EN_TR_T08 Knee Prosthesis Surgical Technique.FH11
Transkript
T08 TOTAL KNEE SYSTEM TOTAL DÝZ SÝSTEMÝ TOTAL KNEE SYSTEM TOTAL DÝZ SÝSTEMÝ The key in orthopaedic sciences SURGICAL TECHNIQUE CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi CONTENTS Introduction ÝÇÝNDEKÝLER 3 Giriþ Tibial Stage 8 Tibial Safha Use of Intra-Medullary Cutting Guide 8 Setting the Tibial Slope 9 Intra Medular Kesi Gaydýnýn Kullanýmý Tibial Eðimin Ayarlanmasý Setting the Level of the Cut 10 Use of the Extra-medullary Alignment Guide 12 Positioning of the Guide 12 Setting the Tibial Slope 13 Setting the Rotation 14 Setting the Level of the Cut 14 Realisation of the Tibial Cut 15 Choosing the Tibial Component 15 Assembly of the Standard and PS Mobile Test Inserts 17 Kesimin Seviyesinin Belirlenmesi Extra Medular Kesi Gaydýnýn Kullanýmý Gaydýn Pozisyonlanmasý Tibial Slopeun Ayarlanmasý Rotasyonun Belirlenmesi Kesim Seviyesinin Belirlenmesi Tibial Kesimin Gerçekleþtirilmesi Tibial Komponentin Belirlenmesi Standart ve PS Mobile Insertlerin Yerleþtirilmesi Femoral Stage Femoral Safha Prepare the Sizing Guide Ölçüm Gaydýnýn Hazýrlanmasý 18 18 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi Positioning of the Guide 18 Placing the Guide 19 Fixing the Guide 20 Gaydýn Konumlandýrýlmasý Gaydýn Yerleþtirilmesi Gaydýn Sabitlenmesi Patella Stage Patellar Safha 22 Patella Resurfacing Technique 22 Inset Patella Technique 24 Inserting the Test Femoral Component 24 Tibial Baseplate 25 Instruments&Trays 26 Patellanýn Yeniden Yüzeylendirilmesi Tekniði Inset Patella Tekniði Test Femoral Komponentin Yerleþtirilmesi Tibial Baseplate El Aletleri&Tavalar SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi Introduction Giriþ T08 Total Knee System is designed and developed for use in cemented and cementless application of Total Knee arthroplasty. T08 Total Diz Sistemi Total Diz artroplastisinde sementli ve sementsiz kullaným için dizayn edilmiþ ve geliþtirilmiþtir. The unique femoral cutting guide combines various functionalities in one component. This enables the surgeon to shape the femur fast and accurate with only one guide positioning and fixing. Benzersiz femur kesi kýlavuzu ile birden çok iþlevi tek bir yapýda toplamaktadýr. Bu sayede cerrah; kýlavuzu bir kez konumlandýrma ile gerekli 5 kesiyi hýzlý ve hatasýz yaparak femuru uygun yapýya getirebilmektedir. T08 Total Knee system offers mobile and fixed insert options. This enables the surgeon to make the appropriate choice for the case. T08 Total diz sistemi, hem mobil hem de sabit insertli (Bað kesen/Koruyan) opsiyonlarýný sunmaktadýr. Bu sayede Cerrah vakanýn gerektirdiði en doðru seçeneði tercih edebilmektedir Material Malzeme T08 Total Knee System manufactured from: -CoCrMo alloy according to ISO 5832-4 for Femoral Components -Tibial Components; -CoCrMo alloy according to ISO 5832-4 for Mobile System -TiAlV alloy according to ISO 5832-3 for Fix System -PE-UHMW (Ultra High Molecular Weight Polyethylene crosslinked according to ISO 5834-1/2 for Patella and inserts. T08 Total Diz Sistemi: -Femoral komponentler ISO 5832-4 standartýna uygun CoCrMo alaþýmýndan -Tibial komponentler; -Mobile yapý için kullanýlan komponent ISO 5832-4 standartýna uygun CoCrMo alaþýmýndan -Fix yapý için kullanýlan komponent ISO 5832-3 standartýna uygun TiAlV alaþýmýndan -Patella ve insertler ISO 5834-1/2 standartýna uygun Ultra Yüksek Moleküler Aðýrlýklý Polietilen (PE-UHMW) çapraz baðlý malzemeden imal edilmiþtir. 3 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi FEMORAL COMPONENT Standard Posterior Stabilizer Cemented Cemented Standart Posterior Kýsýtlatyýcýlý Sementli Ref. Number Ref. Numarasý Co.Cr-alloy Co.Cr-alaþým Sementli Size Ref. Number Style Ebat Ref. Numarasý Tip Co.Cr-alloy Co.Cr-alaþým Size Style Ebat Tip 10281013000 10281013001 10281013002 10281013003 10281013004 10281013005 0 1 2 3 4 5 Right/Sað Right/Sað Right/Sað Right/Sað Right/Sað Right/Sað 10281213000 10281213001 10281213002 10281213003 10281213004 10281213005 0 1 2 3 4 5 Right/Sað Right/Sað Right/Sað Right/Sað Right/Sað Right/Sað 10281023000 10281023001 10281023002 10281023003 10281023004 10281023005 0 1 2 3 4 5 Left/Sol Left/Sol Left/Sol Left/Sol Left/Sol Left/Sol 10281223000 10281223001 10281223002 10281223003 10281223004 10281223005 0 1 2 3 4 5 Left/Sol Left/Sol Left/Sol Left/Sol Left/Sol Left/Sol TIBIAL COMPONENT Standard/Standart Cemented/Sementli Ref. Number Ref. Numarasý Ti alloy Ti alaþým 10253612000 10253612001 10253612002 10253612003 10253612004 10253612005 Mobile Bearing Cemented/Sementli Ref. Number Ref. Numarasý