SURGICAL TECHNIQUE FOR USE WITH

P. F. C.®

SIGMA™ KNEE SYSTEMS

Primary Cruciate-Retaining &Cruciate-Substituting Procedure

INSTRUMENTSSPECIALIST®

CHITRANJAN S. RANAWAT, MD

Clinical Professor of Orthopaedic Surgery

Cornell University Medical College

Chairman, Department of Orthopaedic Surgery

Ranawat Orthopaedic Center

Lenox Hill Hospital

New York, N.Y.

CRUCIATE-SUBSTITUTING PROSTHESIS DESIGNED BY

RICHARD D. SCOTT, MD

Professor of Orthopaedic Surgery,

Harvard Medical School

Orthopaedic Surgeon, New England Baptist

Hospital and Brigham and Women’s Hospital

Boston, Mass.

THOMAS S. THORNHILL, MD

John B. and Buckminster Brown Professor of Orthopaedics,

Harvard Medical School

Orthopaedist-in-chief

Brigham and Women’s Hospital

Boston, Mass.

CRUCIATE-RETAINING PROSTHESIS DESIGNED BY

CONTENTS

Introduction 1

Primary Cruciate-Retaining Procedure 4

Primary Cruciate-Substituting Procedure 41

Appendix I: Ligamentous Balance in Total Knee Arthroplasty 81

Appendix II: The External Femoral Alignment System 90

Appendix III: Intramedullary Alignment Device 91

Appendix IV: Extramedullary Tibial Alignment Device

with Proximal Fixation Spike 96

Appendix V: Femoral and Tibial Insert Compatibility Charts 99

Appendix IV, Surgical Technique, edited by William L. Healy, MD, Chairman,

Department of Orthopaedic Surgery, Lahey Hitchcock Medical Center, Burlington, Mass.

SPECIALIST® 2 TECHNIQUE

INTRODUCTION

Total knee replacement is performed on a rangeof patients, of all ages, with various pathologiesand anatomical anomalies. As no single arthro-plastic approach is appropriate for every knee,the surgeon must be prepared, as the situationindicates, to preserve or substitute for the posterior cruciate ligament. PCL sacrifice isindicated in patients with severe deformity, pronounced flexion contracture and in thegreater number of revision cases. Most primaryand some relatively uncomplicated revisioncases are suitable for cruciate-sparing proce-dures. Where the ligament is to be preserved, it is essential that its balance in flexion be confirmed.

The P.F.C.® Total Knee Systems were designed as comprehensive approaches allowing intraop-erative transition from PCL retention to PCLsubstitution. The major difference in the designfor the two prostheses is the incorporation of anintercondylar post in the PCL substituting tibialinsert and its corresponding intercondylarreceptacle in the femoral component, to com-pensate for the stabilizing restraint of the PCL.They were also designed to provide greaterrestraint in cases of revision surgery, and tomeet the most demanding clinical and institu-tional requirements.

A single integrated set of instruments, the Specialist® 2 Instruments, was designed tomake fully accurate bone resection and toaccommodate most surgical techniques and contingencies.

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BALANCING THE KNEE

The appropriate level of prosthetic constraint isdetermined through preoperative evaluationsubject to intraoperative confirmation. Wheresoft-tissue constraint is identified, the system isdesigned to effectively address it.

Primary Cruciate-Retaining TKRemploys a posteriorly lipped insert, designedfor situations where the PCL is functionallyintact. Where there is tightness in the PCL, aposterior cruciate recession is indicated (seeAppendix I).

Primary Cruciate-Supplementing TKRuses a curved insert with improved contact areato supplement the PCL where the ligament hassufficient functional laxity to accommodate thegreater conformity.

Primary Cruciate-Substituting TKRincorporates a central polyethylene eminence inthe tibial insert to perform the function of anabsent PCL. The corresponding femoral compo-nent uses A/P cuts and chamfers identical tothose of the PCL-retaining component, allowingready transition without revision of the pre-pared implantation site.

Revision TKRThe geometry of the tibial insert allows for substitution of the PCL and/or MCL in revisionand complex primary situations. The selectionof modular tibial and femoral stems and wedgeswill accommodate virtually any revision con-sideration. The system offers three levels ofconstraint to meet the varied requirements ofrevision cases: stabilized, constrained or TC3.

CRITERIA FOR SUCCESSFUL TKR

Appropriate Sizing of ComponentsThis is attained through critical approximationof the A/P dimension of the femoral compo-nent to the lateral femoral profile. Undersizingwill create looseness in flexion and possiblenotching of the femoral cortex. Oversizing willcreate tightness in flexion and increased excur-sion of the quadriceps mechanism.

Accurate Component AlignmentThis is accomplished by resection of the distal femur in the appropriate degree of valgus asdetermined by preoperative evaluation, andresection of the proximal tibia at 90˚ to its longitudinal axis.

Soft-Tissue BalanceThis is realized through the careful sequentialrelease of medial constraining elements invarus deformity and lateral structures in valgus.

Accurate Patellar TrackingThis is effected through accurate positioning of the femoral and tibial components, preciseresurfacing of the patella, careful trial evalua-tion and, where indicated, lateral retinacularrelease.

Dependable Cement FixationThis is achieved through controlled techniquethat ensures the establishment of comprehen-sive bone/cement/prosthesis interlock.

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PREOPERATIVE PLANNING

Full-length extremity roentgenograms areobtained and the mechanical and anatomic axesidentified. Where the intramedullary alignmentsystem is selected, the angle of the anatomic and mechanical axes indicates the appropriateangle to be used in conjunction with the intra-medullary rod and the femoral locating device,thereby assuring that the distal femoral cut willbe perpendicular to the mechanical axis. It ishelpful to draw the femoral and tibial resectionlines on the film as an intraoperative reference.

Radiographic templates are overlaid on thefilms to estimate the appropriate size of theprosthesis. The femoral component is sized onthe lateral view. The A/P size is critical to therestoration of normal kinematics and quadri-ceps function.

INSTRUMENTATION RATIONALE

Specialist 2 instrumentation was designed toaddress the requirements of all total-kneereplacement procedures, to fully assure preciseand dependable resection of the recipient boneand to serve a variety of surgical options. Theinstruments can be customized to meet any spe-cial requirements of the individual surgeon.

Preparation may be initiated at either the femuror the tibia. The instruments may be employedwith either the intra- or extramedullary align-ment approach. Bone resection is made at theappropriate level as determined through a cali-brated stylus assembly. A selection is offered ofslotted and surface-cutting blocks. Spacer blocksare provided for extension and flexion gap eval-uation. Patellar instrumentation is available forcompatible preparation of either resurfaced orinset patellar implants.

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PRIMARY CRUCIATE-RETAINING PROCEDURE

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RICHARD D. SCOTT, MD

Professor of Orthopaedic Surgery,

Harvard Medical School

Orthopaedic Surgeon, New England Baptist

Hospital and Brigham and Women’s Hospital

Boston, Mass.

THOMAS S. THORNHILL, MD

John B. and Buckminster Brown Professor of Orthopaedics,

Harvard Medical School

Orthopaedist-in-chief

Brigham and Women’s Hospital

Boston, Mass.

THE SURGICAL APPROACH

The skin incision is longitudinal and, wherepossible, straight. It is initiated proximally fromthe midshaft of the femur and carried over themedial third of the patella to the medial marginof the tibial tubercle.

The joint is entered through a medial para-patellar capsular approach, extended proximallyto the inferior margin of the rectus femoris and distally to the medial margin of the tibialtubercle.

N.B. Where indicated, the subvastus or the lateral approach may be used.

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EXPOSURE

Exposure and preliminary balance must bebased on the patient’s preoperative deformityand soft-tissue stability. The following is formild varus deformity.

N.B. See Appendix I for discussion of soft-tissue balance.

With the knee in extension, the patella iseverted laterally. The medial tibial periosteumis elevated and a narrow 90˚ Hohmann retrac-tor positioned subperiosteally around themedial border of the medial condyle. Residualperiosteum is dissected posteromedially to thelevel of the insertion of the semimembranosus.The knee is flexed and a partial meniscectomyperformed. Any residual ACL is excised.

With the knee in 90˚ of flexion,the tibia is externally rotatedwith posteromedial dissection,bringing its medial condyleclear of the femur. Medialmeniscectomy is completed,and attention directed to thelateral side.

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A 90˚ Hohmann retractor is positionedbetween the everted patella and the distolat-eral femur, exposing the lateral patellofem-oral ligament, which is incised withelectrocautery.

The retractor is repositioned at theinterval of the iliotibial tract and thetibial attachment of the capsule. The capsule is dissected free from theinfrapatellar fat pad and a lateralmeniscectomy is performed. The lat-eral inferior genicular artery is coagu-lated. The insertion of the iliotibialtract is identified and the capsule dis-sected from the lateral tibial condyle.The retractor is repositioned againstthe lateral tibial condyle.

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ENTERING THE MEDULLARY CANAL

The medullary canal is entered at the midline of the femoral trochlea 7–10 mm anterior to theorigin of the PCL to a depth of about 5–7 cmusing a 5/16" drill.

Care is taken that the drill avoids the cortices. It is helpful to palpate the distal femoral shaftas the drill is advanced. The drill hole may bebiased anteromedially to facilitate unobstructedpassage of the long intramedullary rod to thediaphyseal isthmus, if indicated by pre-operative X-rays

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THE INTRAMEDULLARY ROD

The valgus angle with the appropriateRight/Left designation, as indicated on the pre-operative films, is set and locked into place onthe front of the locating device. The angle canbe set from 0 degrees to 9 degrees in one degreeincrements.

With the rod repositioned in the medullarycanal, the handle is removed and the locatingdevice is placed over the rod.

With the handle assembled onto the longintramedullary rod, the rod is introducedslowly into the canal to the level of the isthmusto confirm unobstructed passage. The rod isfluted to relieve intramedullary pressure andpermit the release of bone matter, avoidingembolization. It is subsequently withdrawn.

THE FEMORAL LOCATING DEVICE

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THE EXTERNAL ALIGNMENT SYSTEM

A radiopaque marker is positioned over theipsilateral hip, parallel and immediately distalto the inguinal ligament. An A/P roentgeno-gram indicates which of four markers mostclosely approximates the rotational center.

