EN_TR_TMC-3 Modular Hip Prosthesis Surgical Technique.FH11
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TMC 3 - TMC 4 MODULAR HIP PROSTHESIS TMC 3 - TMC 4 MODULAR HIP PROSTHESIS C E M E N T E D The key in orthopaedic sciences SURGICAL TECHNIQUE CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS ÝMPLANTLAR VE EL ALETLERÝ TMC-3 Modular Hip Prosthesis C E M E N T E D CONTENTS Introduction Giriþ ÝÇÝNDEKÝLER 2 Femoral Neck Osteotomy 6 Accesing the Femoral Canal 6 Contouring the Stem Envelope 7 Trial Reduction 7 Stem Insertion 8 Head Insertion 10 Instruments&Trays 11 Combination Chart 13 Femoral Boynun Osteotomisi Femoral Kanalý Açmak Raspalama Aþamasý Test Ýmplantýnýn Denenmesi Stemin Yerleþtirilmesi Kürenin Yerleþtirilmesi El Aletleri&Tavalar Kombinasyon Çizelgesi SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ TMC-3 Modular Hip Prosthesis C E M E N T E D Introduction Giriþ The TMC-3 modular hip prosthesis is a solution for total hip replacement namely with the concept of a hybrid system combined with distal centralizer. The form and the length of prostheses are ideal-together with distal centralizer in order to ensure self-centring. This prosthesis is design of conical wedge form with rounded edges in the proximal section corresponds with the anatomical and biomechanical requirements. The main part of the cement mantle is subject to compressive forces. Tensile forces are restricted to the lateral shoulder where the cement merely has the function of a filling material. The implant does not have any sharp edges, as a result of which stress concentrations and resultant cement cracks are avoided. TMC-3 modüler kalça protezi distal merkezleyici ile kombine olmuþ hibrid sistemin bir konsepti olarak ve total kalça yenilemesine bir çözüm olarak geliþtirilen bir protezdir. Protezin distal merkezleyici ile beraber uzunluk ve formu kendi kendini merkezlemeyi saðlayabilmesi için ideal olarak tasarlanmýþtýr. Bu protez anatomik ve biyomekanik ihtiyaçlarý karþýlamasý için proksimal bölgede yuvarlatýlmýþ kenarlara sahiptir ve üçgen bir kesitte tasarlanmýþtýr. Böylece sement tabakasýna sýkýþtýrýcý bir etki yapar. Gerilme kuvvetleri sementin sadece doldurucu malzeme görevi yaptýðý protezin lateral kýsmýnda sýnýrlandýrýlmýþtýr. Baskýnýn oluþmasýný ve sementin çatlamasýný engellemek için implantýn hiç keskin köþesi yoktur. TMC-3 This prosthesis consist of an appropriate number of stem sizes which enable one to obtain the filling of the medullary canal. Furthermore, an optimum thickness of the cement layer can also be achieved. Tapered distal design helps reduce strains in the cement as compared to conventional stem. Also cutted edge at the end of the stem avoid the pain in the distal part of femur and permit wide range of motion.This stem is mostly indicated for all cases of primary implants and all cases in which there is a contraindication for an uncemented stem. Contraindications is revision cases with extensive proximal osseous defect. The neck of the prosthesis has a taper 12/14 allowing standard metal heads to be used. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 2 TMC-3 Modular Hip Prosthesis C E M E N T E D Medular kanalý uygun þekilde doldurabilmesi için protez çeþitli boylarda stem ebatlarýna sahiptir. Bunlara ek olarak sement tabakasý optimum kalýnlýðý da kolayca ulaþýlabilir. Klasik bir stemle karþýlaþtýrýldýðýnda, üçgen formdaki daralan stem yapýsý sementteki gerilmeyi düþürmeye yardýmcý olur. Stemin distaldeki özel formu takýlýrken geniþ bir hareket alaný saðlayarak femurda oluþan aðrýyý azaltýr. Bu stem primer implantlarýn tüm çeþitlerinde ve sementsiz stemin kullanýlmasýnýn mümkün olmadýðý tüm durumlarda kullanýlabilir. Geniþ osseus bozukluklarýnda ortaya çýkan revizyonlarda kullanýlmasý uygun deðildir. Protez boynu standart metal kürelerin kullanýlabilmesi için 12/14 koniðe sahiptir. TMC-3 with collar named