Size Co.Cr alloy Ebat Co.Cr alaþým 0 1 2 3 4 5 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 10282613000 10282613001 10282613002 10282613003 10282613004 10282613005 4 Size Ebat 0 1 2 3 4 5 T08 Total Knee System T08 Total Diz Sistemi TIBIAL INSERT FIXED Posterior Stabilizer Standard/Standart Posterior Kýsýtlayýcýlý Ref. Number Size Thickness Ref. Number Size Thickness 10281517008 10281517010 10281517012 10281517015 10281517018 10281517108 10281517110 10281517112 10281517115 10281517118 10281517208 10281517210 10281517212 10281517215 10281517218 10281517308 10281517310 10281517312 10281517315 10281517318 10281517408 10281517410 10281517412 10281517415 10281517418 10281517508 10281517510 10281517512 10281517515 10281517518 0 0 0 0 0 1 1 1 1 1 2 2 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 10281557008 10281557010 10281557012 10281557015 10281557018 10281557108 10281557110 10281557112 10281557115 10281557118 10281557208 10281557210 10281557212 10281557215 10281557218 10281557308 10281557310 10281557312 10281557315 10281557318 10281557408 10281557410 10281557412 10281557415 10281557418 10281557508 10281557510 10281557512 10281557515 10281557518 0 0 0 0 0 1 1 1 1 1 2 2 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 Ref. Numarasý Ebat Kalýnlýk Ref. Numarasý 5 Ebat Kalýnlýk SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi TIBIAL INSERT MOBILE BEARING Standard/Standart Posterior Stabilizer Posterior Kýsýtlayýcýlý Ref. Number Size Thickness Ref. Number Size Thickness 10282517008 10282517010 10282517012 10282517015 10282517018 10282517208 10282517210 10282517212 10282517215 10282517218 10282517408 10282517410 10282517412 10282517415 10282517418 0 0 0 0 0 2 2 2 2 2 4 4 4 4 4 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 10282557008 10282557010 10282557012 10282557015 10282557018 10282557208 10282557210 10282557212 10282557215 10282557218 10282557408 10282557410 10282557412 10282557415 10282557418 0 0 0 0 0 2 2 2 2 2 4 4 4 4 4 8 10 12 15 18 8 10 12 15 18 8 10 12 15 18 Ref. Numarasý Ebat Kalýnlýk Ref. Numarasý Ebat Kalýnlýk PATELLA Standard Re-Surfacing Ref. Number Size Ref. Number Size 10281717000 10281717001 10281717002 0 1 2 10281737000 10281737001 10281737002 10281737003 0 1 2 3 Ref. Numarasý Ebat SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ Ref. Numarasý 6 Ebat T08 Total Knee System T08 Total Diz Sistemi TIBIAL STEM Ref. Number Ref. Numarasý Co.Cr alloy Size 10282913025 10282913050 25 50 Co.Cr alaþým 7 Ebat SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi TIBIAL STAGE TIBIAL SAFHA USE OF INTRA-MEDULLARY CUTTING GUIDE ÝNTRA MEDULAR KESÝ GAYDININ KULLANIMI Drill a hole using the Drill 10 mm (Ref: 10606511100) bit from attached to tibia of anterior cruciate ligaments. 10 mm çapýndaki drill (Ref: 10606511100) ile anterior Cruciate Ligamentin yapýþtýðý yerden delik açýn. Additional Info/Ek Bilgi After drilling the tibia, it is possible to make use of the bit already assembled on the power tool drill to drill the femoral hole. Tibiayý delerken kullanmýþ olduðunuz drilli femuru delerken de kullanmanýz mümkündür. Introduce the intramedullary rod (Ref:10608021055) and the tibial support (Ref:10608511125) as deep as possible into the tibia. Lower the support the reach contact with the prespinal surface. Tibial destek (Ref:10608511125) ile intramedülar rodu (Ref:10608021055), tibianýn içine mümkün olduðunca derin bir þekilde yerleþtirin. Sonrasýnda tibial desteði prespinal yüzeyle temas edecek þekilde çakýn. Fasten the tibial resection guide on the tibial guides peak point with using the fixation screw. Tibial kesi gaydýný tibial gaydýn üzerine, en üst noktada olacak þekilde fiksasyon vidasý ile sabitleyin. Insert the telescopic rod into the tube of tibial guide. Teleskopik rodu tibial gaydýn tüpü içine takýn. Insert the tibial guide with the into the tibial support and firmly tighten the 3.5 screw with the Screwdriver (Ref: 10604010065) to fix the tibial support. Tibial gaydý tibial desteðe takýn ve yandaki vidayý 3.5 mm tornavidayla (Ref: 10604010065) sabitleyin. