technique guidesynthes.vo.llnwd.net/o16/mobile/synthes international/kyo/cmf/pdf… · 398.902...

Titanium Sternal Fixation System. Forstable internal fixation of the sternum.

Technique Guide

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use ofthe product. Instruction by a surgeon experienced in handling this product ishighly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multi-part instruments,please refer to: www.synthes.com/reprocessing

Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Titanium Sternal Fixation System 2

AO Principles 5

Indications/Contraindications 6

Surgical Technique 7

Alternative Technique with Self-drilling Screws 20

Emergency Reentry 23

Implants 25

Instruments 28

2 Synthes Titanium Sternal Fixation System Technique Guide

The Synthes Titanium Sternal Fixation System provides stableinternal fixation of the sternum following a sternotomy orfracture of the sternum.

Broad variety of sternal plates Different titanium plates according to the anatomical structures and patient’s need are available:


− Sternal body plates for minimal dissection − Star-shaped and H-shaped locking plates for fixation

of the manubrium − Titanium sternal locking straight plate without pin for

transverse fractures*− Straight locking plates for a stable sternal rib-to-rib

fixation

* Contraindicated for use in acute cardiac patients.

1

2

Synthes 3

Self-tapping and self-drilling locking screws Both self-tapping and self-drilling locking screws are availableto accommodate surgeon preference.

* Except Sternal Locking Plate 2.4, straight, without Emergency Release Pin,13 holes, Pure Titanium (460.046), which is contraindicated for use in acutecardiac patients.

Emergency release pin on all plates* Most plates consist of two parts joined by a U-shaped releasepin in the cross section. The release pin allows a quick andeasy sternal reentry in cardiac emergency cases (2).

Secure and stable locking The plate functions like an external fixator, applied internally.The screwhead of the sternal locking screws locks securelyinto the threaded plate hole to provide stable fixation (1).



Construct strength comparisonConstructs loaded in tension in lateral direction. All testswere performed on 10 mm thick composite polyurethanefoam test blocks composed of an inner (cancellous) core of 80 kg/m3 polyurethane foam with a 1.25 mm thick (cortical) shell of 160 kg/m3 polyurethane foam laminated to the exterior.*

* Mechanical test data on file at Synthes.Mechanical test results may not necessarily be indicative of clinical performance.

Sample test construct(X-Plate setup shown)

300

250

200

150

100

50

0

Cerclage wire(8�, 0.8 mm)Stainless steel

X-Plates(2�, 460.037)Titanium

8-Hole straight plates(2�, 460.045)Titanium

Double-T plates(2�, 460.038)Titanium

X-Plates, wide(2�, 460.040)Titanium

Yie

ld lo

ad (

N)

Synthes 5

AO Principles

In 1958, the AO formulated four basic principles, which havebecome the guidelines for internal fixation.1 Those principlesas applied to the Titanium Sternal Fixation System are:

Anatomic reductionFracture reduction and fixation to restore anatomical rela-tionships. A comprehensive implant and instrument selectionaddresses most simple and complex fixation needs.

Stable fixationStability by fixation or splintage, as the personality of thefracture and the injury requires. The Titanium Sternal FixationSystem plate and screw locking technology are optimized to achieve stable bone fixation.

Preservation of blood supplyPreservation of the blood supply to soft tissue and bone bycareful handling and gentle reduction techniques. Instru -mentation and rounded plate profiles and edges on implantsminimize disruption of soft tissue and preserve vascularblood flow for bone healing.

Early mobilizationEarly and safe mobilization of the body part and patient. The Titanium Sternal Fixation System implants, combined withAO technique, provide stable fixation to allow functional aftercare.

1 M. E. Müller, M. Allgöwer, R. Schneider, H. Willenegger (1991)Manual of Internal Fixation, 3rd Edition. Berlin: Springer


Indications /Contraindications

IndicationsPrimary or secondary closure/repair of the sternum followingsternotomy or fracture of the sternum, to stabilize the ster-num and promote fusion.

