APEX TIBIAL NAILING SYSTEM - OrthoXel · enhanced biomechanical and biomedical performance. Cannulated nails from 8.5 to 13mm for insertion ... guide and reposition the C-arm to the

APEX TIBIAL NAILING SYSTEM

Surgical Technique Guide

Apex Tibial Nailing System Surgical Technique Guide 1

Contents Introduction ............................................................................................................................................ 2

Implant Features ..................................................................................................................................... 2

Indications ............................................................................................................................................... 4

Patient Positioning .................................................................................................................................. 5

Preoperative Planning: Nail Size Selection .............................................................................................. 5

Incision and Entry Portal.......................................................................................................................... 6

Reaming .................................................................................................................................................. 9

Nail Insertion ......................................................................................................................................... 10

Distal Locking ......................................................................................................................................... 13

Proximal Locking .................................................................................................................................... 16

Endcap Insertion.................................................................................................................................... 21

Nail Removal.......................................................................................................................................... 22

Implants ................................................................................................................................................. 23

Instruments ........................................................................................................................................... 25

Layout of Instruments in the case ......................................................................................................... 28


Introduction

The Apex Tibial Nailing System includes a comprehensive range of titanium nail, screw, and

endcap sizes to suit patient anatomy. The versatile proximal and distal locking options

provide controlled stability to a wide range of fractures of the tibia (Pg. 4 for indications).

Implant Features Screws Proximal Locking Options

Micromotion Locking

Dynamisation Locking

Standard Locking

Rigid Locking

A patented gliding insert system allows up to 1-mm of controlled axial motion

for two mediolateral screws, while simultaneously controlling torsion to

create a biomechanically optimal construct for secondary bone healing.

Addition of the locking endcap simultaneously locks up to four

proximal screws for ultimate rigidity when needed.

Dynamisation with the gliding insert allows axial fracture compression when

needed with unparalleled torsional stability and establishes a new standard

for stable dynamization.

Universally accepted standard cross-

locking with two oblique screws and a

standard endcap.


Implant Features

Screws

Endcaps

Distal Locking

5mm Extension

10mm Extension

15mm Extension

0mm Extension (Flush with top of Nail)

0mm Locking Endcap

Ø4.5mm length 20 to 100mm for Ø8.5 to 10mm Nails

Ø5.0mm length 25 to 100mm for Ø11.5 to 13mm Nails

Choose from two medio-lateral (ML) and one

antero-posterior (AP) locking screw

The Endcaps prevent ingrowth of tissue, flush (0mm), 5, 10 &

15-mm extensions. The Locking Endcap securely clamps all

proximal locking screws to create a substantially rigid

construct.

Nails Anatomic bend for ease of nail insertion Titanium (Ti6AL4V) Type II anodised for enhanced biomechanical and biomedical performance. Cannulated nails from 8.5 to 13mm for insertion over a ball tip guidewire


Indications

The Apex Tibial Nailing System is intended for temporary fixation and stabilization in

fractures of the tibia. The Apex Nail is indicated for used in adult patients for treatment of:

• Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;

• Fractures involving osteopenic or osteoporotic bone;

• Fractures with bone loss;

• Treatment of pseudoarthosis, non-union, and malunion;

• Correction osteotomy;

• Pathologic fractures and prophylactic nailing of impending pathologic fractures; and

• Reconstruction following tumour resection.


Patient Positioning

Place the patient supine on the radiolucent table. Check leg length and rotation by

comparison to the unaffected limb. Flex the injured limb to 90° and use a bolster or

radiolucent triangle to maintain limb position. A distraction device or temporary external

fixator may be used to maintain fracture reduction if necessary. Position the C-arm to allow

visualisation of the entire tibia in both the AP and lateral views.

Preoperative Planning: Nail Size Selection

Length Estimation

Position the C-arm to produce an AP view of the distal

tibia. Select the Reamer/Nail Diameter Length Gauge

INS-1011 and hold the guide parallel to the tibia. Adjust

the position of the guide so that its distal tip appears at

the intended final position of the implant, ideally at the

level of the physeal scar. Mark the skin at the tip of the

guide and reposition the C-arm to the proximal tibia.

Replace the length gauge and align the tip with the

mark on the skin. Measure the required nail length

from the C-arm view, selecting a length that will place

the proximal end of the implant at or just below the tibial plateau.

Alternative Method: If anatomic length is difficult to measure on the affected limb, carry out

the measurement procedure on the unaffected limb prior to draping.

