Triathlon Tritanium Surgical Protocol

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Triathlon Tritanium Surgical Protocolwith Triathlon Cementless BeadedPA Femoral Component

Triathlon TritaniumSurgical Protocolwith Triathlon Cementless Beaded PA Femoral ComponentDescription. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Triathlon Tritanium Knee Construct. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Femoral Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Step 1 Distal Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Step 2 Femoral Sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Step 3 Anterior, Posterior and Chamfer Cuts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Step 4 PS Box Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Step 5 Femoral Trial Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Tibial Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Step 1A Tibial Preparation: Extramedullary (EM) Referencing. . . . . . . . . . . . . . . . . 22Step 1B Tibial Preparation: Intramedullary (IM) Referencing. . . . . . . . . . . . . . . . . . 24Step 2 Tibial Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Step 3 Tibial Keel Punch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Patella Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Trial Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Tibial Preparation (continued) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Step 4 Tibial Peg Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Femoral Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Tibial Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Tibial Insert Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Patella Implantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Product Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Catalog. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45AcknowledgmentsStryker Orthopaedics wishes to thank the global Triathlon Tritanium Knee SystemSurgeon Advisors for their dedication to the development and refinement of theTriathlon Tritanium Baseplate and Instrumentation.

Triathlon TritaniumSurgical Protocolwith Triathlon Cementless Beaded PA Femoral ComponentDescriptionHowmedica Osteonics Corp.’s total knee systemsinclude the Triathlon Tritanium Baseplate which isdesigned to be used with the Triathlon Primary Kneesystem femoral components, tibial inserts, and patellarcomponents for total reconstructive replacement of theknee joint. The characteristics specific to each device aredetailed on the product label. The Triathlon TritaniumBaseplate is indicated for both cementless and cementedapplications.The Triathlon Tritanium Tibial Baseplate andTritanium Metal-Backed Patella components areindicated for both uncemented and cemented use.The Triathlon All-Polyethylene tibial components areindicated for cemented use only.Femoral Components: The Triathlon TritaniumBaseplate is compatible with the Triathlon cruciateretaining (CR), and cruciate sacrificing (posteriorlystabilized – PS) designs.Additional Indications for Posterior Stabilized (PS)components and Total Stabilizer (TS)* components: Ligamentous instability requiring implant bearingsurface geometries with increased constraint. Absent or non-functioning posterior cruciate ligament. Severe anteroposterior instability of the knee joint.Tibial Components: The Triathlon Tritanium Baseplateis compatible with Triathlon tibial inserts in a cruciateretaining (CR), posterior stabilized (PS), and condylarstabilizing (CS) designs. Tibial inserts are available in arange of thicknesses and in various degrees of constraint.Additional Indications for Total Stabilizer (TS)*components: Severe Instability of the knee secondary tocompromised collateral ligament integrity or function.Note: The Triathlon Tritanium Baseplate is packagedtogether with an Impactor Pad. The Impactor Pad is tobe used during the tibial baseplate impaction step onlyand is to be discarded once impaction has completed.The Impactor Pad is not for implantation.Patellar Components: Patellar resurfacing componentsare available in symmetric and asymmetric optionsin both all-plastic and metal-backed designs. Use of apatellar component is optional. The Triathlon TritaniumBaseplate is compatible with all Triathlon patellarcomponents.Indication for Bone Augments: Painful, disabling joint disease of the knee secondaryto: degenerative arthritis, rheumatoid arthritis, or posttraumatic arthritis, complicated by the presence ofbone loss. Salvage of previous unsuccessful total kneereplacement or other surgical procedure, accompaniedby bone loss.Contraindications*Additional Revision-ONLY Compatibility Note forTriathlon Tritanium Metal-Backed Patella Any active or suspected latent infection in or about theknee joint. The Triathlon Tritanium Metal-Backed Patellais indicated for use with the Total Stabilizer (TS)components including the metal bone augmentationcomponents, the modular stem extensions andoffsets. Only the Tritanium Metal-Backed Patella iscompatible with the revision components.The Tritanium Tibial Baseplate is not compatiblewith the revision components. Distant foci of infection which may causehematogenous spread to the implant site.IndicationsGeneral Total Knee Arthroplasty (TKA) Indications: Painful, disabling joint disease of the knee resultingfrom: noninflammatory degenerative joint disease(including osteoarthritis, traumatic arthritis, oravascular necrosis), rheumatoid arthritis or posttraumatic arthritis. Post-traumatic loss of knee joint configuration andfunction. Moderate varus, valgus, or flexion deformity inwhich the ligamentous structures can be returned toadequate function and stability. Revision of previous unsuccessful knee replacement orother procedure. Fracture of the distal femur and/or proximal tibia thatcannot be stabilized by standard fracture-managementtechniques.2The Triathlon Total Knee System beaded and beadedwith Peri-Apatite components are intended foruncemented use only. Any mental or neuromuscular disorder which wouldcreate an unacceptable risk of prosthesis instability,prosthesis fixation failure, or complications inpostoperative care. Bone stock compromised by disease, infection or priorimplantation which cannot provide adequate supportand/or fixation to the prosthesis. Skeletal immaturity. Severe instability of the knee joint secondary to theabsence of collateral ligament integrity and function.See package insert for warnings, precautions, adverseeffects and other essential product information.Before using Triathlon instrumentation, verify: Instruments have been properly disassembled prior tocleaning and sterilization; Instruments have been properly assembled poststerilization; Instruments have maintained design integrity; and, Proper size configurations are available.For Instructions for Cleaning, Sterilization, Inspectionand Maintenance of Orthopaedic Medical Devices, referto LSTPI-B.