At surgery, the femoral-head locating strip isaligned with the markers. A target screw isintroduced into the position overlying the rota-tional center. Draping is such that the screw isreadily palpated as the coxal reference point.

The alignment tower is assembled ontothe femoral locating device. The align-ment rod is passed through the hole andadvanced to the hip. Where the rod failsto align with the coxal reference point, a different angle is selected.

N.B. Where indicated, as in femoral deform-ity, 0˚ is selected and a short intramedullaryrod is substituted. See Appendix II.

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ROTATIONAL CORRECTION

Orientation is initially determined with refer-ence to the posterior femoral condyles, subjectto subsequent correction at the A/P resection.The calibrated outrigger is centered at thefemoral trochlea, placing it in slight externalrotation and exposing a greater amount ofmedial condyle.

Alternatively, it may be externally rotated untilperpendicular to the mechanical axis of the tibiain 90˚ of flexion.

The femoral locating device is tapped into position at the more prominent condyle (usually the medial).

N.B. It is essential that firm contact be established at the subchondral level of the condyle, clear of anyresidual peripheral osteophytes.

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The base block is slotted; however, if usedwithout the slot and the resection is initiatedfrom the top of the block, 4 mm is added to theresection level. For example, if 9 mm is thedesired resection level, add 4 mm to this andset the block at 13 mm and cut from the surface

of the block. Note the top of the block isengraved “4 mm offset.”

The outrigger and cutting block is lowered ontothe anterior cortex by depressing the button onthe left-hand side of the locating device. Either

1/8" drill bits or Steinmann pins areintroduced through the holes desig-nated zero and enclosed in nn ’s. Theyare advanced into the anterior cortex.

The cutting block is assembled onto the cali-brated outrigger by depressing the buttonlocated on the right proximal end. The resectionof the more prominent condyle, inclusive ofresidual cartilage, will correspond to the distaldimension of the femoral prosthesis. Where the femoral locating device rests on eburnated bone, resection is2 mm less than the distaldimension of the femoralprosthesis to allow forabsent cartilage and toavoid elevation of thejoint line.

THE DISTAL FEMORAL CUTTING BLOCK

The scale for the numbers on the outrigger iseven on the left and odd on the right. The number corresponding to the appropriate resec-tion level is aligned with the inscribed line inthe center of the window of the distal femoral cutting block.

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Note: For PFC Sigma Femoral components, the following distal resection is recommended:Sizes 1.5 through 5 — 9 mm distal resection.Size 6 — 10 mm distal resection.

THE DISTAL FEMORAL CUT

The locating device and intramedullary rod are disengaged from the cut-ting block by depressing the right button on the cutting block. The holeson the block are designated -2, 0, and +2, indicating in millimeters theamount of bone resection each will yield supplemental to that indicatedon the calibrated outrigger.

The oscillating saw blade is positioned through the slot, or, where applic-able, the blade is positioned flush to the top cutting surface of the block.The condyles are resected and the surface checked for accuracy. a aa aaaaa a aa aaaaaa aa aaaaa a aa aaaaa

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THE FEMORAL SIZING GUIDE

The stylus is passed over the anterior corteximmediately proximal to the articular surface.At the appropriate level where the stylus is notimpeded, turn the stylus locking knob clock-wise until tight to fix its position.

The guide is seated flush and centered on theprepared distal femoral surface. The stylus isallowed to move freely within the guide andmoved proximal to the articular surface.

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ROTATIONAL ALIGNMENT

The sizing guide skids are positioned against theposterior condyles. This determines rotationalalignment. Where either condyle is deficient, theguide is rotated such that it lies perpendicular tothe mechanical axis of the tibia.

N.B. Alternatively, the tibia may be prepared first,wherein the A/P femoral cuts are based on the relation-ship of the condyles to the prepared tibial surface.

Where the appropriate position of the stylus isdetermined, secure the stylus arm in position bytightening the arm clockwise. The actualsize of the femur is indicated on the ver-tical shaft of the stylus arm.

The Posterior Reference Femoral Sizing Guide

This sizing guide will positionthe femoral A/P chamfer cut-ting block such that 8 mm will be resectedfrom the posteriorcondyles, corresponding tothe posterior condyle thick-ness of the prosthesis.Inherent in using the poste-rior reference is the fact thatadditional bone, resulting fromfemurs being in-between whole sizes,may be resected from the anterior aspectof the distal femur. The preoperativecondition of the knee joint can aid theselection of the appropriately sizedimplant. Selecting a small sizefemoral component may resultin notching of the femurand may be avoidedby moving the drillguide the appropriateamount anterior to the indi-cated smaller size using themm scale on the upper leftportion of the frame. (A)

The Anterior Reference Femoral Sizing Guide

This sizing guide will position the femoralA/P chamfer cutting block such that the

anterior flange of the prosthesis will generally fitflush with the anterior cortex of the femur. When

the sizing device indicates a whole size, 8 mmwill be resected from the posteriorcondyles, corresponding to the posteriorcondyle thickness of the prosthesis.

Consequently, using the anterior referenceon femurs that are in-between whole sizes

may result in additional bonebeing resected from the posterior

condyles of the femur. The preop-erative condition of the knee joint can aid the selection of the appropriatelysized implant. Care must be taken to

balance the flexion and extension gaps.

A

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Where the guide is pinned in neutral rotation usingthe posterior holes, it will position the A/P cuttingblock such that 8 mm will be resected from the pos-terior condyle, corresponding to the posteriordimension of the prosthesis.

Where, as in most cases, the tibia is resected at 90º to its mechanical axis, the femoral component ispositioned in ~3º of external rotation to produceflexion-gap symmetry. Accordingly, the lateral pos-terior and medial anterior holes are selected, yield-ing 8 mm lateral and 10–11 mm medial resection.The cutting block thus positioned will yield a cut in 3º of external rotation, enhancing patellartracking and promoting flexion-gap symmetry. Itwill reduce soft-tissue release for tight medial flex-ion gap and allow commensurate rotation of thetibial component.

Occasionally, more than 3º of external rotation isindicated for flexion-gap symmetry. Followingremoval of peripheral osteophytes, with 90º of flex-ion and the collateral ligaments tensed with lami-nar spreaders, the external tibial alignment deviceis positioned with its upper platform raised to thelevel of the holes made through the drill guide,which should lie parallel to the platform. Wheremore external rotation is indicated, the medial holeis repositioned anteriorly. In valgus deformity withlateral condylar hypoplasia, the lateral hole is repo-sitioned posteriorly.

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Neutral

3º External Rotation

SURFACE A/P CHAMFER

CUTTING BLOCKS

With the anterior and posterior plates in theirretracted position, make the anterior and poste-rior cuts. The anterior chamfer cut is madethrough the posterior slot and the posteriorchamfer cut is made through the anterior slot.Care is taken that the posterior cruciate and col-lateral ligaments be protected.

SLOTTED A/P CHAMFER

CUTTING BLOCKS

Extend the anterior and posterior plates to create slots on the block. Insert the blade of theoscillating saw (a 1.19 mm saw blade is recom-mended) to the femur and make the anteriorand posterior cuts. The anterior chamfer cut ismade through the posterior slot and the poste-rior chamfer cut is made through the anteriorslot. Care is taken that the posterior cruciateand collateral ligaments be protected.

ANTERIOR, POSTERIOR AND CHAMFER CUTS

The drill guide is removed and the correspond-ing A/P chamfer cutting block selected. Assem-ble the removable handles by depressing thebutton and inserting the handle into the recep-tacle and turning until locked into position. The A/P chamfer cutting block is seated intothe drill holes and flush to the prepared sur-face. The anterior, posterior and chamfer cutsare performed with an oscillating saw.a aa aaaaaa aa aaaaa

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The chamfers are made through the slotted A/P block.

Alternatively, a separate chamfer block can be used to guide the anterior and posteriorchamfer resections.

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The knee is placedin maximal flexionwith the tibia dis-tracted anteriorly and stabilized.

The malleolar clampof the tibial align-ment device ispositioned immedi-ately proximal to the malleoli. Theplatform is raised to the level of thecondyles.

TIBIAL ALIGNMENT

The upper cutting platform is assembled andsecured onto the proximal uprod of the tibialalignment device. A 0,̊ 3˚or 5˚ cutting block canbe chosen.

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THE UPPER PLATFORM

The upper platform is aligned with the medialthird of the tibial tubercle and the medial margin of the lateral intercondylar eminencewith the extremities of the cutting surfaceagainst the anterior cortex.

The exact level of resection will vary according to patient anatomy. As the mediolateral transverseplane of the tibial plateau is usually 3˚ from theperpendicular and the projected cut is perpendicu-lar to the anatomic axis, more bone is typicallyremoved from the lateral condyle.

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The level of 0 is selected whereresection is basedon the more

involved condyle and does notresult in excessive contralateral

resection. The cutting block is securedby the large anterior setscrew.

N.B. Where this indicates greater than 10 mmof resection from the contralateral condyle, ahigher level is indicated. The deficiency is aug-mented with cement, bone graft or a modularwedge, as the situation dictates.

THE TIBIAL STYLUS

The stylus determines the exact level of resection.

The outrigger of the stylus is marked non-slottedand slotted at either end. When the tibial resec-tion is performed from the surface of the block,choose the non-slotted end of the outrigger; con-versely, when the resection is performed throughthe slots, choose the slotted end of the outrigger.There is a 4 mm difference between the top sur-face and the slot.

The cylinder foot is inserted into the slot of thecutting block and adjusted to the appropriatelevel. It is calibrated in 2 mm increments, indicat-ing the amount of bone and residual cartilage tobe resected.

A level of 8 mm or 10 mm is suggested whereresection is based on the less involved condyle.The block is adjusted such that the stylus rests onthe center of the condyle and the cutting block issecured by the large anterior setscrew.

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LOWER ALIGNMENT

Mediolateral alignment is approximately paral-lel to the tibial axis, but as the lateral malleolusis more prominent, bisecting the transmalleolaraxis will prejudice the cut into varus. The midline of the tibia is approximately 3 mmmedial to the transaxial midline. The lowerassembly is translated medially to the palpableanterior crest of the tibia, usually to the secondvertical mark. There are scribe marks at 3 and 6 mm for reference. Where the platform ismedially displaced, adjustment is made at thelower assembly.