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 8 T08 Total Knee System T08 Total Diz Sistemi Set the tibial slope at 0 degree by turning the frontal screw on the tibial guide. Tibial gaydýn üzerindeki ön yüzdeki vidayý çevirerek tibial slopu 0 dereceye ayarlayýn. Attention/Dikkat Ensure that the screw located on to the tibial resection guide (Ref: 10612010101) is directly facing the centre of the tibial plate (the junction of the internal third and two external thirds of the tibial tuberosity) Tibial kesi gaydýnýn (Ref: 10612010101) üzerindeki vidanýn direkt olarak tibial platein merkezine doðru baktýðýna emin olun (Tibial tuberositinin internal 1/3ü ve eksternal 2/3ünün kesiþme noktasý.) SETTING THE TIBIAL SLOPE TÝBÝAL EÐÝMÝN AYARLANMASI Adjust the posterior slope between 0 and 10 degrees on the scale of the tibial guide (Ref: 10608511151) by turning the frontal thumbwhell switch of the guide anticlockwise. Gaydýn ön tarafýndaki mekanizmayý saat yönünün tersine döndürerek tibia gayd (Ref: 10608511151) üzerindeki skalasýndan posterior slopu 0 ile 10 derece arasýnda ayarlayýn. Attention/Dikkat The tibial slope must be set before setting the height of cut. Kesimin yüksekliðini belirlemeden önce tibial slopu belirleyiniz. An excessive slope could damage the tibial insertion of the posterior cruciate ligament. Fazla verilen bir slop posterior baðýn tibial insersiyonuna zarar verebilir. Extract the telescopic rod of the guide and ensure that the lower extremity end of the rod is clearly matching the centre of the ankle. Gaydýn teleskopik rodunu uzatýn ve rodun alt ucunun ayak bileði ekleminin merkezine denk düþtüðüne emin olun. 9 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi SETTING THE LEVEL OF THE CUT KESÝMÝN SEVÝYESÝNÝN BELÝRLENMESÝ Place the tibial stylus (Ref: 10608511172) on the tibial resection guide on the side where tibial resection is expected to be greatest. Place the tibial stylus 0 mm if measurement is performed medially or place it 8 mm if measurement is performed laterally. Tibial stylusu (Ref: 10608511172) tibial kesi gaydýnýn üzerine, tibial kesimin yapýlacaðý yönden yerleþtirin. Tibial ölçüm medialden yapýlacaksa stylus 0 a lateralden yapýlacaksa 8 mmye konumlandýrýlýr. Ensure a sufficient cut of the controlateral compartment with the assistance of the Blade Runner (Ref: 10608511173). ýf necessary use the micrometer adjustment screw to adjust the level of the cut. Blade Runner (Ref: 10608511173) yardýmýyla contro-lateral kompartýmanýn yeterli bir seviyede kesileceðine emin olun. Gerektiði hallerde mikrometrik ayarlama vidasýnýn yardýmýyla yapýlacak kesimin seviyesini ayarlayýn. Drill the two inferior holes located on each side of the fixation screw of the tibial resection guide and inroduce two pins, diameter 3.2 mm (Ref: 10606520570). Tibial kesi gaydýnýn fiksasyon vidasýnýn her iki tarafýnda bulunan alltaki iki deliði 3.2 mm drill ile delin ve çapý 3.2 mm lik iki çiviyi buraya çakýn. Release the tibial resection guide fixation screw. Tibial kesi gaydýnýn fiksasyon vidasýný gevþetin. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 10 T08 Total Knee System T08 Total Diz Sistemi Withdraw the intramedullary rod and remove the tibial guide and tibial support together. Ýntramedüller rodu çekerek çýkartýn, tibial gaydý ve tibia desteði birlikte çýkartýn. Place the tibial resection guide in contact with the tibia, sliding it on the two pins. Tibial kesi gaydýný tibiayla temas edecek þekilde, iki çivinin üzerinden kaydýrmak suretiyle yaklaþtýrýn. After drilling the tibial cutting guides other fixing hole with the 3.2mm drill, fix the tibial cutting guide with 3.2 mm nail (Ref: 10606520255). Tibial kesi gaydý üzerindeki diðer sabitleme deliðini 3.2 mm drill ile deldikten sonra 3.2 mmlik çivinin (Ref: 10606520255) yardýmýyla sabitleyin. 11 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi USE OF THE EXTRA-MEDULLARY ALIGNMENT GUIDE EXTRA MEDULAR KESÝ GAYDININ KULLANIMI Assembly of the upper part Gaydýn üst kýsmýnýn kurulumu Fasten the tibial resection guide on the tibial guides peak point with using the fixation screw. Tibial kesi gaydýný tibial gaydýn üzerine, en üst noktada olacak þekilde fiksasyon vidasý ile sabitleyin. Insert the tibial guide with the into the tibial support and firmly tighten the 3.5 screw with the screwdriver to fix the tibial support. Tibial gaydý tibial desteðe takýn ve yandaki vidayý 3.5 mm tornavidayla sabitleyin. Set the tibial slope at 0 degree by turning the frontal screw on the tibial guide. Tibial gaydýn üzerindeki ön yüzdeki vidayý çevirerek tibial slopu 0 dereceye ayarlayýn. Assembling of the lower part Gaydýn alt kýsmýnýn kurulumu Tibial guide attachment (Ref:10608511152), tibial guide-malleolar pincer (Ref:10608511153) and tibial guidemalleolar pincer attachment (Ref:10608511154) are mounted reference 0 mm. Tibial gayd uzatma parçasý (Ref:10608511152), tibial gayd malleolar pincer (Ref:10608511153) ve tibial gayd malleolar pincer baðlantý parçasý (Ref:10608511154) 0 mm referans alýnarak monte edilir. POSITIONING OF THE GUIDE GAYDIN POZÝSYONLANMASI Position the lower part of the guide taking care that the malleolar pincer is exactly facing the centre of the ankle joint. Gaydýn alt kýsmýný malleolar pincer tam olarak eklem baðýnýn merkezine bakacak þekilde pozisyonlandýrýn. