Proximal Femur Nailing System Surgical Technique. fix.com

Transcription

1 ProximalFemurNailingSystem SurgicalTechnique

2 Implants Introduction The Nail and Lag Screw are made of longitudinal continuous carbon fiber reinforced polymer (PEEK). The screws are made of Titanium-alloy (Ti-6Al-4V). Features of the CarboFix Proximal Femur Nailing System: Anatomically shaped ProximalFemurNail with a slight bend close to its proximal end (M-L Bend) of 5 degrees, and a Caput-collum-diaphyseal angle (CCD) of 130 degrees. Lag Screw is intended for insertion through the Nail proximal screw-hole, into the femoral head. It is available in varying lengths. The Proximal Femur nail is used in an antegrade approach. For further information please refer to the product Instructions for Use. The Nail and Lag Screw are supplied sterile. Implants dimensions are as follows: Proximal Femur Nail LagScrew Screws Lag Screw Proximal Femur Nail

3 SetScrew The Piccolo Composite Proximal Femur Nail is provided with both a short Set Screw ("Sliding Set Screw"), which eliminates Lag Screw rotation, but allows sliding, and a longer Set Screw ("Locking Set Screw"), which also limits Lag Screw sliding. [A Retrograde Femoral Case]

4 Instrumentation AccessGuideWire(Ø3.2mm) Marks the entry point into the medulla canal, and the trajectory. Awl Used to access the medullary canal for insertion of the Nail. The Awl can be positioned over the Access Guide Wire. EntryPortal&EntryTrocar The Entry Portal is a soft tissue protector used during soft tissue tunneling and reaming. The Entry Trocar is used for soft tissue tunneling at the access point. It accommodates a Ø3.2mm Access Guide Wire. The Trocar is locked to the Entry Portal by turning it clockwise. Ø17x300mmDrillBit Used to access the medullary canal. It is to accommodate a Ø3.2mm Access Guide Wire.

5 BallTipGuideWire(Ø2.5mm) Assists in fracture reduction, reaming and medulla canal length measurement. Compatible with conventional reamer sets. Ball Tip diameter is 4.5mm. Supplied sterile; packed separately, for single use. GuideWireRuler Measures the required nail length over the proprietary Ball-Tip Guide Wire. RadiographicRuler Used to determine the required Nail diameter and length. GuideWireExchangeTube Used for replacing the Ball-Tip Guide Wire with the Ø2.5mm Guide Wire. Supplied sterile; packed separately, for single use. GuideWire(Ø2.5mm) The Ø2.5mm Guide Wire is used for Nail insertion into the medulla canal. It may be supplied sterile; packed separately, for single use.

6 InsertionHandle The Insertion Handle is connected to the Nail, and enables Nail insertion ConnectionTube The Connection Tube connects and locks the Handle to the Nail proximal end. BallHexTipScrewdriver Connects to the Nail Adapter for detaching the Insertion Handle from the Nail. May also be used for connecting and detaching the Lag Screw Insertion Handle from the Lag Screw. StrikingAdapter Connects to the Insertion Handle. During Nail insertion, the surgeon can tap on it using a Mallet, or connect it to the Slide Hammer. Mallet The Mallet may be used during Nail insertion. The plastic side of the Mallet should be used for tapping the Striking Adapter gently.

7 LagScrewSleeve,LagScrewKWireSleeve&LagScrewTrocar The Sleeves provide working channel for Lag Screw insertion, and accommodate a Ø2.85mm K-Wire and the Ø10.4mm Drill Bit. The Guide & Drill Sleeves lock to each other. LagScrewKWireDepth(Ø2.85mm) Marks the entry point and trajectory for Lag Screw insertion. Supplied sterile; packed separately. KWireDepthGauge Measures the required Lag Screw length; for use with the Lag Screw K-Wire. DrillBits There are several Drill Bits in the set: Ø10.4mmStepDrillBitfor drilling the hole for the Lag Screw. Ø4.2mmStep Drill BitLong (L: 365mm) for drilling the Distal Screw hole through the Insertion Handle. It has markings along its shaft for measuring the required screw length. Ø4.2mmStepDrillBitShort(L: 180mm) for free hand drilling of the hole for the Distal Screw. Tap For Lag Screw hole tapping.

