`
`In.“
`
`_
`Intragondylar Knee.
`
` Richards
`
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`
`RICHARDS
`
`S&N 1020
`
`S&N 1020
`
`

`

`(3
`
`Richards
`.
`Intracondylar Knee
`
`Technique as described by Charles 0. Bechtel, M.D., Los Angeles, California
`
`©Richard's‘ Manufacturing C0,. inc. 1979
`
`RICHARDS
`
`
`
`
`
`

`

`_
`if)
`"
`4
`
`1, After routine skin preparation, the ieg is draped in the usual manner. If a
`tourniquet is used, the leg is exsanguinated with a Tourniwrap"rl ,' with the
`knee in 60° to 90° flexion, the tourniquet is
`inflated. A median para-patellar
`incision is
`recommended.
`
`
`
`O
`
`2. After dissection and joint debridement,
`the knee is flexed to 90°. All osteophytes on
`the tibia,
`femur and patella should be re-
`moved. The medial and lateral collateral
`liga-
`ments should be divided at their origin from
`the femur. The cruciate ligaments should be
`divided. This allows improved exposure of
`both tibial and femoral surfaces. The capsule
`must be freed lateraily and posteriorly to
`
`allow good mobility of both femur and tibia.
`
`
`
`
`
`

`

`3. A 5/16” diameter hole is drilled directly up into the femoral shaft
`through the central patellar facet of the femur.
`
`
`
`
`
`Femoral Cutting Template
`
`
`
`
`
`
`
`4. The Femoral Cutting Guide is
`
`completely into the hole with the V-shaped
`portion of the guide positioned anteriorly on
`the femur.
`
`inserted
`
`\-
`
`(/
`
`

`

`" 5. The Femoral Cutting Guide has cutting slots to guide a power saw or
`thin—bladed osteotome. The slots are spaced apart the same width as the
`femoral component.
`
`the
`cuts have been made,
`6. Once the initial
`Femoral Cutting Guide is removed and the cuts are
`completed. The saw blade should be kept cool with
`saline.
`-
`
`is necessary to remove the posterior
`It
`7.
`cortex layer of the femoral condyles the same
`
`
`
`
`width as the guiding cuts.
`
`

`

`8. The guide is reinserted and the V-shaped
`portion of the guide is designed to guide the
`power saw to prepare the anterior femur to
`accept the patellar groove.
`
`
`
`
`
`9. Any osteophytes are removed and the
`femoral condyles are trimmed to fit the Fem—
`oral Trial Component.
`
`
`
`
`
`

`

`10. After the preparatory work and broaching of the
`femur
`is complete,
`the appropriate Femoral Trial
`Component (leftr right or neutral} is inserted.
`
`
`
`
`length X-ray of the femur is necessary to
`A full
`
`determinaif the femur has an abnormal bow or
`
`maybe deformed due to previous injury.
`
`
`
`Femoral Trial
`
`11. The Femoral Trial Component
`should seat firmly in the prepared site
`and the femoral
`trial flanges should
`seat on the trimmed femoral condyles.
`If the trial component does not seat
`correctly, additional shaping of bone
`must be done until the trial prosthesis
`fits properly.
`
`JFK.
`
`g
`
`first be
`12. The femoral component must
`fully seated in
`the femoral
`canal. The
`Trephine Guide is
`inserted into the trial
`femoral prosthesis.
`It must be fully engaged.
`The trephine hole is made only into the
`medial femoral condyle.
`
`
`
`
`
`

`

`13. Using the Trephine Guide, the hole for the supporting axle is then
`bored, utilizing the Trephine Cutting Head. The circle savv should be inserted
`until it stops. The bone removed by the saw is not suitable fora bone graft
`later.
`
`
`
`Trephine Cutting Head
`
`
`
`
`
`
`
`
`
`
`
`14. With the knee flexed 90°and the patella retracted
`laterally,
`the tibia will externally rotate from the
`plane of the femur. To prevent misalignment of the
`trial and final components, the tibial tubercle may be
`marked with methylene blue as a guide.
`
`15. The Spacer Template indicates both the thickness
`of bone to be remOved from the tibial plateaus and
`the outline of bone to be removed for the stem of the
`Tibial Component.
`
`
`
`
`Spacer Template
`
`
`
`
`
`

