1 T HE S MITH &N EPHEW T IBIAL I NTERLOCKING N AILS by Thomas A. Russell, M.D., John Charles Taylor, M.D., and David G. LaVelle, M.D. Memphis, Tennessee TABLE OF C O N T E N T S Introduction ................................................................. 2 Design Features – Standard Tibial Nail ...................... 4 Design Features – DELTA ® Tibial Nail ........................ 5 Surgical Technique ...................................................... 6 Catalog Information .................................................... 19 Nota Bene: The technique description herein is made available to the healthcare professional to illustrate the authors’ suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the specific patient. WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Transcript
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THE SMITH & NEPHEWTIBIAL INTERLOCKING NAILS
by
Thomas A. Russell, M.D.,John Charles Taylor, M.D.,and David G. LaVelle, M.D.
Memphis, Tennessee
T A B L E O F C O N T E N T S
Introduction................................................................. 2Design Features – Standard Tibial Nail...................... 4Design Features – DELTA® Tibial Nail ........................ 5Surgical Technique...................................................... 6Catalog Information.................................................... 19
Nota Bene: The technique description herein is madeavailable to the healthcare professional to illustrate theauthors’ suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment isthat which addresses the needs of the specific patient.
WARNING: This device is not approved for screw attachment or fixation tothe posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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esigned by Drs. Toney Russelland Charlie Taylor fromMemphis, Tennessee, the Smith
& Nephew Interlocking Nail System hasgrown to include nails for various femurfractures (including subtrochanteric,intertrochanteric, supracondylar, andipsilateral neck/shaft), tibial fractures,and humeral fractures. These nails areclosed section, cannulated, ASTM F-138stainless steel, and allow interlockingscrews to be placed above and below thefracture site to prevent shortening and tomaintain rotational control. Thestandard locking screws are fullythreaded to ensure optimum bonepurchase and to prevent backing out.
The Interlocking Nail System wasdesigned with two overall goals for thehealing of long bone fractures. The firstwas to improve the clinical success ofpreviously available interlocking nails byreducing complications. The secondoverall goal was to extend the indica-tions of interlocking intramedullarynailing to more complex fractures of thefemur (including ipsilateral neck/shaft,subtrochanteric, and pathologic frac-tures), as well as complex fractures ofthe tibia and humerus.
The primary feature of the interlockingnail is the “non-slotted” or closed sec-tion design. This is different from thefirst widely accepted design for an IMnail which contained a longitudinal slotbeginning at the distal end and proceed-ing proximally either the full length ofthe nail or to within a few centimeters ofthe proximal end.
The closed section design of the inter-locking nail overcomes the biomechani-cal shortcomings of a slotted nail and,therefore, inherently answers some of theoverall design goals. The elimination ofthe slot reduces complications by:
1 . Decreasing torsional shear postopera-tively in the healing bone,
2 . Increasing the amount of materialaround the screw holes,
3 . Reducing torsional rotation duringinsertion of the nail, and
4 . Easing distal targeting.
Another equally important area in thedesign of the interlocking nail concernedthe bending strength. This was especiallycritical in light of the second overalldesign goal of the system: to extend theindications of intramedullary nailing. Itwas felt that smaller nails could be veryuseful in the treatment of open fracturesand in treating small boned patients.H o w e v e r, before this could become ar e a l i t y, “unreamed” interlocking nailswould have to be stronger than their his-torical counterparts which were reportedto have higher breakage rates in nails ofless than 13 mm in diameter.1 , 2 , 3
The practical manifestation of the atten-tion to strength requirements can beseen in the Interlocking DELTA® n a i l sand the DELTA II nails. These nails haveincreased wall thickness in small diame-ters in order to maintain strength whileavoiding the clinical problems of anoverly stiff nail. Clinically these smallerdiameter interlocking nails have beenvery effective in the treatment of open
D
I N T R O D U C T I O N
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fractures where they could be usedwithout reaming. They have also beenused as the nail of choice in patientswith small canals that could not haveeasily withstood the excessive amount ofreaming necessary to insert a standarddiameter intramedullary nail.
REFERENCES1Kyle, R.F.; and Latta, L.L.: Mechanics of FemoralIntramedullary Nailing, AAOS Committee ofBiomechanical Engineering, Las Vegas, 1985.
2Franklin, J.L.; Winquist, R.A.; Benirschke, S.K.;and Hansen, S.T., Jr.: Broken IntramedullaryNails. Journal of Bone and Joint Surgery, 70-A:1463-1471, 1988.
3Bucholz, R.W.: Dilemmas and Controversies inIntramedullary Nailing in The Science andPractice of Intramedullary Nailing, Ed. byB r o w n e r, Bruce D. and Edwards, Charles C., Leaand Febiger, 1987, Philadelphia, pg. 85-89.
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D E S I G N F E A T U R E S – R - T T I B I A L N A I L
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THE RUSSELL-TAYLOR® (R-T)TIBIAL NAIL
The Interlocking Tibial Nails are avail-able in diameters of 11, 12, 13, and14 mm. The nails contain a 15˚ anteriorbend at a point 45 mm from the top ofthe nail. This allows the nail to enter theanterior proximal portion of the tibia.There is a 3˚ anterior bend in the distal64 mm of the nail that serves as a“ramp” for the nail during insertion,thereby reducing the chance for poste-rior cortical comminution. Proximallyand distally, the Tibial Nail uses 5.0 mmfully threaded, self-tapping bone screws.These allow for bi-cortical fixation inorder to reduce the possibility of thescrews backing out.