Note: If primary dynamisation is intended, a shorter nail length must be chosen, and the

implant inserted well below the tibial plateau. Dynamic locking allows up to 6mm of axial

compression, which may result in a protruding nail stem or endcap, especially for unstable

fractures.


Preoperative Planning: Nail Size Selection

Diameter Estimation

Reposition the C-arm to produce an AP view of

the tibial diaphysis. Hold the Reamer/Nail

Diameter Length Gauge INS-1011 over the tibia

at the narrowest portion of the medullary canal.

Read the diameter measurement that most

closely matches the canal.

Note: Nail diameter should be confirmed during

reaming by the cortical chatter technique. The

chosen nail diameter should be 0.5 to 1.5-mm

smaller than the largest reamer used.

Incision and Entry Portal

Approach and Entry Point

Make a 2-cm midline incision along the central axis of the medullary canal, from the centre

of the patellar tendon to the top of the tibial plateau. The subcutaneous approach may be

patellar splitting or parapatellar, either medial or lateral in orientation.

The ideal nail entry point is in line with the axis of the tibia, starting just medial to the lateral

tibial eminence in the AP view and at the anterior edge of the articular margin on tibial

plateau in the lateral view.



Entry K-Wire Placement

Insert the K-Wire Ø1.8mm x Length 350mm INS-1019 into the Keyless Chuck INS-1022 or

cannulated drill and tighten securely by hand. Align the K-wire at approximately 10° to the

tibial shaft. Push the K-wire into the tibial metaphysis, maintaining the 10° alignment to the

tibial shaft. Advance the K-wire approximately 8-10-cm and verify K- wire placement with

the C-arm. Remove the keyless chuck from the K- wire.



Options for Opening the Entry Portal

Option 1:

Place the Skin Protector INS-1023 posterior to the

K-wire and advance it to contact the tibial plateau.

Connect the Opening Reamer Ø13mm INS-1013 to

the cannulated drill and place over the K-wire,

anterior to the skin protector. Enlarge the tibial

opening until the reamer enters the canal. Take

care not to contact the posterior cortex with the

reamer.

Remove the reamer, skin protector, and K-wire.

Option 2:

Alternatively, place the Cannulated Curved Awl

INS-1024 over the K-wire and advance the awl

gradually using a twisting motion, maintaining

alignment with the tibial canal. The awl should not

touch the posterior cortex. After opening the

portal, remove the awl and the K-wire.


Reaming

Place the ball tip reaming guidewire into the

medullary canal, advancing the tip carefully past the

fracture line and into the distal tibia to the desired

depth. Confirm fracture reduction using the C-arm.

Begin reaming with the smallest available reamer

head. Place the reamer over the reaming guide wire,

through the entry portal, and into the medullary

canal. Advance the reamer with steady moderate

pressure. Do not force the reamer. If necessary,

periodically move the reamer up and down the guide

wire to remove reaming debris from the canal and

clear the cutting flutes.

Increase reamer sizes sequentially in 0.5-mm

increments until cortical chatter is detected during

reaming. The chosen nail diameter must be at least

0.5-mm smaller and ideally 1.0-1.5-mm smaller than

last reamer used.

Monitor reaming using the C-arm to avoid eccentric

reaming, loss of reduction, or excessive cortical bone

removal.

Important Technical Note

The Apex Tibial Nail is cannulated and will allow

passage of a straight guidewire or a guidewire with a

ball tip of less than 3.5-mm diameter. If the ball tip is

greater than 3.5-mm exchange the guidewire before

nail implantation.


Nail Insertion

Insertion Assembly

Assemble the Tibial Nail Insertion Handle INS-1003 to

the proximal end of the nail using Tibial Nail Insertion

Bolt INS-1001 and tighten using Combination Wrench

INS-1010 (or optionally Closed-End Ratchet Wrench

INS-1029 if available).

Note: the insertion handle will only attach in a single

orientation to the angled end of the nail.

Attach the Supine Driver INS-1012 if required for

additional grip during insertion.

After the Insertion bolt has been fully tightened and the instrumentation fixed rigidly to the

proximal end of the nail, remove the purple alignment pin from the nail stem.