`

`to the
`16. The head of the tibia should be resected an amount equal
`thickness of the Spacer Template.
`If one tibial plateau is destroyed below
`the thickness of
`the template,
`the defect
`should be filled with bone and/or cement.
`
`-
`”,1;
`l(( \)
`
`
`
`
`
`
`
`.
`(
`3‘»: "
`
`17. The proximal tibia is prepared by inscrib-
`ing a methylene blue line around the inner
`portion of the tibial Spacer Template, with the template aligned properly
`with the tibial tubercle to allow for rotation of the tibia.
`
`

`

`18. After drilling an appropriate size hole
`into the tibia and curetting away an appro~
`priate amount of spongy bone from the
`medullary canal, a Trial Tibial Prosthesis is
`inserted. The plastic hyperextension stop
`should face forward.
`
`
`
`
`
`Tibial Trial
`
`
`
`
`
`
`19. The Tibia Alignment Guide is then in-
`serted over the Tibial Trial with the metal
`
`shaft aligned with the tibial tubercle for cor
`rect rotary alignment.
`
`
`
`
`
`
`
`
`

`

`I
`_
`lilo
`”
`
`“
`:(
`
`.
`g
`
`trial
`20. With the knee flexed beyond 90°, both the femoral and tibial
`components are inserted. The joint is reduced and the black trial axis pin is
`inserted. A trial reduction and necessary adjustments
`should be made at this time. Complete extension and
`flexion to at
`least 90° should be possible. Correct
`alignment of 7° (average) valgus should be present.
`The trephine hole should be inspected to be sure that
`it
`is free of bone chips and its alignment with the axle
`hole is still correct.
`
`Before cementing in the compo—
`IMPORTANT:
`nents, the tourniquet should be released; all bleeders
`can then be visualized and controlled. The leg is again
`exsanguinated with a Tourniwrapt'“ and the tourni-
`quet reinflated.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Trial Axis Instrument
`
`
`
`21. One unit of cement is prepared for the
`tibial componentand is
`inserted with the
`Jet-Vac“ Cement Dispenser. The tibial com—
`ponent is then inserted, with the polyethylene
`bumper again facing anteriorly,
`
`22. The Tibia Alignment Guide is again in-
`serted over
`the tibia. The metal
`shaft
`is
`aligned with the tibial tubercle and alignment
`of the component
`is checked before the ca)
`ment is set, and adjusted if necessary.
`
`
`
`
`
`
`

`

`is
`the Femoral Component
`implantation of
`23.
`next.
`1
`to 2 units of cement should be used. The
`
`surgeon removes cement from the hole bored in
`the medial condyle while the cement
`is still soft.
`Any cement entering the notch of the femoral
`component should be carefully curetted away with
`a plastic Sculp’crn
`instrument. Then the Cement
`Restrictor Retriever instrument is used to retrieve
`the poly plug on the medial Femoral Component.
`Failure to thoroughly immobilize the femur and
`tibia (Step 2} will make Step 23 difficult.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`24. The retriever is inserted in the bored hole
`and the restrictor membrane is punctured.
`The instrument
`is
`then twisted 90° and is
`pulled out of the bored hole. The poly plug in
`the lateral side should not be removed.
`
`Cement Restrictor Retriever
`
`
`
`
`
`Trial Axis Instrument
`
`25. The prosthesis is reduced, and the Black
`Delrin® Trial Axis
`instrument
`is
`inserted
`through the bored hole. The tibial and fem“
`oral components are then aligned. Motion and
`alignment are again checked. Any excess ce—
`ment should be carefully chipped away.
`
`'IO
`
`® Delrin ls a registered tradEmark ml the duPont Company
`
`
`
`
`

`

`
`
`26. After aligning the components, the Trial
`Axis
`instrument
`is
`removed and the final
`metal axle {Trunion Pin)
`is placed using the
`threaded Axis Pin Positioner.
`
`Trunion Pin
`
` Alignment Indicator Mark
`
`
`
`Axis Pin Positioner
`
`
`
`27. The recessed hole of the axis is
`
`then
`
`aligned with the tapped hole of the Tibial
`Component. The metal set screw is inserted
`and the polyethylene lock screw is placed
`securely. The trephine hole in
`the medial
`femoral condyle is packed full of cancellous
`bone. Bone from the top of
`the tibia is
`suitable. ExpOSed raw bone areas should be
`covered with a thin layer of bone wax to
`prevent new bone formation.
`
`
`
`m"
`
`‘
`
`'I1
`
`

