T-PAL. Transforaminal Posterior Atraumatic …synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...T-PAL. Transforaminal Posterior Atraumatic Lumbar Cage System. Technique Guide This

T-PAL. Transforaminal PosteriorAtraumatic Lumbar Cage System.

Technique Guide

This publication is not intended fordistribution in the USA.

Instruments and implants approved by the AO Foundation.

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use ofthe instrument set. Instruction by a surgeon experienced in handling theseinstruments is highly 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

Table of Contents

Introduction

Surgical Technique

Product Information

T-PAL 2

AO Principles 4

Indications and Contraindications 5

Preoperative Planning and Preparation 6

Patient Positioning 7

Access and Exposure 8Minimally invasive transforaminal approach 8Open transforaminal approach 10

Discectomy 11

Disc Space Preparation 12

Trial for Implant Size 13

Implant Preparation 23

PEEK Implant Insertion 26

Titanium Implant Insertion 30

Posterior Support 34

Implant Removal 35

Implants 38

Instruments 40

Sets 44

Applicator Instructions 46

Function control 49

T-PAL Technique Guide DePuy Synthes 1

– Rails on top of the implant, guide and turn the cage between the vertebral bodies into the desired position

– Three x-ray markers help to visualize the implant under radiographic control

T-PAL. Transforaminal PosteriorAtraumatic Lumbar Cage System.

Implant with guiding rails

MaterialAvailable in two materials; PEEK (with Titanium alloy marker pins [TAN]); Titanium alloy (TAN)

Two anterior radiographic marker pinsEnable visualization of the anterior implant positionThe B 1.4 pins are located approximately 2.0 mm from the anterior edge of the implant

One proximal radiographic marker pinEnable visualization of implant tip position whileinsertion

Connection cylinderPermits the pivoting mechanism in combination with the applicator

Axial windowAccommodates autogenous bone graft or bone graft substitute to allow fusion to occur through the cage

Rails on the surfaceGuide and turn the cage into the desired position

Pyramidal teethProvide resistance to implant migration

Self-distracting noseAllows for ease of insertion

Lordotic angle5° to restore the natural spine lordotic curve (except for the 7 mm height)

2 DePuy Synthes T-PAL Technique Guide

– Trial implants can beplaced at the same posi-tion, where after the implant will be placed

– Guided insertion becauseof the pivoting applicatorand the rails on the surface of the implantsand trials

– Secure insertion becauseof permanent connectionto the implants and trialsduring insertion process

– Simple OR techniquebased on one key instru-ment: the applicator

– Designed for minimallyinvasive surgical tech-nique

Guided insertion technique

– One key instrument for insertionof implant and trials

– Applicator allows a controlled andguided insertion based on the pivoting option

– Security button to prevent implantdisengagement

– Applicator is designed for minimally invasive surgeries

One surgery,one instrument

AP trial marker Lateral trial marker


AO Principles

1Müller ME, Allgöwer M, Schneider R, Willenegger H (1995) Manual of Internal Fixation. 3rd, expanded and completely revised ed. 1991. Berlin,Heidelberg, New York: Springer

2Aebi M, Arlet V, Webb JK (2007). AOSpine Manual (2 vols), Stuttgart, New York:Thieme

In 1958, the AO formulated four basic principles1, whichhave become the guidelines for internal fixation. They are:– Anatomical reduction– Stable internal fixation– Preservation of blood supply– Early, active pain-free mobilization

The fundamental aims of fracture treatment in the limbsand fusion of the spine are the same. A specific goal in thespine is returning as much function as possible to theinjured neural elements.2

AO Principles as applied to the Spine2

Anatomical reductionRestoration of normal spinal alignment to improve the biomechanics of the spine.

Stable internal fixationStabilization of the spinal segment to promote bony fusion.

Preservation of blood supplyCreation of an optimal environment for fusion.

Early, active pain-free mobilizationMinimization of damage to the spinal vasculature, dura, andneural elements, which may contribute to pain reduction andimproved function for the patient.


Indications and Contraindications

Intended useThe T-PAL implant is intended to replace lumbar interverte-bral discs and to fuse the adjacent vertebral bodies togetherat vertebral levels L1–S1. The T-PAL implant is designed fora transforaminal approach.

IndicationsIndications are lumbar and lubosacral pathologies in whichsegmental spondylodesis is indicated, for example:– Degenerative disc diseases and spinal instabilities– Revision procedures for post-discectomy syndrome– Pseudarthrosis or failed spondylodesis– Degenerative spondylolisthesis– Isthmic spondylolisthesis

Contraindications– Vertebral body fractures– Spinal tumours– Major spinal instabilities– Primary spinal deformities– Osteoporosis

Important: T-PAL must be applied in combination with posterior fixation.


