Integra. BioMotion Cannulated 1st MPJ Hemi System SURGICAL TECHNIQUE

Transcription

1 Itegra BioMotio Caulated 1st MPJ Hemi System SURGICAL TECHNIQUE

2 Table of Cotets Desig Ratioale...2 System Features...2 Idicatios...2 Cotraidicatios...2 Surgical Techique...3 Step 1 Icisio ad Exposure...3 Step 2 Base Resectio of the Proximal Phalax / Metatarsal Head Preparatio...3 Step 3 Selectio of Implat Size ad Wire Placemet...4 Step 4 Broachig...4 Step 5 Implat Placemet...5 Step 6 Selectio of Implat Size ad Wire Placemet...5 Step 7 Removal... 6 Istrumetatio Orderig Iformatio...Back Cover Desig Ratioale The BioMotio Caulated Hemi System is desiged for use i a simplified, reproducible great toe arthroplasty techique. The caulated istrumetatio provides the surgeo with the ability to precisely alig ad implat the prosthesis while elimiatig uecessary steps. The BioMotio caulated implat features a thi surface, thus reducig the amout of boe resectio eeded ad allowig for retetio of the flexor tedo attachmet sites. The tapered stem matches the atural shape of the medullary caal ad allows the etire surface of the stem to embed i o-broached boe. Color coded sizers aid i proper selectio of the correct implat size ad placemet without the eed for iterim trial sizers. Five sizes offer a sufficiet rage to match virtually all phalax aatomy. System Features Low profile, micro-polished articulatio surface Color coded implats / trial sizers for easy idetificatio Tapered stem to match atural shape of medullary caal Five differet sizes to cover a wide rage of phalax aatomy Maufactured from titaium alloy for stregth ad biocompatibility Caulated implats / istrumets aid i accurate placemet Idicatios The BioMotio hemi implat is idicated for use i the treatmet of degeerative arthritis i the 1st metatarsophalageal joit alog with the followig cliical coditios: Hallux Limitus/Rigidus Hallux Valgus ad pai or istability i the metatarsophalageal joit The BioMotio hemi implat is iteded for press fit ucemeted use. Cotraidicatios Use of the Caulated Hemi System is cotraidicated i cases of active or suspected ifectio or i patiets who are immuocompromised; i patiets previously sesitized to titaium; or i patiets with certai metabolic diseases. It is further cotraidicated i patiets exhibitig disorders which would cause the patiet to igore the limitatios of prescribed post operative care. Other cotraidicatios are as follows: Rheumatoid arthritis No-reduced, high, iter-metatarsal agles Poor Boe Stock 2

3 Surgical Techique Step 3 Selectio of Implat Size ad Wire Placemet 3-1 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. 3-1 Place the color coded sizer flat agaist the resected portio of the phalax. Select the sizer that most closely matches the base of the phalax. Esure that the sizer profile fits etirely withi the profile of, ad does ot exted beyod, the outer margis of the osteotomized phalax. Step 1 Icisio ad Exposure 1-1 Make a 4-5cm curviliear icisio over the dorsal or dorsomedial aspect of the first MPJ. The capsular tissues aroud the joit should be released to maximize exposure of the joit. Care should be take to preserve the superficial vessels ad erves of the surroudig area. 1-1 Oce the appropriate sizer has bee determied, ad positioed over the phalax, drive the guide wire through the ceter hole i the sizer ad ito the ceter of the phalax. The wire should be drive parallel to the log axis of the phalax. Itra-operative radiographs should be take at this time to verify proper placemet of the guide wire through the ceter of the phalax. Note The optioal caulated rasp ca be used to create a flat surface perpedicular to the axis of the guide wire. Step 2 Base Resectio of the Proximal Phalax / Metatarsal Head Preparatio Usig a boe clamp, secure the phalax so a resectio of the base of the proximal phalax ca be performed. Although the amout of boe resected will vary depedig o the patiet, a recommeded amout is 3-5mm. A determiig factor i the amout of boe removal is the amout of decompressio eeded. Resectio of the appropriate amout of boe should be performed perpedicular to the log axis of the toe. Whe practical, care should be take to maitai the isertio of the flexor ad hallucis brevis tedos at the base of the proximal phalax. Remodelig of the metatarsal head should be performed by resectio of ay osteophytes preset. Chodroplasty with feestratio of the metatarsal head ca be performed where appropriate. Step 4 Broachig 4-1 If it is determied that the medullary boe is i good coditio but relatively soft, it is ot ecessary to use the icluded broach. Proceed to step 5. Place the broach over the wire ad verify the correct radial positio of the broach referecig the marked lie o the broach shak. This lie idicates the correct dorsal positioig of the implat whe situated i the phalax ad should be orieted i the 12 o clock positio durig broachig. 4-1 Usig the slidig portio of the istrumet, tap the broach tip ito the boe util the shoulder of the broach is flush with the boe. To remove the broach, tap the slidig portio of the istrumet agaist the rear 3 4

4 Step 5 Implat Placemet Place the implat over the wire ad verify the correct radial positio. The flat edge of the implat should be positioed towards the platar side of the phalax to match the aatomical shape of the phalax. If the broachig optio was utilized, place the tip of the implat ito the broached locatio. If the broachig optio was bypassed, oriet the implat correctly (as described above) ad temporarily secure the implat ito the boe with moderate figer pressure. Slide the hammer over the wire ad place the tip agaist the articulatig surface of the implat. Usig the slidig portio of the istrumet, tap the implat ito the boe util the back edge of the implat s articulatig surface is flush with the boe. Step 6 Verificatio of Motio ad Closure Prior to closig the capsular tissues, the joit should be put through a full rage of motio. If sufficiet dorsiflexio ad decompressio caot be demostrated, the metatarsal head ca be further remodeled, ad the phalax ca be further resected. Post operative maagemet correspods to other arthroplasty procedures of this ature. However, a early post operative physical therapy is recommeded. 5 6

5 Itegra BioMotio Caulated 1st MPJ Hemi System Implats / Guide Wires Referece Descriptio HM1500 BioMotio Implat - X-Small (15mm) HM1700 BioMotio Implat - Small (17mm) HM1900 BioMotio Implat - Medium (19mm) HM2100 BioMotio Implat - Large (21mm) HM2300 BioMotio Implat - X-Large (23mm) HW1100 BioMotio Guide Wire (1.58mm x 101.6mm) Istrumetatio Referece HM3005 HM3010 HM3015 HM3017 HM3019 HM3021 HM3023 HM3030 HM7000 Descriptio BioMotio Slide Broach BioMotio Slide Hammer BioMotio Sizer - X-Small (15mm) BioMotio Sizer - Small (17mm) BioMotio Sizer - Medium (19mm) BioMotio Sizer - Large (21mm) BioMotio Sizer - X-Large (23mm) BioMotio Rasp BioMotio 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 BioMotio, 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. 0M EN LC