail

Instruments: Inserter,Slotted Hammer

Prepare the insertion site in the bonefor the second nail as described before.Place the second nail into the Inserterand repeat the steps described. Insertthe second nail just up to the fracturesite.

Warning:When opening the medial side, becareful not to let the Awl or DrillBit slip posteriorly into the regionof the femoral artery.

Crossing of the fracture site can beperformed immediately after the firstnail has crossed (Option 1) or whenthe first nail is well engaged in thefragment (Option 2), as alreadydescribed in the previous step.

Cross the fracture site with the secondnail in the same manner as that of thefirst: advance to the fracture site, orientthe curved tip to enter the IM canal ofthe further fragment and advance thesecond nail through the fracture siteinto the further fragment.

Both nails are advanced until theyreach the metaphysis.

The nails may be rotated to achieveperfect reduction of the fracture.

Orient the curved tips (and thus thebow of the nail) in the directiondictated by the situation:

Varus/valgus angulation caused by atransverse fracture can be addressed bydirecting the nail tips medially orlaterally as appropriate to counter theangulation forces. A varus angulationcan be corrected by directing the nailtip laterally whereas a valgusangulation can be corrected bydirecting the nail tip medially.

Similarly, in the sagittal plane, arecurvatum angulation can becorrected by directing the nail tipsposteriorly and a flexion angulation bydirecting the nail tips so that theconcave sides face anteriorly.

There are of course possibilities ofcombined deformities as well asbiomechanical factors to be considered.The surgeon must choose the optimalposition of the nails in theintramedullary canal to provide astable frame in spite of the constraints.

During all moments of fracturereduction, great vigilance must betaken to avoid a rotational malunion,as the remodeling is limited in thisaxis.

Figure 17. Second nail crossing the fracture site

15

Operative Technique

Femoral Mid-Shaft

5 - Impacting the Nail Tips

Instruments: Inserter,

Slotted Hammer

Once the position and orientation ofboth nails are satisfactory, they areimpacted into the cancellous bone ofthe metaphysis while maintainingreduction. Use the Large SlottedHammer on the Inserter to impact thenails.

Attention should be paid to thehorizontal plane at all times duringthis reduction step so as to preventrotational malunion.

Impaction of the fracture plays animportant role in final reduction. Alltransverse fractures must be impactedto minimize the potential for later leglength discrepancy. In oblique andspiral fractures and even fractures witha third fragment, impaction providesstabilization of the fracture site at theexpense of slight shortening (5 to 10mm) which is readily compensated forby postoperative overgrowth.

6 - Bending the Nails Prior toCutting

Instrument: Inserter

At this point, the Inserter is still on thenail. There are three options forbending the trailing ends prior tocutting off the excess material:

Option 1) In some cases, the trailingends are not bent at all; theyare simply left to lie againstthe cortical wall aftertrimming.

Option 2) For ease of future removal,the nail ends may be bentaway from the cortex at anangle of approximately 30-60°, according to the limbinvolved and thesurrounding soft-tissuecoverage.

Option3) The third option is tosharply bend the trailingends (>90°) with theintention to fully recessthem into the bone later inthe procedure. Be awarethat removal of a sunkennail is more difficult than aprotruding nail.

Figure 18. Impacting the nail tips

Figures 19 - 21. Options for bending the nail ends

16

Operative Technique

Femoral Mid-Shaft

7 - Cutting the Nail Ends

Instrument: Large Cutter

Remove the Inserter from the nail.Make sure the Large Cutter isassembled as shown and the innersleeve is rotated to the mid positionwhere the cutting holes are open toslide the assembly over the nail,matching the nail diameter with thededicated hole in the assembly. Pushthe Cutter down over the nail to thedesired cutoff point. Be aware that thecutoff point is 3mm off the frontal

plane of the Cutter. After you havepositioned the Cutter at the correctposition, slide the handle piece overthe key on the top of the assembly.You can attach the handle to the keytop on either the right or left side. Theoptimal position to engage the handlewith the assembly is when both handlepieces are at an angle of about 60º.

Cut the nail by moving the handlessmoothly towards each other. Thecutoff portion of the nail is capturedwithin the cutter.

If access to the cutoff point is difficult,you may also mark the nail at thecutoff point with a pen or clamp.Retract the nail far enough to accessthe cutoff point. The cut nail end ispushed back into the intramedullarycanal using the Final Impactor asdescribed next.

8 - Impacting the Cut Nail Ends

Instruments: Final Impactor,

Slotted Hammer, Large Forceps

The Large Final Impactor will leavefrom 7 to 12mm of nail lengthprotruding from the outer cortex,according to the position in which it isplaced on the bone. For the femur, it isrecommended to leave 12mm of nailprotruding from the bone but less isbetter tolerated if the child is small orslender.