Preparation

Set

01.812.001 Set T-PAL

Optional sets

01.809.011 Dilation Instrument Set

01.615.004 Insight Tube Set, Standard Configurationor01.615.002 Insight Retractor Set, Standard Configuration

01.612.100 Set for MIS Support System

01.605.903 Set for Minimally Invasive Posterior Instruments

Have all necessary imaging studies readily available to planimplant placement and visualize individual patient anatomy.

Have all sets readily available prior to surgery.

Preoperative Planning and Preparation


Position the patient

Position the patient in a restored physiological lordosis anddecompress the abdomen to minimize venous stasis.

Patient Positioning


1Approach

Optional sets


01.615.004 Insight Tube Setor01.615.002 Insight Retractor Set

01.612.110 MIS Support System

Locate the correct operative level with fluoroscopic views.Push the Kirschner wire into the desired facet joint. Separatethe posterior soft tissue by inserting the smallest diameterdilator over the Kirschner wire. Repeat with next larger diameter dilator until required dilation is achieved. Use fluo-roscopy to determine the location of dilator.

Access and Exposure Minimally invasive transforaminalapproach

2aRetraction with insight tubes

Instrument set

01.615.004 Insight Tube Set

Optional sets



Determine the appropriate tube length from the depth indicators on the dilators.

Slide the tube over the dilators until it contacts the facet joint.

Use the flex arm to stabilize the tube to the OR table. Remove the dilators and the Kirschner wire.


2bRetraction with insight retractor

Instrument set

01.615.002 Insight Retractor Set

Optional Sets



Determine the appropriate retractor lengths of thecranial/caudal and medial/lateral blades from the depth indicators on the dilators.

Slide the retractor with the cranial/caudal blades over thedilators until the blades contact the facet joints. Distract theblades and introduce the second retractor with the medial/lateral blades.

Use the flex arm to stabilize the retractor to the OR table. Remove the dilators and the Kirschner wire.

3Cut transforaminal window

Instruments

03.605.508 Osteotome, straight, black

03.605.520 Laminectomy Punch, 40°, 4.0 mm, black

Prepare a window for the transforaminal approach usingthe osteotome to remove the inferior facet of the cranial vertebra and the superior facet of the caudal vertebra.

With the punch, additional bone or osteophytes can be removed.


1Retraction with an open transforaminal approach

Instrument

03.812.040 Lamina Spreader for T-PAL

Make a standard open incision, retract the muscle layer toview the desired segment.

Distract the segment if desired. Position the lamina spreaderfor T-PAL at the base of the spinous processes. Distract carefully until required distraction is achieved.

Distraction opens the posterior disc space and promotes exposure both for decompression and delivery of the implant.

2Cut transforaminal window

Instruments



Prepare a window for the transforaminal approach usingthe osteotome to remove the inferior facet of the cranial vertebra and the superior facet of the caudal vertebra.

With the laminectomy punch, additional bone or osteophytes can be removed.

Access and Exposure Open transforaminal approach


Instruments

03.605.507 Rasp, dual-sided, bayoneted, black

03.605.510 Ring Curette, straight, bayoneted, black

03.605.514 Rongeur, curved, 4.0 mm, black


03.605.527 Rongeur, straight, 4.0 mm, black

03.605.529 Curette, rectangular, angled, right, bayoneted, black

03.605.530 Curette, rectangular, angled, left, bayoneted, black

03.803.054 Curette, rectangular, bayoneted, black

389.767 – Shaver for Intervertebral Discs, 389.777 size 7–17 mm

394.951 T-Handle with Quick Coupling

Through an incision above the pedicle, access the foramenand remove disc material, using any of the following instru-ments: box and ring curettes, rongeurs as well as disc shavers.

The annulus must be preserved to provide additional supportfor the T-PAL implant and prevent migration of bone graftand bone graft substitute into the spinal canal.

The shavers can initially be used to ream out disc material orfor final removal of the disc material and cartilaginous tissue.

For removal of the tissue in the far lateral disc space, usethe left/right angled curettes and the curved rongeur.

Important: Provide enough lateral exposure to the disc tominimize dural retraction.

Discectomy


1Prepare endplates

Instrument

03.605.511 Rasp, dual-sided, angled, bayoneted, black

When the discectomy is completed, use the rasp to removethe superficial cartilaginous layers of the endplates to exposethe bleeding bone.

Important: Excessive removal of the subchondral bone mayweaken the vertebral endplate. The entire removal of theendplate may result in subsidence and a loss of segmentalstability.

Disc Space Preparation

2Pack disc space

Instrument

03.605.532 Impactor, curved, standard, bayoneted, black

Before the T-PAL cage is implanted, the anterior and far lateral disc space should be filled with bone graft or bonegraft substitute.

Note: For more information about the filling materialchronOS see page 50.


1

2

3

Trial for Implant Size

1Assemble applicator and connect non detachable trial implant

Instruments

03.812.001 Applicator Outer Shaft

03.812.307– T-PAL Small Trial Implant size 7–17 mm, 03.812.317 non detachable

03.812.507– T-PAL Large Trial Implant size 7–17 mm, 03.812.517 non detachable

03.812.004 Applicator Knob

The applicator must be assembled before insertion of thetrial.