The lower assembly is translated anteroposteri-orly to align it parallel to the tibial axis. Whereposterior slope is desired, the assembly isadvanced anteriorly, or, alternatively, a slopedblock is used (see page 18). Up to 5˚ of slope isgenerally appropriate (5 mm advancement willproduce approximately 1˚ additional slope).There are scribe marks at 1 cm for reference.

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THE TIBIAL ALIGNMENT

The distal portion of the long arm of the tibialalignment device should align with the centerof the talus. a aa aa aa aa aa a Lateral alignment is similarly confirmed.

N.B. Where indicated, varus/valgus corrections are madeby sliding the distal portion of the tibial alignment to theappropriate location.

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Steinmann pins or 1/8" drill bits are intro-duced through the central holes into the tibiastopping well short of the posterior cortex. Thetibial alignment device can either be removedby first unlocking the cutting block, or left inplace for additional stability.

An entry slot is cut with a narrow oscillating sawinto the intercondylar eminence anterior to theattachment of the PCL andan osteotome positioned toshield the ligament.

SECURING THE PLATFORM AND TIBIAL RESECTION

Resection is made either through theslot or on the top surface dependingupon the stylus reference used. A 1.19 mm saw blade is recommendedwhen cutting through the slots.

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It is important that the sagittal dimension and accurate tracking be main-tained and that adequate bone stock be preserved. Problems arise

from inadequate or oblique resection resulting in greater thicknessto the complex, asymmetric positioning of the implant, subse-

quent patellar tilt and implant wear.

It is important that sufficient soft tissue be freed atthe prepatellar bursa to position the calipers at the

anterior cortex.

PATELLAR RESURFACING

The greatest sagittal dimension is at the medianridge. The normal range is 20–30 mm. Thedimension is established and an amount corre-sponding to the size of the selected implantsubtracted. The remainder equals the targetdimension following resection. Where thepatella is small, a minimal residual dimensionof 12 mm should be maintained.

EXAMPLE: (for a 38 mm wide dome or oval/dome patella) From a patella 25 mm thick, 9 mm of articular surface is resected, yielding16 mm of residual bone to accommodate the 9 mm thick implant.

The template is selected that most adequatelycovers the articular surface without overhang.The handle is positioned on the medial side of the everted patella. Where bone is deficienton the lateral side, the next smaller size isselected, but positioned slightly to the medialside to enhance patellar tracking.

The amount of appropriate bone resection, as indicated on the template, is noted.

Patellar Size Resection

32 mm 8 mm35 mm 8.5 mm38 mm 9 mm41 mm 11.5 mm

11

0 10

0 90

80

70

60

50

40

30

20

10

0

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THE PATELLAR CUTTING GUIDE

Synovial tissue is cleared to the level of theinsertions of the quadriceps mechanism and thepatellar ligament.

The prongs of the knurled fork are adjusted tothe predetermined dimension of residualpatella as indicated on the calibrated column.

The leg is placed in exten-sion, the cutting guidepositioned with the prongsof the fork deep to theprepatellar bursa andagainst the anterior patel-lar cortex with the serratedjaws at the superior and

inferior margins of the articular surface. Theswitch is placed to the LOCK position and thejaws closed to firmly engage the patella.

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RESECTION AND DRILLING

Alternatively, the saw blade is inserted into thewell of the cutting surface of either of the jaws.The insert is lifted and the blade thereby con-fined within the slot created, ensuring that thecut will remain flush to the cutting surface. A1.19 mm saw blade is recommended.

The previously selected template is positionedonto the cut surface with the handle positionedon the medial side of the everted patella, suchthat two drill holes lie at the medial side, one atthe lateral. The template is firmly engaged tothe resected surface and the holes fashionedwith the appropriate drill bit.

Resection is performed with an oscillating saw,maintaining the blade flush to the cutting sur-face. The guide is subsequently removed andthe residual dimension checked with calipers,laterally, medially, proximally and distally. Allmeasurements should be equivalent. Asymme-try is addressed with the saw or a bone rasp.a aa a aaaaaaa aaaaaaaaaaa aaaaaa

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THE TRIAL TIBIAL COMPONENT

The knee is placed in maximal flexion, the tibiasubluxed anteriorly with the tibial retractor. Thetibial tray is selected which provides the greatestcoverage of the prepared surface but precludesoverhang anterior to the midcoronal plane.

The tibial tray alignment handle is connected tothe tibial tray trial by retracting the knob, insert-ing the two pins into the anterior portion of thetray trial, indexing the handle to the left andreleasing the knob.

The matching color-coded plastic trial is selectedand inserted into the tray.a aaa aaa aa aa aa aaaaaa aa aaaaaaaa aa aa aaaa aaa aaaaaa aa a aaaaaaa aaaaaaaaaaa aaaaaaaaaaa a aa aaaaaaaa a a aaa28

Where there is a tendency for the trial to rock posteriorly (into flexion), the most common cause is upward sloping or failure to resect adequatelyat the anterior aspect. Less commonly, the posterior condyles have beenunder-resected. The A/P chamfer cutting block is repositioned onto the distal surface and thedeficient cut appropriately revised.

THE TRIAL FEMORAL COMPONENT

Assemble the quick connect slaphammer onto the femoral inserter. With the knee in full flexion, the femoral trial is assembled to thefemoral inserter and positioned onto the prepared surface. The leadingedges are advanced equally, parallel to the distal femoral cut, preserving its precisely prepared configuration. a aa aaaaa a aaa aaaaaaa aaaaa

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With all trial prostheses in place, the knee is care-fully and fully extended, noting medial and lateralstability and overall alignment in the A/P andM/L plane. Where there is any indication of insta-bility, the next greater size tibial insert is substi-tuted and reduction repeated. The insert that givesthe greatest stability in flexion and extension andallows full extension is selected. Where there is atendency for lateral subluxation or patellar tilt inthe absence of medial patellar influence (thumbpressure), lateral retinacular release is indicated.

Rotational alignment of the tibial tray is adjustedwith the knee in full extension, using the align-ment handle to rotate the tray and trial insert intocongruency with the femoral trial.

The appropriate positionis marked with electro-cautery on the anterior tibial cortex.

TRIAL REDUCTION

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OVERALL ALIGNMENT

The tibial alignment handle is assembled to thetrial tibial tray and the two parts of the align-ment rod to the handle.

Where static alignment is correct, the rod will bisect the mechanical axis at the hip, kneeand ankle.

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PLATEAU PREPARATION

With the knee in full flexion and the tibia sub-luxed anteriorly, the trial tibial tray is assem-bled to the alignment handle and placed ontothe resected tibial surface. Care is taken thatproper rotational alignment with the electro-cautery marks be established.

The tray is secured with two short fixation pinsinserted through the holes designated nn .

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P.F.C.® CRUCIFORM KEEL TRAY PREPARATION

Remove the alignment handle from the tray trial and assemble the appro-priately sized cruciform keel punch guide to the tray trial.

Assemble the appropriately sized non-cemented keel punch onto the slap-hammer and insert the punch through the guide and impact until the shoulder of the punch is in contact with the guide. The stem punch is sub-sequently freed, taking care that the punch configuration be preserved.

Where the cemented tray is to be implanted, theappropriately sized cemented tray stem punch issubsequently positioned through the guide andimpacted until the shoulder of the punch is in con-tact with the guide. The cemented stem punch issubsequently freed, taking care that the punch con-figuration be preserved.

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Select the appropriate punch guide, drill bushing, drill and modular keelpunch system. Remove the alignment handle from the tray trial and as-semble the appropriately sized modular tray punch guide to the tray trial.

Seat the appropriately sized drill bushing into the modular tray punch guide.

The matching drill is fully advanced through the drill bushinginto the cancellous bone.

The appropriately sized modular tray keel punch is subse-quently positioned through the guide and impacted until theshoulder of the punch is in contact with the guide. The modu-lar tray keel punch is subsequently freed, taking care that thepunch configuration be preserved.

*UHMWPE (ALL-POLY)

P.F.C.® MODULAR TRAY & UHMWPE* TIBIA PREPARATION

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THE FEMORAL LUG DRILL

Mediolateral positioning of the femoral trial component is confirmedand receptacles prepared for the implant lugs by advancing thefemoral drill through the appropriate holes.

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IMPLANTING THE COMPONENTS

THE TIBIAL COMPONENT

The entire site is thoroughly cleansed with pul-satile lavage. Methylmethacrylate cement is pre-pared and applied by syringe or digital pressurein its low viscous state to assure maximal pene-tration into the trabecular bone.

The universal handle is assembled onto the uni-versal tibial tray inserter and assembled ontothe tibial tray. The tray is carefully inserted,avoiding malrotation. When it is fully seated, sev-eral mallet blows are delivered to the top of theuniversal handle. The nylon tibial tray impactormay be used to further impact the tibial tray. a aaa aa a aaaaaaa aaaaaaaaaa a aaaaaaaa

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UHMWPE TIBIAL COMPONENT

Alternatively, when implanting an all-UHMWPE

tibial component, place the component inappropriate orientation and impact the flat cen-tral proximal portion of the component withthe nylon tibial tray impactor. Excess cement isremoved from the periphery of the tibialplateau, and a final impaction is performed toensure complete seating of the component.

As the cement polymerizes, a trial componentis positioned on the prepared femur. The kneeis placed in full extension to maintain pressureat the bone/tibial implant interface. Slight val-gus stress is maintained to ensure that the tibialimplant not tilt into varus. When the cementhas set, the knee is placed in flexion and thetrial femoral component removed. All extrudedcement is carefully removed with special atten-tion to the posterior compartment.a aaa aaa aaa aaa aaaaaaa a

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THE FEMORAL COMPONENT

The entry hole at the medullary canal is plugged with cancellous bone.All surfaces are thoroughly cleansed with pulsatile lavage. Cement isapplied to the bone at the anterior, anterior chamfer and distal surfacesand to the inner surface of the component at the posterior chamfer andposterior condylar recesses. Care is taken to avoid the articular surface of the implant. The implant is assembled onto the femoral inserter. Careis taken that it be correctly oriented. The leadingedges are advanced equally, paral-lel to the distal surface and protect-ing the carefully configuredsurfaces, until the lugs arefully engaged.