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 12 T08 Total Knee System T08 Total Diz Sistemi Insert the tibial guide into the extramedular guide. Let the upper and lower part of the extramedular guide free to slide into each other. Tibial gaydý, ekstramedular gaydýn içine yerleþtirin. Tibial aparatýn yukarý ve aþaðý bölümlerini birbirinin içine doðru serbestçe kayacak bir þekilde býrakýn. Slightly hammer the first spike at the centre of the tibia, leavng free the second one. Approach the resection guide at a distance of approximately 5 mm from the tibila epiphysis by sliding the upper part of the tibial guide on the tibial support. Tibial destek kolundaki çiviyi tibial platoya çakýn, ikincisini boþta býrakýn. Kesi gaydýna , tibial epipihysisten yaklaþýk 5 mmlik bir uzaklýktan tibial gaydýn üst kýsmýný tibial desteðe kaydýrarak yaklaþýn. SETTING THE TIBIAL SLOPE TÝBÝAL SLOPUN AYARLANMASI Additional info/Ek bilgi Tibial slope will be set according to patients anatomy by moving the lower part of the extramedular guide. Tibial slop, hastanýn anatomisine baðlý olarak, ekstramedular gaydýn alt kýsmýnýn hareket ettirilmesi sonucunda belirlenir. Attention/Dikkat The tibial slope must be set up before setting the level of cut. Kesimin seviyesi belirlenmeden önce tibial slop belirlenmelidir. Until the definitive correct position of the resection guide has not been defined the upper and lower part of the tibial ancillary should remain free to slide into each other. Kesi gaydýnýn nihai pozisyonlandýrýlmasý belirlenene dek tibial aparatýn yukarý ve aþaðý bölümleri birbirine doðru rahatça kayabilecek þekilde serbest býrakýlmalýdýr. An excessive slope choice could damage the tibial insertion of the posterior cruciate ligament. Haddinden fazla bir slop seçimi posterior cruciate ligamentin tibial insersiyonuna zarar verebilir. 13 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi SETTING THE ROTATION ROTASYONUN BELÝRLENMESÝ The control of the rotation of the resection guide can be done taking the fixation screw as reference for the center of the guide. the screw should face the center of the tibia.Also check that the lower part is correctly centred on the mid point of the ankle joint. The long pin can now be hammered and fixed in the tibial surface. Kesi gaydýnýn rotasyonunun kontrolü gaydýn ortasýndaki fiksasyon vidasý referans alýnarak yapýlýr. Vida tibianýn merkezi yönüne bakmalýdýr. Bunlara ilaveten aþaðý kýsmýn ayak bileði ekleminin merkezine doðru ortalanarak konumlandýrýldýðý da kontrol edilmelidir. Bu noktadan sonra uzun çivi tibianýn yüzeyine çakýlarak sabitlenebilir. SETTING THE LEVEL OF THE CUT KESÝM SEVÝYESÝNÝN BELÝRLENMESÝ Place the tibial stylus (Ref: 10608511172) on the tibial resection guide on the side where tibial resection is expected to be greatest. Place the tibial stylus 0 mm if measurement is performed medially or place it 8 mm if measurement is performed laterally. Tibial stylusu (Ref: 10608511172) tibial kesi gaydýnýn üzerine, tibial kesimin yapýlacaðý yönden yerleþtirin. Tibial ölçüm medialden yapýlacaksa stylus 0a lateralden yapýlacaksa 8 mmye konumlandýrýlýr. Ensure a sufficient cut of the controlateral compartment with the assistance of the Blade Runner. ýf necessary use the micrometer adjustment screw to adjust the level of the cut. Blade Runner yardýmýyla contro-lateral kompartýmanýn yeterli bir seviyede kesileceðine emin olun. Gerektiði hallerde mikrometrik ayarlama vidasýnýn yardýmýyla yapýlacak kesimin seviyesini ayarlayýn. Drill the two inferior holes located on each side of the fixation screw of the tibial resection guide and inroduce two pins, diameter 3.2 mm (Ref: 10606520570). Tibial kesi gaydýnýn fiksasyon vidasýnýn her iki tarafýnda bulunan alltaki iki deliði 3.2 mm drill ile delin ve çapý 3.2 mmlik iki çiviyi (Ref: 10606520570)buraya çakýn. