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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
Apex Tibial Nailing System Surgical Technique Guide 2
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.
Apex Tibial Nailing System Surgical Technique Guide 3
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
Apex Tibial Nailing System Surgical Technique Guide 4
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.
Apex Tibial Nailing System Surgical Technique Guide 5
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.
Apex Tibial Nailing System Surgical Technique Guide 6
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.
Apex Tibial Nailing System Surgical Technique Guide 7
Incision and Entry Portal
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.
Apex Tibial Nailing System Surgical Technique Guide 8
Incision and Entry Portal
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.
Apex Tibial Nailing System Surgical Technique Guide 9
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.
Apex Tibial Nailing System Surgical Technique Guide 10
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.
Apex Tibial Nailing System Surgical Technique Guide 11
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.
Apex Tibial Nailing System Surgical Technique Guide 12
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.
Apex Tibial Nailing System Surgical Technique Guide 13
Distal Locking
Important Technical Note:
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.
Apex Tibial Nailing System Surgical Technique Guide 14
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.
Apex Tibial Nailing System Surgical Technique Guide 15
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.
Apex Tibial Nailing System Surgical Technique Guide 16
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.
Apex Tibial Nailing System Surgical Technique Guide 17
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.
Important Safety Note:
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.
Apex Tibial Nailing System Surgical Technique Guide 18
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.
Important Technical Note:
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.
Apex Tibial Nailing System Surgical Technique Guide 19
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.
Apex Tibial Nailing System Surgical Technique Guide 20
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.
Important Safety Note:
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.
Apex Tibial Nailing System Surgical Technique Guide 21
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.
Important Technical Note:
The patient’s leg should be positioned in flexion to provide easy access to the proximal nail
stem for endcap insertion.
Apex Tibial Nailing System Surgical Technique Guide 22
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.
Apex Tibial Nailing System Surgical Technique Guide 23
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°
Apex Tibial Nailing System Surgical Technique Guide 24
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
Apex Tibial Nailing System Surgical Technique Guide 25
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
Apex Tibial Nailing System Surgical Technique Guide 26
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
Apex Tibial Nailing System Surgical Technique Guide 27
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
Apex Tibial Nailing System Surgical Technique Guide 28
Layout of Instruments in the case
Apex Tibial Nailing System Surgical Technique Guide 29
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