Stable fractures of the isthmus (trans-verse and short oblique uncomminutedfractures) may be treated without lock-ing screws. Fractures proximal to theisthmus require two proximal lockingscrews whereas more distal fracturesshould be locked with two distal screws.All unstable fractures should be lockedwith two screws distally and proximally,thereby maintaining length and pre-venting rotation. The Tibial Nail has aunique Proximal Drill Guide that allowsfor accurate nail insertion and place-ment of the proximal screws. Designedto address the widening spectrum ofindications for nailing fractures of thetibia, the Tibial Nail allows for theintramedullary fixation of tibial shaftfractures including those that are seg-mental or severely comminuted. If thecanal is large enough, the Tibial Nail,11-14 mm diameter, may be insertedwithout reaming.
Positive lock keywayprovides secureinstrument fit foraccurate proximaltargeting.
Closed-section design fortorsional stability.
11, 12, 13, and14 mm diametersare available.
Transfixing holes allowproximal and distalinterlocking with 5.0 mmfully-threaded screws.
Cold work expansionof distal screw holesfor increased strength.
Available in lengths of28.5 cm to 38 cm.(Upon request, certainlonger lengths areavailable.)
The DELTA Design has increased wallthickness to maintain the strengthintegrity in the smaller diameter nail forthe treatment of open fractures andpatients with small medullary canals.
R-T STANDARD R-T DELTA
15O proximal bend.
3O distal bend.
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THE R-T DELTA TIBIAL NAIL
The Interlocking DELTA Tibial Nails are avail-able in shaft diameters of 8, 9, and 10 mm.The proximal end of these nails is tapered to12 mm to give the extra strength necessary fornail insertion and proximal interlocking. Thenails contain a 15˚ anterior bend at a point45 mm from the top of the nail. This allowsthe nail to enter the anterior proximal portionof the tibia. There is a 3˚ anterior bend in thedistal 64 mm of the nail that serves as a“ramp” for the nail during insertion, therebyreducing the chance for posterior corticalcomminution. Proximally and distally, theDELTA Tibial Nail uses 4.5 mm fully threaded,self-tapping bone screws. These allow for bicortical fixation in order to reduce the possi-bility of the screws backing out. Indicationsfor the DELTA Tibial Nail are the same asthose listed for the Standard Tibial Nail.
The DELTA Tibial Nails may be insertedreamed or unreamed. The unique combin a-tion of strength and smaller size offered inthis implant gives particular advantages inthe treatment of open fractures, patients withsmall medullary canals, and congenitalproblems. If the canal is large enough, aD E LTA Tibial Nail, 8-10 mm diameter, maybe inserted without reaming.
NOTE: Due to the smaller diameter and con-sequent reduction in strength of the 8 mmD E LTA Tibial Nails, these implants areintended to be nonweight bearing devices.Auxiliary support with a PTB cast or orthosisis necessary. The patient must be cautionedagainst significant weight bearing prior togood callus formation. The implant may beexchanged for a larger, stronger nail subse-quent to the management of soft tissueinjuries. If a reamed technique is to be used,it is recommended that a 9 mm diameter orlarger nail be implanted.
8, 9, and 10 mmdiameters are available.
Closed-section design fortorsional stability.
Positive lock keywayprovides secure instru-ment fit for accurateproximal targeting.
Transfixing holes allowproximal and distalinterlocking with 4.5 mmfully-threaded screws.
Cold work expansionof distal screw holesfor increased strength.
Available in lengths of27 cm to 36 cm. (Uponrequest, certain longerlengths are available.)
3O distal bend.
15O proximal bend.
12 mm proximaldiameter.
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PREOPERATIVE PLANNING
Preoperative radiographs of the unin-jured tibia may be used to establishproper nail diameter, expected amountof reaming, and final nail length forseverely comminuted fractures. X-raytemplates for the R-T Tibial Nail and theR-T DELTA Tibial Nail are available forpreoperative planning. The nail lengthshould permit the proximal end to becountersunk with the distal end centeredin the distal epiphysis.
Distraction of the diaphyseal fracturemust be attained with traction before ini-tiating closed antegrade intramedullarynailing (except in acute cases).
Further impaction is occasionally seenwhen severely comminuted fractures arelater dynamized. This risk should beconsidered during selection of naillength to prevent later nail migrationinto the ankle or nail protrusion out ofthe proximal tibia.
The nail size used depends on the size ofthe patient and the extent of tibial com-minution. It should be noted, however,that a small but consistent percentage ofcomplications due to nail fatigue failureremain. Therefore, it is always recom-mended that the largest implant suitablefor the patient be used.
NOTE: Intramedullary nails are neitherintended to carry the full load of thepatient acutely, nor intended to carry asignificant portion of the load forextended periods of time. All patientsshould be cautioned against significantweight bearing prior to good callus for-mation. For this reason, patients who areobese and/or noncompliant, as well aspatients who could be predisposed todelayed or nonunions, must have auxil-iary support.
Fractures situated in the shaded area canbe treated with the R-T Tibial or the
D E LTA Tibial Interlocking Nail.
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PATIENT POSITIONING
Place the patient in a supine position onthe fracture table; a well padded barbeneath the distal thigh. The hip shouldbe flexed at approximately 70˚-90˚ andthe knee flexed at such an angle to allowa horizontal orientation of the tibia(C-arm manipulation is easier with ahorizontal tibia.) Rotational alignmentis achieved by aligning the iliac crest,patella, and second ray of the foot. Applytraction through either a calcaneal trac-tion pin or special foot holder (Figure 1) .For simple nailing, the surgeon maystand medial or lateral with the C-armopposite the surgeon. For interlocking, itis necessary to have access to medial andlateral aspects of the leg, with the C-armbrought in from the lateral.
PATIENT PREPARATION
Scrub and prepare the patient in thestandard manner. Drape the affectedlower extremity from the distal thigh tothe calcaneal traction pin. Cover theimage intensifier arm with a sterileisolation drape.