`

`Patellar Preparation
`
`implantation of the patellar
`The patella is then prepared for
`component,
`it the surgeon deems patellar replacement necessary.
`With the leg in full extension and the patella retracted laterally,
`the border of the patella is cleared of soft tissue and all osteo—
`phytes are removed. A heavy dark suture is placed in the substance
`of the tendon at either end of the patellar crest. The sutures will
`identify the original position of the patellar crest after it has been
`osteotomized. This procedure is crucial to correct orientation of
`the plastic Patellar Component.
`
`
`
`Jig is aligned over the crest and two 1/ ”
`The Patellar Drill
`diameter drill holes are started through the guide holes in the jig.
`The jig is then removed and the holes are deepened until they
`reach the outer cortex of
`the patella. The drill should not
`penetrate the cortex. The holes are enlarged by rocking the drill
`slightly from side to side. Final deepening should be done with the
`small lVlcEIroy Curette, as this will not penetrate the cortex.
`
`border of the patella.
`
`A black plastic Trial Patellar Component of the size closest to the
`natural patella is selected. The level of the patellar osteotomy
`should correspond to the thickness of the trial component. The
`correct
`level
`is marked with methylene blue around the entire
`
`The osteotomy is then carried out in a single straight cut with a
`reciprocating saw or an osteotome. The portion of bone removed
`is compared to the trial component to be sure enough bone has
`been removed.
`I
`
`in place on the remaining patella and the cut
`is put
`The trial
`surface is checked to see that it
`is even to insure that the crest
`aligns with the sutures identifying the line of the natural crest.
`
`The fixation pegs on the Trial Patellar Component should fit
`loosely into the fixation holes to allow for minor adjustment of
`the Final Patellar Component while the cement is soft.
`
`
`
`12
`
`

`

`
`
`The flat underside of the Trial should fit flush against the cut
`surface of
`the bone. Any necessary adjustments to the bone
`should be made at this time.*
`
`When bony preparation has been completed, the Tibial Patellar
`Component
`is
`inserted and the patella is
`reduced with the
`implanted femoral and tibial components. The knee is carried
`through a full range of flexioneextension. The patellar component
`should glide smoothly through the complete range of
`joint
`motion.
`in valgus knees,
`the patella is
`frequently displaced
`laterally and there is an associated contracture of the lateral
`patellar retinaculum. A release of the retinaculum should be done.
`A vastus lateralis release may occasionally be necessary.
`
`thickness to allow the Trial
`*Some very small patellas will not be of sufficient
`Component
`to lie flush against
`the bone. This can be compensated for before
`implantation of the Final Patellar Component by removing the last segment of each
`fixation peg with a rongeur.
`If this step is necessary, the final
`implant should be \
`prepared and used as atrial for the finai testing and preparation stage.
`
`.
`
`-
`
`,
`7
`‘ OK
`"
`'
`
`The surgeon should attempt to visualize the patellar component
`during flexionrextension to insure that the component is tracking
`in the center of the femoral groove throughout its travel. Minor
`tracking adjustments may be made by enlarging the drill holes in
`the patella.
`-
`
`When a satisfactory trial reduction and testing has been achieved,
`the cement
`is pressed on the prepared surface of the patella,
`completely filling all holes.
`
`firmly until the cement sets.
`
`The plastic Patellar Component is pushed firmly in
`position of the patella. Excess cement is cleared from
`around the edges of the implant. The patella is
`reduced (While the cement is still soft) and the knee is
`carried through 60° of
`tlexioneextension with the
`surgeon exerting firm pressure on the top of the
`patella. This aids final seating of the component. With
`the surgeon still maintaining pressure on the patella,
`the knee is then brought into full extension and held
`
`Range of motion is again tested, both with the patella dislocated and reduced.
`Sometimes motion will be found to be greater with the patella dislocated. The limited
`motion with the patella reduced to the proper position is caused by a contracture of
`the quadriceps muscle. The decision to correct the contracture will depend upon its
`severity. It may be done at this time or as a secondary procedure.
`
`A thorough inspection of the entire joint is made (with X-ray assistance if necessary) to
`identify and remove any loose cement or bone debris. Any ectopic bone, bony spurs,
`or excess cement around the periphery of the implant components should be removed.
`
`Closure is then accomplished with interrupted sutures in the capsule. After each 2 or 3
`sutures are put in place, the knee should be flexed to 90°to insure that the sutures are
`properly in position and will not pull out. Wound suction tubes are then put in place
`and the closure of the wound completed. A pressure dressing is applied.
`
`13
`
`