TMC-4 is also available. TMC-4 has same features with TMC3. The presence of a board medial collar together with a precise calcar preparation, allows excellent collar/calcar contact for load distribution and cement pressurization. TMC-4 diye adlandýrýlan, TMC-3ün yakalý formuda mevcuttur. TMC-4, TMC-3 ile ayný özelliklere sahip bir protezdir. Protezin bu yakalý kýsmý kemiðin calcar kýsmýnýn hazýrlanmasýyla bu kýsma tutunur ve oluþan bu yapý binen yükü daðýtýr ve sementin baskýlanmasýný saðlar. TMC-4 Material Malzeme The TMC-3 and TMC-4 modular hip prosthesis is manufactured from casting Co.Cralloy according to ASTM F 75 - ISO 5832-4. This alloy is characterized by demonstrating excellent biocompatibility together with a high resistance of corrosion and superiormechanical strenght. TMC-3 ve TMC-4 modüler kalça protezleri ASTM F 75 ve ISO 5832-4 standartlarýna uygun olarak CoCr döküm malzemeden üretilmiþtir. Bu alaþým mükemmel biyolojik uyumu, korozyona karþý yüksek dayanýmý, üstün mekanik dayanýklýlýðýyla bilinir. 3 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ TMC-3 Modular Hip Prosthesis C E M E N T E TMC-3 TMC-4 Ref. Number Ref. Number Co.Cr-alloy Co.Cr-alloy Stem Ebatý Stem Boyu L mm Konik Ebatý (mm) 10263013006 10263013008 10263013010 10263013012 10263013014 10262153006 10262153008 10262153010 10262153012 10262153014 6.0 8.0 10.0 12.0 14.0 113.5 130.5 135.0 140.0 145.0 12/14 12/14 12/14 12/14 12/14 Ref. Numarasý Co.Cr Alaþým L K D Ref. Numarasý Co.Cr Alaþým Stem Size K mm Stem Length Cone Size (mm) Cement Plug Sement Týkacý Reduced the potential for distal migration of bone cement within the medullary canal during prosthetic implantation, thus enhancing the chance for lateral displacement of bone cement and trabecular interstitialpenetration. Be result of wedging of fins in medular canal, plug can be anchored at the desired depth. Protez implantasyonu sýrasýnda medular kanalda gerçekleþen sementin distal olarak yer deðiþtirme potansiyelini düþürür. Böylece sementin lateral olarak yer deðiþtirme þansýný ve trabecular dokular arasý giriþi arttýrýr. Sement plug üzerindeki kanatçýklarýn medular kanal içerisinde sýkýþmasý sonucunda istenen derinliðe yerleþtirilir. Ref. Number Referans Numarasý 10247007001 10247007002 10247007003 10247007004 10247007005 10247007006 10247007007 10247007008 10247007009 10247007011 10247007013 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 4 Size Ölçü (Ø) 9 10 11 12 13 14 15 16 17 19 21 TMC-3 Modular Hip Prosthesis C E M E N T E D Distal Centralizer Distal Merkezleyici The distal centralizer with a three point - star configuration, helps improve cortical diaphyseal contact and stem alignment. Distal merkezleyicinin üç köþeli yýldýz yapýdadýr, kortikal diaphyseal baðlantýnýn iyileþtirilmesine ve stemin hizalanmasýna yardýmcýdýr. Size Ölçü Ref. Number (Ø) 8 8 10 12 14 Referans Numarasý 10246007001 10246007002 10246007003 10246007004 10246007005 Combining Stem Size Kombine Edilen Stem Ölçüsü 6 mm stem 8 mm stem 10 mm stem 12 mm stem 14 mm stem Material Malzeme PE-UHMW crosslinked material meets ASTM F 648 and ISO 5834-1/2 standards. Selected for its, high degree of purity, good biotolerance, good mechanical performance and friction properties. Yüksek saflýk oraný, biyolojik uygunluðu mekanik çalýþma performansý ve sürtünebilme özelliðinden dolayý ASTM F 648 ve ISO 5834-1/2 standartlarýna uygun PE-UHMW çapraz baðlý malzeme seçilerek üretilmiþtir. Please Note : This document is intended as a guide for the surgeon only. There are multiple techniques for the insertion of TMC-3 and TMC-4 Modular Hip Prosthesis and, as with any surgical procedure, a surgeon should be thoroughly trained and beware that this procedure is appropriate for the patient before proceeding. Not: Bu doküman cerrahlar için bir klavuz niteliðindedir. TMC-3 ve TMC-4 Modüler Kalça Protezlerinin uygulanmasý için çoklu teknikler mevcuttur ve diðer cerrahi iþlemlerde olduðu gibi cerrah derinlemesine eðitimli olmalý ve iþlemin hastaya uygun olduðundan emin olmalýdýr. 