ContraindicationsThe Sternal Locking Plate 2.4, straight, without emergencyrelease pin is contraindicated for primary closure of the sternum.

Synthes 7

Surgical Technique

1Position patient

Position the patient with the arms tucked along the sides.Avoid placing arms at 90° on arm boards, as this makeschest closure more difficult.

2 Debride (for secondary closure of the sternum)

Remove existing wires. Debride the involved sternal edgesuntil they are free of devitalized tissue and down to bleedingtissue. Hemostasis should be obtained.

A curette can be used to remove any nonviable cartilaginousrib.

Note: A sternal bone specimen should be sent to pathologyto assess for osteomyelitis, and to microbiology for culture.This will help the infectious disease consultant to determinethe appropriate antibiotic therapy.


3Expose ribs laterally, if necessary

Beginning medially, elevate the pectoralis major muscles withoverlying soft tissue attached to create flaps and permit laterapproximation in the midline.

It is usually not necessary to perform a second incision at the shoulder to release the pectoral muscle insertion.

Following debridement and muscle elevation, pulse lavagethe entire surgical site with an adequate volume of salinewith antibiotics.

Surgical Technique

4 Determine sternal edge thickness

Instrument

319.110 Depth Gauge for Screws � 1.5 and 2.0 mm, measuring range up to 26 mm

Alternative instruments

03.501.074 Universal Calliper

03.501.065 Calliper

Using the depth gauge, determine the thickness of the ster-nal edges adjacent to each rib where a plate may be placed.

Add 3 mm to the thickness of the sternal edge to accountfor the plate thickness and to determine the appropriatelength drill bit with stop.

Synthes 9

5Reduce sternum

Instruments

398.903 Sternal Reduction Forceps, angled, with ratchet lock

398.985 Reduction Forceps with Points, ratchet lock, length 180 mm

Alternative instrument

398.902 Sternal Reduction Forceps

Reduce the sternum using reduction forceps on both the superior and inferior aspects of the sternum.

When placing the forceps, care should be taken to avoid theintercostal and mammary vessels and nerves.

Note: Sternum can also be reduced with stainless steel surgical wire, if desired.

Caution: Avoid direct contact of stainless steel wires with titanium implants to avoid galvanic corrosion.


Surgical Technique

6 Cut and contour template

Instrument

329.400 Bending Template for Reconstruction Plates 2.4 to 4.0, length 295 mm

Cut the bending template to a length that allows placementof a minimum of four screws on each side of the fracture/osteotomy line.

Contour the template to the sternum and ribs.

Synthes 11

7Select plate

Instrument

391.967 Shortcut 2.4/THORP, without rasp, required in pairs


391.990 Cutting Pliers for Plates and Rods

Select the appropriate length titanium sternal locking plate.Center the release pin on the sternum with sufficient platelength on each side to allow a minimum of four lockingscrews on each side.

The plate can be cut to length, if necessary, using the Short-cut plate cutters.

– Push the cutters from the opposite sides over the plate.– Discs must show no distance to each other.– Close handles with one hand.

As an alternative, cutting pliers for plates and rods may beused.

Note: All steps of preparation and implantation of the Ster-nal Locking Plate have to be done with the assembled plate.Do not disassemble the plate by pulling out the EmergencyRelease Pin.


Surgical Technique

8 Contour plate

Instrument

329.142 Bending Pliers with Nose, for Pure Titanium Plates 2.4 and 2.7


391.963 Universal Bending Pliers, length 165 mm

Orient the plate so that the titanium emergency release pin isparallel to the midline of the sternum. The closed end of theemergency release pin should be oriented cranially. Contourthe plate to match the template. The top side of the plate isetched with the part number, and the holes are countersunkto allow the screws to seat fully.

Use the bending pliers with nose to make in-plane bendsfirst, followed by out-of-plane bends.

Contour the plate with the emergency release pin inserted. If the emergency release pin interferes with the bending tool,it can be temporarily removed.

Note: Be careful not to deform the pin section of the platehalves while contouring. If this portion of the plate is bent,the plate could break or the emergency release pin could be-come stuck in the plate.