`

`Post Operative Care
`The patient is maintained in bed for three to five days, being allowed to turn freely as
`pain allows. The compression bandage is then removed and a small, sterile bandage
`applied. Mobilization of the knee should then be initiated by the physical therapist. It
`is imperative that full extension and 90° or more of flexion be obtained during the
`following seven days,
`if at all possible.
`In patients sensitive to pain.
`it is advisable to
`give them hypodermic medication (such as Demerol®), and follow this by passive
`motion of the knee when medication becomes effective, one-half to two hours later.
`Manipulation of the knee under general anesthesia is usually of little value.
`If
`it
`is
`necessary, it should be done with great caution.
`Ambulation with crutches can be started from the fifth to the seventh day.
`Weight-bearing on the affected leg should be limited to about 10 percent of body
`weight. When progress is satisfactory, the patient may be given bathroom privileges.
`Training on the stairs with the aid of crutches and a railing should be started when
`coordination is satisfactory. The patient can usually be discharged from the hospital
`ten to fourteen days postoperative. Weight-bearing should be restricted to 10 percent
`for at
`least six weeks from date of surgery. At that time, X—rays are obtained and if
`satisfactory healing has occurred, increased weight—bearing may be started. If healing is
`unsatisfactory, a further period of 10 percent weight—bearing should follow (rheuma—
`toid arthritis or severe osteoporosis should require at
`least 12 weeks of
`limited
`weight~bearing). When the patent is dismissed from the hospital, a program of passive
`and active stretching should be started. MuScle conditioning exercises should be
`delayed until the patient has progressed to full weightnbearing.
`
`14
`
`.,,...............I: n‘ wimhmn l ahnrmnries. a division of Sterling Drug C0,, lmz.
`
`

`

`IMPLANTS
`
`Richards Intracondylar Knee, Neutral
`12-9700
`
`Richards Intracondylar Knee, Left
`1 2—9701
`
`Richards Intracondvlar Knee, Right
`12-9702
`
`Patella Component, Large
`1 2—0750
`
`Patella Component, Medium
`120751
`
`Patella Component, Small
`1 2-0752
`
`TRIALS 2
`(l
`i
`I
`
`.f
`1!]
`
`Femoral Trial, Neutral
`11—3000
`
`Femoral Trial, Left
`1 1-3001
`
`Femoral Trial, Right
`1 1-3002
`
`Tibial Trial
`11:3010
`
`
`
`F:
`,._
`
`'-
`.
`
`
`
`
`
`
`
`Patella Trial, Large
`1 1-1875
`
`Patella Trial, Medium
`1 1-1876
`
`Patella Trial, Small
`1 1~1 877
`
`
`
`
`
`
`
`

`

`
`
` Cement Restrictor Retriever
`1
`
`1 1-3009
`
`J3
`Trephine Guide Assembly
`1 1-3003
`
`
`
`Trephine Cutting Head
`1 1—3004
`
`
`
`1
`?
`'1
`1
`Tibial Alignment Guide
`1 143005
`
`Spacer Template
`11-3006
`
`
`Trial AXis Instrument
`1 1301 1
`
`
`
`Axis Pin Positioner
`11-0260
`
`
`
`Screwdriver
`1 10264
`
`V
`
`‘
`
`-
`
`.1
`
`
`
`\“r
`
`1"
`
`
`i
`-
`g
`Patella Drill Jig
`1 1—1892
`
`
`
`Femoral Cutting Template
`1 1-3007
`
`16
`
`5/16" Stainless Steel Twist Drill
`21:0454
`
`

