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Zimmer® Gender Solutions™
NexGen® High-Flex Implants
Because Women and Men are Different
Something new is taking shape
Womenandmenaredifferent.That’snotnewstothemedicalestablishment.WhatisnewsisthatZimmerisfirstintheorthopaedicindustrytoaddressthisfact…
withtheintroductionoftheZimmer®Gender Solutions™ NexGen®High-FlexImplants.
Whatmakesthemrevolutionaryisthewayinwhichtheycompensateforthemostimportantdifferences
betweenwomen’sandmen’sknees.Itisn’tstrictlyamatterofsize;it’samatterofshape.
Why a woman’s knee?Agrowingbodyofresearchhasledtobreakthroughsindistinctivefemaleandmalediagnosesandtreatments—forconditionsrangingfromheartdiseasetorheumatoidarthritis.Theneedtoaccountforgender-specificsolutionsinorthopaedicsisapparent.
• Orthopaedicsurgeonshavereportedanatomicaldifferencesinwomen’sandmen’skneesforyears.1,2,3,4,5,6,7,8
• Orthopaedicsurgeonsoftenhavetoconsiderintraoperativeadjustmentsduringkneesurgerytoaccommodatewomen’sanatomicaldifferences.4
• Womenaccountfornearlytwo-thirdsofkneearthroplastiesperformedannuallyintheU.S.9,10
• Womenarethreetimesmorelikelythanmentoforegokneearthroplasty.11
It’s all about shape.
Two distinct populations: women and menPioneeringresearchconductedbyZimmerhasmappedtheanatomicaldifferencesbetweenfemaleandmaleknees,12,13layingthefoundationforthedesignanddevelopmentofGender SolutionsHigh-FlexFemoralImplants.
• Three-dimensionalCTdatawascollectedandanalyzedformorethan800femursandpatellas.
• Significantdifferenceswereidentifiedbetweenfemaleandmalekneeanatomy.
• PlottingM/LandA/Pdimensionsofthedistalfemurrevealstwodistinctpopulations:femaleandmale.
Implantdesignsthatdistinguishbetweenfemaleandmaleanatomicaldifferencesallowforimprovedimplantfitandfewerintraoperativeadjustments.
Gender SolutionsHigh-FlexFemoralImplantsaddressthedistinctivedifferencestypicallyfoundinthefemaleanatomy.
“Historically we have shaped the patients to fit the implants. Now we have implants shaped to fit the patients.”
Robert E. Booth, Jr., M.D.
55
60
65
70
75
80
50 55 60 65 70 75 80
A/P
Overall A/P (mm)
Mid
-Box
M/L
(mm
)
Male Data
Average Male Data
Female Data
Average Female Data
M/L Mid-Box
Mid-box M/L vs. overall A/P
Traditional implant GenderSolutions High-FlexFemoral Implant
Anterior flange thickness Researchhasshownthatthefemalekneehasaless-pronouncedanteriorcondylethanmales.2,13Thisless-pronouncedanteriorcondyleresultsinlessbonebeingresectedfromthefemaleknee:
• 0.8mmlessonthelateralcondyle(p<0.02).13
• 1.3mmlessonthemedialcondyle(p<0.01).13
Gender SolutionsHigh-FlexFemoralImplantsaddressthedistinctiveanteriorcondyledifferencesby:
• Reducingtheanteriorflangethicknessoftheimplant.
• Recessingthepatellarsulcus.
• RetainingtheclinicallysuccessfulNexGenpatellararticulation.
• Avoidingoverstuffingthatmaylimitpostoperativerangeofmotion14,15thatcanoccurwhenplacingatraditionalimplantonaresectedfemaleknee.
It’s all about shape –Modified Anterior Flange
Female Male DifferenceLateral condyle height (mm) 10.1 10.9 0.8Medial condyle height (mm) 5.1 6.4 1.3
Male resection Female resection
GenderSolutions High-FlexFemoral Implant
Traditional implant
Anterior flange widthThefemoralanteriorresectionofthefemaleboneisnarrowerthanthemalefemoralanteriorresection.
Female resectionMale resection
Increased Trochlear Groove Angle Patellarmaltrackingremainsaconcern— particularlywithfemales— followingtotalkneearthroplasty.5
ResearchdocumentsthatwomenhaveastatisticallysignificanthigherQ-anglethanmen.6,7,8
Gender SolutionsHigh-FlexFemoralImplantsreplicatethedistinctQ-angledifferencebyincreasingthetrochleargrooveangleoftheimplantthreedegrees.
Traditional implant GenderSolutions High-FlexFemoral Implant
“Twenty-five years ago TKA femoral components were symmetrical. As we recognized the need to improve patellar tracking, industry responded by offering left and right components. Providing an implant that better accommodates the patellar tracking typical of the female patient is just one of the design innovations that the GenderSolutionsNexGen High-Flex Femoral Components offers.”
Aaron G. Rosenberg M.D., Professor of Orthopaedic Surgery
Male
Female
Whenatraditionalimplantisplacedontoaresectedfemaleknee:
• Theimplantmayoverhangtheboneatthedistal,anterior,andposteriorM/Linterfaces,whichmayleadtosoft-tissueirritationandaffectsoft-tissuebalancing.1,3,4
• Thesurgeonmaybefacedwithintraoperativeadjustmentstocompensatefortheoverhang.
Gender SolutionsHigh-FlexFemoralImplantshavebeennarrowedmediolaterally.
Thisallowssurgeonstoaddressthefemalepopulationwithunprecedentedaccuracy.
CTdatadocumentsdistinctiveshapedifferencesinfemaleandmaledistalfemurs.12,13
Femalefemursare:
• Moretrapezoidal-shaped.
