super retrograde - zimmer biomet · super retrograde nail ream first 6cm to 13mm diameter....

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12mm diameter

13mm diameter

Super Retrograde

15mm

6mm diameter screws

locking end cap

15mm

A Super Retrograde Femoral Nail is available using

6mm distal screws, 5mm proximal screws and a

locking end cap. Nail diameter 12mm, distal end

13mm diameter.

15mm

15mm

10mm, 11mm and 12mm diameters

5mm diameter bolts

13mm diameter washers

locking T-nut

NOTE: Illustration shown using

nut, bolt and washers.

15mm

30mm

1

This brochure is presented to demonstrate the surgi-

cal technique utilized by J. Dean Cole, M.D., Orlando,

Florida. Biomet, as the manufacturer of this device,

does not practice medicine and does not recommend

this or any other surgical technique for use on a spe-

cific patient. The surgeon who performs any implant

procedure is responsible for determining and utilizing

the appropriate techniques for implanting the pros-

thesis in each individual patient. Biomet is not

responsible for selection of the appropriate surgical

technique to be utilized for an individual patient.

Anatomic Design, Optimal Patient Sizing

Proven clinical results.1–5

A/P proximal screw placement for ease of use with patient

positioning and intraoperative imaging.

The strength and biocompatibility of titanium alloy.

Fully cannulated, closed section nail design.

Anatomic design and uncompromising fit via a 5° anterior

bend and an anterior bow.

Optimal patient sizing 10, 11 and 12mm nail diameters,

nail lengths from 20–44cm.

The option of a nut/bolt and washer for distal fixation.

Fully threaded 5mm titanium screws.

Precise, reproducible instrumentation.

12mm diameter

Clinical management of supracondylar

fractures, especially those proximal

to a solidly-fixed femoral total knee

prosthesis, present the challenge of

providing adequate stability, often

with a compromised surgical approach.

The literature would suggest that alter-

natives to historic methods of open

reduction, pinning, and/or internal fixation

be selected as treatments of choice.

Indications may include: open and closed

acute distal femoral fractures, pathological

fractures, malunions, nonunions, osteo-

tomies, failed plate-screw osteosyntheses

of the distal femur, fractures proximal to a

total knee arthroplasty and fractures distal

to a total hip prosthesis.

The Biomet® Retrograde Femoral Nail

is anatomic and offers the advantages of

optimal patient sizing over short, straight

nail designs. Furthermore, its anterior-

posterior proximal screws promote

ease-of-use with desired patient positioning

and intraoperative imaging.

Supracondylar (Extraarticular)Fractures

Fractures Proximal to Total KneeArthroplasties

Fractures Distal to Total HipArthroplasties Intracondylar (Intraarticular) Fractures

2

Patient PositioningThe patient is placed in a supine position on a radiolucent

table. The limb is prepped and draped with a split drape in

a sterile fashion.

Flex the knee 90°– 120° (120° is recommended) over a

well padded thigh support to provide access for adequate

reduction and fixation. An assistant is needed to stabilize

reduction during canal preparation.

Incision and Entry PointThe incision is centered over, but not through, the patellar

ligament, with the retinaculum being incised sharply both in the

medial and lateral aspects of the patellar ligament (Figure A).

Palpate to locate the intracondylar notch.

To restore a normal valgus inclination angle, the entry site

should be oblique to the transverse plane of the femur. The

instrumentation and nail will enter from the medial aspect

(Figure B).

Care must be taken to avoid an entry point that is straight at the

intracondylar notch. Such an approach may place the femur in a varus

alignment. Entry point should be located above PCL at superior aspect

of intracondylar notch.

A

B

3

D

Canal Reaming and Guide Wire PlacementA 5/32" diameter Steinmann pin is placed at the superior

border, anterior to the patient’s anterior cruciate ligament

and its position confirmed by the C-arm image.

Note: If the pin placement is placed low, the anterior cruciate may be

inadvertently reamed.

Following pin placement, sequential rigid reamers are used to

expand the entry site (Figure C). Flexible reamer is shown in

Figure D.

Insert the ball-tipped guide wire and advance past the frac-

ture site using image intensification. If reaming is indicated,

progressive reaming is performed in 0.5mm increments over

the guide wire. It is recommended that the surgeon ream to

one millimeter greater than the diameter of the nail to be

inserted.* When reaming is completed, the ball-tipped guide

wire is replaced with a 1/8" (3.2cm) diameter nail driving

guide, using an exchange tube.

If reaming is not performed, the nail driving guide is inserted

and advanced past the fracture site with image intensification.