Figure 1
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21-6600
41-5330
11-2007
11-5057
SURGICAL APPROACH AND TIBIALPREPARATION
Make a 5 cm incision medial to the patellarligament. Using the Curved Awl, open themedullary canal proximal to the tibialt u b e r o s i t y, in the midline behind or slightlymedial to the patellar ligament (Figure 2) .An excessively distal placement of the entrysite may result in entering the tibia at toosteep an angle and either splitting the tibia,or breaking out through the posterior cor-tex. Ream the proximal fragment of thetibia to 12 mm diameter using the SkinProtector while reaming.
GUIDE ROD INSERTION ANDREDUCTION
To assist in fracture reduction or thereamed technique, three unique3.2 mm Guide Rods are available. Simplefractures will utilize the Straight GuideRod while more severely displacedfractures may require the use ofthe Curved Tip Guide Rod. Forobstructed intramedullary canals, the cut-ting edge of the Spade Tip Guide Rod maybe helpful in obtaining shaft reduction. Usethe 3.0 mm Guide Rod for the unreamedtechnique.
Introduce the selected Guide Rod by meansof the T-Handle Jacob’s Chuck to the levelof the fracture. Confirm its containmentwithin the tibia by means of A-P and lateralviews. Reduce the proximal fragment to the
distal fragment by means of theInternal Fracture Alignment Device.Advance the Guide Rod until it is cen-tered in the distal fragment 0.5–1.0 cm
proximal to the ankle joint (Figure 3).
Figure 2
Figure 3
11-0257
1 1 - 2 0 2 1
7 1 1 1 - 8 2 1 7
11-2059
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Remove the Internal FractureAlignment Device. Verify containmentof the Guide Rod within the tibia byimage intensification.
Using the flexible reamers over a GuideRod, ream the entire tibia in 0.5 mmincrements until the desired diameterhas been achieved (Figure 4) . The finalreamer diameter should be verified withthe Reamer Te m p l a t e .
The R-T Tibial Nails are 0.2 mm larger indiameter than their stated size and DELTATibial Nails are 0.1 mm larger in diameterthan their stated size. Therefore, select anail 1 mm to 1.5 mm smaller than the finalreamer used. Never insert a nail that has alarger diameter than the last reamer u s e d .
Introduce the Medullary Exchange Tu b eover the Reamer Guide Rod to maintainfracture reduction. Replace the ReamerGuide Rod with a 4 mm Nail Guide Rod.Remove the Medullary Exchange Tu b e .
NAIL SELECTION
For the unreamed technique, Inter-changeable Sounds can be used to deter-mine the diameter of the canal andproper nail size prior to insertion of thenail (Figure 5) . Sounds are mounted tothe T-Handle Shaft and inserted manu-ally over the 3.2 mm ball tip guide rodand NOT DRIVEN. If resistance isencountered, STOP, and withdraw theSound. The largest diameter Sound that
11-0257
11-2060
11-8180
Figure 5
Figure 4
Use a 3 mm Nail Guide Rod for theD E LTA Tibial Nail.
D E L T A
1 1 - 5 1 1 5
1 1 - 2 0 2 0
1 1 - 2 0 2 3
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can pass easily through the isthmus isthe correct diameter for the nail.Preoperative estimates of canal d i a m e t e rshould be obtained as a secondary esti-mate of the correct nail diameter. Neverinsert a nail that has a larger diameterthan the last Sound used.
Uncomminuted distal fractures mayrequire a smaller diameter nail orreaming as compared to comminutedisthmus fractures because of the longinterference fit within the canal.
Verification of the proper nail lengthmay be determined by two separatem e t h o d s .
— Nail Length Gauge
Position the Nail Length Gauge anterior
to the tibia (unaffected tibia preopera-
tively; affected tibia intraoperatively)
with its distal end centered in the distal
epiphysis. Move the C-arm to the proxi-
mal end of the tibia and read from the
image intensifier the correct nail length
directly from the stamped measurements
on the Nail Length Gauge (Figure 6) .
— Guide Rod Method
With the distal end of the Guide Rodcentered in the distal epiphysis, overlapa second Guide Rod to the portion of thereduction Guide Rod extending proxi-mally from the tibial entry portal.Subtract the length (XXX mm) of theoverlapped Guide Rods from 900 mm todetermine the nail length (Figure 7) .
1 1 - 2 0 5 8
Figure 6
Figure 7
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NAIL INSERTION
Attach the selected nail to the ProximalDrill Guide with the Hexagonal Bolt(Figure 8) . When assembled properly,the keyed post of the Proximal DrillGuide will be positioned on the medialside of the nail (Figure 9) . Next attachthe Supine Driver to the Hexagonal Boltof the guide. Tighten with an Open EndWrench. Using the handle to control nailrotation, insert the nail by tapping theSlotted Hammer on the Supine Driver(Figure 10) . It is very important toNEVER HIT directly on the Proximal DrillGuide; use the insertion instruments only.
1 1 - 2 0 2 5
1 1 - 0 5 6 4
Supine Driver
N a i l
Drill Sleeves
P r o x i m a lDrill Guide
Hexagonal Bolt
1 1 - 2 0 2 4Figure 8
Figure 10
Figure 9
1 1 - 5 1 7 5
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Figure 13
Figure 12
1 1 - 2 0 5 6
1 1 - 2 0 0 4
1 1 - 2 0 4 9
1 1 - 2 0 1 2
1 1 - 5 0 5 9
1 1 - 2 0 0 8
Withdraw the Guide Rod. (It is necessaryto remove the Guide Rod before finalseating to prevent incarceration.)Continue inserting the nail until theproximal tip of the nail is flush with thetibial entry portal (Figure 11) . Shouldextraction of the nail be necessary,attach the Extractor Tube to the SupineDriver and apply backward blows withthe Slotted Hammer. Be careful to avoidlevering the nail/tube assembly.