5 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ TMC-3 Modular Hip Prosthesis C E M E N T E D Femoral Neck Osteotomy Femoral Boynun Osteotomisi Because of the normal anteversion of the femoral neck, the prosthesis can only be positioned in the correct axial direction if the lenght of neck stump is medially no more than 1 cm. Femoral boynun normal anteversionundan dolayý, protezin doðru bir þekilde eksenel pozisyonlanmasý için, boyunda kalan parçanýn medial olarak 1 cmden fazla olmamasý gereklidir. A very important step is the trapezoidal opening of the medullary cavity. This opening, which may be made with a Tuke saw, should reach the tip of the greater trochanter. Then the femoral head is removed using an Femoral Head Extractor (Ref: 10606100001). The resected cancellous bone is removed with a gouge to expose the medullary canal. Buradaki önemli nokta medular boþluðun trapezoidal þekilde açýlmasýdýr. Bu iþlemde motorlu testere kullanýnýz. Bu iþlemle büyük trokanterin ucuna kadar ulaþýlmalýdýr. Sonra Femoral kafa, Tirbiþon (Ref: 10606100001) kullanýlarak çýkarýlýr. Kesilmiþ olan spongioz kemik parçalarý küretler yardýmýyla çýkarýlarak, medular kanal açýða çýkarýlýr. Accessing the Femoral Canal Femoral Kanalý Açmak After appropriate resection of the femoral head, the medullary cavity is opened using the Awl (Ref:10610331003), taking care to avoid damage to the cancellous structure. Femoral kafayý uygun bir þekilde kesip çýkardýktan sonra medular boþluk Awl yardýmýyla açýlýr (Ref:10610331003), spongioz yapýya zarar vermemek için dikkatli olunmalýdýr. Check the axis and ensure cortical continuity. Ekseni kontrol ediniz ve kortikal devamlýlýktan emin olunuz. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 6 TMC-3 Modular Hip Prosthesis C E M E N T E D Contouring the Stem Envelope Raspalama Aþamasý Widening of the medullary cavity with sized rasps (Ref:10610360...) and Modular Rasp Handle (Ref:10610011050) and Rasp Bar (Ref:10610001001) , anteversion from 10° to 15°. Starting with the smallest rasp , they are inserted in ascending size until complete locking. Check the rasp anteversion. The rasps must be inserted to optimum level determined by the 45° cut. Uygun büyüklükteki raspalar (Ref:10610360...) ve modüler raspa sapý (Ref:10610011050) ile oyuk, dýþarýya doðru 10° - 15° açý yapacak þekilde geniþletilir. En küçük raspa ile baþlayarak, kilitlrme olana kadar raspa büyütülerek devam edilir. Raspanýn anteversiyonu kontrol edilir. Raspa 45° kesimle belirlenmiþ olan optimum seviyeye kadar sokulur. Attention/Dikkat Never force impaction when the rasp is blocked in the diaphysis. Raspa diaphysiste bloklandýðýnda çakmak için zorlamayýnýz. The final rasp should be rotationally stable to assure stability of the implant. Ýmplantýn sabit durabilmesi için son kullanýlan raspanýn rotasyonel hareket yapmamasý gerekir. After complete locking of the rasp in the diaphysis, the broach handle is removed. Raspanýn diaphysiste kilitlenmesi tamamlanýnca raspa sapýný çýkarabilirsiniz. Trial Reduction Test Ýmplantýnýn Denenmesi 15). Positioning of the appropriate Test heads for THR S-M-L-XL-XXL (Ref:10608280011-15). Uygun pozisyonlama için test küreleri SMLXLXXL ölçülerindedir. (Ref:10608280011- A test head is fitted to the neck by pushing it onto the taper. To remove a test head, simply pull it. Test küresi konik üzerine bastýrýlarak takýlýr. Test küresi yerinden çekilerek çýkartýlýr. The test head (Ref: 106082800 . .) is mounted. After trial reduction leg length, muscle tension, stability and extent of movement must be checked. Test küresini (Ref:106082800 . .) monte ediniz. Deneme yerleþtirmesi yapýldýktan sonra bacak uzunluðu, kas gerilmesi, denge ve hareket alaný kontrol edilmelidir. The test head and rasp are removed. Daha sonra test küre ve raspa sökülür. 