Bi-Metric Total Hip System - Biomet Size：1.68 M | View：398 | Page：21Bi-MetricTotal Hip Systemcurrency1 provenerformanceP“Closed-Pore”porous coatingpotentially sealsthe proximalfemur.(Biomet)“Open-Pore”porous coatingallowsdebrismigration.(Competition) AUTHOREvans and DeLeeMauerhan, et al.McLaughlinMulti-Center StudyMallory, et al.RothmanCapello, McClainHeekin, et ...
Bi-MetricTotal Hip Systemcurrency1 provenerformanceP“Closed-Pore”porous coatingpotentially sealsthe proximalfemur.(Biomet)“Open-Pore”porous coatingallowsdebrismigration.(Competition) AUTHOREvans and DeLeeMauerhan, et al.McLaughlinMulti-Center StudyMallory, et al.RothmanCapello, McClainHeekin, et al.Woolson, MaloneyKim, et al.Kim, et al.Smith, HarrisEngh REFERENCESubmitted for PublicationJ. Arthroplasty, 1997JBJSBiomet Clinical Report 1994AAOS 1995Orthopedics 1994Trans. Int’l Symposium 1992JBJS 1993J. Arthroplasty, 1992Orthop. Trans, 1992–93Orthop. Trans, 1992–93CORR, 1995Presentation, 1992 HIP IMPLANT SYSTEMBi-Metric® (Biomet)Integral® (Biomet)Taperloc™ (Biomet)Taperloc,™ Mallory-Head,®Bi-Metric,® Integral® (Biomet)Mallory-Head® (Biomet)Taperloc™ (Biomet)Omnifit® (Stryker)PCA® (Howmedica)Harris/Galante™ (Zimmer)PCA® (Howmedica)AML® (DePuy)Harris/Galante™ (Zimmer)AML® (DePuy) YEARS FOLLOWED5–13 years5–8 years8 –12.5 years5 years6.5 years avg. follow-up7 years2–6 years5–7 years3.5 years avg. follow-up2–7 years2–7 years4.5 years avg. follow-up7.5 years avg. follow-up OSTEOLYSIS 0.0% 0.0% 6.0% 0.4% 0.0% 3.0% 44.7% 18.0% 22.0% 37.0% 55.8% 31.0% 28.0%P erformance provenPlasma Spray Porous CoatingBiomet’s proprietary plasma spray application is unique in comparison to other techniques due to the fact thatonly the titanium powder used to create the coating is heated, not the substrate of the implant – which can result in aweakened material. The porosity of the plasma spray porous surface allows for bone to penetrate and create a mechanical bondwith the porous coating. The pore size of Biomet’s plasma-sprayed components falls within a 100 to 1,000 micron range, thusproviding the optimal pore range for implant fixation and stability. The closed pore plasma porous spray has demonstratedexcellent clinical results since 1984.Bi-MetricTotal HipSystemA Member of theAlliance Familycurrency1PP he Bi-MetricTotal Hip System,since its introduction,continues to provide a highdegree of versatility and unsurpassed clinicalperformance. After a 5 to 13 year follow-up onthe Bi-Metric Porous Primary,1 Evansand DeLee found: • 0% Distal Thigh Pain • 0% Distal Osteolysis • 6% Stress Shielding • 100% SurvivorshipThe Bi-Metric is an essential part of theAlliance family which comprises the largestassembly of hip implants utilizing one simple,accurate and reproducible set of instruments.Designed to off-load stresses gradually fromproximal to distal, all Bi-Metric componentsincorporate Biomet’s proven bi-planar tapergeometry. The stem geometry promotesincreased proximal off-loading and fills agreater portion of the metaphysis than acylindrical, parallel sided implant. This greatlyreduces the chances of proximal boneresorption and distal hypertrophy.1Evans, JA, DeLee, JC, Outcome of a Tapered, Titanium, Proximal Load-Bearing, Non-Cemented Femoral THA Component: Submitted for Publication.Ti-MetricPrimaryThe Bi-Metric’s 3˚ tapered stem design (A) provides forexcellent proximal fit and minimizes removal of distalcortical bone as compared to a straight, cylindrical design (B).Modular Head Options(Available in 22, 26, 28 and 32mm Diameters)CoCrZirconia / CoCr29mm Neck(-5)31mm Neck(-3)34mm Neck(STD)CoCr37mm Neck(+3)40mm Neck(+6)43mm Neck(+9)46mm Neck(+12)Zirconia/CoCrZirconia28mm Neck(-6)(A) (B)Bn Bi-Planar Stem TaperProvides enhanced proximal stressoff-loading and initial implant stability.n Titanium Alloy Plasma SprayPorous CoatingThe coating’s “closed pore” design actsas a