PROXIMAL INTERLOCKING R-TTIBIAL NAIL
Proximal and distal interlocking involvesthe use of 5.0 mm locking screws. There-fore, the 4.0 mm Tr o c a r, 4.0 mm Ti b i a lDrill, Green and Gold Drill Sleeves, andthe 5.0 mm Hexdriver Shaft are required.
Insert the 8 mm Green Drill Sleevethrough the superior hole in theProximal Drill Guide to determine theproper location of the incision. Removethe Green Drill Sleeve. Make a skin inci-sion on the medial side to bone. Insertthe 8 mm Green and 4 mm Gold DrillSleeves. Attach the 4 mm Trocar to theT-Handle Jacob’s Chuck. Insert the4 mm Trocar into the Gold Drill Sleeveand dimple the cortex (Figure 12) .Remove the Tr o c a r. Insert the 4 mmTibial Drill and drill through both cor-tices; make depth measurements usingthe 4 mm Tibial Drill calibrations andread the length against the top of theGold Drill Sleeve (Figure 13) . Withdrawthe Gold Drill Sleeve.
Figure 11
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The locking screw length may be con-firmed by using the Depth Gauge andreading the length against the top of theGreen Drill Sleeve (Figure 14) . TheDrill Sleeves must be against the cortexfor accurate reading. Connect the QuickConnect T-Handle to the 5.0 mmHexdriver Shaft. Insert the selected5.0 mm self-tapping screw through theGreen Drill Sleeve (Figure 15) . Repeatthe procedure for the second proximals c r e w.
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Figure 14
Figure 15
1 1 - 2 0 8 5
1 1 - 6 0 1 1
1 1 - 2 0 8 7
1 1 - 2 0 8 6
PROXIMAL INTERLOCKINGR-T DELTA TIBIAL NAIL
The procedure for proximal and distalinterlocking for the R-T DELTA Ti b i a lNail is identical to the R-T Tibial Nail.H o w e v e r, several product and instru-ment size substitutions are necessary:
4.5 mm locking screws versus 5.0 mm lockings c r e w s
3.5 mm Trocar versus the 4.0 mm Tr o c a r3.5 mm Tibial Drill versus the 4.0 mm Ti b i a l
D r i l l3.5 mm Black Drill Sleeve versus 4.0 mm Gold
Drill Sleeve4.0/4.5 mm Hexdriver Shaft versus 5.0 mm
Hexdriver Shaft
D E L T A
1 1 - 2 0 9 6
1 1 - 5 0 5 8
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Using a slotted hammer, drive the guidepin to the lateral side of the rod. Removethe T-handle chuck from the guide pinand obtain a lateral image of the femur.The guide pin should point directly tothe center of the hole within the rod. Ifthis is not the case, make adjustments asn e c e s s a r y. Once proper alignment hasbeen obtained, withdraw the guide pin;place the drill in the previously madehole, and drill through the rod andopposite cortex.
Determine the length of the screw usingthe Screw Depth Gauge. Place the screwin its proper position. Repeat the proce-dure on the distal screw hole. The lastimage should be that of a lateral, con-firming satisfactory placement of thes c r e w s .
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FREEHAND TECHNIQUE FORDISTAL TARGETING
The most frequently used technique fordistal targeting of screws is the freehandtechnique as described by Robert F. Hall,J r., M.D., Chairman, Division ofOrthopaedic Surgery, Cook CountyHospital, Chicago, Illinois.
Place the image intensifier in the lateralposition and scan the distal area. A truelateral image should be noted and thescrew holes should be circular. Other-wise, adjust leg rotation to obtain a truelateral image of the rod. When the holesare completely circular, center a ringforceps over the proximal hole on thelateral side of the leg. Then introduce a#10 blade within the confines of the ringforceps; make a longitudinal incisionalong the midline axis of the leg, carry-ing the incision down to bone. Repeatthe procedure on the distal screw hole.Connect the two incisions with anapproximately 3 cm long incision,which is carried down to the bone.
Place a 4.0 mm trocar attached to the T-handle chuck, angled at 45˚ over theproximal screw hole. Using the imagei n t e n s i f i e r, adjust the guide pin until thepoint is centered over the screw hole.Return the image intensifier to the ante-r i o r-posterior view and maintain con-stant pressure on the guide pin to pre-vent skidding. Swing the guide pinperpendicular to the axis of the bone.Adjust the angle on the A-P image sothat the guide pin will be driven towardsthe hole in the nail. Now the guide pin islined up both in the lateral and the A-Pplanes.
FREEHAND TECHNIQUE FORDISTAL TARGETING
Same as standard nail, but substitutethe 3.5 mm trocar for the 4.0 mmguide pin.
D E L T A
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1Attach the handle foruse as left-handed orright-handed.
5Attach power drill to theCole Radiolucent Drill.Tighten with a T-handledchuck key.
9Rotate the Cole Radio-lucent Drill parallel orin line with the C-arm.
2Select the properdrill bit size andinsert tapered endinto the drill.
6Place drill bit ontothe skin.
1 0Verify concentric posi-tion of the drill bit inthe hole of the nailand two opaque rings.Drill through bone.
CO L E RA D I O L U C E N T DR I L L — AB B R E V I AT E D TE C H N I Q U E
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3Place the locking cap overthe drill bit with one handwhile preventing rotationof the hollow tube withthe other hand.
7Use imageintensificationto verifyplacementin the centerof the perfectcircle.
1 1After drilling, slide the screwlength sleeve over the drill bit.Read correct screw length fromtop of screw length sleeve.