7 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ TMC-3 Modular Hip Prosthesis C E M E N T E D Remove any loose, unsupportive, cancellous bone from the canal with a Curettes (Ref: 10605210005-1060521002510605210103). Close the distal canal with a medullary plug at least at 1 cm distal to the tip of the stem. Pay attention in the choice of the distal plug, to ensure that it can resist to the cement pressure. Clean the intramedullary canal with pulse lavage and dry it. Keep the canal packed until cement is ready to be injected. Küretler (Ref: 10605210005-1060521002510605210103)yardýmýyla kanaldaki fazlalýk ve destek yapmayan spongioz kemik kalýntýlarýný temizleyiniz. Distal kanalý sement týkacý yardýmýyla stemin ucunun en az 1 cm altýnda olacak þekilde kapatýnýz. Distal sement týkacýný seçerken dikkat ediniz, onun sementin uygulayacaðý basýnca karþý koyabileceðinden emin olunuz. Medular kanalý temizleyiniz ve kurutunuz. Sement enjekte edene kadar kanalý hazýr bekletiniz. Stem Insertion Stemin Yerleþtirilmesi The size of the centralizer is established with using the table. An established size introducing rod plug is mounted on the introducing rod (Ref: 10608151020) to test the distal centralizier. Measure is taken with the introducing rod from the shoulder of the prosthesis. Then introducing rod is inserted into the femur. Check if it is inserted easily to determined depth. If not use 1 size smaller distal centralizier. Distal merkezleyicinin ebatý yandaki tabloya uygun olarak tespit edilir. Distal merkezleyiciyi test etmek için, belirlenen ebatta bir introducing rod plug alýnarak introducing rod (Ref: 10608151020) üzerine monte edilir. Introducing rod üzerinden protezin ölçüsü alýnýr. Daha sonra introducing rod kemik içerisine gönderilerek belirlenen derinlikte sýkýþýp sýkýþmadýðýna bakýlýr. Eðer sýkýþýyor ve istenilen derinliðe gönderilemiyorsa bir küçük ebat introducing rod tercih edilmelidir. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 8 Introducing Rod Introducing Rod Plug TMC-3 Modular Hip Prosthesis C Distal Centralizer (Intr. Rod Plug)Size E M N T E D Combining Stem Size Distal Merkezleyici Ölçüsü (Ø) Kombine Edilen Stem Ölçüsü 8 8 10 12 14 6 mm stem 8 mm stem 10 mm stem 12 mm stem 14 mm stem Mount the determined centralizer on the stem. Also mount a cement plug test on the introducing rod. Take the measure with the introducing rod from the shoulder of the prosthesis. Check if the test cement plug seated tightly in destermined depth with inserting the introducing rod into the femur. If not, change the test cement plug until determine the appropriate size. Tespit edilen merkezleyici steme monte edilir. Ýntroducing roda bir cement plug test vidalanýr. Ýntroducing rod ile centralizer takýlmýþ protezin boy ölçüsü bulunur. Daha sonra test sement týkacý introducing rod ile kemiðe gönderilerek istenilen mesafede týkama yapýp yapmadýðýna bakýlýr. Eðer yapmýyorsa test sement týkacý deðiþtirilerek doðru ebat tespit edilir. E Introducing Rod Distal Centralizer Distal Merkezleyici Cement Plug Test The Bone Plug is mounted on the Untroducing Rod. Insertion of the Bone Plug. The centralizer is mounted on the prosthesis, in accordance with the planned size or the size determined using the introducing rod with plug. Sement Plug Ýntroducing Roda monte edilerek kemik içerisine gönderilir. Önceden tespit edilen distal merkezleyici protezin ucuna takýlýr. Cement is injected. Insertion of the TMC3 stem with the distal centralizer. Sement doldurulur. Distal Merkezleyici ile TMC-3 stem kemiðe yerleþtirilir. 