The inserter is subse-quently released and seat-ing completed with thefemoral impactor and amallet. All extrudedcement is cleared with ascalpel and curette.

38

THE PATELLAR COMPONENT

The patellar implant may be cemented at thesurgeon’s convenience with either of the othercomponents. The cut surface is thoroughlycleansed with pulsatile lavage. Cement isapplied to the surface and the componentinserted.

The patellar clamp is designed to fully seat andstabilize the implant as the cement polymerizes.It is positioned with the silicon O-ring centered

over the articular surface of the implant and themetal backing plate against the anterior cortex,avoiding skin entrapment. When snug, the han-dles are closed and held by the ratchet untilpolymerization is complete. Excessive compres-sion is avoided as it can fracture osteopenicbone. All extruded cement is removed with acurette. To release the clamp, place the lockingknob in the unlocked position and squeeze thehandles together to release the pawl.

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THE TIBIAL INSERT

The trial insert is removed and the perma-nent insert introduced into the implantedtibial tray and seated posteriorly, its anterior margin resting on the lip.

The anterior margin is tapped with a nylon mallet,deflecting it past the lip of the tray into position.Seating is confirmed by circumferential inspection.

Alternatively, the permanent insert may beinserted at any convenient time during thecementing procedure.

When a curved insert topography is utilized andthe flexion gap is snug, it may be difficult toextract a trial insert and introduce the permanentone. In such a case, the permanent insert shouldbe implanted prior to cementing the femoral component.

CLOSURE

The tourniquet is released and bleeding controlledby electrocautery. A closed-wound suction drainis placed in the suprapatellar pouch and broughtout through the lateral retinaculum. The fat pad,quadriceps mechanism, patella tendon, and medialretinaculum are reapproximated with interruptedsutures.

The knee is put through a range of motion fromfull extension to full flexion to confirm patellartracking and the integrity of the capsular closing.The final flexion against gravity is noted for post-operative rehabilitation.

Subcutaneous tissue is reapproximated and theskin closed with sutures or staples.

40

CRUCIATE SUBSTITUTING PROCEDURE

41

CHITRANJAN S. RANAWAT, MD

Clinical Professor of Orthopaedic Surgery

Cornell University Medical College

Chairman, Department of Orthopaedic Surgery

Ranawat Orthopaedic Center

Lenox Hill Hospital

New York, N.Y.

THE SURGICAL APPROACH

42

The extremity is appropriately prepared anddraped. A tourniquet is applied and, followingapplication of an Esmarch bandage, inflated.

A long straight incision is initiated 12 cm proxi-mal to the superior margin of the patella and anequivalent distance distal to its inferior margin.Reducing, thereby, the degree of skin retractionand lowering the risk of subsequent adipose tis-sue necrosis.

The incision is developed at the deep fasciallevel to the tendon of the rectus femoris and thepatellar tendon. Undermining of the bilateralskin flaps is avoided. The tendon of the rectusfemoris is incised and the incision carried2–3 mm medial to the medial margin of thepatella, the patellar tendon and, subperios-teally, 5 cm distal to the superior margin of thetibial tubercle.

EXPOSURE

The patella is everted laterally and the kneeplaced in full flexion. The cruciate ligamentsand the menisci are excised (see Appendix I,pages 81– 89). Where indicated, preliminarysoft-tissue release is performed. Where the kneeis tight and in varus, a curved osteotome ispassed along the medial tibial border posteriorto the midcoronal plane to release the menis-cotibial ligament and promote anterior subluxa-tion of the tibia.

43

N.B. For discussion of soft-tissue balancing, see Appendix I.

The knee is placedin maximal flexionwith the tibia dis-tracted anteriorly and stabilized.

The malleolar clampof the tibial align-ment device is posi-tioned immediatelyproximal to themalleoli. The plat-form is raised to thelevel of the condyles.

TIBIAL ALIGNMENT

44

THE UPPER PLATFORM

The upper platform is aligned with the medialthird of the tibial tubercle and the medial margin of the lateral intercondylar eminencewith the extremities of the cutting surfaceagainst the anterior cortex.

The exact level of resection will vary according to patient anatomy. As the mediolateral transverseplane of the tibial plateau is usually 3˚ from theperpendicular and the projected cut is perpendicu-lar to the anatomic axis, more bone is typicallyremoved from the lateral condyle.

45

The level of 0 is selected whereresection is basedon the more

involved condyle and does notresult in excessive contralateral

resection. The cutting block is securedby the large anterior setscrew.

N.B. Where this indicates greater than 10 mmof resection from the contralateral condyle, ahigher level is indicated. The deficiency is aug-mented with cement, bone graft or a modularwedge, as the situation dictates.

THE TIBIAL STYLUS

The stylus determines the exact level of resection.

The outrigger of the stylus is marked non-slottedand slotted at either end. When the tibial resec-tion is performed from the surface of the block,choose the non-slotted end of the outrigger; con-versely, when the resection is performed throughthe slots, choose the slotted end of the outrigger.There is a 4 mm difference between the top sur-face and the slot.

The cylinder foot is inserted into the slot of thecutting block and adjusted to the appropriatelevel. It is calibrated in 2 mm increments, indicat-ing the amount of bone and residual cartilage tobe resected.

A level of 8 mm or 10 mm is suggested whereresection is based on the less involved condyle.The block is adjusted such that the stylus rests onthe center of the condyle and the cutting block issecured by the large anterior setscrew.

46

LOWER ALIGNMENT

Mediolateral alignment is approximately paral-lel to the tibial axis, but as the lateral malleolusis more prominent, bisecting the transmalleolaraxis will prejudice the cut into varus. The midline of the tibia is approximately 3 mmmedial to the transaxial midline. The lowerassembly is translated medially to the palpableanterior crest of the tibia, usually to the secondvertical mark. There are scribe marks at 3 and 6 mm for reference. Where the platform ismedially displaced, adjustment is made at thelower assembly.

The lower assembly is translated anteroposteri-orly to align it parallel to the tibial axis. Whereposterior slope is desired, the assembly isadvanced anteriorly, or, alternatively, a slopedblock is used (see page 18). Up to 5˚ of slope isgenerally appropriate (5 mm advancement willproduce approximately 1˚ additional slope).There are scribe marks at 1 cm for reference.

47

THE TIBIAL ALIGNMENT

The distal portion of the long arm of the tibialalignment device should align with the centerof the talus.

Lateral alignment is similarly confirmed.

N.B. Where indicated, varus/valgus corrections are madeby sliding the distal portion of the tibial alignment to theappropriate location.

48

Steinmann pins or 1/8" drill bits are intro-duced through the central holes into the tibiastopping well short of the posterior cortex. Thetibial alignment device can either be removedby first unlocking the cutting block, or left inplace for additional stability.

SECURING THE PLATFORM AND TIBIAL RESECTION

Resection is made either through theslot or on the top surface dependingupon the stylus reference used. A 1.19 mm saw blade is recommendedwhen cutting through the slots.

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ENTERING THE MEDULLARY CANAL

The medullary canal is entered at the midline of the femoral trochlea 7–10 mm anterior to theorigin of the PCL to a depth of about 5–7 cmusing a 5/16" drill.

Care is taken that the drill avoid the cortices. It is helpful to palpate the distal femoral shaftas the drill is advanced. The drill hole may bebiased anteromedially to facilitate unobstructedpassage of the long intramedullary rod to thediaphyseal isthmus, if indicated by pre-operative X-rays.

50

THE INTRAMEDULLARY ROD

The valgus angle with the appropriateRight/Left designation, as indicated on the pre-operative films, is set and locked into place onthe front of the locating device. The angle canbe set from 0 degrees to 9 degrees in one degreeincrements.

With the rod repositioned in the medullarycanal, the handle is removed and the locatingdevice is placed over the rod.

With the handle assembled onto the longintramedullary rod, the rod is introducedslowly into the canal to the level of the isthmusto confirm unobstructed passage. The rod isfluted to relieve intramedullary pressure andpermit the release of bone matter, avoidingembolization. It is subsequently withdrawn.

THE FEMORAL LOCATING DEVICE

51

THE EXTERNAL ALIGNMENT SYSTEM

A radiopaque marker is positioned over theipsilateral hip, parallel and immediately distalto the inguinal ligament. An A/P roentgeno-gram indicates which of four markers mostclosely approximates the rotational center.

At surgery, the femoral-head locating strip isaligned with the markers. A target screw isintroduced into the position overlying the rota-tional center. Draping is such that the screw isreadily palpated as the coxal reference point.

The alignment tower is assembled ontothe femoral locating device. The align-ment rod is passed through the hole andadvanced to the hip. Where the rod failsto align with the coxal reference point, a different angle is selected.

N.B. Where indicated, as in femoral deform-ity, 0˚ is selected and a short intramedullaryrod is substituted. See Appendix II.

52

ROTATIONAL CORRECTION

Orientation is initially determined with refer-ence to the posterior femoral condyles, subjectto subsequent correction at the A/P resection.The calibrated outrigger is centered at thefemoral trochlea, placing it in slight externalrotation and exposing a greater amount ofmedial condyle.

Alternatively, it may be externally rotated untilperpendicular to the mechanical axis of the tibiain 90˚ of flexion.

The femoral locating device is tapped into position at the more prominent condyle (usually the medial).

N.B. It is essential that firm contact be established at the subchondral level of the condyle, clear of anyresidual peripheral osteophytes.

53

The base block is slotted; however, if usedwithout the slot and the resection is initiatedfrom the top of the block, 4 mm is added to theresection level. For example, if 9 mm is thedesired resection level, add 4 mm to this andset the block at 13 mm and cut from the surface

of the block. Note the top of the block isengraved “4 mm offset.”

The outrigger and cutting block is lowered ontothe anterior cortex by depressing the button onthe left-hand side of the locating device. Either

1/8" drill bits or Steinmann pins areintroduced through the holes desig-nated zero and enclosed in nn ’s. Theyare advanced into the anterior cortex.