4Use the T-handled chuckkey over the chuck endof the Cole Radiolucent Drillto prevent the shaft fromrotating. Tighten the lockingcap. Remove T-handledchuck key.
8After making an incision to boneand placing the drill bit on bone,center bit within the perfect circlewith long axis of bit perpendicularto long axis of nail.
1 2Remove drill. Insertcorrect size bone screw.
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POSTOPERATIVE CARE
Dynamization means removal of eitherthe proximal or distal locking screws toallow axial loading of the tibia. There isno certain time interval when dynamiza-tion should occur. However, a generalguideline would be about 12 weeks post-o p e r a t i v e l y. Dynamization is not alwaysindicated to promote fracture healingand certainly dynamization should notbe considered if it will compromise thetibial construct. Refer to the Wa r n i n g sand Precautions Section of ImportantMedical Information in this brochure foradditional information on postoperativec a r e .
In nails locked in the dynamic mode, thelocking screws are removed at the sametime of nail removal. In a nail lockeds t a t i c a l l y, the surgeon should decide onwhich screws, either proximal or distal,are contributing most to fracture stabil-ity and remove the less critical screw ifdynamization is indicated. The patientshould not be permitted to fully weightbear on the operative leg locked in thestatic mode acutely. Weight bearing of apatient with dynamic interlocking pro-gresses according to stability of the frac-ture. Weight bearing status is increasedbased on the X-ray and clinical findingsof the healing of the fracture site.
NAIL REMOVAL
To extract the nail, remove the lockingscrews and attach the Extractor Bolt tothe proximal end of the nail. Thenattach the Extractor Tube and applybackward blows with the slotted ham-m e r. Be careful to avoid levering thenail/tube assembly. See ExtractionTechnique (62-11752) for more details.
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I M P L A N T S
R-T TIBIALINTERLOCKING NAILSR - T Tibial Interlocking Nails are0.2 mm larger in diameter thantheir stated size.
Cat. No. D i a m e t e r L e n g t h
1 2 - 2 1 8 4 11 mm 28.5 cm1 2 - 2 1 8 5 11 mm 30.0 cm1 2 - 2 1 8 6 11 mm 31.5 cm1 2 - 2 1 8 7 11 mm 33.0 cm1 2 - 2 1 8 8 11 mm 34.5 cm1 2 - 2 1 8 9 11 mm 36.0 cm1 2 - 2 1 9 0 11 mm 38.0 cm1 2 - 2 2 1 1 * 11 mm 40.0 cm1 2 - 2 2 1 2 * 11 mm 42.0 cm
1 2 - 2 1 9 1 12 mm 28.5 cm1 2 - 2 1 9 2 12 mm 30.0 cm1 2 - 2 1 9 3 12 mm 31.5 cm1 2 - 2 1 9 4 12 mm 33.0 cm1 2 - 2 1 9 5 12 mm 34.5 cm1 2 - 2 1 9 6 12 mm 36.0 cm1 2 - 2 1 9 7 12 mm 38.0 cm1 2 - 2 2 1 4 * 12 mm 40.0 cm1 2 - 2 2 1 5 * 12 mm 42.0 cm
1 2 - 2 2 0 4 13 mm 28.5 cm1 2 - 2 1 9 8 13 mm 30.0 cm1 2 - 2 1 9 9 13 mm 31.5 cm1 2 - 2 2 0 0 13 mm 33.0 cm1 2 - 2 2 0 1 13 mm 34.5 cm1 2 - 2 2 0 2 13 mm 36.0 cm1 2 - 2 2 0 3 13 mm 38.0 cm
1 2 - 2 2 0 5 14 mm 30.0 cm1 2 - 2 2 0 6 14 mm 31.5 cm1 2 - 2 2 0 7 14 mm 33.0 cm1 2 - 2 2 0 8 14 mm 34.5 cm1 2 - 2 2 0 9 14 mm 36.0 cm1 2 - 2 2 1 0 14 mm 38.0 cm*Available upon request.
5 1 - 2 0 0 0 Tibial Implant, Case Lid5 1 - 2 0 0 1 Tibial Implant, Nail Tr a y5 1 - 2 0 0 2 Tibial Implant, Screw Tr a y5 1 - 2 0 0 3 Tibial Implant, Case Lid, Nail, and Screw Tr a y
R - T D E LTA / Tibial Instrument Set(not shown)Cat. No. 11-2006
26
Cat. No. D e s c r i p t i o n Q t y.1 1 - 0 2 5 7 T-Handle Jacob’s Chuck 11 1 - 0 5 6 4 1 1 / 1 6 " Open End Wr e n c h 21 1 - 2 0 0 4 Trocar for 5 mm Screws 31 1 - 2 0 0 7 Guide Rod for Reamer–Spade Tip 3.2 mm x 900 mm 31 1 - 2 0 0 8 Tibial Nail Driver/Extractor Tu b e 11 1 - 2 0 1 2 8.0 mm Drill Sleeve (Green) 11 1 - 2 0 1 8 Internal Fracture Alignment Device 11 1 - 2 0 2 0 Guide Rod For Nails–Straight 4.0 mm x 900 mm 31 1 - 2 0 2 1 Guide Rod For Reamer–Straight 3.2 mm x 900 mm 31 1 - 2 0 2 3 Reamer Te m p l a t e 11 1 - 2 0 2 4 Supine Driver 11 1 - 2 0 2 5 Tibial Proximal Drill Guide with Bolt 11 1 - 2 0 3 7 Percutaneous Knife Handle 11 1 - 2 0 4 1 Ti b i a l / D E LTA Tibial Extractor Bolt 11 1 - 2 0 4 9 Tibial Drill 4.0 mm x 305 mm 31 1 - 2 0 5 6 4.0 mm Drill Sleeve (Gold) 11 1 - 2 0 5 8 Nail Length Gauge 11 1 - 2 0 5 9 D E LTA Guide Rod for Nail 3.0 mm x 900 mm 31 1 - 2 0 7 8 Tibial Instruments Sterilizing Case 11 1 - 2 0 8 6 D E LTA 3.5 mm Drill Sleeve ( B l a c k ) 11 1 - 2 0 8 7 D E LTA Tibial Drill 3.5 mm x 254 mm 11 1 - 2 0 9 6 D E LTA Hexdriver Shaft for 4.0/4.5 mm Screws 11 1 - 5 0 5 7 Guide Rod for Reamer–Curved Tip 3.2 mm x 900 mm 31 1 - 5 0 5 8 Screw Length Gauge 11 1 - 5 0 5 9 Hexdriver Shaft 5.0 mm 11 1 - 5 1 7 5 Slotted Hammer 11 1 - 6 0 1 1 Quick Release T- H a n d l e 11 1 - 9 6 5 7 Blunt Medullary Reamer 12 1 - 6 6 0 0 Curved Aw l 14 1 - 5 1 1 3 Medullary Exchange Tu b e 14 1 - 5 3 3 0 Skin Protector 1