potential barrier to the migrationof particulate debris and providesrotational stability and provenlong-term fixation.n Forged TitaniumEnsures biocompatibility and fatiguestrength; titanium displays a lowermodulus of elasticity for enhancedload transfer.n Available in both collaredand collarless designs.n Cemented option also available.n PMMA distal centralizer used to preventvarus or valgus stem positioning.The Bi-Metric Porous Primary Hip Prosthesis is marketedfor noncemented use in skeletally mature patientsundergoing primary hip replacement surgery as a resultof noninflammatory degenerative joint disease.Performance rovenPBi-Metric Head/Neck Componentsi-MetricHead/Neck34mmResection45mmResection55mmResectionn Bi-Planar Stem TaperProvides enhanced proximal stressoff-loading and initial implant stability.n Interlok® SurfaceInterlok finish provides enhancedcement-to-implant bonding.n Three ProximalResection LevelsProvide increased flexibilityto conform to and matchthe patient’s anatomy.• 34mm Resection Level – Primary resection level.• 45mm Resection Level – Bone deficiency at the level of the lesser trochanter.• 55mm Resection Level – Bone deficiency below the lesser trochanter.n PMMA Distal Stem Positioner(150mm and 200mm Lengths)Centralizes the stem in the distal canalto help prevent varus and valgusstem placement.n Available LengthsThe implant is offered in 150mm and200mm straight stems and in a 250mmbowed option for unmatched flexibility.The Bi-Metric Head/Neck Prosthesis is marketedfor cemented application.BPerformance rovenP200mmLength250mmLength150mmLengthi-MetricRevisionRevision stems have a distal anterior bowto anatomically fit the femur.Bn Proximal Bi-Planar Stem TaperProvides enhanced proximal stressoff-loading and initial implant stability.n Titanium Alloy Plasma SprayPorous CoatingThe coating’s “closed pore” designacts as a potential barrier to the migrationof particulate debris and providesexceptional rotational stability and provenlong-term fixation.n Forged TitaniumEnsures biocompatibility and fatiguestrength; titanium displays a lowermodulus of elasticity for enhancedload transfer.n CollarProvides additional support and stresstransfer in the calcar region and aids inrotational stability.n Available LengthsThe implant is offered in 200mm,250mm, and 300mm options to addressexpanded indications.Revision Stems are marketed for usewith bone cement in the United States.Performance rovenP200mmLength250mmLength300mmLengthRasp in-linewith femoralshaft1StepFemoral HeadResectionOnce the hip is dislocated, the femoralneck cut can be made either by using thefemoral broach as a template (Fig. 1)or by using the femoral resectiontemplate (Fig. 2).Fig. 1Cut-linealong trialhead/broachjunctionTrial headcenter, onfemoral headcenter, in-linewith the tip ofthe greatertrochanter2StepReaming theDistal FemurA starter drill bit (Fig. 3) or a hollowchisel (Fig. 4) can be used to open thefemoral canal. Once the canal has beenlocated, begin reaming with the smallesttapered reamer. Enlarge the canal in asequential fashion until cortical “chatter”is encountered (Fig. 5).Fig. 3 Fig. 4Biomet, as the manufacturer of this device, does notpractice medicine and does not recommend anyparticular surgical technique for use on a specificpatient. The surgeon who performs any implantprocedure is responsible for determining and utilizingthe appropriate techniques for implanting theprosthesis in each individual patient. Biomet is notresponsible for selection of the appropriate surgicaltechnique to be utilized for an individual patient.Fig. 5Fig. 2i-MetricPrimarySurgicalTechniqueBBroachingthe ProximalFemurBegin broaching with the broach that is 2or 3mm smaller than the last size reamer.It is important that the broach is orientedso that the medial/lateral axis of thebroach is parallel with the anatomicmedial/lateral axis of the femoral neck(Fig. 6). A sequentially larger broach isused until ideal or templated size isreached (Fig. 7). With the proper sizebroach in place, the calcar can be planedflush by using the calcar trimmer *(Fig. 8).3Step4StepTrialReductionWith the final broach still in place,provisional head/necks are selected todetermine the appropriate neck length andto restore the lateral offset (Fig. 9). A trialreduction is carried out to ensure thatproper leg length and joint stability havebeen achieved (Fig. 10).