The cutting block is assembled onto the cali-brated outrigger by depressing the buttonlocated on the right proximal end. The resectionof the more prominent condyle, inclusive ofresidual cartilage, will correspond to the distaldimension of the femoral prosthesis. Where the femoral locating device rests on eburnated bone, resection is2 mm less than the distaldimension of the femoralprosthesis to allow forabsent cartilage and toavoid elevation of thejoint line.

THE DISTAL FEMORAL CUTTING BLOCK

The scale for the numbers on the outrigger is even on the left and odd on the right. Thenumber corresponding to the appropriateresection level is aligned with the inscribedline in the center of the window of the distalfemoral cutting block.

54

THE DISTAL FEMORAL CUT

The locating device and intramedullary rod are disengaged from the cut-ting block by depressing the right button on the cutting block. The holeson the block are designated -2, 0, and +2, indicating in millimeters theamount of bone resection each will yield supplemental to that indicatedon the calibrated outrigger.

The oscillating saw blade is positioned through the slot, or, where applic-able, the blade is positioned flush to the top cutting surface of the block.The condyles are resected and the surface checked for accuracy. a aa aaaaa a aa aaaaaa aa aaaaa a aa aaaaa

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EVALUATING THE EXTENSION GAP

The knee is placed in full extension and laminaspreaders applied medially and laterally. Theextension gap must be rectangular in configura-tion. Where it is trapezoidal, the bilateral softtissue must be balanced (see Appendix I). Bonecuts are not altered.

A set of spacer blocks measures the gap and indicatesthe appropriate thickness of the tibial insert, subjectto reevaluation at trial reduction.

When using blocks to assess flexion and extensiongaps, a 1 mm shim should be used for the extensiongap and the spacer is removed when assessing theflexion gap. This will compensate for the 1 mm differ-ence between the distal and posterior resection levels.

Medialtightness

Balanced

56

The appropriaterod is selectedand assembled tothe femoral A/Pcutting block, theappropriateRIGHT/LEFT desig-nation to the ante-rior. The pins areretracted.

N.B. Alternatively, the femoral sizing guide is usedto position and size the component (see pages 14-16). With positioning established, any appropriateA/P cutting block may be used.

SIZING THE FEMORAL COMPONENT

ASSEMBLING THE FEMORAL A/P CUTTING BLOCK

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Careful preoperative planning, including theapplication of templates to lateral radiographs,is critical to the sizing of the femoral compo-nent. Priority is given to reestablishment of theA/P dimension, as this will restore normalkinematics and quadriceps function. Undersiz-ing will cause looseness in flexion and possiblenotching of the anterior femoral cortex. Over-sizing will create tightness in flexion andincreased tension in the quadriceps mechanism.Where a stabilizing or constraining insert isused, a matched size relationship between thecomponents must be maintained.

POSITIONING THE CUTTING BLOCK

Rotation is determined with the knee in 90° offlexion and the block positioned such that itsposterior surface is parallel tothe resected tibial plateau, creat-ing the desired rectangular flex-ion gap.

The retractable pins are subse-quently tapped into the distalfemur.

ROTATIONAL ADJUSTMENT

58

a aa a aaaaThe rod is introduced into the preparedintramedullary hole until the cutting block isseated flush to the cut distal surface.

The foot of the stylus assem-bly is fully seated in itsreceptacle on the anteriorsurface of the block such thatit reads 0.

The cutting block is adjustedposteriorly until the stylus (slotted arm) is in contact withthe anterior femoral cortex.

EVALUATING THE FLEXION GAP

Lamina spreaders are positioned bilaterallybetween the resected proximal tibial surfaceand the posterior surface of the block. Tension is applied.

N.B. Further ligamentous release is not recom-mended at this stage.

Medialtightness

Balanced

59

ANTERIOR AND POSTERIOR FEMORAL CUTS

The anterior and posterior cuts are made with the blade of the oscillating saw held flushagainst the respective surfaces. The cuts are checked for accuracy and the cutting block removed.

60

a aa aaaa aa aaaa aa aaaaaa aa a aaaaaaa aaaaaaaaa aaa aa a aaaaaaa aaaaaaaaaa a aa aaa a aaaaa aaa aa a aa aAlternatively, the slotted A/P cham-fer block may be substituted for the cut-ting block, positioned into the distalbilateral holes. A 1.19 mm saw blade is recommended.

The chamfer cuts can be made throughthe slotted A/P block at this time.

Alternatively, a separate chamfer blockcan be used to guide the anterior andposterior chamfer resections.

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MEASURING FLEXION GAP

Spacer blocks are used tomeasure the gap at 90° offlexion. When using blocksto assess flexion and exten-sion gaps, a 1 mm shimshould be used for the exten-sion gap and removed whenassessing the flexion gap.This will compensate for the1 mm difference between thedistal and posterior resectionlevels.

Where further distal femoralresection is required to estab-lish equivalent flexion andextension gaps, the Stein-mann pins are returned totheir original position in theanterior femoral cortex andthe distal femoral cuttingblock repositioned using theholes designated +2 and +4as indicated.

The long alignment rodshould pass through the cen-ter of the talus and lie paral-lel to the lateral tibial axis.

61

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THE FEMORAL NOTCH CUT

Place the trial femoral component onto the preparedfemur and position it such that the lateral flange of thetrial component meets the lateral margin of the femur.Overhang of the flange is avoided where possible.

With electrocautery, mark the medial/lateral location ofthe trial with lines drawn on the distal femur withineach border of the intercondylar notch.

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THE FEMORAL NOTCH GUIDE

The appropriate femoral notch guide is appliedto the distal femur, seated flush upon the cutanterior and distal surfaces. It is centered aboutthe two lines, previously made, within theintercondylar notch.

Where the posterior margins of the guide fail to align with the cut posterior condyles, the cuts are accordingly revised.

Steinmann pins are introduced in the sequencedisplayed: anterior (1), contralateral distal (2),anterior (3) and distal (4).

63

a aa a aaaaaaa aaa aaThe notch is created with an oscillating saw and anosteotome.

A 1/2" x 1.19 mm blade isrecommended.

Alternatively, the femoral notch/chamfer guide may be employed for the notch andchamfer cuts.

M/L size of implant is at the arrows indicated below. The mediolateral positioningof the guide is confirmed.

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Steinmann pins are introduced in the sequence displayed:anterior (1), contralateral distal (2), anterior (3) and distal (4).

The notch is created with bilateraland superior transverse cuts, asdescribed above. A 1/2" x 1.19 mmsaw blade is recommended.

65

a aaa aaa aaa aaa aaa aaaaaaa aaaaaaaa aa aa aa aaaa a a aa aa aa a aa aaaaaa aThe chamfers are fashioned with the oscillating saw using theappropriate slots. A 1.19 mm saw blade is recommended.

66

It is important that the sagittal dimension and accurate tracking be main-tained and that adequate bone stock be preserved. Problems arise

from inadequate or oblique resection resulting in greater thicknessto the complex, asymmetric positioning of the implant, subse-

quent patellar tilt and implant wear.

It is important that sufficient soft tissue be freed atthe prepatellar bursa to position the calipers at the

anterior cortex.

PATELLAR RESURFACING

The greatest sagittal dimension is at the medianridge. The normal range is 20–30 mm. Thedimension is established and an amount corre-sponding to the size of the selected implantsubtracted. The remainder equals the targetdimension following resection. Where thepatella is small, a minimal residual dimensionof 12 mm should be maintained.

EXAMPLE: (for a 38 mm wide dome or oval/dome patella) From a patella 25 mm thick, 9 mm of articular surface is resected, yielding16 mm of residual bone to accommodate the 9 mm thick implant.

The template is selected that most adequatelycovers the articular surface without overhang.The handle is positioned on the medial side of the everted patella. Where bone is deficienton the lateral side, the next smaller size isselected, but positioned slightly medial to enhance patellar tracking.

The amount of appropriate bone resection, as indicated on the template, is noted.

Patellar Size Resection

32 mm 8 mm35 mm 8.5 mm38 mm 9 mm41 mm 11.5 mm

11

0 10

0 90

80

70

60

50

40

30

20

10

0

THE PATELLAR CUTTING GUIDE

Synovial tissue is cleared to the level of theinsertions of the quadriceps mechanism and thepatellar ligament.

The prongs of the knurled fork are adjusted tothe predetermined dimension of residualpatella as indicated on the calibrated column.

The leg is placed in exten-sion, the cutting guidepositioned with the prongsof the fork deep to theprepatellar bursa andagainst the anterior patel-lar cortex with the serratedjaws at the superior and

inferior margins of the articular surface. Theswitch is placed to the LOCK position and thejaws closed to firmly engage the patella.

67

RESECTION AND DRILLING

Alternatively, the saw blade is inserted into thewell of the cutting surface of either of the jaws.The insert is lifted and the blade thereby con-fined within the slot created, ensuring that thecut will remain flush to the cutting surface. A1.19 mm saw blade is recommended.

The previously selected template is positionedonto the cut surface with the handle positionedon the medial side of the everted patella, suchthat two drill holes lie at the medial side, one atthe lateral. The template is firmly engaged tothe resected surface and the holes fashionedwith the appropriate drill bit.

Resection is performed with an oscillating saw,maintaining the blade flush to the cutting sur-face. The guide is subsequently removed andthe residual dimension checked with calipers,laterally, medially, proximally and distally. Allmeasurements should be equivalent. Asymme-try is addressed with the saw or a bone rasp.a aa a aaaaaaa aaaaaaaaaaa aaaaaa

68

THE TRIAL TIBIAL COMPONENT

With the knee in maximal flexion, the tibia issubluxed anteriorly with the tibial retractor.

The tibial tray is selected which provides thegreatest coverage of the prepared surface with-out overhang anterior to the midcoronal plane.

The appropriate color-coded nylon trial isinserted into the tray.a aa aaa aaaaaaa aa aaa aaa aa aa aa a aaaaaaa aaaaa aaa aaaaaa aa aaaaa a aa a aaaaaaa aaaaaaaaaa a aaaaaaaaaaa a a a aaaa

69

THE TRIAL FEMORAL COMPONENT

THE FEMORAL COMPONENT BOX

ASSEMBLY

1) Place the two outrigger tabs of the box trial intothe recesses of the posterior condyles.