A second nail driving guide of equal length is then used to

measure the length of the medullary canal. The selected nail

should be at least one centimeter shorter than the measured

canal to permit countersinking of the nail.

C

4

*NOTE: When using the standard 10mm–11mm nails, ream the first 6cm distally (entry site) to 12mm to accept

the larger diameter of the distal nail end. Super Retrograde Nail ream first 6cm to 13mm diameter.

Outrigger Assembly and Nail InsertionThe driver bolt (1) is passed through the driver bushing (2) and

attaches to the nail (3) (Figure E). The two tangs on the

underside of the driver must engage with the two slots on the

distal end of the nail. The target arm (4) engages the driver

bushing, with the arm placed lateral to the nail. The driver bolt

is then firmly tightened using the 3/8" hex socket T-wrench,

(5) locking the driver bushing to the nail (Figure F). The

threaded driver handle (6) locks the target arm to the driver

bushing (Figure G).

The slide hammer may be inserted into the driver handle

(Figure H). The nail is placed over the nail driving guide and

driven down the medullary canal. The fracture should be ade-

quately reduced and out to length during insertion of the nail

and should be monitored with the image intensifier (Figure I).

The nail driving guide is removed after the nail passes the

fracture site. The nail is recessed 5.0mm below the articular

cartilage, this allows for maximal fixation (Figure J).

F

G

I

J

E

H

(3)

(2)

(1)

(4)

(5)

(6)

5

Distal Screw InsertionThe distal target is placed over the target arm and tightened

using the hex socket T-wrench. The trocar guide is placed into

the guide tube and the assembly is inserted through the hole

in the distal target (Figure K). After making a small stab inci-

sion, under fluoroscopic control, pass the guide tube with the

trocar until it contacts the bone. Remove the trocar and replace

it with the drill bushing. The 4.3mm calibrated drill is used to

perforate the lateral cortex, pass through the nail and perfo-

rate the medial cortex (Figure L). With the drill guide bushing

assembly held firmly against the lateral cortex, the appropriate

screw length is read on the calibrated drill bit. Alternatively, a

depth gauge may also be used to determine or verify the

length of the locking screw (Figure M). The drill bushing is

removed and the appropriate 5.0mm diameter screw is inserted

through the guide tube using the 3.5mm hex drive T-wrench

(Figure N). The screw head is seated when the ring on the

T-wrench reaches the guide tube. The second distal locking

screw is placed in a similar fashion (Figure O). All screw

placements (proximal and distal) should be verified before

removing the driving assembly from the nail, to prevent the

need to reattach.

Note: The Super Retrograde Femoral Nail requires a 6.Omm diameter distal locking

screw, requiring a 5.Omm drill bushing and twist drill. Due to the larger head diameter

of the 6.Omm screw, the guide tube and drill bushing must be removed and the

appropriate 6.Omm diameter screw is inserted through the distal target using the

5.Omm hex drive T-wrench.

K

L

M

N O

6

Distal Screw Insertion Using the Nut/Bolt and WasherThe instruments are assembled in the usual manor as used

with the fully threaded screw. A new 5.0mm drill bushing is

used to receive the 5.0mm drill. After making a small stab

incision, under fluoroscopic control, the 5.0mm drill is used

to perforate the lateral cortex, pass through the nail and per-

forate the medial cortex. Remove the 5.0mm drill.

Place the calibrated alignment guide through the 5.0mm drill

bushing, lateral cortex, nail, and into the medial cortex. Make

a small stab incision on the medial side under fluoroscopic

control over the end of the protruding alignment guide. The

cannulated reamer with stop is placed over the end of the

alignment guide (Figure P). The medial side is reamed

to the depth stop on the reamer to receive the T-nut. The

alignment guide will be pushed to the lateral side during the

reaming process. It is important to use the alignment guide

with the reamer for proper alignment of the T-nut and bolt.

Remove the cannulated reamer with stop.

With the calibrated alignment guide in place and the end

protruding on the medial side, the T-nut and washer is placed

over the end of the alignment guide and seated by using the

3.5mm hex T-wrench. This is achieved by pushing on the

T-wrench (Figure Q).

P

Q

7

With the T-nut and washer fully seated, the bolt length can be

determined by reading the calibrations on the lateral side of

the calibrated alignment guide, at the

bone interface. Calibrations allow for

10.0mm initial engagement of thread

and 15.0mm of compression.* To read

the calibrations, move the distal target

away from the femur (Figure R). After

selecting the correct bolt length, remove

the alignment guide, along with the distal

target, guide tube and drill bushing.

Insert the bolt and washer through the lateral cortex, pass

through the nail and turn into the T-nut using the 3.5mm hex

T-wrench on both the lateral and medial sides (Figure S).