SurgicalProtocol

Triathlon Tritanium Knee ConstructThis protocol demonstrates the technique for implantinga Triathlon cementless beaded femoral componentwith the Triathlon Tritanium baseplate and compatibleTriathlon Tritanium Metal-Backed Patellar component.Triathlon Tritanium Baseplate The Triathlon Tritanium baseplate is designed to besimilar to the Triathlon Primary baseplate. It offersthe same profile and insert locking mechanism. The Triathlon Tritanium baseplate features fourcruciform pegs.Figure 1 The Triathlon Tritanium baseplate features Stryker’sTritanium 3D porous metal technology on theunderside of the baseplate, the proximal end ofthe keel and the proximal end of each of the fourcruciform pegs. It is available in eight sizes and is indicated for bothcementless and cemented applications. Surgeons mayselect an option based on preference and local boneconditions. The Triathlon Tritanium baseplate is compatible withall available posterior stabilizing (PS) and cruciateretaining (CR) Triathlon femoral components forboth cemented and cementless applications, andaccepts available Triathlon cruciate retaining (CR),condylar stabilizing (CS) and posterior stabilizing(PS) inserts.Triathlon Peri-ApatiteCementless Beaded Femur The Triathlon cementless beaded femoralcomponents are available in both posterior stabilizing(PS) and cruciate retaining (CR) configurations. The Triathlon cementless femoral components aremade from cobalt-chrome. They are coated withcobalt-chrome beads and are available with andwithout Peri-Apatite (PA) technology.Figure 24 Peri-Apatite (PA) is Stryker’s technology forapplication of Hydroxyapatite (HA) to threedimensional beaded constructs.

Triathlon Primary Tibial Inserts Compatible Triathlon inserts are available in threeconfigurations – cruciate retaining (CR), anteriorlipped/condylar stabilizing (CS) and posteriorstabilizing (PS).CR Triathlon primary inserts are available in eight sizeswith thicknesses of 9, 11, 13, 16 and 19mm, withadditional available thicknesses of 22 and 25mm forthe PS inserts.CS Triathlon primary inserts are available withconventional polyethylene as well as Stryker’s X3highly crosslinked polyethylene.PSFigure 3Triathlon TritaniumMetal-Backed Patella The Triathlon Tritanium Metal-Backed Patellais indicated for both cemented and cementlessapplications. The Triathlon Tritanium Metal-Backed patellarcomponents are available in symmetric andasymmetric configurations. There are a total of 9sizes which are compatible with all Triathlon femoraland tibial components.Symmetric Metal-Backed The Triathlon Tritanium Metal-Backed Patellafeatures Stryker’s Tritanium 3D porous metaltechnology, made from commercially pure titanium,on the metal underside of the patella. The Triathlon Tritanium Metal-Backed patellarcomponents are available with conventionalpolyethylene.Asymmetric Metal-BackedFigure 45