2) Insert the two anterior tabs into the recesses ofthe anterior flange.

3) Turn the angled screw, located in the side of thebox, until tight.

Note: Do not overtighten the screw or attempt toremove the screw from the box trial as this willresult in damage to the box trial attachment.

The femoral trial is positioned on the prepared dis-tal femur and the accuracy of the cuts is evaluated.

Where the component tends to rotate posteriorly(rocking into flexure) the A/P cuts may requireadjustment. Where there is lateral rocking, thedepth of the notch is inadequate.

All appropriate modifications are made at this time.

70

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71

With all trial prostheses in place, the knee is care-fully and fully extended, noting medial and lateralstability and overall alignment in the A/P andM/L plane. Where there is any indication of insta-bility, the next greater size tibial insert is substi-tuted and reduction repeated. The insert that givesthe greatest stability in flexion and extension andallows full extension is selected. Where there is atendency for lateral subluxation or patellar tilt inthe absence of medial patellar influence (thumbpressure), lateral retinacular release is indicated.

Rotational alignment of the tibial tray is adjustedwith the knee in full extension, using the align-ment handle to rotate the tray and trial insert intocongruency with the femoral trial.

The appropriate positionis marked with electro-cautery on the anterior tibial cortex.

TRIAL REDUCTION

OVERALL ALIGNMENT

The tibial alignment handle is assembled to thetrial tibial tray and the two parts of the align-ment rod to the handle.

Where static alignment is correct, the rod will bisect the mechanical axis at the hip, kneeand ankle.

72

PLATEAU PREPARATION

With the knee in full flexion and the tibia sub-luxed anteriorly, the trial tibial tray is assem-bled to the alignment handle and placed ontothe resected tibial surface. Care is taken thatproper rotational alignment with the electro-cautery marks be established.

The tray is secured with two short fixation pinsinserted through the holes designated nn .

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P.F.C.® CRUCIFORM KEEL TRAY PREPARATION

Where the cemented tray is to be implanted, theappropriately sized cemented tray stem punch issubsequently positioned through the guide andimpacted until the shoulder of the punch is in con-tact with the guide. The cemented stem punch issubsequently freed, taking care that the punch con-figuration be preserved.

74

Remove the alignment handle from the tray trial and assemble the appro-priately sized cruciform keel punch guide to the tray trial.

Assemble the appropriately sized non-cemented keel punch onto the slap-hammer and insert the punch through the guide and impact until the shoulder of the punch is in contact with the guide. The stem punch is sub-sequently freed, taking care that the punch configuration be preserved.

Select the appropriate punch guide, drill bushing, drill and modular keelpunch system. Remove the alignment handle from the tray trial and as-semble the appropriately sized modular tray punch guide to the tray trial.

Seat the appropriately sized drill bushing into the modular tray punch guide.

The matching drill is fully advanced through the drill bushinginto the cancellous bone.

The appropriately sized modular tray keel punch is subse-quently positioned through the guide and impacted until theshoulder of the punch is in contact with the guide. The modu-lar tray keel punch is subsequently freed, taking care that thepunch configuration be preserved.

*UHMWPE (ALL-POLY)

P.F.C.® MODULAR TRAY & UHMWPE* TIBIA PREPARATION

75

IMPLANTING THE COMPONENTS

THE TIBIAL COMPONENT

The entire site is thoroughly cleansed with pul-satile lavage. Methylmethacrylate cement is pre-pared and applied by syringe or digital pressurein its low viscous state to assure maximal pene-tration into the trabecular bone.

The universal handle is assembled onto the uni-versal tibial tray inserter and assembled ontothe tibial tray. The tray is carefully inserted,avoiding malrotation. When it is fully seated, sev-eral mallet blows are delivered to the top of theuniversal handle. The nylon tibial tray impactormay be used to further impact the tibial tray. a aaa aa a aaaaaaa aaaaaaaaaa a aaaaaaaa

76

UHMWPE STABILIZED TIBIAL

COMPONENT

Alternatively, when implanting an all-UHMWPE

tibial component, place the component inappropriate orientation and impact the flat cen-tral proximal portion of the component withthe nylon tibial tray impactor. Excess cement isremoved from the periphery of the tibialplateau, and a final impaction is performed toensure complete seating of the component.

As the cement polymerizes, a trial componentis positioned on the prepared femur. The kneeis placed in full extension to maintain pressureat the bone/tibial implant interface. Slight val-gus stress is maintained to ensure that the tibialimplant not tilt into varus. When the cementhas set, the knee is placed in flexion and thetrial femoral component removed. All extrudedcement is carefully removed with special atten-tion to the posterior compartment.a aaa aaa aaa aaa aaaaaaa a

77

THE FEMORAL COMPONENT

The entry hole at the medullary canal is plugged with cancellous bone.All surfaces are thoroughly cleansed with pulsatile lavage. Cement isapplied to the bone at the anterior, anterior chamfer and distal surfacesand to the inner surface of the component at the posterior chamfer andposterior condylar recesses. Care is taken to avoid the articular surface of the implant. The implant is assembled onto the femoral inserter. Care is taken that it be correctly oriented. The leadingedges are advanced equally, parallel tothe distal surface and protecting thecarefully configured surfaces, until the lugs are fully engaged.

The inserter is subse-quently released and seat-ing completed with thefemoral impactor and amallet. All extrudedcement is cleared with ascalpel and curette.

78

THE PATELLAR COMPONENT

The patellar implant may be cemented at thesurgeon’s convenience with either of the othercomponents. The cut surface is thoroughlycleansed with pulsatile lavage. Cement isapplied to the surface and the componentinserted.

The patellar clamp is designed to fully seat andstabilize the implant as the cement polymerizes.It is positioned with the silicon O-ring centered

over the articular surface of the implant and themetal backing plate against the anterior cortex,avoiding skin entrapment. When snug, the han-dles are closed and held by the ratchet untilpolymerization is complete. Excessive compres-sion is avoided as it can fracture osteopenicbone. All extruded cement is removed with acurette. To release the clamp, place the lockingknob in the unlocked position and squeeze thehandles together to release the pawl.

79

THE TIBIAL INSERT

The trial insert is removed and the perma-nent insert introduced into the implantedtibial tray and seated posteriorly, its anterior margin resting on the lip.

The anterior margin is tapped with a nylon mallet,deflecting it past the lip of the tray into position.Seating is confirmed by circumferential inspection.

Alternatively, the permanent insert may beinserted at any convenient time during thecementing procedure.

When a curved insert topography is utilized andthe flexion gap is snug, it may be difficult toextract a trial insert and introduce the permanentone. In such a case, the permanent insert shouldbe implanted prior to cementing the femoral component.

CLOSURE

The tourniquet is released and bleeding controlledby electrocautery. A closed-wound suction drainis placed in the suprapatellar pouch and broughtout through the lateral retinaculum. The fat pad,quadriceps mechanism, patella tendon and medialretinaculum are reapproximated with interruptedsutures.

The knee is put through a range of motion fromfull extension to full flexion to confirm patellartracking and the integrity of the capsular closing.The final flexion against gravity is noted for post-operative rehabilitation.

Subcutaneous tissue is reapproximated and theskin closed with sutures or staples.

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LIGAMENTOUS BALANCE IN TOTAL KNEE ARTHROPLASTY

MEDIAL LIGAMENTOUS RELEASE FOR FIXED VARUS DEFORMITY

The suggested sequence of ligamentous releaseto correct varus or valgus deformity andquadriceps-mechanism imbalance is described.There is no general agreement on the order;there is on the principles.

• Preliminary soft-tissue release is performed atthe start of surgery, based upon preoperativeevaluation.

• Balance is established by eliminating soft-tissue contractures, not by modifying thebone cuts.

• Final correction is established at trial reduction.

Following removal ofperipheral osteophytes, themedial meniscus (1) andthe meniscotibial ligament(2) are excised. In rheuma-toid arthritis and minimaldeformity, this is often sufficient.

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AP

PE

ND

IX

I

Where further release is indicated, the posteriorexpansion of the deep medial collateral liga-ment is released from its tibial attachment (3)using a curved osteotome.

Where still further release is indicated, themedial tibia is denuded subperiosteally (4).

Where, following trial reduction, furtherrelease is indicated, the superficial portion ofthe medial collateral ligament is releasedfrom its tibial attachment (5). Generally, thisis indicated only in severe deformity associ-ated with significant flexion contracture.a aa a aaaaaaa aaaaaaaaaaa aa a a aaa aaaaaaa aaaaa aa aaaa aaa aaaaaaa aaaa a aa a aaaaaaa aaaaaaaaaa82

Lateral retinacular release is performed on theinternal surface in the longitudinal plane. Careis taken that the lateral superior genicularartery be protected; it is isolated at the inter-muscular septum as it penetrates the retinacu-lum superficially, retracted proximally as theretinacular incision is carried to the level of thejoint-line, distally as the incision is extendedsuperiorly to the intermuscular septum (3).

Where indicated, further release is effected byextending the distal terminus of the incisiontransversely to the lateral margin of the patellartendon (4) and posteriorly to the lateral collat-eral ligament.

Following removal of peripheral osteophytes,initial release comprises medial meniscectomy(1) and release of the iliotibial band from its tib-ial insertion (2). A lateral quadriceps retinacularrelease is indicated where there is poor patellartracking at trial reduction.

LATERAL LIGAMENTOUS RELEASE FOR FIXED VALGUS DEFORMITYa aa a aa aa a aaa aa a aaaaaaa aaaaa aa a aaaaaaa aaaaaaaaaaa aaa aaaaaaa a83

Where balance requires still further release,dissection is extended posteriorly, freeing the intermuscular septum (7) and the lateralhead of the gastrocnemius (8).

Care is taken that the posterolateralneurovascular structures be preservedand that the insertion of the bicepsfemoris, which overlies the commonperoneal nerve, remains intact.

a aa a aaaaaaa aaaaaaaaaa a aaaaaaaaaaa aaa aaa aaa aa aaaaaaaa aaaaaaaaa a aa a aaaaaaa aaaaaaaaaaa aa aaaaaaa a aa aaaaaa aaa aaa aa aa aa aaaWhere still further release is indicated, the lateral collateral ligament and popliteus tendonare released from the femoral epicondyle andallowed to slide posteriorly (5).