* U.S. Pat. No. 4,306,550Fig. 7Fig. 9Fig. 10Fig. 8Fig. 65aStepInsertinga PorousComponentThe stem corresponding to the size of thefinal broach is threaded onto the steminserter/extractor and impacted into a fullyseated position (Fig. 11).If desired, another trial reduction can beaccomplished after implantation of thestem and prior to impacting the modularhead onto the stem. Provisional heads inseven neck lengths allow trial reductionsto be performed, using the actual femoralcomponent, to again ensure proper leglength and stability.After fully seating the femoral component,the appropriate modular head is impactedonto the femoral neck. The hip is nowready to be reduced.5bStepFig. 11Fig. 12Insertingan InterlokComponentThe reaming and broaching are accom-plished in the same fashion as a porouscomponent. The implant should be under-sized by a minimum of 2mm to allow foradequate cement thickness. Example: Reamand broach to 11mm. Implant a size9mm interlok stem. A distal cementrestrictor is placed in the canal to allow a2cm cement column below the tip of the stem(Fig. 12). Cement is injected into the canal ina retrograde fashion and pressurized. Slideappropriate sized distal centralizer ontostem. Example: A 9mm size stem acceptsa 9mm centralizer sleeve. The stem isinserted to a fully seated position andextraneous cement is removed. Once cementhardening has been achieved, a trial reduc-tion can be completed and the correctmodular head chosen for reconstitution ofleg length, lateral offset and stability.Insertinga RevisionComponentThe revision components are an extendedversion of the primary stems utilizing thesame design criteria. The revision compo-nent uses the same rasp as the primarystem devices.Distal femoral reaming for the 200mm,250mm and 300mm femoral componentsshould be accomplished with flexiblereamers over a guide wire to avoid distalcanal perforations (Fig. 13). The flexiblereamers should be used to over-ream thedistal medullary canal by approximately1mm to accommodate the distal anteriorbow in the prosthetic stems.Once femoral preparation is completed,trial long stem components are availableif desired. The trial long stem is identicalto the final implant, minus theporous coating.Final component insertion can then becarried out. The appropriate size stem isthen seated into the femoral canal.Example: Final broach size is 17mm.Implant a size 17mm revision compo-nent. (Fig. 14). Trial reduction can thenbe accomplished to determine properneck length.5cFig. 14Fig. 13Step1StepPreparingthe ProximalFemurDetermination of Resection LevelThe proximal femoral cuts can be fashionedby utilizing the trial prosthesis as a guide(Fig. 1). The head/neck prosthesis comes in34, 45, and 55mm calcar resection levels.In general, the 34mm calcar is utilized insituations where there has been little, if any,bone destruction in the proximal femur anda platform can be maintained at approxi-mately 1cm above the lesser trochanter. The45mm design is utilized for bony defectsdown to the lower level of the lessertrochanter and the 55mm prosthesis fordefects below the lesser trochanter (Fig. 2).Fig. 1Fig. 2i-MetricHead/NeckSurgicalTechniqueB2StepFemoralCanalPreparationDetermination of Stem LengthThe head/neck prosthesis comes in150mm, 200mm and 250mm lengths.Femoral preparation is accomplished byone of three methods after determiningstem