Femoral PreparationStep 1 Distal ResectionFemoralPreparationExposure Triathlon Total Knee Arthroplasty can be performedthrough any standard approach. A standard anteriormid-line incision or other suitable approaches suchas mid-vastus, sub-vastus or quadriceps sparing maybe used based on surgeon preference. Any previous incision can be used or incorporated todecrease the risk of skin slough. The capsule is entered through a medial parapatellarapproach.Figure 5Femoral Intramedullary (IM) Alignment The Universal Driver allows for attachment of alldrills and pins. It may be attached directly to areamer, drill, or a Jacob’s chuck. Locate the IM drill hole. It is approximately 1cmanterior to the femoral attachment of the posteriorcruciate ligament and slightly medial to the mid-lineof the distal femur.Figure 6 Attach the 3/8 IM Drill to the Universal Driver anddrill into the IM canal. The first diameter will createa tight fit around the IM Rod. If further clearanceis desired, continue to drill until the larger stepdiameter opens the hole. Attach the T-Handle Driver to the 5/16 IM Rod. Insert the IM Rod into the Femoral Alignment Guideas far proximal as possible. The Femoral AlignmentGuide is designed for use on either the left or rightknee and may be set to 5 , 6 or 7 of valgus. Set the instrument to the desired angle by pullingback on the black knob of the Femoral AlignmentGuide and placing it in the appropriate notch. Advance the rod, with attached guide, slowly up theIM canal until the desired depth is reached.Figure 76

Button6541-4-801Universal -5383/8 IM DrillFemoralPreparationInstrument Bar6541-4-800T-Handle Driver6541-4-5165/16 IM RodFigure 8 Snap the Universal Resection Guide onto theAdjustment Block and insert the posts of theAdjustment Block into the two holes in the FemoralAlignment Guide. Place the Femoral Alignment Guide in contact withthe more prominent distal femoral condyle and alignthe guide in neutral position.Tip: Align the Femoral Alignment Guide to the transepicondylar axis. The guide should usually have contactwith both medial and lateral trochlea for more stability. Impact the distal captured pins in the FemoralAlignment Guide to aid in stabilization.6541-1-657Femoral Alignment Guide6541-1-721Universal Resection Guide6541-1-600Adjustment Block6541-4-003Headless Pins – 3 Note: Impacting a distal capture pin that does notmake contact with the femoral condyle may result in anundesirable change in the alignment guide position. Pin the Distal Resection Guide to the anterior femur.7

Femoral PreparationStep 1 Distal Resection (continued)FemoralPreparation The Adjustment Block allows for an 8mm (the distalthickness of the femoral component) and 10mm(used to aid in the correction of a flexion contracture)resection level.Tip: The thickness of the resected femoral condyleshould be measured. In some cases, a greater resectionmay be required. This can be accomplished by adjustingthe block as described below to achieve a greaterresection ( 2mm or 4mm).Button Press the black button on the end of the AdjustmentBlock and pull to set the resection to the desired level.Figure 9 Pin the Universal Resection Guide to the anterior femur.Note: If the medial “O” pin hole is too close to the edge ofthe bone (on smaller femurs), use the holes marked “2”which are closer to the center of the bone. Please note:this will limit the amount of further resection to 2mm.8