Cat. No. D e s c r i p t i o n Q t y.1 1 - 5 1 2 8 5.6 mm Pseudarthrosis Chisel 11 1 - 8 1 0 0 6.0 mm Flexible Reamer–End Cut 11 1 - 8 1 0 1 6.5 mm Flexible Reamer–Pilot Nose 11 1 - 8 1 0 2 7.0 mm Flexible Reamer–End Cut 11 1 - 8 1 0 3 7.5 mm Flexible Reamer–Pilot Nose 11 1 - 8 1 0 4 8.0 mm Flexible Reamer–End Cut 11 1 - 8 1 0 5 8.5 mm Flexible Reamer–Pilot Nose 11 1 - 8 1 0 7 9.0 mm Interchangeable Reamer Head–End Cut 11 1 - 8 1 0 8 9.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 0 9 9.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 0 10.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 1 10.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 2 11.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 3 11.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 4 12.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 5 12.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 6 13.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 7 13.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 8 14.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 1 9 14.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 0 15.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 1 15.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 2 16.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 3 16.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 4 17.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 5 17.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 6 18.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 7 18.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 8 19.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 2 9 19.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 3 0 20.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 3 1 20.5 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 3 2 21.0 mm Interchangeable Reamer Head–Pilot Nose 11 1 - 8 1 5 0 Small Flexible Shaft 21 1 - 8 1 5 1 Large Flexible Shaft 21 1 - 8 1 6 5 5.0 mm T-Handle Reamer 11 1 - 8 1 6 7 6.0 mm T-Handle Reamer 11 1 - 8 2 3 0 Flexible Reamer/Sound Case 1
R - T Flexible Reamer Set Without Sounds(not shown)Cat. No. 11-2145
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IMPORTANT MEDICAL INFORMATIONWarnings and Precautions
RICHARDS INTRAMEDULLARY NAIL SYSTEM
IMPORTANT NOTE
Intramedullary nails provide an alternative to open reduction and fixation of a varietyof fractures. The objective of this closed technique as compared to open techniquesis to provide fixation with minimal trauma, reduced risk of infection, and reducedblood loss. As with all orthopedic devices, success varies with the patient; even inthe less difficult case there is a risk of complications. The surgeon is cautioned thatany of the circumstances listed under categories below may reduce the chances of asuccessful outcome.
BASIC STRUCTURE
The Richards Intramedullary Nail System consists of interlocking intramedullarynails, interlocking reconstruction nails, and intramedullary hip screw systems. All ofthese systems listed previously accept locking screws. The locking screws reducethe likelihood of shortening and rotation of femoral shaft fractures. All nails are avail-able in a variety of diameters and lengths. All implantable devices are for single useo n l y .
Intramedullary interlocking nails and femoral/recon nails are curved or straightnails that contain holes proximally and distally to accept locking screws.
Interlocking reconstruction nails are curved nails that contain holes proximally toaccept screws which thread into the femoral head for compression and rotationalstability; distally there are two holes to accept locking screws. Interlocking recon-struction nails are available in a variety of diameters and lengths in left and rightmodels, as proximal screw holes are anteverted 8° with respect to the plane contain-ing the curve of the nail.
Intramedullary hip screw systems contain a pre-bent nail containing holes proxi-mally and distally to accept a lag screw and locking screws, respectively.Intramedullary hip screws are available in a variety of diameters, lengths andneck/shaft angles.
The ReVision™ Nail consists of an intramedullary nail with holes at each end toaccept 5.0 mm locking screws. The locking screws reduce the likelihood of shorten-ing and rotation of the fusion site.
Interlocking retrograde nails have proximal and distal holes for locking screws.
M A T E R I A L S
Intramedullary nails, locking screws, sleeves, draw bolts, set screws, and lag screwsare manufactured from stainless steel (ASTM F 138 and ISO 5832/1).
The general principles of patient selection and sound surgical judgment apply to theintramedullary nailing procedure. The size and shape of the long bones present limit-ing restrictions on the size and strength of implants.
Indications for interlocking intramedullary nails include severely comminuted, spi-ral, large oblique and segmental fractures; nonunions and malunions; and bonelengthening/shortening. Femoral interlocking nails include the indication for proximal,middle and distal third femoral shaft fractures. Tibial interlocking nails also includethe same indications for tibial shaft fractures.
Humeral interlocking intramedullary nails are indicated for humeral shaft frac-tures, including severely comminuted, spiral, large oblique and segmental fractures;nonunions and malunions, proximal, middle and distal third shaft fractures; poly-trauma and/or multiple fractures; humerus reconstruction, following tumor resectionand grafting; and prophylactic nailing of impending pathologic fractures.