9 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ TMC-3 Modular Hip Prosthesis C E M E N T E D With the Impactor (Ref:10607031325), the stem is pushed in a distal-lateral direction, in order to avoid a varus position. Varustan kaçýnmak için Ýmpactor (Ref:10607031325) ile stem distal/lateral doðrultusunda bastýrýlýr. In order to achieve this, the impactor is aligned obliquely in a lateral direction, and not strictly axially, during insertion. Buna ulaþmak için yerleþtirme esnasýnda impactor lateral pozisyonda eðimli olarak hizalanýr. Attention/Dikkat Use Impactor&Extractor (Ref: 10607031321) with inserting it in extracting hole below the stem neck to remove the stem. Stemi yerinden çýkarmak için boyun kýsmýnýn altýnda bulunan çýkartma deliðini ve Çakma ve Çýkarma Pimini (Ref: 10607031321) kullanýnýz. Head Insertion Kürenin Takýlmasý The stem taper must be thoroughly cleaned before placing the head. The definitive head is positioned with a slight rotational movement. Seat the head tightly with tap on the Femoral Head Impactor (Ref:10607020003). Küre yerleþtirmeden önce stemin koniði iyi ce temizlenmelidir. Belirlenmiþ küre, hafif bir dairesel hareketle yerine yerleþtirilir. Küre, Femoral Çakýcýya (Ref:10607020003) vurularak sýkýca yerine oturtulur. Reduction and check of functioning. Oturmasýný ve iþleyiþini kontrol edin. SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 10 TMC-3 Modular Hip Prosthesis C E M E N T E D Instruments & Trays/El Aletleri & Tavalar tray 1 tray 2 10601330001 Handle for Setting Device 10602101101 Hohmann Retractor - Type 1 10602101102 Hohmann Retractor - Type 2 10602311001 Cement Pusher 10605210002 Straight Chisel 10605210025 Spoon Curette with Swan Necked Þaft Tutucu Ekartör hohmann - Tip 1 Ekartör Hohmann - Tip 2 Sement Ýttirici Düz Keski Spatul Küret - Kuðu boyunlu Guj Curette 10605210103 Guj Küret - Kanallý 10606100001 Femoral Head Extractor 10607031321 Impactor & Extractor for TMC-3 Týrbiþon Çakma Pimi 11 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ TMC-3 Modular Hip Prosthesis C E M E N T E D 10607031325 Impactor for TMC-3 Çakýcý Repositioning Lever 10607031330 Pozisyon Verdirici KoluRESÝM DEÐÝÞECEK Repositioning Lever Synthetic Top 10607031332 Pozisyon Verdirici Kolu - Synthetic Top Repositioning Top 10607031335 Pozisyon Verdirici kolu - Repositioning Top 10608021011 Gauge For Femoral Head 10608081013 Ruler Küre Çap Ölçer Cetvel Plug for Introducing Rod for TMC-3 Introducing Rod Plug Ø8 Ø10 Ø12 Ø14 10608151008 10608151010 10608151012 10608151014 10608151020 Introducing Rod for Medullary Plug for TMC-3 Introducing Rod Test Head for THR Test Küre 10608280011 10608280012 10608280013 10608280014 10608280015 S M L XL XXL Bone Plug Test Test Bone Plug 11 14 16 19 21 10608470011 10608470014 10608470016 10608470019 10608470021 10610001001 Rasp Bar Raspa Pimi 10610011050 Modular Rasp Handle 10610331003 Medullary Awl Reamer - CLS & TMC-3 Modüler Raspa Sap AWL Oyucu Prosthesis Rasp for TMC-3 & TMC-4 Raspa 10610331006 10610331008 10610331010 10610331012 10610331014 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ Ø6 Ø8 Ø10 Ø12 Ø14 12 TMC-3 Modular Hip Prosthesis C E M E N T E D Combination Chart/Kombinasyon Çizelgesi Expansion Cup Uncemented (Sementsiz Expansion Cup) Press fit Cup Uncemented (Sementsiz Press fit Cup) Insert forExpansion Cup Uncemented (Sementsiz Expansion Cup için Insert) Insert for Press fit Cup Uncemented (Sementsiz Press fit Cup için Insert) Modular Head (Modüler Küre) Acetabular Reinforcement Acetabular Cup Cemented (Sementli Acetabular Cup) Cage (Acetabular Destek Kafesi) Acetabular Ring (Acetabular Destek Halka) Modular Bipolar Cup Uncemented (Sementsiz Modüler Bipolar Cup) Unipolar Head (Unipolar Küre) 13 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ TMC-3 Modular Hip Prosthesis C E M E N T E D Notes/Notlar SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 14 TMC-3 Modular Hip Prosthesis C E M E N T E D Notes/Notlar 15 SURGICAL TECHNIQUE / CERRAHÝ TEKNÝK IMPLANTS & INSTRUMENTS / ÝMPLANTLAR VE EL ALETLERÝ 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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