• NarrowerintheM/LdimensionwhencomparedtoamalefemurofthesameA/Pdimension.
55
60
65
70
75
80
50 55 60 65 70 75 80
Overall A/P (mm)
Mid
-Box
M/L
(mm
)
A/P
Male Data
Zimmer NexGen High-Flex Femorals
Female Data
Zimmer Gender Solutions High-Flex Femorals
M/L Mid-Box
Female and male aspect ratio
It’s all about shape –Modified ML/AP Aspect Ratio
Female-to-male comparison
Femoral mapping —applying the scienceToaddresstheissueofoverhanginfemalekneearthroplasty,Zimmerhasdevisedauniquepatentpendingmethodforpredeterminingthecontourofaresectedboneandthefitofanimplantonthebone,andappliedthisnovelmethodinitsdevelopmentoftheGender Solutions High-FlexFemoralImplant.
2) This shape is then extracted… 3) …and unfolded into a two-dimensional profile.
4) The resection planes of the female bone are rendered in a two-dimensional profile and overlayed on the implant profile.
6) Additional female data sets are then added to increase the statistical accuracy.
7) A two-dimensional female profile is created…
8) …that replicates the shape of the female bone.
1) The three-dimensional inner box shape of the traditional implant is determined.
5) Arrows indicate the areas where traditional implants overhang the female bone.
Traditional implant overhangs female bone
GenderSolutionsHigh-Flex Implant on female bone showslittle to no overhang
Gender Solutions NexGen CR-Flex and LPS-Flex
Contact your Zimmer representative or visit us at www.zimmer.com
• BuiltuponZimmer’s30-yearsofclinicalsuccesswithtotalkneearthroplasty.
• Safelyaccommodateshighflexion —upto155degrees—forpatientswiththeabilityanddesiretodoso.
• CanbeimplantedusinganyZimmersurgicaltechniqueincludingZimmer ® Minimally Invasive Solutions™(MIS™)Procedures.
Zimmer Gender Solutions High-FlexFemoralImplantsarespecificallydesignedtoalleviatekneepain,restoremobility,andofferoptimalfitandfunctionality.Toachievethesegoals,Gender SolutionsHigh-FlexFemoralImplantsaddressthedistinctivecharacteristicstypicallyseenwithawoman’sknee.Because women and men are different.
References:
1.HittK,ShurmanIIJ,GreeneK,etal.Anthropometricmeasurementsofthehumanknee:correlationtothesizingofcurrentkneearthroplastysystems.J Bone Joint Surg.2003;85:155-122.
2.PoilvachePL,InsallJN,ScuderiGR,Font-RodriguezDE.Rotationallandmarksandsizingofthedistalfemurintotalkneearthroplasty,Clin Orthop.1996;331:35-46.
3.VaidyaSV,RanawatCS,AroojisA,LaudNS.AnthropometricmeasurementstodesigntotalkneeprosthesesfortheIndianpopulation.J Arthroplasty.2000;15(1):79-85.
4.ChinKR,DaluryDF,ZurakowskiD,ScottRD.Intraoperativemeasurementsofmaleandfemaledistalfemursduringprimarytotalkneearthroplasty.J Knee Surg.2002;15(4):213-214.
5.CsintalanRP,SchulzMM,WooJ,McMahonPJ,LeeTQ,GenderDifferencesinPatellofemoralJointBiomechanics,Clin Orthop.September,2002;402:260-269.
6.AgliettiP,InsallJN,CerulliG.Patellarpainandincongruence.I:Measurementsofincongruence.Clin Orthop.1983;176:217-224.
7.HsuRWW,HimenoS,CoventryMB,ChaoEYS.Normalaxialalignmentofthelowerextremityandloadbearingdistributionattheknee,Clin Orthop.1990;255:215-227.
8.WoodlandLH,FrancisRS.Parametersandcomparisonsofthequadricepsangleofcollege-agedmenandwomeninthesupineandstandingpositions.American Journal of Sports Medicine.1992;20:208-211.
9.U.S.DepartmentofHealthandHumanServices,CentersforDiseaseControlandPrevention,NationalCenterforHealthStatistics.2003NationalHospitalDischargeSurvey,AdvanceDataNo.359.July8,2005;Table8:14.
10.U.S.DepartmentofHealthandHumanServices,CentersforDiseaseControlandPrevention,NationalCenterforHealthStatistics.2003NationalHospitalDischargeSurvey,AdvanceDataNo.359.July8,2005;Table10:16.
11.HawkerG,WrightJ,CoyteP,etal.,Differencesbetweenmenandwomenintherateofuseofhipandkneearthroplasty,The New England Journal of Medicine.342:1016-1022,2000.
12.MahfouzM,BoothRJr,Argenson,J,Merkl,BC,AbdelFatahEE,KuhnMJ.Analysisofvariationofadultfemorausingsexspecificstatisticalatlases.Presentedat:ComputerMethodsinBiomechanicsandBiomedicalEngineeringConference;2006.
13.DataonfileatZimmer14.ScottNW.Pearlsonavoidanceandtreatmentofintraoperativeand
postoperativecomplications–exposureofthestiffknee.Presentedat:AmericanAssociationofHipandKneeSurgeons,KneeSocietySpecialtyDay;March25,2006.
15.BengsBC,ScottRD.Theeffectofpatellarthicknessonintraoperativekneeflexionandpatellartrackingintotalkneearthroplasty.J Arthroplasty.2006;21(5):650-655.
GenderSolutionsNexGen LPS-Flex
GenderSolutionsNexGen CR-Flex
97-5764-001-00Rev.230MLPrintedinUSA©2006Zimmer,Inc.