Nail Insertion

Important Safety Check

Before implanting the nail, verify

the alignment of the proximal drill

guide assembly. Attach the Tibial

Radiolucent ML Guide INS-1002 to

the insertion handle. Assemble the

drill targeting sleeves by placing

the Yellow Ø4.0mm Drill Sleeve

INS-1027 into the Green Ø10mm

Drill Sleeve INS-1025 and then

passing these through the proximal

ML hole in the radiolucent drill

guide. Slip the Twist Drill Ø3.5mm x length 305mm INS-1016 through the drill sleeves and

verify that the drill bit passes through the centre of the locking hole in the nail. Remove drill

bit and sleeves and replace them in the distal hole of the radiolucent guide. Again, confirm

that the drill bit passes easily through the locking hole of the nail. If the alignment is

accurate for both holes, remove the drill bit, sleeves, and radiolucent guide.

Note: if the 3.5-mm drill bit does not pass through either of the locking holes during this

safety check, do not implant the nail. This situation can occur if the alignment pin was

removed before assembly of the tibial nail insertion handle and insertion bolt. To correct the

alignment, remove the insertion handle and insertion bolt and replace the alignment pin.

Then, reattach the insertion assembly as shown on page 10. Repeat the alignment safety

check.

Alternative Approach: The Tibial Radiolucent Guide Oblique INS-1005 can also be used.


Nail Insertion

Nail Implantation

With all drill guides removed, pass the nail over the guidewire and into the tibial entry

portal. Use a twisting motion and steady pressure to advance the nail into the medullary

canal. If additional force is required to seat the nail, attach Slide Hammer INS-1014 and slide

the impact weight to generate axial light blows. Use of any other device to generate impact

on the insertion assembly may damage the implant and instruments. If necessary, consider

additional reaming or a smaller-diameter nail.

Take care when passing the fracture line and advance the nail until the proximal stem sits

below the tibial plateau. Confirm fracture reduction and final nail position using the C-arm

in both the AP and lateral views.

Important Technical Note:

Removing the drill guides before nail implantation enables easier manoeuvring of the

implant and reduces the potential for damage or loosening of the drill guide during nail

insertion.

Important Safety Note:

In distal-third fractures, at least two locking screws must be located below the fracture line.

Confirm the position of the distal tip using the C-arm.


Distal Locking


Distal locking should be completed first. This allows the surgeon to perform a backstroke of

the slide hammer to close the fracture gap when appropriate.

Screw and Drill Bit Selection

The Apex Tibial Nail has two ML locking holes and one AP locking

hole. The use of at least two distal locking screws is recommended to

avoid premature screw failure.

Nail Ø Locking Screw Ø

Drill Diameter Drill Sleeve

8.5 &10mm 4.5mm 3.5mm

(INS-1016) Black

(INS-1028)

11.5 & 13mm 5.0mm 4.0mm

(INS-1017) Yellow

(INS-1027)

Freehand Technique

Verify the nail position in the distal tibia in both the AP and lateral views.

Align the C-arm to produce a perfect circle image for the intended locking hole. Align a

scalpel blade with this hole and make a stab wound down to the bone.

Place the tip of the drill bit through the skin and confirm its alignment with the chosen hole

on the C-arm image. Drill though both cortices.

Confirm that the drill has passed through the locking hole before withdrawing the drill from

the tibia.


Distal Locking Measure Required Screw Length

The required screw length is determined using Locking Screw Depth Measurement Gauge

INS-1015 and Yellow Ø4.0mm Drill Sleeve INS-1027. Place the gauge through the two

cortices of the pilot hole until the hook grasps the far cortex. Slide the drill sleeve over the

gauge and read the screw length required directly from where the end of the drill sleeve

aligns with the gauge.

Select a screw of appropriate diameter and length and

insert using Locking Screw Driver INS-1008.

Using the C-arm, verify that the tip of the locking screw

does not project past the far cortex.

Repeat the procedure for any additional screws.


Distal Locking

Alternative Technique for Measuring Required Screw Length:

Insert K-Wire Ø1.8mm x Length 350mm INS-1019 through both cortices and remove the

drill hand piece. Slide the Red Ø2.0 drill sleeve INS-1026 and Length Gauge used with K-

Wire INS-1021 over the K-wire, read the screw length required directly from where the end

of the K-wire aligns with the gauge.


Proximal Locking

Proximal Locking Configurations

Proximal Dynamisation: One gliding bone screw allows

axial movement with enhanced torsional stability

Proximal Micromotion: Two ML bone screws provide

torsional stability with controlled axial movement..

Proximal cross-locking: Two oblique bone screws and an optional locking endcap provide stability for proximal fractures.


Proximal Locking

Mediolateral Locking Screws

Confirm that the nail and tibial nail insertion handle are still firmly connected.

Attach Tibia Radiolucent ML Guide INS-1002 to

the insertion handle by tightening the black knob.