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 14 T08 Total Knee System T08 Total Diz Sistemi Release the tibial resection guides fixation screw. Tibial kesi gaydýnýn fiksasyon vidasýný gevþetin. Withdraw the extramedullary guide and remove the tibial guide and tibial support together. Ekstramedular gaydý çýkartýn, tibial gaydý ve tibia desteði birlikte çýkartýn. Attention/Dikkat While tibial guide and extramedullary guide is being removed ensure that tibial resection guide is not moving. Tibial gaydýn ve ekstramedular gaydýn sökülmesi sýrasýnda tibial kesi gaydýnýn yerinden oynamamasýna dikkat edilmelidir. Place the tibial resection guide in contact with the tibia, sliding it on the two pins. Tibial kesi gaydýný tibiayla temas edecek þekilde, iki çivinin üzerinden kaydýrmak suretiyle yaklaþtýrýn. After drilling the tibial cutting guides other fixing hole with the 3.2mm drill, fix the tibial cutting guide with 3.2 mm nail (Ref: 10606520255). Tibial kesi gaydý üzerindeki diðer sabitleme deliðini 3.2 mm drill ile deldikten sonra 3.2 mmlik çivinin (Ref: 10606520255) yardýmýyla sabitleyin. REALISATION OF TIBIAL CUT TÝBÝAL KESÝMÝN GERÇEKLEÞTÝRÝLMESÝ Perform the tibial cut using the saw blade. Býçak aracýlýðýyla kesimi gerçekleþtirin. Attention/Dikkat Saw Blade to be used for cutting must be 1.2 mm thickness. To use a thinner blade makes imporer cutting. Kesim esnasýnda kullanýlan býçaðýn kalýnlýðý 1.2 mm olmalýdýr. Kesim için daha ince bir býçak kullanýlmasý kesimde hataya sebep olacaktýr. CHOOSING THE TIBIAL COMPONENT TÝBÝAL KOMPONENTÝN BELÝRLENMESÝ Choose the size of tibial component using the trial baseplates. Deneme baseplatelerini kullanarak tibial komponentin uygun boyunu seçin. 15 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi To strengthen the fit of the tibial trial baseplate and avoid translation movements during the preparation of the keel, put in place two 2.7 pins (Ref: 10606520130) in the holes of the trial tibial baseplate located posteriorly. Then barrel is mounted on the trial baseplate and drilling process is performed with 10 mm drill. Tibia deneme baseplateinin tam olarak yerine oturmasýný saðlamak ve keel yuvalarýnýn hazýrlanmasý sýrasýnda ortaya çýkacak translasyon hareketini önlemek için deneme tibial baseplateine posterior olarak konumlandýrýlmýþ iki deliðe 2.7 mmlik iki adet pini (Ref: 10606520130) yerleþtirin. Daha sonra deneme baseplatei üzerine Barrel monte edilerek 10 mm lik Drill ile delme iþlemi gerçekleþtirilir. Attention/Dikkat If tbial stem is not used, perform drilling up to first line on the drill. If tibial stem is used, perform drilling up to second line Delme iþlemi tibial stem kullanýlmadýðý durumlarda drill üzerindeki ilk çizgiye kadar, tibial stem kullanýlacaðý durumlarda ikinci çizgiye kadar yapýlmalýdýr. After drilling, assemble the Slide Hammer Attachment (Ref: 10608521033), the Puncher (Ref: 106085210 . . )and the Slide Hammer (Ref: 10608521032) together thus create the frame of the keel. Delme iþlemi yapýldýktan sonra Hareketli Çakýcý-Çýkarýcý Ucu (Ref: 10608521033), Puncher (Ref: 106085210 . . ) ve Hareketli Çakýcý-Çýkarýcý (Ref: 10608521032) birbirine monte edilerek keelin dýþ hatlarýný oluþturun. When adding an tibial stem after using the puncher itself, the test tibial stem of the chosen length must be screwed to the end of the puncher and the whole unit introduced through the trial baseplate to prepare the path for the tibial stem. Puncherý kullanýldýktan sonra ilaveten bir tibial stemin eklenmesi gerektiði hallerde seçilen boyun testi punchera vidalanmalý ve tüm aparat tial steme gerekli yolu açmak için deneme baseplateinin içine yerleþtirilmelidir. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 16 T08 Total Knee System T08 Total Diz Sistemi Place a appropriate size trial insert and mount the test tibial component handle to the baseplate Uygun test inserti yerleþtirin ve Test Tibial Komponent Tutucuyu baseplatee monte edin. Assess tibial correction of the knee in extension. Control the orthogonal aspect of the tibial cut by introducing the centromedullary rod in one of the holes at the extremity of the trial baseplate handle. Ekstensiyon halindeki dize gereken tibial düzeltme iþlemini yapýn. Deneme baseplateinin tutacacaðýný ucunda bulunan deliklerden birine merkezi-medüller rodu yerleþtirmek suretiyle tibial kesimin orthogonal görünümünü elde edebilirsiniz. Additional info/Ek bilgi In order to pre-select the size of tibial insert, the resected part of the tibia may be superimposed on the trial baseplate. Tibial insert ün boyunu önceden belirleyebilmek için tibianýn kesilmiþ bölümünü deneme baseplateiyle üstüste koyun. ASSEMBLY OF THE STANDARD AND PS MOBILE TEST INSERTS STANDART ve PS MOBIL BEARING TEST INSERTLERÝN YERLEÞTÝRÝLMESÝ 17 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi FEMORAL STAGE FEMORAL SAFHA PREPARE THE SIZING GUIDE ÖLÇÜM GAYDININ HAZIRLANMASI Fix the handle (Ref: 10608021051) on the femoral anterior sizing guide (Ref: 10608021050). Tutma kolu (Ref: 10608021051) Femoral anterior ölçüm gaydýna (Ref: 10608021050) takýlýr. Introduce the Intramedular rod through the orientation hole and set the femoral valgus (right or left side) with pulling the orientation pin (established from the pre-operative planning). Place the posterior wedge 3 ° (Ref: 10608521023) on medial. Intramedülar rodu oryantasyon deliði yardýmýyla yerleþtirin ve ameliyat öncesi planlamada belirlenmiþ olan açý derecesinde oryantasyon mandalýný çekin, femoral valgusu ayarlayýn ve býrakýn. 