Where further release is indicated, the posteriorcruciate ligament is evaluated and, where nec-essary, sacrificed (6).

N.B. Priority of steps 5 and 6 is a matter of preference. a aa a aaaaaaa aa aaa aaa aaa aaaaaa aa aa aa aa aaa aaa aa aaaaaaaa aaaaaaaaa84

BALANCING THE POSTERIOR CRUCIATE LIGAMENT

In cruciate-retaining total-knee replacement, thereare three indicators for PCL tightness identified attrial reduction: limited flexion with excessivefemoral rollback, anterior lift-off of the tibial trayand palpable ligamentous tension in flexion.

Possible causes include residual posterior/posteromedial osteophytes and loose bodiessuch as meniscal segments. It is essential during initial exposure that all peripheral pos-terior osteophytes be cleared, that the meniscibe completely removed and that the attach-ments of the PCL be defined.

Problems commonly arise from failure to clearthe posterior horns of the menisci, including theposterior meniscofemoral ligament, and failureto identify synovial adhesions.

85

Where the surgeon elects to increase the poste-rior slope, it should not exceed a total of 7˚, asexcessive posterior slope will complicate liga-mentous balance in flexion and extension. It ispreferable, therefore, that the PCL be recessed.

PCL recession is possible at either the tibial orfemoral attachments, but as the anterior andposterior fibers at the femoral attachment differin tension in transition from extension to flexionand as compromising this attachment increasesthe likelihood of evulsion, preliminary recessionat the tibial attachment is recommended.

The diagram below shows the changes in PCLtension throughout range of motion.

86

In extension, the bulk of the PCL is relaxed and only the posterior band is tight. In flexion, the bulk of the PCL becomes tight and the small posterior band is loose.

The tibial attachment is elevated subper-iosteally along the entire proximal margin suchthat the ligament is allowed to recede incre-mentally until flexion tension in trial reductionis satisfactory with normal patellar tracking.

Where tightness persists, further release is indi-cated, which may be performed at the femoralattachment. This can produce laxity; to lessenthe likelihood, a supplemental curved compo-nent is introduced. The knee is placed in 90˚ offlexion and the tensed fibers incrementallyfreed from the femoral attachment with sharpdissection until the supplemental component isaccepted without anterior lift-off of the tray.

N.B. Residual posterior osteophytes or undetectedbone fragments can impinge upon the componentsand promote lift-off.

87

BALANCING FLEXION AND EXTENSION GAPS

Where the joint line is maintained, flexion andextension gaps are usually found to be bal-anced at trial reduction, but where there is pre-operative deformity and contracture, imbalancemay be present.

RESIDUAL FLEXION CONTRACTURE

Where there is restriction in extension but notin flexion, additional bone is removed from thedistal femur. This affects the extension gap butnot the flexion gap. Where contracture persistsfollowing appropriate retinacular release and removal of posterior osteophytes and scartissue, depending on severity, removal of anadditional 2–4 mm of distal femur is indicated.

The Steinmann pins are returned to their origi-nal position in the anterior femur and the distalfemoral cutting block returned to the pins usingthe holes designated +2 as the degree of con-tracture indicates. The distal cut is accordinglyrevised.

Chamfers are subsequently revised to maintainthe correct configuration; anterior and posteriorcuts are not. This affects ligamentous tension inextension but not in flexion.

88

RESIDUAL TIGHTNESS IN FLEXION

AND EXTENSION

A thinner tibial insert or additional tibial resec-tion is indicated, as either will affect flexion andextension gaps. Where resection is selected, it isrecommended that 2 mm of proximal tibia beremoved. The Steinmann pins are returned totheir drill holes in the anterior tibial cortex andthe cutting block repositioned on the pins,using the holes designated +2. The cut isaccordingly revised.

RESIDUAL TIGHTNESS IN FLEXION ONLY

Where such is the case, excessive PCL tension is indi-cated, and the PCL should be recessed. Recession iseffected as described above. Residual posterior osteo-phytes, soft tissue, and loose bodies may be factorsand must be addressed. In the rare case where ten-sion persists following appropriate correction, 5˚ ofadditional posterior slope may be indicated. The pinsare returned to the anterior cortex and the 5˚ cuttingblock positioned using the holes designated nn. Finalslope should not exceed 7˚.

Alternatively, tightness in flexion may be addressedby downsizing the femoral component, providedanterior femoral notching be avoided. The pins arereturned to the distal femoral surface, the designatedcutting block positioned, and the cuts revised. Asadditional posterior condyle is resected, flexion gap is increased.

N.B. For discussion of soft-tissue balancing, see above.

89

With the rod repositioned in themedullary canal, the handle isremoved and the locating device isplaced over the rod.

The tower is assembled to the locating device, the alignment rod

introduced through the hole and advanced to the hip. Resection is as previously described.

THE EXTERNAL FEMORAL ALIGNMENT SYSTEM

In patients with femoral deformity or with total hip replacement, the

intramedullary alignment system is not appropriate. The short

intramedullary rod coupled to the femoral locating device (set at 0˚),

tower and alignment rod are employed. The femoral head is identified

preoperatively, radiopaque markers positioned parallel and just distal

to the inguinal ligament. An A/P radiograph identifies the marker

which approximates the center of the hip.

At surgery, the femoral head locating device is taped over theradiopaque markers, the large-headed screw introduced into the holeover the identified marker. Draping is such that the screw is readily palpated as the coxal reference point.

90

AP

PE

ND

IX

II

INTRAMEDULLARY ALIGNMENT DEVICE

PREOPERATIVE PLANNING

Where the Specialist® 2 Intramedullary TibialAlignment System is to be used, it is essentialthat the appropriate point of entry on the tibialplateau be accurately determined. In most cases, this point will be centered on the tibialspine in both the medial/lateral and anterior/posterior aspect. In some cases, it may beslightly eccentric.

Using full-length extremity radiograms, linesare constructed along the central axis of the tibiaon the A/P view by determining mid-points ofthe diameter of the tibia in the diaphysis at least10 centimeters apart. A line defined by thesetwo points is extended proximally to the kneejoint and distally to the ankle joint. The point ofintersection with the tibial plateau determinesthe point of entry in the medial lateral plane.This line should pass at or near the center of theankle joint. If it does not, it is usually because ofexcessive tibial bowing. In this circumstance, itis preferable to use an external tibial alignmentsystem.

In the lateral view, a point is defined at the mid-point of the tibial plateau and anotherpoint defined at the mid-point of the isthmus.The line defined by these two points will definethe appropriate placement of the intramedul-lary tibial alignment rod in the lateral plane.

These lines are projected to the tibial plateau;their intersection determines the appropriatepoint of entry.

N.B. The entry point for the intramedullary align-ment rod is a critical starting point for accuratealignment of the intramedullary tibial alignment sys-tem. Selected correctly, neutral alignment in theanteroposterior and lateral planes is easily achieved.

91

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III

ENTERING THE MEDULLARY CANAL

The knee is flexed maximally, the tibial retractorinserted over the posterior cruciate ligament and the tibia subluxed anteriorly. All soft tissue iscleared from the intercondylar area. The tibial spineis resected to the highest level of the least affectedtibial condyle. Entrance to the medullary canal isfacilitated with a 5/16" step drill bit which makes apilot hole to assure accuracy.

The intramedullary rod is passed down into themedullary canal until the isthmus is firmly engaged.

92

POSITIONING THE GUIDE

The handle is removed and the I.M. tibial alignment guide is positionedon the I.M. rod. The I.M. guide should sit flush to the resected tibial spine.

It is suggested the level of resection be set at 8 or 10 mm. This is accom-plished with use of the stylus, set at the appropriate resection level (seefootnote), positioned in the center of the condyle of the least affected side.

Alternatively, to use the reference scale on the front of the outrigger tomeasure the resection level, the scale as indicated is relative to cuttingthrough the slot. To adjust for cutting on the surface of the block, add4 mm to the front scale. For example, when cutting on top of the slottedblock and an 8 mm resection is desired, set the outrigger for 12 mm andproceed to cut on the surface of the block. Note, the top of the cuttingblock is engraved 4 mm offset.

N.B. For a full explanation of the stylus, refer to page 21 of this manual.

THE I.M. TIBIAL ALIGNMENT GUIDE

ASSEMBLING THE GUIDE

As a posterior slope is usually desired, a 3˚ or a5˚ posteriorly sloped cutting block is selected. a aa a aaaaaaa aaaaaaaaaa aa a aaaaaaa aaaaaaaaaa aa a aaaaaaa aaaaaaaaaa aa aaaaaaaa aaaaa

93

ROTATIONAL ALIGNMENT

When the level of resection has been determined, the alignment tower, tibial side, is inserted into the tibial cutting block and rotated such that thecenter of the block is aligned with the medial third of the tibial tubercle.

The long alignment rod is passed through the appropriate hole to theankle. It should align with the center of the talus. Lateral alignment is similarly confirmed.

94

An entry slot is cut with a nar-row oscillating saw into the intercondylar eminence anteriorto the attachment of the PCL and

an osteotome positioned to shield the ligament.

Resection is made either through the slot or onthe top surface depending upon the stylus refer-ence used. A 1.19 mm saw blade is recommendedwhen cutting through the slots.

Steinmann pins or 1/8" drill bits are introducedthrough the central holes, marked with a nn, intothe tibia stopping well short of the posterior cor-tex. The intramedullary alignment device isremoved from the cutting block and the I.M. rodis subsequently removed.

N.B. Where indicated, varus/valgus corrections aremade by removing one of the pins and allowing theblock to pivot on the other. The pin is subsequentlyrepositioned through a more peripheral hole.