8 LagScrewDriver(LagScrewInsertionHandleAssembly) A two-component insertion handle for the Lag Screw, combined of an outer tube and an inner rod. The driver distal end design prevents relative rotation between the Lag Screw and the driver. SlidingLimitDriver An instrument designed to assess in limiting Lag Screw sliding. It is inserted via the Connection Tube, to rotate a screw located within the Nail proximal end. DistalScrewGuide&DrillSleeve,DistalScrewTrocar The Guide Sleeve is a working channel through which the Drill Sleeve and the Trocar are inserted. The Drill Sleeve accommodates the Ø4.2mm Drill Bit. The Guide & Drill Sleeves lock to each other. FreeHandDrillSleeve A working channel for Ø4.2mm Drill Bits. It is radiolucent and is used for drilling, in free hand technique, the distal screw hole(s).

9 DistalScrewDepthGauge Used to measure the required Distal Screw length. Screwdriver Used to insert or remove the Screws and the Nail Cap. PowerDriveScrewdriver For use with a power drive. NailRemovalAdapter For Nail removal; connects to the Nail proximal end as well as to the Slide Hammer. SlideHammer Used for Nail removal by connecting it to the Nail Removal Adapter. Optionally, it may be used for Nail insertion. In such cases it is connected to the Striking Adapter.

10 ProcedureSteps Note:Theentireprocessshallbeperformedunderfluoroscopicvisualization. Entry&Preparation 1. Makeskinincisionofapproximately2.5cmfromthegreatertrochantertowards theiliaccrest.achieveaccesstothebone. 2. UsetheØ3.2mmAccessKWiretomarktheentrypoint. Therearetwowaystoenterthebone: A. Use the Awl over the Access KWire to perforateanentryhole.theawldiameteris 17mm,tofitthediameteroftheNail. B. InserttheEntryTrocarintotheEntryPortal, andlockitbyrotatingitclockwise.

11 InsertThePortalAssemblyovertheKWire,so thatthekwirepassesthroughthecenterhole oftheentrytrocar; Use the adjacent holes of the Entry Trocar in ordertoimprovekwireposition,ifrequired: RotatetheEntryTrocarsothattheholes arelocatedasdesired. InsertaKWirethroughthedesiredhole, andremovetheonethatwasincorrectly placed. RemovetheEntryTrocar. Use the Ø17mm Drill Bit over the KWire to accessthebone. 3. For LongNailsInsert the BallTipGuide Wireinto the medulla canal past the fractureline.performreamingifdesired.theballtipguidewirecanbeusedwith anyconventionalintramedullaryflexiblefemoralreamingsystem,andaccording toitsinstructionsforuse.theguidewireshaftdiameteris2.5mm,andtheball Tipdiameteris4.5mm. Finalreamingshouldbe1 1.5mmlargerthantheselectedNaildiameter.

12 NailMeasurement(forLongNails) 4. MeasuretheFemurlengthanddiameterusinga RadiographicRuler. Optional: the required nail length can be measured by using the Guide Wire Ruler. A marker on the BallTip Guide Wire marks the requirednaillength. 5. Use a Guide Wire Exchange Tube to exchange the BallTip Guide Wire by the Ø2.5mmGuideWire,onwhichthenailwillbeinserted. NailInsertion 6. Connect the Handle to the Nail proximal end using theconnectiontube. Make sure the protrusions on the Insertion Handle match the grooves on the nail. Verify the nail is orientedproperly.