length. Thorough debridement of thefemur and accurate preparation of theplatform is necessary for the prosthesis.For 150mm stems, tapered reamers areused to prepare the diaphyseal region(Fig. 3). Tapered reaming continuessequentially until cortical chatter and thereamer is at least 2.0cm below the finalimplant level. When using a 200mmstraight stem, cylindrical reamers should beutilized in the same manner as the taperedreamers to prepare the femoral canal.Flexible reamers are recommended whenusing a 250mm bowed implant due to theanterior bow of the femur. Note: Thedepth markings on the shank of thereamers DO NOT indicate leg lengthmeasurements when used with thehead/neck replacement components.Broaching of the proximal femur is notgenerally necessary, or even possible,when dealing with the compromised femur.If the proximal femur is not entirelycompromised, a broach can be used tofurther shape the proximal envelope(Fig. 4). Broaching is initiated in asequential fashion and continues until thecorresponding size of the last reameris reached.Fig. 3Fig. 4Taperedreaming150mmlengthCylindricalreaming200mmlengthFlexiblereaming250mmlength3StepHead/NeckTrialInsertion andReductionTrial InsertionThe trial prosthesis should be very stablewhen it is driven in place. Once the trial isin position, mark with methylene bluewhere the keel comes into contact withthe medial calcar (Fig. 5).After marking the location for the keel,remove the trial stem and prepare agroove or recess in this same location onthe medial bone using a power bur(Fig. 6). After the groove has beenfashioned, reinsert the trial stem, makingsure it seats firmly on the horizontalfemoral platform.Trial ReductionWith the trial calcar prosthesis in place(Fig. 7), a trial reduction can be per-formed to evaluate proper leg length andlateral offset. Note: A trial reductioncannot be performed with thebroach. This will not provide accu-rate leg length and offset measure-ments. Modular trial prosthesesare available for 200mm and250mm stems, while one-piecetrials are used for 150mm stems.Fig. 6Fig. 5Fig. 74StepHead/NeckComponentInsertionA distal cement restrictor is placed in thecanal to allow a 2.0cm cement columnbelow the tip of the stem (for 150mmlength stems). Cement is injected into thecanal in a retrograde fashion and pressur-ized. Note: When using the Bi-Metrichead/neck implants, one mustdownsize the implant to allow for anadequate cement mantle. Example:Ream and broach to 13mm. Implantan 11mm head/neck stem. The stemcan be inserted with the forked inserter(Fig. 8). Place medial keel into medialcalcar slot. Extraneous cement is thenremoved. Once cement hardening hasbeen achieved, a trial reduction can becompleted to access the correct modularhead, proper leg length, lateral offsetand stability. The appropriate modularhead can then be impacted onto thestem (Fig. 9).Fig. 9Fig. 8i-MetricParts ListingBBi-Metric Porous Prosthesis162310162251162311162252162312162253162313162254162314162255162315CollarlessPart No.CollaredPart No.Stem DiameterStemLength mm 7.0mm 8.0mm 9.0mm10.0mm11.0mm12.0mm13.0mm14.0mm15.0mm16.0mm17.0mm115120125130135140145150155160165162370162626162371162627162372162628162373162629162374162630162375162301162302162303162304162305162306Bi-Metric Interlok® ProsthesisPart No.CollarlessPart No.CollaredStem DiameterStemLength mm 7.0mm 9.0mm11.0mm13.0mm15.0mm17.0mm115125135145155165162387162388162389162390162391162392PMMA Centering Sleeves162907162909162911162913162915162917Part No. Size 7.0mm 9.0mm11.0mm13.0mm15.0mm17.0mm162350162351162352162353162354162355162356162357162358162359162340162341162342162343162344162345162346162347162348162349Porous Bi-Metric Collared Long Stem ProsthesisPart No.Stem Diameter 9.0mm Stem Bowed Right 9.0mm Stem Bowed Left11.0mm Stem Bowed Right11.0mm Stem Bowed Left13.0mm Stem Bowed Right13.0mm Stem Bowed Left15.0mm Stem Bowed