`

`IMPORTANT MEDICAL INFORMATION
`WARNINGS AND PRECAUTIONS
`RICHARDS INTRACONDYLAR KNEE
`
`311114152
`
`-.__/
`
`IMPORTANT NOTE
`
`The total knee implant operation is a remarkably
`successful procedure. Its success, however. probably
`cannot reaCh 10!) percent, and even in an uncomplia
`cated case,
`there is some risk. The patient and
`physician must realize that any of the circumstances
`listed under
`the relevant categories, below, may
`reduce the chance of a successful outcome and an
`increased percentage of risk must be accepted.
`The goals of the total knee replacement are to
`decrease pain,
`increase function and increase mobila
`ity. To accomplish these goals, patients should be
`aslected:
`l1l who have and will maintain adequate
`bone Support,l21 who are able and willing to follow
`their physician's directions generally, and particu-
`larly with respect to no or minimal weight-bearing in
`postoperative care. Provide substantial and even
`cement support for the prosthesis and have support
`for
`the cement. Patients should be precautioned
`against heavy labor, active sports or any activity
`which places heavy or abrupt
`loads on implanted
`prostheses.
`DESCRIPTION OF PHOSTHESIS
`The Richards lntracondylar Total Knee Prosthesis is
`a hinge-style total knEe replacemEnt for those cases
`which present uncorrectablc ligamentous instabiiity
`or other surgical considerations preventing the use of
`a more
`conservative
`prosthesis. The prosthesis
`provides a posteriorly placed axis and a femoral
`patellar facet. While providing substantial strength,
`the stEm design permits minimal removal of cortical
`bone for hingestyle lowafriction arthroplasty. Avail-u
`ablerin left and right styles with an anatomical 7
`angulation of the femoral component, as well as a
`neutral style.
`INDICATIONS, CONTRAINDICATIONS AND
`ADVERSE EFFECTS
`GENERAL: The general principles of patient selec-
`tion and sound surgical judgment apply to the total
`knee procedure. Additional Indications and Contra
`indications are:
`INDICATIONS
`Patients with the following conditions that in addi-
`tion, have severe ligamentous instability or condi
`tions not permitting satisfactory use of non—hinged
`knee replacement:
`1. Patient conditions of rheumatoid arthritis, osteo-
`arthritis, post traumatic arthritis and secondary
`arthritis including, but not limited to:
`acromegly
`ankylosing spondylitis
`avascular necrosis
`cancer
`Gaucher’s disease
`gout
`Paget’s disease
`systemic lupus erythematows;
`2. Old,
`remote osteomyeiitis with an extended
`drainage-free period;
`in which case, the patient
`should be warned of an above normal danger of
`infection;
`3. Unsuccessful
`osteotomies,
`hemiarti‘lroplasties,
`and conservative therapy.
`4. Unsuccessful arthrodesis, or arthrodesis in poor
`position or with disabling pain.
`Most of the diagnoses listed above and below may
`also increase the chance of complications and reduce
`the chance of a satisfactory result.
`CONTRAINDICATIONS
`1. Patient conditions correctable by use of a non-
`hinged knee prosthesis.
`2. Patient physical condition that would eliminate
`or tend to eliminate adequate implant andlor
`
`cement support, e.g.-
`(1) blood supply limita—
`tions from previous surgery, alcohol agglutina-
`tion, Etc.,
`l2l
`insufficient quantity or quality of
`bone resulting from conditions such as: cancer.
`obesity, osteoporosis, etc.. (3) infections or other
`conditions which lead to reduced fixation.
`3. Patient mental or neurological conditions which
`tend to pre-ampt the patiEnt's ability or willing-
`ness to restrict activities, cepecially during the
`healing period, 9.9.:
`alcohol abuse
`Charcot's disease
`drug use
`mentai illness
`-
`senility
`4. Patient conditions or predispositions which tend
`to place extreme loads on implants, 62.9.:
`active sports
`claudication
`heavy labor
`deficiencies of muscles or ligaments
`history of falls
`neurological deficiencies
`obesity
`disablement of other ioints, e.g.;
`ankles (especially ipsilateral)
`
`hips and
`
`corrected by other
`not
`contractures
`5. Severe
`procedures.
`Contraindications may be relative or absolute and
`must be carefully weighed against the patient’s entire
`evaluation.
`
`POSSIBLE ADVERSE EFFECTS