Check the plate against the template to ensure it has thecorrect shape.

Note: The smaller sternal body plates can be bent with universal bending pliers.

Caution: Use bending screws for severe bends to preventplate hole deformation while contouring the plate.

Synthes 13

9 Position plate

Position the plate to allow placement of a minimum of fourscrews on each side of the fracture/osteotomy line.

For sternal locking straight plates, position the plate on thesuperior portion of the rib to avoid the intercostal vessels andnerves during drilling.


Surgical Technique

10Drill

Instruments

03.501.008– Drill Bit � 1.5 mm with Stop, 03.501.018 length 82 / 8 –18 mm, 2-flute, for J-Latch Coupling

03.501.000 Drill Guide 1.5, with thread, for Sternal Locking Plates

Note: The alternative technique with self-drilling screws can be used (see page 20).

Insert the 1.5 mm threaded drill guide into the plate to en-sure the locking screw will be aligned with the plate hole.

For the sternum, use the drill bit with stop of the properlength as determined in step 4. Drill bits with stop are avail-able in lengths ranging from 8 mm to 18 mm, in 2 mm in -crements, matching the locking screw lengths. Irrigate duringdrilling to avoid thermal damage to the bone.

Notes– Recognize that the thickness of the adjacent ribs may be

less than the sternal edge.– For medial screws, drill bicortically.– For lateral screws, drill bicortically wherever possible.

Caution– Do not drill any deeper than necessary, to avoid the risk

of pneumothorax.– Do not drill in the region above the internal mammary

arteries.

Remove the 1.5 threaded drill guide.

Synthes 15

11 Select and insert first screw

Instruments

313.940 Screwdriver, cruciform, with Holding Sleeve, for Cortex Screws � 2.4 mm


Optional instruments

311.023 Ratcheting Screwdriver Handle, with Hexagonal Coupling

313.939 Screwdriver Shaft 2.4/3.0, cruciform, not self-holding, with Hexagonal Coupling

313.970 Holding Sleeve, for Nos. 313.960 and 314.448

Determine the depth of the drilled hole using the depthgauge through the plate to confirm the appropriate screwlength.

Be careful not to extend the tip of the depth gauge past theposterior cortex of the sternum/rib.

Select the proper length � 3.0 mm titanium locking screw. The screw should be no longer than necessary to engage theposterior cortex, to avoid deeper injury. The tip of the screwshould not extend more than 0.5 mm beyond the posteriorcortex.

Note: Screw length can be determined using the screwlength indicator on the module.

Insert the locking screw through the plate and tighten manually until secure.

25°


Surgical Technique

12Drill and place remaining screws

Insert a second screw on the opposite side of the fracture/osteotomy line following steps 10 and 11. Insert all remain-ing screws in the same manner.

After the plate has been fixated to the sternum/ribs, it is important to verify that the prong is bent medially to preventmigration of the pin.

Note: Avoid over-bending of the flat prong (>25°), as this can lead to breakage.

Synthes 17

13 Insert remaining plates

Place remaining plates following steps 6 through 12.

Synthes recommends a minimum of three plates in the sternal body for optimal sternal closure following a full sternotomy.

Note: If one plate is used in combination with stainless steelsurgical wires, Synthes recommends using at least four wiresin the sternal body for closure of a full sternotomy. If twoplates are used in combination with stainless steel wires, aminimum of two wires should be used.

Caution: Avoid direct contact of stainless steel wires with titanium implants to prevent galvanic corrosion.


Surgical Technique

14 Manubrium plate (optional)

Instrument


A plate can be placed on the manubrium for extra support, if needed. Several star-shaped and H-shaped plates are available for placement on the manubrium. Follow guidelinesin steps 7 through 12 to place this plate.

The manubrium plates can be bent with universal bendingpliers.

The H-shaped and star-shaped plates are intended only foruse on the manubrium where fixation to the rib is impractical.