THE BOLT AND WASHER WILL NOT PASS THROUGH THE

DISTAL TARGET AND SHOULD BE REMOVED. Repeat

steps for second nut/bolt (Figure T).

*Note: Length range of 5.Omm diameter bolt with T-nut is as follows.

Bolt Length Range

50mm 50–65mm

60mm 60–75mm

70mm 70–85mm

80mm 80–95mm

S

T

8

R

Proximal Screw Insertion Using the Freehand Technique

The image intensifier is positioned about the proximal femur

such that either of the proximal screw holes appears as a

circle in the center of the viewing screen. A pointed awl or

Steinmann pin is placed on the skin anteriorly, with the tip

centered on the screw hole, as seen on the image intensifier

(Figure U). A 3–4cm incision is made and a blunt dissection

is carried to the anterior cortex. The drill, with guide tube, is

placed on the bone with the point centered within the screw

hole, as seen on the image intensifier. The 4.3mm diameter

drill with stop is brought in line with the axis of the beam

and drilled through the anterior cortex, nail and posterior

cortex. The position of the 4.3mm diameter drill should be

confirmed with the image intensifier before it is withdrawn.

Note: Anatomic structures to consider on proximal locking include the femoral

artery (medial side) and/or the sciatic nerve (posterior side).

An alternate technique for placing the proxi-

mal screws is using the Biomet® Radiolucent

Targeting Device (Figure V).

Screw Length/InsertionThe length of the screw is measured with the depth gauge

and an appropriate 5.0mm diameter screw is inserted, using a

Williams self-holding screwdriver (Figure W).

U

W

9

Biomet® Radiolucent Targeting Device

V

X

End Cap Placement After the driver assembly is removed, an end cap is inserted

into the end of the nail using the hex-drive T-wrench. As an

alternative, the locking end cap, which engages the most

distal screw, may be used.

Nail RemovalWhen a nail is to be removed, the proximal locking screws

should be left in place until the extractor adaptor is attached

to the nail. The end cap is removed and the nail extractor

adaptor is threaded into the distal end of the nail. The screws

are removed with the hex drive T-wrench. The slap hammer is

threaded into the nail extractor adaptor and the nail is

removed (Figure X).

Postoperative CarePatients are started on gentle range-of-motion exercises of

the hip and knee. Weight bearing progresses as changes in

callus formation are noted.

10

Titanium Retrograde Femoral NailPart Number

Length

20cm24cm28cm32cm34cm36cm38cm40cm44cm

10mmDiameter

343520343524343528343532343534343536343538343540343544

11mmDiameter

343620343624343628343632343634343636343638343640343644

12mmDiameter

343720343724343728343732343734343736343738343740343744

Titanium Nut/Bolt/WasherPart Number

33-34546033-34546233-34546433-34546633-345472

245890

Description

5 x 50–65mm Bolt5 x 60–75mm Bolt5 x 70–85mm Bolt5 x 80–95mm BoltLocking T-Nut 5mm

Titanium Washer 13mm

Ti-Screw Buttress Thread5mm DiameterFully Threaded

Part Number

33-34542033-34542233-34542433-34542633-34542833-34543033-34543233-34543433-34543633-34543833-34544033-34544233-34544433-34544633-34544833-345450

Length

25mm30mm35mm40mm45mm50mm55mm60mm65mm70mm75mm80mm85mm90mm95mm100mm

Titanium End Cap345220

Titanium Fixation screws usea 3.5mm hex drive wrench

Titanium Super RetrogradeFemoral Nail

Distal End 13mmPart Number

12mm diameter

344920344924344928344932344934344936344938344940344944

Length

20cm24cm28cm32cm34cm36cm38cm40cm44cm

Titanium Locking End Cap345216

Ti-Screw Buttress Thread6mm DiameterFully Threaded

Part Number

345532345534345536345538345540345542345544345546345548

Length

60mm65mm70mm75mm80mm85mm90mm95mm100mm

Above nails use a 6.0mm diameterscrew distally and a 5.0mm diam-eter screw proximally

6mm screws used only on distalholes of Super Retrograde FemoralNail, uses a 5.0mm hex drivewrench.

Uses 3.5mm hex drive wrench.

NOTE: The locking end cap number 345216

designed for the Super Retrograde Femoral Nail can

also be used to lock the most distal screw in the

standard 10, 11 and 12mm diameters Retrograde

Femoral Nail.