Do not impact the aiming instrumentation or

exert excessive force on the drill guide, drill

sleeves, or drill bits. Doing so may damage the

instruments or cause mis-alignment of the drilled

holes.

Assemble the trocar combination by sliding the Yellow Ø4.0mm Drill Sleeve INS-1027 into

the Green Ø10mm Drill Sleeve INS-1025. Slide the pair of sleeves into the desired hole in the

drill guide and up to the skin. Insert the Trocar Ø4.0mm x Length 240mm INS-1018 and

make a stab incision to the bone. Remove the trocar and inner yellow drill sleeve.


Proximal Locking

Slide the green drill sleeve to the

bone, pressing firmly against the

near cortex. Lock in position by

rotating the black locking dial

clockwise as shown in the

diagram.


Select the correct drill sleeves and drill bit to suit

the chosen nail.

Nail Ø Locking Screw Ø

Drill Diameter Drill Sleeve

8.5 &10mm 4.5mm 3.5mm

(INS-1016) Black

(INS-1028)

11.5 & 13mm 5.0mm 4.0mm

(INS-1017) Yellow

(INS-1027)

Drill through both cortices until the tip of the drill

penetrates the far cortex. Remove the drill bit.


Proximal Locking

Check that the green drill sleeve remains firmly

pressed against the near cortex. Insert Locking

Screw Depth Measurement Gauge INS-1015

through both cortices until the hook grasps the

far cortex. Read the screw length required

directly from where the end of the drill sleeve

aligns with the gauge.

Remove internal yellow sleeve, leaving the outer

green sleeve. Select a screw of appropriate

diameter and length and insert using Locking

Screw Driver INS-1008.

Using the C-arm, verify that the tip of the locking

screw does not project past the far cortex.

Repeat the procedure for any additional screws.


Proximal Locking

Oblique Locking Screws

Attach Tibia Radiolucent Guide Oblique INS-1005 to

the Tibial Nail Insertion Handle INS-1003 by tightening the black knob.

Drill, measure, and insert oblique screws in the cross-locking configuration as described in

the mediolateratal screw procedure.

If desired, proximal cross-locking can be

performed with the leg in a semi-extended

position to neutralise the quadriceps forces on

the proximal bone fragment and fascilitate

fracture reduction.


Drilling for proximal cross-locking requires special

care to avoid damaging the tibial nerve, common

peroneal nerve, popliteal artery, and the

tibiofibular joint. Avoid these structures by

stopping the drill bit before it completely

penetrates the far cortex.


Endcap Insertion

Standard Endcaps

The purpose of the endcap is to prevent bony

ingrowth around the nail by filling the nail cannulus

and part of the entry portal if necessary. Endcaps

are available in a range of lengths from flush (0-mm)

up to 15-mm.

To place a standard endcap, first remove all aiming

and insertion instrumentation. Select an appropriate

endcap and thread the endcap into the proximal

end of the nail using Endcap Driver INS-1007.

Locking Endcap

In addition to the standard endcaps, a locking endcap is

also available that engages with the proximal stem insert

to secure the proximal screws and create a fixed-angle

construct.

To place a locking endcap, first remove all aiming and

insertion instrumentation. Thread the locking endcap into

the proximal end of the nail with Endcap Driver INS-1007.


The patient’s leg should be positioned in flexion to provide easy access to the proximal nail

stem for endcap insertion.


Nail Removal

Make an incision and expose the nail entry site. Clear any tissue growth from around the

endcap. Remove the end cap with Endcap Driver INS-1007. Attach Tibial Nail Extraction Bolt

INS-1004 to the end of the nail and tighten using Combination Wrench INS-1010 (or

optionally Closed-End Ratchet Wrench INS-1029 if available).

Remove all locking screws using Locking Screw Driver INS-1008.

If required attach the Supine driver INS-1012 and or Slide hammer INS-1014. Use light blows

of the slide hammer to extract the nail.