Turn the Impactor so that the desiredlength of protruding nail is indicatedon the side which is closest to and facesthe cortex (the opposite length will befacing the surgeon). Impact the nailsinto the metaphyseal bone whilstfirmly maintaining the reduction. Ifthe nail has been over inserted use theLarge Forceps to retract the nail.

Final fluroscopic verification in bothfrontal and lateral planes is made priorto wound closure.

Image 10. Large Cutter

Figure 22. Impacting the nail ends

Figures 23 - 25. Options for nail impaction

17

Operative Technique

Forearm Mid-Shaft

1 - Incision and Insertion Pointsfor Radial Shaft Fracture

Instruments: Small Awl

The cortical insertion hole is madewith the Awl which is first applied at a90° angle (perpendicular) to the cortex.Once the first cortex is penetrated, theawl-to-bone angle is lowered to shapean oblique opening in the direction ofthe fracture.

The Small ø3.2mm Awl or Smallø3.2mm Drill Bit is recommendedwhen nails of the following diametersare used:


2 - Radial Nail Insertion

Instrument: Universal Chuck withT-Handle

Engage the selected nail with theUniversal Chuck by sliding its end intothe center of the opening. Locking thegrip on the nail can be achieved byturning the Chuck clockwise. Foroptimal grip make sure that the nail iscaptured in the center of the Chuck asit can happen that the nail is clampedwith a slight offset.

Introduce the nail into the boneopening with the hook facing awayfrom the fracture. When the oppositecortex is felt, rotate the nail 180° sothat the hook now faces the fractureand is ready to be glided progressivelythrough the intramedullary canal.

Warning:Do not grip the T-Handle withyour palm over the center of thestrike plate, as the nail end willprotrude from there.

Figure 26. Cortical opening

Figure 27. Radial nail insertion

18

Operative Technique

Forearm Mid-Shaft

3 - Crossing the Fracture Sitewith the Radial Nail

Instruments: Universal Chuck with

T-Handle, Slotted Hammer

The nail is pushed forward in the canalusing slight rotational movements toavoid blockage.

When the fracture site is reached, thenail tip must be rotated 180° so that itis oriented just below the oppositefragment. Drive the nail through thefracture site into the second fragment,using the Slotted Hammer. Continueinserting the nail up to the metaphysis.The concave bow of the nail must befacing the ulna.

Monitor nail advancement withfluroscopy.

Figures 28 - 30. Crossing the fracture site with the radial nail

19

Operative Technique

Forearm Mid-Shaft

4 - Cortical opening for the UlnarNail

Instrument: Small Awl

Perform the skin incision for the ulnarnail. Prepare the insertion site in theulnar bone for the second nail. Theulnar entry site is on the posterolateralaspect of the olecranon so that the endof the nail will be buried in the shortelbow extensor muscle (anconeus) andpermit leaning the elbow on the table.The medial approach is to be avoidedas there is a risk of damaging the ulnarnerve.

The Small ø3.2mm Awl or Smallø3.2mm Drill Bit is reccommendedwhen nails of the following diametersare used:


5 - Insertion of Ulnar Nail

Instrument: Universal Chuck with

T-Handle

Place the ulnar nail into the UniversalChuck by sliding its end over thecenter of the opening. Locking thegrip on the nail is achieved by turningthe Chuck clockwise. For optimal gripmake sure that the nail is captured inthe center of the Chuck as it canhappen that the nail is clamped with aslight offset.

Advance the nail just down to thefracture site.

Figure 31. Cortical opening for the ulnar nail

Figure 32. Cortical opening for the ulnar nail

20

Operative Technique

Forearm Mid-Shaft

6 - Crossing the Fracture Sitewith the Ulnar Nail

Instruments: Universal Chuck withT-Handle, Slotted Hammer

Cross the ulnar fracture site with thesecond nail in the same manner as thatof the radial nail: Advance to thefracture site, orient the curved tip toenter the IM canal of the furtherfragment and hammer the second nailthrough the fracture site into thefurther fragment.

Continue inserting the ulnar nail downto the distal ulnar metaphysis andorient the concave bow of the nailtowards the radius.

Ascertain that the nails are orientedcorrectly: the curved tip of the radialnail must be oriented towards themedial aspect whereas the curved tip ofthe ulnar nail must be orientedtowards the lateral aspect. Thus the twoconcave aspects of the nails are face toface and the construct is furtherstabilized by the spreading of theintraosseous membrane.