3 ° dýþ rotasyon kamasýný (Ref: 10608521023) mediale konumlandýrýn. Fix the anterior sizing stylus to the femoral anterior sizing guide (left or right bone laterally) Anterior ölçüm stylusunu femoral anterior ölçüm gaydýna takýn. (sað veya sol kemiðin lateraline) POSITIONING OF THE GUIDE GAYDIN KONUMLANDIRILMASI Flex the knee to 90 degree. Drill, using the gauged 10 mm diameter drill in the axis of the femur, immediately up front the femoral insertion of the Posterior Cruciate Ligament. Ameliyat edilecek dizi 90 derecelik bir açýya getirin. 10 mm çapýndaki drill i kullanarak femur eksenini hemen posterior Cruciate Ligamentin önündeki femur insersiyonundan delmeye baþlayýn. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 18 T08 Total Knee System T08 Total Diz Sistemi PLACING THE GUIDE GAYDIN YERLEÞTÝRÝLMESÝ Fix the femoral anterior sizing guide to the femur with using intramedular rod. Measure the bone size with stylus on the anterior side. Measuring of femoral anterior sizing guide and measuring of scale on stylus must be matched. Verify the measuring with using femoral anterir sizing guide control attachment. Then make sure there is a contact between guide and posterior and distal edge of the condyles. Femoral anterior ölçüm gaydý intramedular rod ile femur a takýlýr. Anteriordan stylus ile ölçüm yapýlýr. Femoral anterior ölçüm gaydý üzerinde okunan ölçü ile Stylus üzerindeki skalada bulunan ölçü birbiri ile eþleþmelidir. Kontrol sacý yardýmýyla ölçüm gaydýnýn yan kýsmýnda bulunan referans kanallarýndan ölçüm doðrulamasý yapýlýr. Son aþama olarak gaydýn, kondilin posterior ve distaline temas ettiðinden emin olunuz. Hammer two Ø4.00 mm nails (Ref: 10606520670) into femur through the reference holes on the femoral anterior sizing guide and remove the intramedular rod and femoral anterior sizing guide. Femoral anterior ölçüm gaydý üzerindeki referans deliklerinden femura 2 adet Ø4 (Ref: 10606520670) çivi çakýlýr ve ölçüm gaydý ve intramedular rod çýkarýlýr. 19 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi FIXING THE GUIDE GAYDIN SABÝTLENMESÝ Fix the femoral anterior sizing guide and determined size cutting guide onto the nails. Then mount the Femoral Cutting Guide Attachment (Ref: 10608521012) on the assembly. Fix the Femoral Cutting Guide Attachment on the peak point of the cortex with the two 2.7 mm pins. Femoral anterior ölçüm gaydý ile belirlenen ölçüdeki kesi gaydý referans çivilerinin üzerinden takýlýr, sonra Femoral Kesi Gaydý Sabitleme Kolu (Ref: 10608521012) takýlýr. Sabitleme kolu korteksin en tepe noktasýna 2 adet 2.7 mmlik çivi ile sabitlenir. Check for the last time that posterior and distal contact with the condyles is ensured. Son birkez , kondiller ile posterior ve distal temasýn gerçekleþtiðini kontrol edip temastan emin olun. Fix the guide laterally and medially with Ø3.2 mm nails in four places (During the fixing process cutting block must be immobile). Femoral kesi bloðu lateralden ve medialden Ø 3.2 mm çiviler ile 4 yerden sabitlenir. (Bu iþlem sýrasýnda kesi bloðu kesinlikle hareket etmemelidir.) Femoral cuts in the following order: Kesi sýralamasý þu þekilde olmalýdýr: 1- Anterior 2- Posterior 3- Anterior Chamfer 4- Posterior Chamfer 5- Distal (8 mm) 1 2 Attention/Dikkat After anterior and posterior cuts performed referans nails are removed and cutting is continued. Anterior ve Posterior kesiler yapýldýktan sonra referans çivileri sökülerek diðer kesilere devam edilir. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 20 T08 Total Knee System T08 Total Diz Sistemi 3 4 Check that all cuts correctly performed. The implant will be ready for application. Distal kesim tamamlandýðýnda femur implant uygulamaya hazýr olur. 5 Remove the nails. Çivileri sökün. Remove the cutting block. Kesi bloðunu çýkartýn. Additional info/Ek bilgi Saw Blade to be used for cutting must be 1.2 mm thickness. To use a thinner blade makes imporer cutting Kesim esnasýnda kullanýlan býçaðýn kalýnlýðý 1.2 mm olmalýdýr. Kesim için daha ince bir býçak kullanýlmasý kesimde hataya sebep olacaktýr. FEMUR 21 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi PATELLA STAGE PATELLAR SAFHA PATELLA RESURFACING TECHNIQUE PATELLANIN YENÝDEN YÜZEYLENDÝRÝLMESÝ TEKNÝÐÝ Lock the patella resection guide into the universal patella clamp. After carefully releasing the periphery of the patella, position the resection guides at the appropriate resection level, with the assistance pf the patellar stylus and firmly lock. Patella kesi gaydýný patella kýskacýna kenetleyin. Dikkatli bir þekilde patellanýn periferisini serbest býraktýktan sonra patellar stylusun yardýmýyla kesi gaydlarýný uygun kesim seviyesinde konumlandýrýn ve kýskacý, saðlamca kilitleyin. Perform the patellar cut through the slots of the resection guides. Kesim gaydýnýn oluklarý içinde patellar kesimi gerçekleþtirin. Open the patellear clamp, remove the two resection guides and position the spike jaw and drilling template. Patella kýskacýný açýn, iki kesi gaydýný da yerinden çýkartýn ve spike jaw ve delici þablonu konumlandýrýn. Apply the drilling template on the resected surface of the patella and drill three holes with the 5 mm diameter drill guide. Delici þablonu patellanýn kesilmiþ olan yüzeyine uygulayýn ve 5mm çaplý delici gayd yardýmýyla üç adet delik açýn. Remove the drill guide, select the correct size of trial patella and put in place. Four sizes are available (0,1,2,3). Kesici gaydý yerinden çýkartýn, deneme patellalarýnýn arasýndan doðru boyu seçin ve yerine oturtun. (dört deðiþik ölçüsü mevcuttur : 0,1,2,3) SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 22 T08 Total Knee System T08 Total Diz Sistemi INSET PATELLA TECHNIQUE ÝNSET PATELLA TEKNÝÐÝ Select the size of patella using the different barrels (Ref: 106085305..). Farklý ölçülerdeki barelleri (Ref: 106085305..) kullanarak patellanýn ebatýný belirleyin. Lock the corresponding guide of the selected diameter on the patellar clamp equipped with its spike jaws. Sivri uçlarý olan patella kýskacýný uygun çaptaki gayda kenetleyin. Ensure that the reaming depth ring is correctly adjusted. ýntroduce the reamer of corresponding diameter into the guide and ream until contact is made between the ring of the reamer and the upper part of the guide. If the reamer depth is inadequate, it is possible to increase this by raising the reamer ring. Oyucu derinlik halkasýnýn doðru bir þekilde ayarlandýðýna emin olun. Uygun çaptaki oyucuyu gayda yerleþtirin ve oyucu ile gaydýn üst kýsmý temas edene dek uygulayýn. Eðer delinecek derinlik yetersiz ise oyucu halkasý kaldýrýlarak derinlik arttýrabilir. 15 Place the trial patella, holding it with the two jaws expressly designed to this purpose mounted on the clamp. Deneme patellasýný kýskacýn üzerine bu amaçla yerleþtirilmiþ olan jawlardan tutarak yerleþtirin. 23 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi Attention/Dikkat The reaming power tool must be operated once the reamer has been completely introduced into the guide. In order to reduce any risk of fracturing the patella, reaming must be performed with caution at low speed, keeping the patellar clamp closed. Oyucu motor, oyucu ancak gaydýn içine tamamen yerleþtirildikten sonra çalýþtýrýlmalýdýr. Patellanýn kýrýlma riskini ortadan kaldýrmak için oyma iþlemi dikkatlice en düþük güçte; patella kýskacý kapalý haldeyken yapýlmalýdýr. INSERTÝNG THE TEST FEMORAL COMPONENT TEST FEMORAL KOMPONENTÝN YERLEÞTÝRÝLMESÝ Position the described test femoral component to the femoral component impactor (Ref: 10608521105) . Hammer the test femoral component to the femur wit using slide hammer. Belirlenen test femoral komponenti Femoral Komponent Çakýcýya (Ref: 10608521105) yerleþtirin. Hareketli çakýcý-çýkarýcýyý kullanarak test femoral komponenti femura çakýn. Drill the peg holes on trial femoral component with Ø7 mm (Ref: 10606511070)drill. Test femoral komponent üzerindeki deliklerden Ø7 mm (Ref: 10606511070) drill ile peg deliklerini açýn. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 24 T08 Total Knee System T08 Total Diz Sistemi Check correct alignment of the lower limb, introducing the intramedular rod into the test tibial component handle. Ýntramedular rodu test tibial komponent tutucu içerisinden geçirerek aks açýlarýný kontrol edin. TIBIAL BASEPLATE May be position 25 or 50 mm extension. If has been considered necessary, the baseplate should be screwed. 25 ve 50mm uzatma takýlabilir. Gerekli durumlarda tibial base plate vida ile sabitlenebilir. 