Implants

Nail sizes

Nail Length (mm)

Catalogue Number

8.5mm Ø 10mm

255 T01-850255 T01-100255

270 T01-850270 T01-100270

285 T01-850285 T01-100285

300 T01-850300 T01-100300

315 T01-850315 T01-100315

330 T01-850330 T01-100330

345 T01-850345 T01-100345

360 T01-850360 T01-100360

375 T01-850375 T01-100375

390 T01-850390 T01-100390

405 T01-850405 T01-100405

420 T01-850420 T01-100420

Nail Length (mm)

Catalogue Number

Ø 11.5mm Ø 13mm

255 T01-115255 T01-130255

270 T01-115270 T01-130270

285 T01-115285 T01-130285

300 T01-115300 T01-130300

315 T01-115315 T01-130315

330 T01-115330 T01-130330

345 T01-115345 T01-130345

360 T01-115360 T01-130360

375 T01-115375 T01-130375

390 T01-115390 T01-130390

405 T01-115405 T01-130405

420 T01-115420 T01-130420

10°

59m

m

31

mm

2°


Implants

Screw sizes

Endcap sizes

Standard Endcap Catalogue Number

Length (mm)

Locking Endcap Catalogue Number

Length (mm)

E01-000 0 LE01-000 0

E01-005 5

E01-010 10

E01-015 15

Catalogue Number Ø 4.5mm

Catalogue Number Ø 5mm

LS01-45020 20

LS01-50025 25

LS01-45025 25

LS01-50030 30

LS01-45030 30

LS01-50035 35

LS01-45035 35

LS01-50040 40

LS01-45040 40

LS01-50045 45

LS01-45045 45

LS01-50050 50

LS01-45050 50

LS01-50055 55

LS01-45055 55

LS01-50060 60

LS01-45060 60

LS01-50065 65

LS01-45065 65

LS01-50070 70

LS01-45070 70

LS01-50075 75

LS01-45075 75

LS01-50080 80

LS01-45080 80

LS01-50085 85

LS01-45085 85

LS01-50090 90

LS01-45090 90

LS01-50095 95

LS01-45095 95

LS01-50100 100

LS01-45100 100

5mm

15mm

10mm

0mm


Instruments

Standard Instrumentation

Catalogue Number

Description Image

INS-1007 Endcap Driver

INS-1008 Locking Screw Driver

INS-1010 Combination

Wrench

INS-1011 Reamer/Nail

Length/Diameter Gauge

INS-1012 Supine Driver

INS-1013 Opening Reamer

Ø13mm

INS-1014 Slide Hammer

INS-1015 Locking Screw Depth

Measurement Gauge

INS-1016 Twist Drill Ø3.5mm

X Length 305mm

INS-1017 Twist Drill Ø4.0mm

X Length 305mm

INS-1018 Trocar Ø4.0mm X

Length 240mm

INS-1019 K-Wire Ø1.8mm X

Length 350mm

INS-1021 Length Gauge used

with K-Wire

INS-1022 Keyless Chuck


Instruments

Standard Instrumentation (contd.)

INS-1023 Skin Protector

INS-1024 Cannulated Curved AWL

INS-1001 Tibial Nail

Insertion Bolt

INS-1002 Tibial

Radiolucent ML Guide

INS-1003 Tibial Nail Insertion Handle

INS-1004 Tibial Nail

Extraction Bolt

INS-1005 Tibial

Radiolucent Guide Oblique

INS-1025 Green Ø10mm

Drill Sleeve

INS-1026 Red Ø2.0mm Drill Sleeve

INS-1027 Yellow Ø4.0mm

Drill Sleeve

INS-1028 Black Ø3.5mm

Drill Sleeve


Instruments

Instrument Cases

Optional Instrumentation

INS-1006 Apex Tibial Nail System Tray I

INS-1033 Apex Tibial Nail System Tray II

INS-1034 Apex Tibial Nail System Tray III

INS-1029 Closed-End

Ratchet Wrench

INS-1020 Reamer / Nail

Screw Template

INS-1032 Guide Rod, Ø2.4mm x

Length 900mm

INS-1030 Drill Bit

Ø3.5mm x Length 150mm

INS-1031 Drill Bit

Ø4.0mm x Length 150mm


Layout of Instruments in the case


Layout of Instruments in the case

OrthoXel, Rubicon Centre,

Bishopstown, Cork T12 Y275

Telephone: 021-2429 500

Email: [email protected] Website: www.orthoxel.net

Contact Details

©OrthoXel DAC. Subject to modifications. OrthoXel DAC own, use or have

applied for the following trademarks; OrthoXel, Apex, Apex Nail,

Micromotion and Micromotion Nail.

All products listed above are CE marked.

CK-DHF1-IFU-003 Rev 4 Apex Tibial Nailing System Surgical Technique Guide

mailto:[email protected]

http://www.orthoxel.net/

Documents

APEX TIBIAL NAILING SYSTEM - OrthoXel · enhanced biomechanical and biomedical performance. Cannulated nails from 8.5 to 13mm for insertion ... guide and reposition the C-arm to the