6541-1-600Adjustment BlockFemoralPreparationInstrument Bar6541-1-657Femoral Alignment GuideFigure 10Distal Resection After the Universal Resection Guide is pinned inplace, remove the IM Rod. The Femoral AlignmentGuide and the Adjustment Block may be removed bysqueezing the black tabs on the Adjustment Block. The distal femoral resection is made.6541-1-721Universal Resection Guide6541-4-806Universal Alignment Handle6541-4-602Universal Alignment RodsTip: Use saline irrigation during distal femoral resection. An optional Modular Capture – may be attached tothe Universal Resection Guide. Squeeze the blacktabs on the Modular Capture – Distal Resection toinsert into the Universal Resection Guide. Whenusing a modular capture, a .050 (1.25mm) blade isused. Remove the Modular Capture, measure the resectionand check the resection for flatness. Remove theUniversal Resection Guide.6541-1-723Modular Capture – Distal Resection6541-4-003Headless Pins – 3 9

Femoral PreparationStep 2 Femoral SizingFemoralPreparationHole for Pinto ReferenceWhiteside’s Line Assemble the Femoral Sizer with the Femoral Stylusin the lateral hole (for both a left or right knee) andset the stylus length to an approximate size. Set the rotation to LEFT for a left knee and RIGHTfor a right knee and adjust to the desired amount ofexternal rotation. The Femoral Sizer also sets the final rotation of thefemoral component. Additional checks for rotationmay be made by lining up the epicondyles with thereference lines marked “EPI” or assessing Whiteside’sline with a pin through the hole in the top of the guide.“EPI”LineIndicatorFigure 11Note: In the event of a hypoplastic femoral condyle: Pinthe Femoral Sizer through the EPI hole on the unaffectedside for stability. Rotate the Femoral Sizer and assessrotation using the rotational checks mentioned above. Position the assembly flush on the resected distalfemur, sliding the feet of the Femoral Sizer underthe posterior condyles. The Femoral Stylus pointshould be placed at the anticipated level of resection,commonly the lateral cortex. It is important that the Femoral Stylus point rest onbone and not on soft tissue.Figure 12 The size is determined by the position of the scribemark on the Femoral Stylus shaft within the sizingwindow.Figure 1310

6541-1-603Femoral SizerFemoralPreparationInstrument Bar6541-1-605Femoral Stylus6541-4-003Headless Pins – 3 Figure 146541-4-400Bladerunner It is recommended that the anterior resection level bechecked to further confirm the correct size by slidinga Bladerunner through the sizing guide’s size-specificanterior slots and assessing the resection. If it appearsthat there is a potential for notching, the next largersize component will need to be chosen. Ensure thefemoral component chosen is compatible with thesize of the tibial component selected during tibialpreparation. Once size confirmation is complete, attach the 1/8 Peg Drill to the Universal Driver and create fixationpin-holes (for the 4:1 Cutting Block) through theholes on the face of the Femoral Sizer marked “EPI”.11

Femoral PreparationStep 3 Anterior, Posterior and Chamfer CutsFemoralPreparation4:1 Cutting Block Fixation Locate the fixation pegs of the appropriate sizeExpress 4:1 Cutting Block into the pin holes createdon the distal femur.Note: Check run-out of the anterior cut. If not enoughanterior bone is resected, consider selecting the nextsmaller size 4:1 Cutting Block. Ideally, the cut should beflush with the distal femur. Pin the 4:1 Cutting Block in place for stability.Figure 15Femoral Anterior, Posterior andChamfer Cuts Complete the remaining four femoral boneresections. The use of a .050 (1.25mm) thick sawblade isrecommended.Figure 16 The order of bone resections is not critical; however,a recommended sequence for improved stability ofthe 4:1 Cutting Block is:1. Anterior cortex.2. Posterior condyles.3. Posterior chamfer.4. Anterior chamfer.Note: Cutting the anterior chamfer last helps stabilize thecutting guide. It is advisable to pay close attention to minimizingthe bias on the sawblade during these resections. Remove the 4:1 Cutting Block.12

PS Box Preparation If it is determined that a PS femoral

The Triathlon Tritanium baseplate is designed to be similar to the Triathlon Primary baseplate . It offers the same profile and insert locking mechanism . The Triathlon Tritanium baseplate features four cruciform pegs . The Triathlon Tritanium baseplate features Stryker’s Tritanium 3D porous metal technology on the

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