Integra. TruArch Cannulated Subtalar Implant System SURGICAL TECHNIQUE

Transcription

1 Itegra TruArch Caulated Subtalar Implat System SURGICAL TECHNIQUE

2 Table of Cotets Desig Ratioale...2 System Features...2 Idicatios...2 Cotraidicatios...2 Surgical Techique...3 Step 1 Icisio / Isertio of Guide Wire...3 Step 2 Probe Isertio / Dilatio...4 Step 3 Trial Sizer Selectio ad Placemet...4 Step 4 Implat Isertio ad Positioig...5 Step 5 Implat Placemet Verificatio / Guide Wire Removal...5 Step 6 Evaluatio ad Closure...5 Removal... 6 Istrumetatio Orderig Iformatio...Back Cover Desig Ratioale The TruArch Subtalar Arthroereisis System is desiged to aid i the correctio of a wide rage of flatfoot disorders resultig i a hyperproated foot ad ustable subtalar joit. The system features a titaium alloy, coical, partially threaded implat with soft tissue i growth slots ad chaels. The color coded, caulated system promotes ease of use ad accurate placemet with miimum tissue disruptio. A uique driver/implat iterface system facilitates accurate repositioig or implat removal. System Features Tapered desig for aatomical fit withi the sius tarsi Threads desiged to miimize irritatio ad prevet migratio Reverse thread iterface for easy removal Caulated system for simple, reproducible results Wide rage of sizes to accommodate all patiet aatomy Maufactured from titaium alloy for stregth ad biocompatibility Idicatios The TruArch subtalar implat is idicated for use i the treatmet of the hyperproated foot ad stabilizatio of the subtalar joit. It is desiged to block forward, dowward ad medial displacemet of the talus, thus allowig ormal subtalar joit motio but blockig excessive proatio ad the resultig sequela. Idicatios iclude: Severe proatio Calcaeal valgus deformity Platarflexed talus Failed correctio with log term orthotic treatmet Cogeital ad paiful flatfoot deformity Repair of tarsal coalitios Subtalar istability Posterior tibial tedo dysfuctio Paralytic flat foot deformity The TruArch Subtalar implats ad guide wires are iteded for sigle use oly. Cotraidicatios Use of the subtalar implat system is cotraidicated i cases of active or suspected ifectio or i patiets who are immuocompromised; i patiets previously sesitized to titaium; i patiets with iadequate boe stock; i patiets with superstructural aligmet deformities; or i patiets with certai metabolic diseases. 2

3 Surgical Techique Step 2 Probe Isertio / Dilatio 2-1 As the maufacturer of this device, Itegra does ot practice medicie ad does ot recommed this or ay other surgical techique for use o a specific patiet. The surgeo who performs ay implat procedure is resposible for determiig ad usig the appropriate techiques for implatig the device i each patiet. 2-1 The caulated probe is iserted over the guide wire with a getle, twistig, ad circular motio to ope the sius tarsi, dilate the tarsal caal ad stretch the iterosseous talocalcaeal ligamet. Step 1 Icisio / Isertio of Guide Wire 1-1 A small 1 2cm icisio is made o the lateral aspect of the foot over the sius tarsi area alog the relaxed ski tesio lies. It is importat to avoid the itermediate dorsal cutaeous erves as well as the sural erve, which should course superior ad iferior to the icisio respectively. 1-1 The probe is positioed from lateral to medial across the lateral sius tarsi ad ito the sius caalis, alog the axis of the subtalar joit. The probe should be advaced alog the path of the guide wire, i a directio iferior ad slightly posterior to the medial malleolus. Durig this maeuver the iterosseous talocalcaeal ligamet may be partially released. Step 3 Trial Sizer Selectio ad Placemet The sizer estimated to most closely match the patiet s aatomy is placed over the guide wire ad iserted ito the sius tarsi from lateral to medial, by turig the hadle clock-wise util the implat is seated i the sius tarsi cavity, at a level about flush with the lateral eck of the talus o a AP fluoroscopy. The correct sizer should limit abormal calcaeal eversio. 1-2 The deep fascia ad capsule overlyig the sius tarsi is idetified ad icised, allowig etrace ito the lateral sius tarsi. If the cervical ligamet is ecoutered, it may be retracted allowig etry ito the sius tarsi. Miimal dissectio is performed i the sius tarsi. A sius tarsectomy is ot performed. 1-2 From a eutral calcaeal positio, approximately 2 4 degrees of joit eversio is preferred. Itra-operative radiographs should be take to evaluate the placemet of the sizer. Oce the appropriate sizer is cofirmed, check the marked lies o the sizer hadle shaft that will idicate proper implat depth, as related to the ski icisio. 1-3 The guide wire is the placed through the sius tarsi from lateral to medial util tetig is oted iferior ad slightly posterior to the medial malleolus, where the caalis termiates at the medial akle