`fracture of
`1. Loosening,
`bending,
`cracking. or
`femoral or tibial components, usually attribut-
`able to one or more factors included in Contra-
`indications, above, and/or Warnings and Pie
`cautions, below.
`2. Flotation phenomenon, flexion contracture, de-
`creased range of motion, or lengthening or short-
`ening of the leg, caused by improper positioning.
`loneliness of components or extraneous bone or
`cement.
`3. Fractures of the tibia or femur: Postoperative
`fractures are usually stress fractures. Fractures
`are usually evidence of defects in the cortex due
`to prior screw holes, misdirected reaming, andlor
`inaderquacy or maldistribution of cement. Intra-
`operative fractures are usually associated with
`revision
`surgery
`deformity
`andfor
`severe
`osteoporosis.
`Infection, both acute post-op wound infection
`and late deeo wound sepis. Also,
`low—grade
`synovitis.
`5. Neuropathies: especially common peroneal nerve
`with valgus deformity.
`6. Cardiovascular
`disorders: Wound
`hematoma,
`thromboembolic disease, including venous throm-
`bosis and pulmonary embolus.
`7. Tissue reactions: Macrophage and foreign body
`reaction adjacent
`to implants.
`resulting from
`foreign material
`in tissues. Also, myositis ossifi-
`cans, especially in males with hypotropic arthri-
`tis, limited pre-operativa range of motion andfor
`previous myositis. Myositis ossificans is increased
`with prior surgery or presence of infection.
`
`4.
`
`WARNINGS AND PRECAUTIONS
`fracture of
`Loosening, bending,
`cracking, andfor
`implants and other complications may result from
`failure
`to observe
`the following warnings and
`precautions.
`
`PREvDPEFIATIVE
`1. Use extreme care in 'handling and storage of
`implant components, particularly metal compo-
`nents. Cutting, bending or scratching the surface
`of components tends to reduce the strength,
`fatigue resistance andfor wear characteristics of
`the implant system. These,
`in turn, may cause
`cracks andr'or
`internal
`stresses
`that
`are not
`obvious to the eye and may lead to fracture of
`the component. Special protection for implants
`and instruments during storage is reCOmmended
`when axpoged to corrosive environments such as
`salt air, Etc.
`2. Extra implant components are recommended,
`espeCialiy if ETO restarilization is required. All
`packages and implants should be thoroughly in-
`spected prior to surgery for possible damage. Do
`not steam or dry heat sterilize plastic implants as
`temperature involved may cause deformation of
`the material. (See Sterilization saction, below.)
`3. Patient conditions and/or predispositions such as
`addressed in Contraindications, above, should be
`avoided.
`4. Allergies and other reactions to device materials,
`although infrequent, should be considered, tested
`(if appropriate) and ruled out prc—operatively.
`5. Certain special surgical
`instruments are required
`to perform this surgery. Review of the use and
`handling of these instruments is very important.
`6. Richards Surgical Technique brochure available
`upon request at no charge, should be reviewed
`prior to initial surgery.
`
`INTRAAOPERATIVE
`1. The correct saleCtion of the implant is Extremely
`important. The appropriate type must be custom
`fitted to the patient. Inadequate Cement support,
`or improper positioning may result in loosening,
`bending, Cracking. or fracture of the component.
`cement andlor bone.
`2. Adequate and continuous support of components
`(particularly tibial} by both cement and bone, are
`of utmost importance. Layering of cement and
`inclusion of air or blood should be avoided. Use
`of a cement Injector tends to aid in introduction
`of
`a continuous bolus of cement,
`free of env
`trapped air, blood or layers.
`3. Wi‘lEn preparing beds and positioning the tibial
`component, check for proper tibial alignment
`and note that
`the tibia may be diaplaoed or
`externally rotated by the
`retraction of
`the
`patella.
`
`4. Revision procedures for previous arthroplasty,
`etc., are technically demanding and difficult
`to
`exercise. Common errors include misplacement
`of the incision, inadequate exposure or mobilizes
`(ion,
`inadequate removal of ectopic bone,
`im-
`proper positioning of components or inadequate