Synthes 19

15Closure and postoperative considerations

Irrigate the wound again with antibiotic-containing saline. Insert one #10 Jackson Pratt or Blake flat drain under eachpectoral muscle flap and bring out through separate inferiorincisions.

Approximate pectoral muscles with interrupted #1 Vicryl suture, and close skin and subcutaneous tissue in layers.

Drains are usually removed when output is consistently less than 20 ml per drain per day.

Note: Do not pull or lift the patient by the arms for 6 weeks.Do not raise arms higher than 90° at shoulder level.


Self-drilling locking screws are available as an alternative tothe self-tapping locking screws.

1 Determine sternal edge thickness and position plate

Determine the sternal edge thickness and position the plateas described in step 1 to 9 of the surgical technique withself-tapping screws.

Alternative Technique with Self-drilling Screws

Synthes 21

Caution – Recognize that the thickness of the adjacent ribs may be

less than the sternal edge. – Screw lengths 14 mm and longer should not be used in

the area of the ribs.2

– For medial screws, insert bicortically. For lateral screws, insert bicortically whenever possible.

– Do not insert screws any deeper than necessary, to avoidthe risk of pneumothorax.

– Do not insert screws in the region above the internalmammary arteries.

– After surgery, routinely perform a chest x-ray to excludethe possibility of a pneumothorax.

2 Select and insert first screw

Instrument

313.940 Screwdriver, cruciform, with Holding Sleeve, for Cortex Screws � 2.4 mm

Select the proper length � 3.0 mm titanium sternal self-drilling locking screw based on sternal edge thickness deter-mination as described in step 4 of the self-tapping screwssection (add 3 mm to the thickness of the sternal edge to account for the plate thickness).

The self-drilling locking screw should be inserted perpendi -cular to the plate and the screw axis should be aligned withthe thread axis of the plate hole.

Caution: The self-drilling locking screw should be no longerthan necessary to engage the posterior cortex, to avoiddeeper injury. The tip of the screw should not extend morethan 0.5 mm beyond the posterior cortex. In the area of theribs, predrilling may facilitate the determination of the appro-priate screw length.

Insert the sternal locking screw through the plate and tighten manually until secure.

Note: Screw length can be determined using the screwlength indicator on the module.

2 M. Mohr, E. Abrams, C. Engel, et al. (2007) Geometry of human ribs pertinent to orthopedic chestwall reconstruction. J Biomech 40:1310 –1317


3 Place remaining screws

Insert a second sternal self-drilling locking screw on the op-posite side of the fracture/osteotomy line following steps 1to 2 of the alternative technique with self-drilling screws. Insert all remaining sternal self-drilling locking screws in thesame manner.

Complete the procedure following steps 13 through 15 ofthe surgical technique with self-tapping screws.

Alternative Technique with Self-drilling Screws

Synthes 23

Remove emergency release pinRemove the emergency release pins from the plates. Discard the pins. Pins must not be reused.

Separate the two plate halves to open the sternum.

Note: Plate and screw removal is necessary for re-entry withthe Sternal Locking Plate 2.4, straight, without emergencyrelease pin or if sternal bony fusion has occurred. To facilitateplate and screw removal, the Synthes Universal Screw Re-moval Set 01.505.300 may be used.

Emergency Reentry

25°


Insert emergency release pin To reclose the sternum, a forceps or reduction instrumentmay be used to return the plate halves to their original posi-tions. Remove any soft tissue that could prevent them frominterdigitating properly.

Once the plate halves are coupled, insert a new titaniumemergency release pin. The closed end of the emergency re-lease pin should be oriented cranially with the sloped bendoriented anteriorly.

Bend the flat prong on the pin medially 20°–25°, to reducethe chance of pin migration.

Note: Avoid over-bending of the flat prong (>25°), as this can lead to breakage.