25 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi Instruments & Trays/El Aletleri & Tavalar Tibia instrument tray 1 Tibia instrument tray 2 Tibia el aletleri tava 1 Tibia el aletleri tava 2 Tibia instrument tray 3 Tibia el aletleri tava 3 Femur instrument tray 1 Femur instrument tray 2 Femur el aletleri tava 1 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ Femur el aletleri tava 2 26 T08 Total Knee System T08 Total Diz Sistemi Pens Çivi Tutucu Pense Screw Driver Tornavida / 3,5 Drill Adaptor Drill Tutucu Adaptör Drill Bit Drill / Ø3,2 Drill Bit Drill / Ø5 Drill Bit Drill / Ø7 Drill Bit Drill / Ø10 Nail Çivi / Ø2,7X40 Nail Çivi / Ø3,2X55 Nail Çivi / Ø3,2X70 Nail Çivi / Ø4,0X70 Impactor Bar Çakýcý Pimi Universal Femoral Component Impactor 10607150005 Üniversal Femoral Komponent Çakýcý Femoral Anterior Sizing Guide Femoral Anterior Çivi Ölçüm Gaydý 27 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi 10608021051 Femoral Anterior Sizing Guide Handle 10608021053 Femoral Anterior Sizing Guide Control Attachment Femoral Anterior Ölçüm Kaydý Tutma Kolu Femoral Anterior Ölçüm Kaydý Kontrol Sacý Intramedular Rod for Tibia Intramedular Rod / Tibia Posterior stabilisation Shaft Peg for Test Tibial Insert Test Tibia Ýnsert Posterior Stabilizasyon Parçasý Test Tibial Component Test Tibial Komponent 0 1 2 3 4 5 Test Tibial Component Handle Test Tibial Komponent Tutucu Barrel Barrel Tibial Support Tibial Destek Parçasý Tibial Guide Tibial Gayd Tibial Guide Attachment Tibial Gayd - Uzatma Parçasý Tibial Guide - Malleoler Pincer Tibial Gayd - Malleoler Pincer Tibial Guide - Malleoler Pincer Attachment Tibial Gayd - Maleoler Pincer Baðlantý Parçasý Telescope Teleskop SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 28 T08 Total Knee System T08 Total Diz Sistemi Tibial Stylus Tibial Stylus Blade Runner Blade Runner Tibial Component Impactor Tibial Komponent Çakýcý Test Tibial Stem Test Tbial Stem 25 50 Notching Intsrument Yuva Açýcý Distal Wedge Distal Wedge Anterior Chamfer Wedge Anterior Chamfer Wedge Femoral Cutting Guide Attachment Femoral Kesi Gaydý Sabitleme Kolu Posterior Wedge Posterior Kama / 3° Slide Hammer Hareketli Çakýcý - Çýkarýcý Slide Hammer Attachment Hareketli Çakýcý - Çýkarýcý Ucu Puncher Puncher 0-1 2-3 4-5 Femoral Component Impactor Femoral Komponent Çakýcý 29 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi Patellar Clamp Patella Tutucu Spike Jaw Patella Sivri Uçlu Çene Patella Recection Guide Patella Kesi Gaydý Right / Sað Left / Sol Pressurizing Jaws Patella Bastýrýcý Çene Dirilling Template Patella Delik Þablonu Barrel Barrel 0 1 2 Patella Reamer Patella Oyucu 0 1 2 Patella Stylus Patella Stylus Calliper Gauge Kumpas Test Tibial Insert / 0 Test Tibia Insert / 0 Test Tibial Insert / 1 Test Tibia Insert / 1 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 30 T08 Total Knee System T08 Total Diz Sistemi Test Tibial Insert / 2 Test Tibia Insert / 2 Test Tibial Insert / 3 Test Tibia Insert / 3 Test Tibial Insert / 4 Test Tibia Insert / 4 Test Tibial Insert / 5 Test Tibia Insert / 5 Posterior stabilisation Shaft for Test Femoral Component T08 Test Femoral Komponent Posterior Stabilizasyon Þaftý Test Femoral Component TTest Femoral Komponent Right / Sað 0 Right / Sað 1 Right / Sað 2 Right / Sað 3 Right / Sað 4 Right / Sað 5 Left / Sol 0 Left / Sol 1 Left / Sol 2 Left / Sol 3 Left / Sol 4 Left / Sol 5 Test Patella Component Test Patella Komponent 0 1 2 31 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ T08 Total Knee System T08 Total Diz Sistemi Test Re-Surfacing Patella Component Test Re-Surfacing Patella Komponent 0 1 2 3 Femoral Cutting Guide Femoral Kesi Gaydý 0 1 2 3 4 5 90° Resection Guide 90° Tibial Kesi Gaydý 10608610008 10608610010 10608610012 10608610015 10608610018 Mobile Bearing Test Tibial Insert / 0 MB Test Tibia Insert / 0 10608610208 10608610210 10608610212 10608610215 10608610218 Mobile Bearing Test Tibial Insert / 2 MB Test Tibia Insert / 2 10608610408 10608610410 10608610412 10608610415 10608610418 Mobile Bearing Test Tibial Insert / 4 MB Test Tibia Insert / 4 Mobile Bearing Punch Handle MB Test Tibial Komponent Çakýcý - Çýkarýcý Ucu Mobile Bearing Test Tibial Component MB Test Tibial Komponent 0 1 2 3 4 5 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 32 Revision 03 / Printed in TURKEY - 09/11 - TIPSAN Design The products being manufactured by TIPSAN A.S. has been certified from SZUTEST (Strojírensk Zkuební Ústav) for EC certificate (CE 1015) according to Annex II. 3 and II.4 of Council Directive 93/42/EEC concerning medical devices Kemalpasa Cd. 7404/1 Sk. No: 3 Pinarbasi - IZMIR - TURKEY Tel: +90 232 479 56 54 Fax: +90 232 479 58 27 marketing@tipsan.com.tr www.tipsan.com.tr
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