Right15.0mm Stem Bowed Left17.0mm Stem Bowed Right17.0mm Stem Bowed Left31-47364031-47364131-47364231-47364331-47364431-47364531-47364631-47364731-47364831-47364931-47365031-47365131-47365231-47365331-47365431-47365531-47365631-47365731-47365831-473659200mmLengthPart No.200mmLengthProvisionalPart No. Part No. Part No.250mmLength250mmLengthProvisional300mmLengthDescription16236016236116236216236316236416236516236616236716236816236931-16233031-16233131-16233231-16233331-16233431-16233531-16233631-16233731-16233831-16233931-16234031-162341Bi-Metric CoCr Head/Neck ProvisionalProximal – 200 and 250mmPart No.StemDiameterResectionLevel 11.0mm 11.0mm 11.0mm 13.0mm 13.0mm 13.0mm 15.0mm 15.0mm 15.0mm 17.0mm 17.0mm 17.0mm344555344555344555344555 11.0mm 13.0mm 15.0mm 17.0mm 11.0mm 13.0mm 15.0mm 17.0mm31-16234231-16234331-16234431-16234531-16234631-16234731-16234831-162349Bi-Metric CoCr Head/Neck ProvisionalDistal – 200 and 250mmPart No.StemDiameterLengthmm20020020020025025025025012-16258012-16258112-16258212-16258312-16258412-16258512-16257412-16257512-16258612-16258712-16258812-16258912-16259012-16259112-16257612-16257712-16259212-16259312-16259412-16259512-16259612-16259712-16257812-162579250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 Lt250 Rt250 LtLengthmmBi-Metric CoCr Head/Neck Prosthesis250mmPart No.StemDiameterResectionLevel 9.0mm 9.0mm 11.0mm 11.0mm 13.0mm 13.0mm 15.0mm 15.0mm 9.0mm 9.0mm 11.0mm 11.0mm 13.0mm 13.0mm 15.0mm 15.0mm 9.0mm 9.0mm 11.0mm 11.0mm 13.0mm 13.0mm 15.0mm 15.0mm34343434343434344545454545454545555555555555555512-16238012-16238112-16238212-16238312-16238412-16238512-16238612-16238712-162388Bi-Metric CoCr Head/Neck Prosthesis150mmPart No.StemDiameterLengthmmResectionLevel 9.0mm 11.0mm 13.0mm 9.0mm 11.0mm 13.0mm 9.0mm 11.0mm 13.0mm150150150150150150150150150343434454545555555StemDiameter12-16248012-16248112-16248212-16248912-16248312-16248412-16248512-16249012-16248612-16248712-16248812-162491Bi-Metric CoCr Head/Neck Prosthesis200mmPart No.LengthmmResectionLevel 9.0mm 11.0mm 13.0mm 15.0mm 9.0mm 11.0mm 13.0mm 15.0mm 9.0mm 11.0mm 13.0mm 15.0mm20020020020020020020020020020020020034343434454545455555555531-16238031-16238131-16238231-16238931-16238331-16238431-16238531-16239031-16238631-16238731-16238831-162391Bi-Metric CoCr Head/Neck Provisional150mmPart No.StemDiameterLengthmmResectionLevel 9.0mm 11.0mm 13.0mm 15.0mm 9.0mm 11.0mm 13.0mm 15.0mm 9.0mm 11.0mm 13.0mm 15.0mm150150150150150150150150150150150150343434344545454555555555P.O. Box 587, Warsaw, IN 46581-0587 • 219.267.6639 • ©1998 Biomet, Inc. All Rights Reservedweb site: http://www.biomet.com • eMail: email@example.comForm No. Y-BMT-567/073198/MAlliance InstrumentationCASE #595551 – Insertion/ExtractionCASE #595552 – Alliance Tapered ReamersCASE #595553 – Alliance BroachesBi-Metric X-Ray Templates162396 Bi-Metric Primary12-162397 Bi-Metric Head/Neck162395 Bi-Metric RevisionCASE # 595551 – Insertion/Extraction31-473622 Resection Guide466365 Drill Bit31-473625 Osteotomy Guide31-473679 Moore Hollow Chisel31-473590 Femoral Inserter with Fork31-473639 Femoral Inserter with Neck Control31-473621 Slap Hammer with Thread Tip31-476946 Universal Head Driver424456 Universal Head ExtractorCASE #595552 – Alliance Tapered Reamers31-473200 7mm31-473201 8mm31-473202 9mm31-473203 10mm31-473204 11mm31-473205 12mm31-473206 13mm31-473207 14mmCASE #595553 – Alliance Broaches31-473611 7 x 115mm31-473670 8 x 120mm31-473612 9 x 125mm31-473671 10 x 130mm31-473613 11 x 135mm31-473672 12 x 140mm31-473614 13 x 145mm31-473673 14 x 150mm31-473615 15 x 155mm31-473674 16 x 160mm31-473616 17 x 165mm31-473675 18 x 170mm31-473617 19 x 175mm31-473610 Broach Handle31-473593 Broach Extractor31-473701 Calcar Trimmer31-473208 15mm31-473209 16mm31-473210 17mm31-473211 18mm31-473212 19mm31-473213 20mm31-483630 T-HandleBi-MetricTotal Hip Systemcurrency1 provenerformanceP