Emergency Reentry

Implants

Titanium Sternal Locking Body Plates

460.037 Sternal Locking Plate 2.4, X-shaped, 5+5 holes, Pure Titanium

460.038 Sternal Locking Plate 2.4,Double-T-shaped, 7+7 holes, Pure Titanium

460.039 Sternal Locking Plate 2.4, angle-shaped, 12 holes, Pure Titanium

460.040 Sternal Locking Plate 2.4, X-shaped, wide,5+5 holes, Pure Titanium

Synthes 25

Titanium Sternal Locking Straight Plates

460.045 Sternal Locking Plate 2.4, straight, 8 holes, Pure Titanium



460.024 Sternal Locking Plate 2.4, straight, 30 holes, Pure Titanium, sterile

460.046 Sternal Locking Plate 2.4, straight, 13 holes, without Emergency Release Pin,Pure Titanium

For sterile implants add suffix “S”.


Implants

Titanium Sternal Locking Manubrium Plates

460.027 Sternal Locking H-Plate 2.4, small, 4+4 holes, Pure Titanium

460.028 Sternal Locking H-Plate 2.4, large, 4+4 holes, Pure Titanium

460.035 Sternal Locking Plate 2.4, star-shaped, 3+3 holes, Pure Titanium

460.036 Sternal Locking Plate 2.4, star-shaped, 6+6 holes, Pure Titanium

460.022 Emergency Release Pin (TAN)

For sterile implants add suffix “S”.

Synthes 27

Titanium Sternal Locking Screws

Sternal UniLOCK self-tapping screws, � 3.0 mm

Art. No. Length

413.578 8 mm

413.580 10 mm

413.582 12 mm

413.584 14 mm

413.586 16 mm

413.588 18 mmFor screws in pack of 5, add suffix “.05”

Sternal UniLOCK self-drilling screws, � 3.0 mm

Art. No. Length

04.501.110 10 mm

04.501.112 12 mm

04.501.114 14 mm

04.501.116 16 mm

04.501.118 18 mm

04.501.120 20 mm

Bending screw

497.689 Bending Screw for UniLOCK Reconstruction Plates

For sterile screws add suffix “S”.


A full portfolio of instruments for preparationand insertion of the implants is available:

398.902 Sternal Reduction Forceps

Instruments

391.967 Shortcut 2.4/THORP, without rasp, required in pairs

329.400 Bending Template for ReconstructionPlates 2.4 to 4.0, length 295 mm

398.903 Sternal Reduction Forceps, angled, with ratchet lock

398.985 Reduction Forceps, ratchet lock, length 180 mm

Synthes 29


329.142 Bending Pliers with Nose, for Pure Titanium Plates 2.4 and 2.7

03.501.065 Calliper

Drill Bit � 1.5 mm, with Stop, 2-flute, for J-Latch Coupling

Art. No. Length/Stop

03.501.008 82/ 8 mm

03.501.010 82/10 mm

03.501.012 82/12 mm

03.501.014 82/14 mm

03.501.016 82/16 mm

03.501.018 82/18 mm

03.501.000 Drill Guide 1.5, with thread, for Sternal Locking Plates

03.501.074 Universal Calliper



313.939 Screwdriver Shaft 2.4/3.0, cruciform, not self-holding, with Hexagonal Coupling

313.940 Screwdriver, cruciform, with HoldingSleeve, for Cortex Screws � 2.4 mm

305.695 Insert for Module, for Bending Screw � 4.0 mm

313.970 Holding Sleeve, for Nos. 313.960 and 314.448

311.023 Ratcheting Screwdriver Handle, with Hexagonal Coupling

Instruments

Synthes 31

391.990 Cutting Pliers for Plates and Rods

0123 036.

000.

009

AD

60

1000

29

© 1

0/20

10 S

ynth

es, I

nc. o

r its

aff

iliat

es

All

right

s re

serv

ed

Synt

hes,

Sho

rtcu

t an

d U

niLO

CK

are

trad

emar

ks o

f Sy

nthe

s, In

c. o

r its

aff

iliat

es

All technique guides are available as PDF files at www.synthes.com/lit

Ö036.000.009öAD=ä

technique guidesynthes.vo.llnwd.net/o16/mobile/synthes international/kyo/cmf/pdf… · 398.902...

Documents