13 TightentheConnectionTubetotheHandleusing theballhextipscrewdriver.donotapplyhigh torque. 7. ConnecttheStrikingAdaptertotheHandle. 8. InserttheNailintothecanal,overtheGuideWire. Ifneeded,theMalletcanbeusedtoinserttheNail.Usetheplasticpartofthe MallettotapontheStrikingAdapter. Important:Donotuseexcessiveforce.UseslightstrokesonlytopositiontheNail. DonotuseoscillatingmovementstoinserttheNail.TapontheAdapteronly.

14 DuringNailinsertion,assurefracturereductionusing fluoroscopy. TheNailiscorrectlylocatedwithinthecanaloncethe Nailproximalend(theareaofconnectionoftheNail to the Insertion Handle, as can be seen using fluoroscopy) is aligned with the tip of the greater trochanter. RemovetheGuideWire. LagScrewInsertion 9. Make skin incision where Lag Screw hole is located, andachieveaccesstothebone. 10. Place the Lag Screw Sleeve, with the KWire Sleeve andkwiretrocarwithinit,insidethelagscrewhole ofthehandle.lockthesleevestothehandleusingthe lockingknobonthehandle. Locking Knob

15 Remove the Trocar and insert a Ø2.85mm KWire throughthekwiresleeve. Ensurethatthesleevesareincontactwiththelateral cortex, while verifying the anatomic position under fluoroscopy(apandlateralfluoroscopy):thekwire shallbepositionedintheinferior1/3 rd ofthecervical femur. 11. EvaluatetherequiredLagScrewlengthusingtheLag ScrewDepthGaugeovertheKWire. 12. RemovetheKWireSleeve.

16 13. UnderfluoroscopydrillaholefortheLagScrewusing the cannulated Step Drill Bit over the LagScrew K Wire.ThedistaltipoftheStepDrillBitshallgetasfar asthelagscrewdistaltipshallbelocated.verifythat thesleevesareincontactwiththebone. AstopperprovidedontheDrillBitcanbesettothe desireddrillingdepthbasedonthelagscrewlength evaluation. VerifytheLagScrewlengthaccordingtotheStep DrillBitscale.ThedistalpartoftheStepDrillBitis markedwithlinesindicatingtheavailablelagscrew lengths, at 10 mm steps, with the most proximal line corresponding to a 110 mm long Lag Screw. RemovetheStepDrillBit. Prepare the hole created for Lag Screw insertion withthehelpofthecannulatedscrewtapoverthe LagScrewKWire. RemovetheScrewTap. Stopper Length Indication

17 14. ConnecttheLagScrewDrivertotheselectedLagScrew.AligntheLagScrewDriver tubewiththerecessesatthelagscrewproximalend,androtateitsrodclockwise, tothreaditintothelagscrew. The BallHexTip Screwdriver can be used for final tightening. Do not apply high torque. 15. Insert the Lag Screw, through the Lag Screw Sleeve, while verifying proper positioning of the fracture.thelagscrewdriverismarkedwithlines indicatinginsertiondirection makesureoneof themarksisalignedwiththemarkonthehandle.

18 16. If desired compaction may be performed; rotate the knob on the Lag Screw Driver to achievethedesiredcompaction. Compactionofupto15mmcanbeachieved. 17. SelecttherequiredSetScrew. UsetheSlidingLimitDrivertoinserttheSetScrew throughtheconnectiontubeintothenailproximal end. GentlyrotatetheSetScrewwithintheNailproximal endclockwisetoslightlytightenthesetscrew. Remove the Lag Screw Driver by counterclockwise rotationofitsrod.theballhextipscrewdrivermay beused. RemovetheLagScrewSleeveandtheKWire. DistalScrews 18. Make skin incision where Distal Screw hole is located, and achieve access to the bone.