Forearm interlocking intramedullary nails are indicated for radial and ulnar shaftfractures, including severely comminuted, spiral, large oblique and segmental frac-tures; nonunions and malunions; proximal middle and distal third shaft fractures;polytrauma and/or multiple fractures.
Interlocking reconstruction nails are indicated for the following: Subtrochantericfractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck frac-tures; severely comminuted shaft fractures; femur reconstruction following tumorresection and grafting; bone shortening/lengthening; and prophylactic nailing ofimpending pathologic fractures.
Femoral/recon antegrade nails are indicated for shaft fractures including severelycomminuted, spiral, large oblique and segmental fractures; nonunions and malu-nions; bone lengthening/shortening; femur reconstruction following tumor resectionand grafting; fractures in osteoporotic bone; severely comminuted shaft fractures;pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylarfractures; and prophylactic nailing of impending pathologic fractures. Additional indi-
cations for the femoral/recon antegrade include: subtrochanteric fractures with lessertrochanteric involvement; ipsilateral femoral shaft/neck fractures.
Retrograde nails are indicated for shaft fractures including severely comminuted,spiral, large oblique and segmental fractures; nonunions and malunions; bonelengthening/shortening; femur reconstruction following tumor resection and grafting;fractures in osteoporotic bone; severely comminuted shaft fractures; pathologic frac-tures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; andprophylactic nailing of impending pathologic fractures. Additional indications for retro-grade nails include: severely comminuted supracondylar fractures with or without dif-ficult intra-articular extension, fractures that require opening the knee joint to stabilizethe femoral condylar segment. Also, fractures above total knee implants.
Intramedullary hip screw systems are indicated for intertrochanteric and high sub-trochanteric fractures, femoral neck fractures, and subcapital fractures. Indicationslimited to the intramedullary hip screw long stem device only are comminuted neckand shaft fractures, femur reconstruction following tumor resection, prophylactic nail-ing of impeding pathologic fractures, and leg length discrepancies secondary tofemoral fracture.
Indications for the ReVision Nail include the following: degeneration, deformity, ortrauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocal-caneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascularnecrosis of the talus following trauma; failed total ankle replacement with sub-talarintrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis;severe deformity secondary to untreated talipes equinovarus or neuromuscular dis-ease; and severe pilon fractures with trauma to the sub-talar joint.
C o n t r a i n d i c a t i o n s
1 . These systems should not be used in crossing open epiphyseal plates.
2 . Insufficient quantity or quality of bone, obliterated medullary canal or conditionswhich tend to retard healing, also, blood supply limitations, previous infections,e t c .
3 . Foreign body sensitivity; where material sensitivity is suspected, appro p r i a t etests should be made and sensitivity ruled out prior to implantation.
4 . Active infection.
5 . Conditions which tend to impair the patient’s ability or willingness to restrict activ-ities or to follow directions during the healing period.
6 . The forearm nail should not be used in children who have not reached skeletalm a t u r i t y .
In addition to the contraindications listed above, reconstruction nails are also not rec-ommended for any fracture which can be suitably fixed with a standard interlockingintramedullary nail.
In addition to the contraindications listed above, intramedullary hip screw systemsare also contraindicated for a severe bow or gross distortion of the femur.
Possible Adverse Effects
1 . Loosening, bending, cracking or fracture of the nails or screws, or loss of fixationin bone attributable to nonunion, osteoporosis, markedly unstable comminutedfractures or one or more of the factors listed in Contraindications above and/orWarnings and Precautions, below.
2 . Loss of anatomic position with nonunion or malunion with rotation or angulation.
3 . Infections, both deep and superficial.
4 . Allergies and other reactions to device materials.
5 . Irritational injury of soft tissues, including impingement syndrome.
6 . Supracondylar fractures from retrograde nailing.
WARNINGS AND PRECAUTIONS
W A R N I N G : This device is not approved for screw attachment or fixation to theposterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
P r e o p e r a t i v e
1 . Use care in handling and storage of implant components. Cutting, sharply bend-ing or scratching the surface can significantly reduce the strength and fatigueresistance of the implant system. This, in turn, could induce cracks and/or nonin-ternal stresses that could lead to fracture of the implants. Implants and instru-ments in storage should be protected from corrosive environments such as saltair, moisture, etc. Inspection and trial assembly are recommended prior tosurgery to determine if instrument components or implants have been damagedduring storage or prior procedures.
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2 . Patient conditions and/or predispositions, such as those addressed inContraindications, above, should be avoided.
3 . An adequate inventory of implant sizes should be available at the time ofs u r g e r y .
4 . Allergies and other reactions to device materials, although infrequent should beconsidered, tested for (if appropriate), and ruled out preoperatively.
5 . Certain special surgical instruments are required to perform this surgery includ-ing an image intensifier and an appropriate fracture table. Review of the use andhandling of these instruments is recommended.
6 . Before the initial experience, we recommend that the surgeon acquaint himselfwith the device and attend a technique seminar. Surgical technique brochuresare available upon request at no charge, and should be reviewed by the surgeonprior to initial surgery. Skill in the use of this technique should be acquired onless complicated fractures before attempting its use in unstable, difficult frac-tures. The surgical technique provides reaming information for each nail.
7 . The patient should be advised that a second more minor procedure for theremoval of implants is usually necessary.
O p e r a t i v e
1 . Please refer to the surgical technique for the specific nail for important reamingdirections and modular nail assembly techniques.
2 . Selection of the proper nail length and diameter is extremely important; thepatient’s age, weight and cortical bone quantity must be evaluated for the properimplant selection. It should be noted that a small but consistent percentage ofcomplications due to nail fatigue failure remain. Therefore, it is always recom-mended that the largest implant suitable for the patient be used.