Figure 33. Crossing the fracture site with the ulnar nail

21

Operative Technique

Forearm Mid-Shaft

7 - Impacting the Nail Tips

Instruments: Universal Chuck with

T-Handle, Slotted Hammer

Use the Slotted Hammer to impact thenails into their respective metaphysesfor the final reduction.

Once the position and orientation ofboth nails are satisfactory, they areimpacted into the cancellous bone ofthe metaphysis while maintainingreduction. Use the Slotted Hammer onthe Universal Chuck with T-Handle toimpact the nails. Make sure to only tapon the strike plate of the T-Handle foran insertion force in line with the nail.

Attention should be paid to thehorizontal plane at all times duringthis reduction step to preventrotational malunion.

8 - Bending the Nail Ends Priorto Cutting

Instrument: Universal Chuck with

T-Handle

At this point, the Universal Chuck isstill on the nail. There are two optionsfor bending the trailing ends prior tocutting off the excess material:

Option 1) In some cases, the trailingends are not bent at all; they are simplyleft to lie against the cortical wall aftertrimming.

Option 2) For ease of future removal,the nail ends may be bent away fromthe cortex at an angle of approximately30-60°, according to the limb involvedand the surrounding soft-tissuecoverage.

Figure 34. Impacting the nail tips

Figure 35. Bending the nail ends prior to cutting

22

Operative Technique

Forearm Mid-Shaft

9 - Cutting the Nail Ends

Instrument: Cutter

Remove the Universal Chuck from thenail.

Cut the end of the nail with the Cutter,facing the golden cutting bladestowards the cortex. The black rubberjaws are facing the operator and areholding the clipped nail endpreventing it from flying off when thenail end is cut.

Cut the nail end as close as possible tothe cortex leaving at least 3mm of thenail end protruding from the cortex.

Warning: Although there is a rubbergrip designed to keep the clipped nailend from flying out of the Cutter, useof eye protection is advised.

If access to the cutoff point is difficult,you may also mark the nail at thecutoff point with a pen or clamp.Retract the nail far enough to accessthe cutoff point. The cut nail end ispushed back into the intramedullarycanal using the Final Impactor asdescribed next.

10 - Impacting the Nail Ends

Instruments: Small Final Impactor,Slotted Hammer

The Small Final Impactor will leavefrom 3 to 5mm of the nail lengthprotruding from the outer cortex,according to the position in which it isplaced on the bone.

Turn the Impactor so that the desiredlength of protruding nail is indicatedon the side which is closest to and facesthe cortex (the opposite length will befacing the surgeon). Impact the nailsinto the metaphyseal bone while firmlymaintaining the reduction.

It is fundamental to completelypronate and supinate the forearm toascertain full range of motion.

Final fluoroscopic verification in bothfrontal and lateral planes is made priorto wound closure.

Figure 36. Cutting the nail ends



23

Operative Technique

Removing the Nails

Instruments: Forceps,

Slotted Hammer, Universal Rod

Engage the Forceps to the exposed nailend. The Forceps require only a fewmillimeters of the nail end for removalin most cases. Engage the Forceps inline with the nail either straight on orfrom the side in a perpendicularmanner.

Adjust the Forceps jaw width byturning the adjustment knob at the

handle end. Squeeze the handlesforcefully. If you have adjusted the jawwidth correctly you will feel a distinctlock. Adjust the width of the jaws ifthe handles do not lock or can not besqueezed to lock.

Drive the nail out of the bone usingthe Slotted Hammer against theUniversal Rod which can be threadedinto the end or the side of the Forceps.If you have engaged the Forcepsperpendicularly you are advised tothread the Universal Rod into the side

of the Forceps in order to apply theextraction force inline with the nail inthe IM canal.

Hold the handle firmly with one handto prevent the handles from springingopen when hammering on theassembly.

Removal with forceps only Difficult removal

Figure 39. Options for nail removal

24

Operative Technique

After each use, all instruments shouldbe cleaned. Instruments withremovable parts should bedisassembled prior to cleaning. Steelbrushes should not be used to cleanthe instruments.

Cannulated instruments should bethoroughly cleaned and opened priorto washing and disinfection. Standardproprietory detergents anddisinfectants can be used in accordancewith the manufacturer’srecommendations.

Prior to autoclaving, instrumentsshould be checked for cleanliness.Instruments with moving parts mustbe lubricated with autoclavable oil.

Universal Chuck with T-HandleClean the Universal Chuck withT-Handle after every use. Use a softbrush and neutral pH detergent towash the debris from the Chuck and

cannulation. It is essential to lubricatethe Universal Chuck with T-Handleperiodically with autoclaveable oil tomaintain smooth operation of thechuck. After cleaning, apply a singledrop of oil to each Chuck jaw and rearbushing.