4 Step 4 Implat Isertio ad Positioig 4-1 Removal 4-1 The color-coded subtalar implat is placed over the guide wire ad positioed at the etrace of the sius tarsi cavity. Utilizig the caulated isertio driver, isert the subtalar implat ito the sius tarsi cavity by rotatig the driver clock-wise. Cotiue util the predetermied depth is cofirmed by the marked lies o the driver shaft reachig the idetical positio previously oted o the sizer shaft. The removal driver ca be threaded ito the proximal ed of the implat usig forward pressure ad turig couter clockwise. Oce egaged, the implat will tur couter clockwise ad pullig (removal) force ca be applied. Step 5 Implat Placemet Verificatio / Guide Wire Removal Itra-operative radiographs are oce agai take to evaluate the degree of correctio ad placemet of the implat. O a AP view, the leadig ed of the implat should be 1/3 to 1/2 the distace across the subtalar joit. If the implat is determied to be too far i a medial or lateral directio, the isertio driver ca be used i either directio to adjust positioig. The isertio driver ad guide wire are removed whe satisfactory positioig of the implat is obtaied. Step 6 Evaluatio ad Closure 6-1 The area should be irrigated, ad the subtalar joit motio should be reevaluated. Sigificat reductio of excess subtalar joit proatio should ow be appreciated. Closure of the capsule, subcutaeous tissue ad ski layers are performed ad the foot is placed i a mildly compressive dressig. Post-operative care, assumig o adjuctive procedures were performed, cosists of protective weight bearig i a below-the-kee walkig cast or walkig boot for 2 4 weeks. A gradual retur to limited activity i 4 6 weeks is permitted as tolerated. 5 6

5 Itegra TruArch Caulated Subtalar Implat System Implats / Guide Wires Referece Descriptio TA0800 TruArch Implat - X-Small (8mm) TA0900 TruArch Implat - Small (9mm) TA1000 TruArch Implat - Medium (10mm) TA1100 TruArch Implat - Large (11mm) TA1200 TruArch Implat - X-Large (12mm) TW1100 TruArch Guide Wire (1.60mm x 228.6mm) Istrumetatio Referece TA3008 TA3009 TA3010 TA3011 TA3012 TA3105 TA3110 TA3115 TA7000 Descriptio TruArch Sizer - X-Small (8mm) TruArch Sizer - Small (9mm) TruArch Sizer - Medium (10mm) TruArch Sizer - Large (11mm) TruArch Sizer - X-Large (12mm) TruArch Probe TruArch Driver TruArch Removal Driver TruArch Sterilizatio Tray Availability of these products might vary from a give coutry or regio to aother, as a result of specific local regulatory approval or clearace requiremets for sale i such coutry or regio. Always refer to the appropriate istructios for use for complete cliical istructios. No cotractual documet. The maufacturer reserves the right, without prior otice, to modify the products i order to improve their quality. Warig: Applicable laws restrict these products to sale by or o the order of a physicia. For more iformatio or to place a order, please cotact: Uited States, Caada, Asia, Pacific, Lati America USA fax Iteratioal fax itegralife.com/cotact Maufacturer: Ascesio Orthopedics, Ic Camero Road, Suite 100 Austi, TX USA TrueArch, Itegra ad the Itegra logo are registered trademarks of Itegra LifeScieces Corporatio or its subsidiaries i the Uited States ad/or other coutries Itegra LifeScieces Corporatio. All rights reserved. Prited i USA. 2.5M EN LC