3 . Care should be taken not to scratch, bend sharply, or cut metal components dur-ing surgery for the reasons stated in number one of the preoperative section ofWarnings and Precautions. Once removed from the patient, implants shouldnever be reused since internal stresses (in the implant) that are not visible maylead to early bending or fracture.
4 . A stable construct should be achieved and verified under image intensification.
5 . For femoral interlocking intramedullary nails, the trochanteric entrance holeshould be in line with the femoral medullary canal in the lateral aspect of thetrochanteric fossa and n o t at the tip of the trochanter. An excessive lateral place-ment of the entrance hole may result in eccentric reaming and comminution ofthe medial cortex of the proximal fragment at the fracture site.
6 . For tibial interlocking intramedullary nails, the entrance hole of the tibia should beproximal to the tibia tubercle in the midline behind or slightly medial to the patel-lar ligament. An excessive distal placement of the entrance hole may result inentering the inner distal cortex at a steep angle and splitting the bone.
7 . The use of Locking Screws is necessary for strength and compatibility. Pleaserefer to the surgical technique or product catalogue for information on the correctsize of screws for each nail.
8 . For retrograde insertion of humeral interlocking intramedullary nails, nails areinserted through a hole 1 cm wide by 2 cm long starting 2-3 cm proximal to theolecranon fossa. The entry portal is in the lateral aspect of the greater tuberosityfor antegrade insertion. An incorrect entry portal will increase the chance ofbreaking the humeral cortex during nail insertion.
9 . For interlocking reconstruction nails, the proper sized proximal screws are nec-essary. Both proximal screws should be used where possible for better fixationof the femoral head.
1 0 . In certain cases a bone graft may be appropriate.
1 1 . For intramedullary hip screw systems, the intramedullary nail uses the Richardsstandard lag screw proximally in conjunction with an intramedullary hip screwsleeve and set screw.
1 2 . For the ReVision Nail, the inner diameter of bone must be 1.0-1.5 mm largerthan the inserted nail whether reamed or not. Nail diameter “sounds” are avail-able to determine inner bone diameter.
P o s t o p e r a t i v e
1 . Intramedullary nails are neither intended to carry the full load of the patientacutely, nor intended to carry a significant portion of the load for extendedperiods of time.
Postoperative directions and warnings to patients by physicians andappropriate nursing care are extremely important, particularly those admo-nitions that concern early weight bearing or active use of the extremities.These activities substantially increase the stress on implants that can leadto complications. For this reason patients who are obese and/or noncom-pliant, as well as patients who could be pre-disposed to delayed or non-union, must have auxiliary support. The implant may be exchanged for alarger, stronger nail subsequent to the management of soft tissue injuries.
2 . Additional postoperative precautions should be taken when the fracture lineoccurs within 5 cm of the nail’s screw hole, as this situation places greater stresson the nail at the location of the transverse screw hole.
3 . Supplemental support may be necessary for those patients using externaldevices for ambulatory assistance.
4 . Periodic X-ray examinations for at least the first six (6) months postoperativelyare recommended for close comparison with postoperative conditions to detectchanges in position, nonunion, loosening, bending or cracking of components.With evidence of these conditions, patients should be closely observed, the pos-sibilities of further deterioration evaluated, and the benefits of reduced activityand early revision considered.
5 . While the surgeon must make the final decision on implant removal, wheneverpossible and practical for the individual patient, fixation devices should beremoved once their service as an aid to healing is accomplished. In the absenceof a bursa or pain, removal of the implant in elderly or debilitated patients is nots u g g e s t e d .
6 . Even after full healing, the patient should be cautioned that refracture is morelikely with the implant in place and soon after its removal, rather than later, whenvoids in the bone left by implant removal have been filled in completely.
7 . Patients should be cautioned against unassisted activity that requires walking orl i f t i n g .
8 . Postoperative care and physical therapy should be structured to prevent loadingof the operative extremity until stability is evident.
PACKAGING AND LABELING
All implants are provided sterile and should be accepted only if the factory packagingand labeling arrive intact. If the sterile barrier has been broken, refer to theResterilization section below for additional instructions.
S T E R I L I Z A T I O N
Metal components have been sterilized by a minimum of 25 kilo Grays of gammairradiation. Inspect packaging for punctures or other damage prior to surgery.
R E S T E R I L I Z A T I O N
Metal components may be resterilized, if necessary, by steam autoclaving in appro-priate protective wrapping, after removal of all the original packaging and labeling.Protect prosthesis, particularly mating surfaces, from contact with metal or other hardobjects. The following process parameters are recommended for these devices:
Table 2: Sterilization Information - Pulsing Vacuum Cycle
T e m p e r a t u r e 270° - 275° F
Pulse 1: Steam to 12 psig, vacuum to approximately 5"Hg.
Pulse 2: Steam to 12 psig, vacuum to approximately 20"Hg.
Pulse 3: Steam to 12 psig, vacuum to approximately 25"Hg.
Pulse 4: Steam 27-30 psig, exposure time 4.0 min. ± 5 sec.,post vacuum ≥ 25"Hg.
I N F O R M A T I O N
For further information, please contact Customer Service at (800) 238-7538 for callswithin the continental USA and (901) 396-2121 for all international calls.
Caution: Federal Law (USA) restricts this device to sale by or on the order of ap h y s i c i a n .
3433179 Rev. 0 1/97
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Smith & N e p h e w, Inc. • 1450 Brooks Road • Memphis, TN 38116 U.S.A.(901) 396-2121 • For information: 1-800-821-5700 • For orders and order inquiries: 1 - 8 0 0 - 2 3 8 - 7 5 3 8