Open and close the Chuck severaltimes and wipe away the excess oil witha dry towel. Wash and sterilize theInserter before use.

Large CutterThe Cutter has movable parts. Todisassemble the Cutter, unscrew thestop nut and remove the cutting innersleeve from the handle piece.

Following the cleaning, and beforeautoclaving, lubricate the cutting sleevewith autoclavable oil. The cuttingsleeve must be adequately lubricated toensure smooth cutting.

Reassemble the Cutter by inserting thecutting sleeve into the handle piece andsecure the sleeve with the stop nut.Move the cutting sleeve from one stopside to the other and wipe off theexcess oil with a towel. Wash andsterilize the Cutter before use.

For more information see “Instructionsfor Cleaning and Sterilization”L24002000.

Care and Maintenance

25

Ordering information - Implants

Stainless Steel Diameter Total TitaniumREF mm Length REF

mm

FLEXIBLE NAIL

0197-1500 S0197-1750 S0197-2000 S0197-2250 S0197-2500 S0197-3000 S0197-3500 S0197-4000 S

1.501.752.002.252.503.003.504.00

0196-1500 S0196-1750 S0196-2000 S0196-2250 S0196-2500 S0196-3000 S0196-3500 S0196-4000 S

300300300300450450450450

For non sterile implants, please remove ‘S’ from the reference number

26

Ordering information - Instruments

Optional Instruments

0193-2200 X-Ray Ruler

0193-3200 Reduction Instrument

0193-2600 Tissue Protection Sleeve

0193-1100 Awl Curved, ø3.2mm

0193-1300 Awl, Curved, ø5.0mm

0193-4350(S)Drill Bit, ø3.2x180mm

0193-4500(S)Drill Bit, ø5.0x180mm

0193-2800 Universal Chuck with T-Handle

6983-5000 Slotted Hammer, Small

1806-0113 Universal Rod, Short

0193-3400 Forceps, Small

Optional Metal Tray

0193-9200 Optional Set (complete incl. Instr.)

0193-9215 Instrument Tray, Optional

1806-9700 Universal Tray Lid

REF DescriptionREF Description

Basic Instruments

0193-2400 Bending Instrument

0193-1200 Awl, Straight, ø3.2mm

0193-1000 Awl, Straight, ø5.0mm

0193-3000 Inserter (space for 2 in Basic)

1806-0170 Slotted Hammer

702951 Cutter

0193-1600 Final Impactor, ø2.5mm

0193-1400 Final Impactor, ø4.0mm

0193-3600 Forceps, Large

1806-0110 Universal Rod

0193-1800 Cutter, Large

Basic Metal Tray

0193-9100 Basic Set (complete incl. Instruments)

0193-9110 Instrument Tray, Basic

0193-9150 Insert, Basic

0193-9190 Silicone Mat

1806-9700 Universal Tray Lid

Please note that these pictures are an indication only and are not to scale.

27

Ordering information - Instruments

Extraction Instruments

0193-3800 Chisel

700664 Hohmann Retractor, 6mm

700666 Periosteal and Freer Elevator

1806-6102 Teardrop Handle, AO coupling

0193-4100 Crown Drill, Ø2 mm



0193-4200 Conical Extractor, female,left hand, ø2 mm



Extraction Metal Tray

0193-9300 Extraction Set (complete incl. Instr.)

0193-9315 Instrument Tray, Extraction

Other available Instruments

702900 Table Plate Bender

702900-23 Bending Sleeve Universal (PEEK)

702951-1 Replacement Components for Cutter

REF Description

Please note that these pictures are an indication only and are not to scale.

28

References

1. Lascombes P. Embrochage centromédullaire élastique stable. Elsevier Masson, Paris, 2006, 321pp.

2. Lascombes P, Haumont T, Journeau P. Use and abuse of flexible intramedullary nailing in children and adolescents. JPediatr Orthop. 2006 ; 26 : 827-34.

3. Kocher, MS, Sucato, DJ. What's new in pediatric orthopaedics. J Bone Joint Surg. 2006 ; 88-A : 1412-21.

4. Prévot J, Métaizeau JP, Ligier JN, Lascombes P, Lesur E, Dautel G. Embrochage centromédullaire élastique stable. EditionsTechniques – Encyclopédie Médicale Chirurgicale (Paris, France). Surgical techniques-Orthopaedics-Traumatology, 44-018,1993, 13pp.