`cement support. Increased operative time, blood
`loss,
`increased incidence of pulmonary embolus
`and wound hematoma can be expected with
`revision procedures.
`5. With rheumatoid arthritis, especially for those
`patients on steroids, bone may be extremely
`osteoporotic.
`6. Care should be taken not to scratch, bend, or cut
`motal components during surgery for the reasons
`stated in Number One of the pre-operative sec-
`tion of Warnings and Precautions. Once removed
`from the patient,
`implants previously implanted
`should never be reused, since internal stresses
`which are not visible may lead to early bending
`or fracturE.
`7. During curing of cement, care should be takEn to
`prevent moving implant components. A tight fit
`of
`implant
`to cement and cement
`to bone is
`essential
`to prevent motion which may lead to
`bone resorption andlor cement cracking.
`8. Prior
`to closurE,
`the surgical
`site should be
`thoroughly cleaned of bone chips, extraneous
`cement, ectopic bone, Etc. Foreign particles at
`the metal-plastic interface may cause excessive
`wear and/or friCtion. Ectopic bone andfor bone
`spurs may lead to painful or restricted motion.
`Range of motion should be thoroughly checked
`for restricted motion.
`POSTOFERATIVE
`1. Postoperative directions and warnings to patients
`by physicians, and patient care are extremely
`important. Nonweigi‘It-bearir'igI after
`surgery is
`recommended to allow healing of bone to
`provide proper bone and cement support. Evi-
`deuce suggests healing may require six weeks' or
`longer, and a period shorter than this increases
`the possibility of loosening, bending, cracking,
`and/'or fr Cture of implants.
`2. Patients
`should be precautioned against
`un-
`assisted activity, particularly use of toilet facil-
`ities,
`kneeling,
`and other activities
`requiring
`walking.
`3. Use extreme care in patient handling. Support
`should be provided to the operative leg when
`moving the patient. While placing the patient an
`bedpans, changing dressings, clothing. and similar
`activities, precautions should be taken to avoid
`placing any load on the aparative part of
`the
`body.
`4. Postoperative therapy should be structured to
`prevent loading of the operative knee.
`5. Periodic x-rays are recommended for close com-
`parison with post-op conditions to detect
`long
`term evidence of changes in the bone, the ce-
`ment, or changes in the position or loosening.
`bending, or cracking of components. With evi-
`dence of
`these conditions, patients shouid be
`closely observed,
`the possibilities of
`further
`deterioration Evaluated, and the benefits of re-
`ducing activities and/or early revision considered.
`UTILIZATION AND TMFLANTATION
`1. With both knee and hip disease, generally operate
`on hips prior to knees and on the more diseased
`side of each pair of joints first in order to make
`rehabilitation more effective.
`2. Bone scanning may help identify postoperative
`problems such as infection,
`loosening, or ectopic
`bone formation; however, most postoperative
`complications can be identified on periodic roua
`tine radiographs.
`
`PACKAGING AND LABELlNG
`Richards implants and sterilized products should be
`accepted only if received by the hospital or surgeon
`with the factory packaging and labeling intact.
`STERlLiZATlON
`The Richards Intracondylar Knee is supplied assem»
`bled in a non—sterile condition. The implant should
`be
`completely
`disassembled
`and
`sterilized
`by
`ethylene oxide gas using techniques recommended
`by the sterilizer manufacturer. Do not steam or dry
`heat
`sterilize plastic components. Recommended
`aeration time is 48 hours at room temperature or 8
`hours at (SO-degrees C. to 32 hours at Elli-degrees C.
`with power aeration. Consult recommendations of
`aerator manufacturer.
`
`INFORMATION
`Where further information is desired, please contact
`the Manager, Customer Service Division, Richards
`Manufacturing Company,
`Inc., 1450 Brooks Road,
`Memphis,Tennessee 38116.
`
`17
`
`

`

`337R
`
`® R
`
`ICHARDS MANUFACTURING COMPANY, INC.
`1450 BROOKS RD., MEMPHIS, TENN. 38116 - 396—2121
`CALL TOLL FREE: 800-238—7533 (IN TN. 800-582v6282]
`IN CANADA. RICHARDS SURGICAL LrM‘TED, 7524 BATH ROAD. MALToN, ONTARIO. L4T 1L2. (415) 57’7'9744
`
`