SECURING THE CUTTING BLOCKa aa a aaaaaaa aaaaaaaaaa aa a aaaaaaa aaaaaaaaaa aa a aaaaaaa aaaaaaaaaa aa aaaaaaaa aaaaaTIBIAL RESECTION

95

96

EXTRAMEDULLARY TIBIAL ALIGNMENT DEVICEWITH PROXIMAL FIXATION SPIKE

The knee is placed in maximum flexion with thetibia distracted anteriorly and stabilized. The malleo-lar clamp of the tibial alignment device is positionedproximal to the malleoli. With the appropriate transverse tibial cutting guide attached to the tibial alignment device, the proximal spike is placed in the center of the tibial eminence and seatedto the depth of the shortest, or anterior, spike. Thecutting block is advanced posteriorly to the proximaltibia and the head containing the spikes is tightened.

a aaa aaaaaa aaa aa a aaaaaaa aaaaaaaaaa a aaaaaaaaaaa aa aaaaaa aa aaaaaaaa aThe lower assembly istranslated anteroposteriorlyto align it parallel to the tibialaxis. Where posterior slope isdesired, the assembly is advanced anteri-orly, or, alternatively, a sloped block is used(see page 18). Up to 5˚ of slope is generallyappropriate (5 mm advancement will produceapproximately 1˚ additional slope). There arescribe marks at 1 cm for reference.

Mediolateral alignment is approximately parallel to thetibial axis, but as the lateral malleolus is more promi-nent, bisecting the transmalleolar axis will prejudice thecut into varus. The midline of the tibia is approximately3 mm medial to the transaxial midline. The lowerassembly is translated medially to the palpable anteriorcrest of the tibia, usually to the second vertical mark.There are scribe marks at 3 and 6 mm for reference.Where the platform is medially displaced, adjustment ismade at the lower assembly.

Adjustable Head

Set Knob

AP

PE

ND

IX

IV

A level of 0 mm or 2 mm is selected whereresection is based on the more involvedcondyle and does not result in excessive contralateral resection. The block is adjustedsuch that the stylus rests on the center of thecondyle and the block is secured by the largelateral knob.

97

a aaa aaaaaa aaa aa a aaaaaaa aaaaaaaaaa a aaaaaaaaaaa aa aaaaaa aa aaaaaaaa aAppropriate rotation is established and theshorter spike is seated in the proximal tibia,securing the medial/lateral, anteroposterior,and rotational positions. With the set knob ofthe adjustable head free, slide the cutting blockforward until contact with the anterior tibia is established. Tighten the set knob. The cylin-der foot of the stylus is inserted into the slot of the cutting block and adjusted to the appropriate level. A level of 8 mm or 10 mm is suggested where resection is based on theless involved condyle.

98

a aaa aaaaaa aaa aa a aaaaaaa aaaaaaaaaa a aaaaaaaaaaa aa aaaaaa aa aaaaaaaa aSteinmann pins or 1/8" drill bits are intro-duced through the central holes into the tibia,stopping well short of the posterior cortex.The cutting block is unlocked, the black lat-eral knob loosened and the set knob securingthe head loosened. The uprod is pulled anddisengaged from the cutting block. Connectthe quick connect slap hammer to the headand disengage the spikes from the proximaltibia. The tibial alignment device is removedand the appropriate resection performed.

Appendix IV, Extramedullary Tibial Alignment Device with Proximal Fixation Spike Surgical Technique, edited by William L. Healy, MD, Chairman, Department of Orthopaedic Surgery, Lahey HitchcockMedical Center, Burlington, Mass.

SIZE 1.541AP/61ML PLI n n n

CRUCIATE RETAINING— FEMORAL AND TIBIAL INSERT COMPATIBILITY

FEMORAL COMPONENT

TIBIAL INSERTS

SIZE 2.559AP/63ML

SIZE 361AP/66ML

SIZE 465AP/71ML

SIZE 569AP/73ML

SIZE 674AP/78ML

CVD, CVD+XLK n n

CVD, CVD+XLK n n n n

CVD, CVD+XLK n n n

CVD, CVD+XLK n n n n

CVD, CVD+XLK n n n

CVD, CVD+XLK n n n

CVD, CVD+XLK n n

SIZE 243AP/64ML PLI n n n n n

SIZE 2.545AP/67ML PLI n n n n n

SIZE 347AP/71ML PLI n n n n n

SIZE 451AP/76ML PLI n n n n n n

SIZE 555AP/83ML PLI n n n n

SIZE 659AP/89ML PLI n n n

SIZE 1.553AP/57ML

SIZE 256AP/60ML

POSTERIOR LIPPED8, 10, 12.5, 15, 17.5, 20 (mm)

CURVED8, 10, 12.5, 15, 17.5, 20 (mm)

CURVED PLUS XLK8, 10, 12.5, 15, 17.5, 20 (mm)

99

CR

AP

PE

ND

IX

V

CRUCIATE SUBSTITUTING PRIMARY AND REVISION—FEMORAL AND TIBIAL INSERT COMPATIBILITY

FEMORAL COMPONENTS

TIBIAL INSERTS

SIZE 2.559AP/63ML

CS TC3

SIZE 361AP/66ML

CS TC3

SIZE 465AP/71ML

CS TC3

SIZE 569AP/73ML

CS TC3

SIZE 674AP/78ML

CS TC3

SIZE 1.541AP/61ML PS SP n n n n

TC3 n n

TC3 n n n n

TC3 n n n

TC3 n n n n

TC3 n n n

TC3 n n

SIZE 243AP/64ML PS SP n n n n n n n n

SIZE 2.545AP/67ML PS SP n n n n n n

SIZE 347AP/71ML PS SP n n n n n n n n

SIZE 451AP/76ML PS SP n n n n n n

SIZE 555AP/83ML PS SP n n n n n

SIZE 659AP/89ML PS SP n n n

SIZE 1.553AP/57ML

CS TC3

SIZE 256AP/60ML

CS TC3

CS TC3

POSTERIOR STABILIZED8, 10, 12.5, 15, 17.5, 20, 22.5, 25 (mm)

STABILIZED PLUS10, 12.5, 15, 17.5, 20, 22.5, 25, 30 (mm)

TC3 10, 12.5, 15, 17.5, 20, 22.5, 25, 30 (mm)

SP

PS

TC3

100

NOTES

NOTES

2M0206SP2-007 (Rev. 6)

Printed in USA. ©1998 DePuy Orthopaedics. All rights reserved.

DePuy Orthopaedics, Inc. 700 Orthopaedic DriveWarsaw, IN 46581-0988USATel: +1 (800) 366 8143Fax: +1 (574) 267 7196

DePuy International LtdSt Anthony's RoadLeeds LS11 8DTEnglandTel: +44 (113) 387 7800Fax: +44 (113) 387 7890

For more information about DePuy products, visit our web site at www.jnjgateway.com.

LCS® Complete™ – P.F.C.® Sigma™ RP Mobile Bearing Total Knee System

Important:This essential product information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for allnecessary information.

IndicationsCemented Use:The LCS® Complete™ – P.F.C.® Sigma™ RP Mobile Bearing Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoidarthritis. The RPF insert and femoral component are indicated where a higher than normal degree of post-operative flexion is required. The rotatingplatform prosthesis and modular revision components are indicated for revision of failed knee prostheses.

Uncemented Use:The porous coated Keeled and Non-Keeled M.B.T.™ (Mobile Bearing Tibial) Tray configurations of the LCS Total Knee System are indicated fornoncemented use in skeletally mature individuals undergoing primary surgery for reconstructing knees damaged as a result of noninflammatorydegenerative joint disease (NIDJD) or either of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies. The Rotating Plat-form device configuration is indicated for use in knees whose anterior and posterior cruciate ligaments are absent or are in such condition as to justifytheir sacrifice. The P.F.C. Sigma RP Curved bearings when used with the P.F.C. Sigma Cruciate Retaining Femoral Component can be used inposterior cruciate ligament retaining procedures.

Contraindications:The use of the LCS Complete – P.F.C. Sigma RP Mobile Bearing Total Knee System is contraindicated in:• the presence of osteomyelitis, pyrogenic infection or other overt infection of the knee joint;• patients with any active infection at sites such as the genitourinary tract, pulmonary system, skin or any other site. Should a patient have any

infection prior to implantation, the foci of the infection must be treated prior to, during and after implantation.• patients with loss of musculature or neuromuscular compromise leading to loss of function in the involved limb or in whom the requirements

for its use would affect recommended rehabilitation procedures. • patients with severe osteoporosis or other metabolic bone diseases of the knee. • patients with any of the following conditions:• lesions of the supporting bone structures (e.g. aneurysmal or simple bone cysts, giant cell tumor or any malignant tumor), • systemic and metabolic disorders leading to progressive deterioration of solid bone support, • the presence of severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity, fixed

deformities greater than 60° of flexion, 45° of genu varus or valgus, • known drug or alcohol addiction, • skeletally immature individuals and the presence of allergic reaction to implant metals or polyethylene are also contraindications for the non-

cemented, porous coated, M.B.T. and LCS Complete – P.F.C. Sigma RP Mobile Bearing device configurations, and for the cemented use of all device configurations of the LCS Complete – P.F.C. Sigma RP Mobile Bearing Total Knee System.

Contraindications for use without cement:Noncemented use of the Porous Coated Keeled or Non-Keeled M.B.T. Tray device configurations is contraindicated in patients with sufficient loss inquantity or quality of bone stock (as determined on X-ray) such that successful noncemented fixation is unlikely. Additional contraindications maybecome apparent at the time of surgery. These include: • vascular deficiency at the bone site; • inadequate bone stock to assure both a firm press fit and close apposition of the cut bone surfaces to the prosthesis; • the inability to make bone cuts so as to assure both correct component position and intimate apposition of bone and prosthetic surfaces;• inadequate bone quality (e.g. severe osteoporosis) and lack of stability of the implanted components.

In the presence of any of the above conditions the components should be fixed with cement.

Warnings and Precautions:Components labeled for “Cemented Use Only” are to be implanted only with bone cement. The following conditions tend to adversely affect knee replace-ment implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints.The P.F.C. stem extensions can only be used with M.B.T. revision trays and LCS Complete Revision and Modular femoral components.

Adverse Events:The following are the most frequent adverse events after knee arthroplasty: change in position of the components, loosening, bending, cracking,fracture, deformation or wear of one or more of the components, infection, tissue reaction to implant materials or wear debris; pain, dislocation, sub-luxation, flexion contracture, decreased range of motion, lengthening or shortening of leg caused by improper positioning, looseness or wear of compo-nents; fractures of the femur or tibia.