11

Instruments

Retrograde FemoralDriver Bushing (coded red)471788

Retrograde FemoralDistal Target (coded red)471790

Calibrated Twist Drill (sterile)4.3mm x 254mm (distal)471656

Twist Drill w/Stop4.3mm x 203mm (proximal)471657

Williams Screwdriver3.5mm Hex Drive (self holding)472358

Rigid Reamer 5/32" dia cannulation471468 8mm dia471469 9mm dia471458 10mm dia471459 11mm dia471460 12mm dia471461 13mm dia

Steinmann Pin 5/32" dia x 12" lg27-362093 nonsterile (pk/6)25-362093 sterile (pk/5)

Driver Bolt471525

Target Arm471630

Driver Handle 471535 threaded471635 plain

Guide Tube (2 each)471545

Trocar for Guide Tube471546

Drill Bushing 4.3mm (2 each)471650

Hex Drive T-wrench 3.5mm (2 each)457118

Hex Drive Power Bit 3.5mm457119

T-wrench 3/8" Hex449110

Nail Extractor Adaptor471560

Depth Gauge34-513644

Slide Hammer471565

Instrument Case592028

Instruments Used With Nut/Bolt

Calibrated Alignment Guide471780

Cannulated Reamer w/Stop471782

Drill Bushing 5mm (2 each)471784

Calibrated Twist Drill 5mm x 254mm471786

Instruments Used With SuperRetrograde Femoral Nail(Distal Holes Only)

Drill Bushing 5mm (2 each)

471784

Calibrated Twist Drill 5mm x 254mm

471786

Hex Drive T-wrench 5mm

472248

Instrument Case

Instruments Used with Nut/Bolt

12

Modular Flexible Reamer System

Reamer Reamer HeadsHeads Ti-Nitrited

467734 8.0mm 467634467736 8.5mm 467636467738 9.0mm 467638467740 9.5mm 467640467742 10.0mm 467642467744 10.5mm 467644467746 11.0mm 467646467748 11.5mm 467648467750 12.0mm 467650467752 12.5mm 467652467754 13.0mm 467654467756 13.5mm 467656467758 14.0mm 467658467760 14.5mm 467660467762 15.0mm 467662467764 15.5mm 467664467766 16.0mm 467666467768 16.5mm 467668467770 17.0mm 467670467772 17.5mm 467672467774 18.0mm 467674467776 18.5mm 467676467778 19.0mm 467678467780 19.5mm 467680467782 20.0mm 467682

Reamer Shafts

467716 8.0mm Dia. 40cm Length467718 8.0mm Dia. 52cm Length

Sterilization Case

593243

Suggested AdditionalInstrumentation

Guide Pin Handgrip469675

Telescoping Nail Measuring Gauge469380

Ball Tip Guide 3.2mm x 98cm469060

Medullary Alignment Tube w/Ring 8mm

469388 (pk/6)469389 (ea)

Medullary Alignment Tube w/o Ring 8mm 469392 (pk/6)469393 (ea)

Skin Protector

476920

Reduction Lever

469385

Canal Sizer—Cannulated469310 10mm469311 11mm469312 12mm

Distal Target Awl 4.3mm471794

X-ray Scale475920

Nail Driving Guide 3.2mm x 80cm (2 each)467210

Radiolucent Distal Targeting Device471830 Device471845 4.3mm drill bit w/stop

13

Biomet® is a registered trademark of Biomet, Inc.1 Ostrum RF and, Poka A; “Ipsilateral Femoral Hip and Shaft Fractures: A Management Protocol.” A Supp. to Am. J. of

Orthopedics, IS:4–11, 1999.2 Morgan E, Ostrum RF, DiCicco J, McElroy J and Poka A; “Effects of Retrograde Femoral Intramedullary Nailing on the

Patellofemoral Articulation.” J. Orthop Trauma, 1:13–16, 1999.3 Ostrum RF, DiCicco J, Lakatos and Poka A; “Retrograde Intramedullary Nailing of Femoral Diaphyseal Fractures.”

J. Orthop. Trauma, 7:464–468, 1998.4 Ryan MG, Khan AM and Meinhard BP; “Distal Femur Fractures and Retrograde Intramedullary Rod Fixation.” A Supp. to

Am J. Orthopedics, 2S:46–50, 1998.5 Cole JD, Huff WA and Blum DA; “Retrograde Femoral Nailing of Supracondylar, Intercondylar and Distal Fractures of the

Femur.” A Supp. to Am. J. Orthopedics, 5S:22–30, 1998.

P.O. Box 587, Warsaw, IN 46581-0587 • 219.267.6639 • ©1999 Biomet, Inc. All Rights Reservedweb site: http://www.biomet.com • eMail: [email protected]

Form No. Y-BMT-568R/113099/K