5. Bar-On E, Sagiv S, Porat S. External fixation or flexible intramedullary nailing for femoral shaft fractures in children – Aprospective randomized study. J Bone Joint Surg 1997 ; 79-B : 975-8.

6. Caglar O, Adsoy MC, Yazici M., Surat A., Comparison of compression plate and flexible intramedullary nail fixation inpediatric femoral shaft fractures. J Pediatr Orthop B. 2006 ; 15 : 210-4.

7. Flynn JM, Luedtke LM, Ganley TJ, Dawson J, Davidson RS, Dormans JP, Ecker ML, Gregg JR, Horn BD, Drummond DS.Comparison of titanium elastic nails with traction and a spica cast to treat femoral fractures in children. J Bone JointSurg. 2004 86-A : 770-7.

8. Flynn JM, Hresko T, Reynolds RA, Blasier RD, Davidson R, Kasser J. Titanium elastic nails for pediatric femur fractures: amulticenter study of early results with analysis of complications. J. Pediatr Orthop. 2001 ; 21 :4-8.

9. Ligier JN, Métaizeau JP, Prévot J, Lascombes P. Elastic Stable Intramedullary Nailing of Femoral Shaft Fractures inChildren. J Bone Joint Surg. 1988; 70-B: 74-7.

10. Fernandez FF, Egenolf M, Carsten C, Holz F, Schneider S, Wentzensen A. Unstable diaphyseal fractures of both bones ofthe forearm in children: plate fixation versus intramedullary nailing. Injury. 2005 ; 36 : 1210-6.

11. Lascombes P, Prévot J, Ligier JN, Métaizeau JP, Poncelet T. Elastic stable intramedullary nailing in forearm shaft fracturesin children: 85 cases. J Pediatr Orthop. 1990 ; 10 : 167-71.

12. Mseddi MB, Manicom O, Filippini P, Demoura A, Pidet O, Hernigou P. Intramedullary pinning of diaphyseal fractures ofboth forearm bones in adults: 46 cases. Rev. Chir Orthop. 2008 ; 94 : 160-7.

13. Reinhardt KR, Feldman DS, Green DW, Sala DA,Widmann RF, Scher DM. Comparison of intramedullary nailing toplating for both-bone forearm fractures in older children. J. Pediatr Orthop. 2008 ; 28 : 403-9.

14. Fernandez FF, Eberhardt O, Langendörfer M,Wirth T. Treatment of severely displaced proximal humeral fractures inchildren with retrograde elastic stable intramedullary nailing. Injury. 2008 ; 24 (ahead of print).

15. Green J, Werner F, Dhawan R, Evans P, Kelley S, Webster A. A biomechanical study on flexible intramedullary nails usedto treat pediatric femoral fractures. J Orthopaedic Research. 2005 ; 23 : 1315-20.

16. Mahar AT, Lee SS, Lalonde FD, Impelluso T, Newton PO. Biomechanical comparison of stainless steel and titanium nailsfor fixation of simulated femoral fractures. J Pediatr Orthop. 2004 ; 24 : 638-41.

17. Mani US, Sabationo CT, Sabharwal S, Svach DJ, Suslak A, Behrens FF. Biomechanical comparison of flexible stainlesssteel and titanium nails with external fixation using a femur fracture model. J Pediatr Orthop. 2006; 26 : 182-7.

18. Wall EJ, Jain V, Vora V, Mehlman CT, Crawford AH. Complications of titanium and stainless steel elastic nail fixation ofpediatric femoral fractures. J Bone Joint Surg. 2008 ; 90-A :1305-13.

19. Axel Baumann, Dipl.-Ing.*, Nils Zander, Dipl.-Ing.§, * DOT GmbH, Charles-Darwin-Ring 1a, 18059 Rostock, Germany.§Stryker Trauma GmbH, Prof.-Küntscher-Str. 1-5, 24232 Schönkirchen/Kiel, Germany Ti6Al4V with Anodization Type II:Biological Behavior and Biomechanical Effects.March 2005.

29

Notes

Stryker Trauma GmbHProf.-Küntscher-Strasse 1-5D-24232 SchönkirchenGermany

www.osteosynthesis.stryker.com

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 anyparticular product before using it in surgery. The information presented in this brochure is intended to demonstrate aStryker product. Always refer to the package insert, product label and/or user instructions including the instructionsfor Cleaning 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, T2 kids.

All other trademarks are trademarks of their respective owners or holders.The products listed above are CE marked.

Literature Number: B1000063LOT A3608

Copyright © 2008 Stryker

t2 kids pediatricflexiblenail · 2 contents 1. introduction&rationale 3 2....

Documents