19 FortheshortNails(180,200mmlength) 19. PlacetheDistalScrewGuideSleeve,withtheDrillSleeveandTrocarwithinit,inside theappropriatehandlehole. AfterpositioningoftheSleeves,removetheTrocar. 20. Drill a holefor thescrew using the long Ø4.2mm DrillBit.DrillBitgraduationmarksmaybeusedto assessscrewlengthagainstthedrillsleeve. RemovetheDrillBitandDrillSleeve.

20 21. Select the appropriate length of the Ø5.0mm Screw, by using the Distal Screw Depth Gauge and/orthedrillbitgraduationmarks(asindicated above). 22. InserttheScrewthroughtheGuideSleeve,by using the Screwdriver (Power Screwdriver couldalsobeused). RemovetheScrewdriverandGuideSleeve. Note:Alternatively, freehand drillingmaybeperformed;insuchcase,please Followthenextsteps. FortheLongNails( mmlength) 23. Distaldrillingisperformedin freehand technique. Tinytantalumrodsmarkers,locatednearthedistalholes,assistinlocatingthe centeroftheholes.

21 Uponproperpositioning,whilethexraybeamisperpendiculartothehole,the2 radiopaquemarkersateachsideoftheholeshouldbealignedintoasingledot.in properpositioningasingledotshouldbeseenateachsideofthehole. Radiopaque Markers Holefor Screw Radiopaque Markers Holefor Screw DrillaholefortheInterlockingScrewusingthe short Ø4.2mm Step Drill Bit through the Free HandDrillSleeve,infreehandtechnique. 24. SelecttheappropriatelengthoftheØ5.0mmScrew,byusingtheDistalScrewDepth Gauge. 25. InserttheScrewbyusingtheScrewdriver(PowerScrewdrivercouldalsobeused). X IncorrectAlignmentofMarkersfor DistalScrewsInsertion Correct AlignmentofMarkersforDistal ScrewsInsertion

22 NailCapInsertion 26. RemovetheConnectionTube(counterclockwise rotation)anddisconnectthehandlefromthe Nail. 27. The Nail Cap shall be inserted by using the Screwdriver. There are 3 available Nail Cap lengths: 0, 5 & 10mm. TheNail Capincorporates twoembedded radiopaque markersforvisualization underfluoroscopy. 28. Closethebonepenetrationpointsaccordingtothesurgicalprocedure.

23 NailRemoval 1. Makeskinincisionandexposetheboneentryhole. 2. ConnecttheScrewdrivertotheNailCapattheNailproximal end,andremovethecapbycounterclockwiserotation. 3. UsetheSlidingLimitDrivertoreleasetheLagScrew rotate thesetscrewcounterclockwise. 4. MakeskinincisionwherethedistalScrewislocated.Usingthe Screwdriver,removetheScrewbycounterclockwiserotation. 5. MakeskinincisionwheretheLagScrewislocated.Connectthe LagScrewDrivertotheLagScrewandremovetheLagScrew bycounterclockwiserotation. 6. ScrewtheNailRemovalAdapterontothenail sproximalend. 7. ConnecttheSlideHammertotheNailRemovalAdapter. UselightstrokesoftheSlideHammertoremovetheNail fromthebone. 8. Closethepenetrationpointsaccordingtothesurgical procedure.

24 Fordetailedprocedure,indications,contraindications,possibleadverseevent,warningsandprecautions,refertotheInstructionsforUse Caution:IntheU.S.A.,federallawrestrictsthisdevicetosalebyorontheorderofaphysician. 1 MANUFACTURED BY: U.S.A.OFFICE: ECAUTHORIZED REPRESENTATIVE: CarboFix OrthopedicsLtd. 11Ha hoshlimst., Herzeliya ,Israel Tel: Fax: info@carbofix.com CarboFix OrthopedicsInc Beach Drive SW Ocean Isle Beach, NC 28469, USA Tel: usa@carbofix.com MEDNETGmbH Borkstrasse10,48163Münster Germany Ver.002_ Patentsarepending