Attach the applicator knob to the proximal end of the appli-cator outer shaft by turning the knob counterclockwise untilit stops (1).

Select an appropriately size trial implant. Insert the trial im-plant shaft into the applicator outer shaft making sure thatthe arrow on the outer shaft is aligned with the distal open-ing of the trial implant shaft (2). The trial implant shaftshould now be trapped inside the applicator outer shaft (3).

Turn the applicator knob clockwise to secure the trial implant.During this attaching procedure the security ring moves upwards, so that the green color band is visible. Continue toturn the knob until it is tightened.

Important: Ensure the arrows on the end of the applicatoralign with those on the trial implant. The contact surfacesbetween the trial and the applicator should have no gap (3).

Note: For disassembly pull the security ring down, turn theapplicator knob counterclockwise until it stops. Push thesmall button on the applicator knob and simultaneously pullthe trial implant shaft out of the applicator outer shaft. Turnthe applicator knob clockwise. For detailed disassembly in-structions please refer to page 48.

Important: Please read first the applicator instructions onpage 46 –47.


1

2

3


Optional: Assemble applicator and connect trialimplant

Instruments


03.812.003 Applicator Inner Shaft


The applicator must be assembled before insertion of thetrial.

Attach the applicator knob to the proximal end of the appli-cator outer shaft by turning the knob counterclockwise untilit stops (1).

Insert the applicator inner shaft into the applicator outershaft making sure that the arrow on the outer shaft isaligned with the distal opening of the inner shaft (2). The applicator inner shaft should now be trapped insidethe outer shaft (3).

Note: For disassembly pull the security ring down, turn theapplicator knob counterclockwise until it stops. Push thesmall button on the applicator knob and simultaneously pullthe inner shaft out of the outer shaft. Turn the applicatorknob clockwise. For detailed disassembly instructions pleaserefer to page 48.

Important: Please read first the applicator instructions onpage 46 –47.


1 2

3

Connect trial implant to the applicator

Instruments




03.812.007– T-PAL Small Trial Implant, size 7–17 mm03.812.017

03.812.207– T-PAL Large Trial Implant, size 7–17 mm03.812.217

Connect an appropriately sized trial implant to theapplicator. Pull the security ring down and simultaneouslyturn the knob at the proximal end of the applicator counter-clockwise. The applicator jaws open (1). Place the jaws overthe proximal end of the trial implant making sure to align thearrows on the end of the applicator with those on the trialimplant (2).

Turn the applicator knob clockwise to close the jaws. Duringthis closing procedure the security ring moves upwards, sothat the green color band is visible (3). Continue to turn theknob until it is tightened (2).

Note: When the applicator knob remains tightened, the trialimplant can not pivot or detach.

Important: Ensure the arrows on the end of the applicatoralign with those on the trial implant. The contact surfacesbetween the trial implant and the applicator should have nogap (2).


10 –15°

1

2

3


2Insert trial implant

Optional instrument

SFW691R Prodisc-L Combined Hammer

Recheck the firm connection of trial implant to applicator. Insert the trial implant into the disc space, ensuring that theorientation of the trial implant is correct. The trial implant tipshould be orientated medial. Maintain 10 –15° between theapplicator handle and the sagittal plane during trial implantinsertion (1).Controlled and light hammering on the applicator may be required to advance the trial implant into the intervertebraldisc space. Use fluoroscopy to confirm position and fit of thetrial implant. The tip should be positioned near the anterioredge of the adjacent vertebral bodies (2).

Notes:– Firm connection of trial implant to applicator can be

checked manually by applying pressure on the lateral sideof the trial implant with the thumb. Trial implant shouldnot pivot.

– Use soft tissue retractor 389.857 –389.859 to protectsoft tissue.

– Use fluoroscopy during the insertion to confirm anteriorpositioning of the trial implant.

Important:– The trial tip indicates approximate final anterior position

of trial implant (3).– Maintain 10 –15° between the applicator handle and the

sagittal plane during trial implant insertion.


10 –15°

10 –15°

2

13 Position trial implant

Optional Instrument


Turn the applicator knob counterclockwise until it stops (1)

Note: Ensure applicator knob is turned counterclockwise un-til it stops to avoid trial or applicator outershaft deformation.

Controlled and light hammering on the applicator may be required to pivot the trial implant into final position (2).Use fluoroscopy during the pivoting procedure and confirmfit and position of the trial implant. Each trial has amedial/lateral and an anterior/posterior opening for positioncontrol. If the trial implant appears too small or too tight, trythe next larger or smaller size height until the most secure fitis achieved.

Note: Ensure that the trial implant is positioned where theimplant will be placed.

Important:– Maintain 10 –15° between the applicator handle and the

sagittal plane during trial implant insertion.– Do not detach the trial implant in the disc space.


10 –15°

1 2

Optional: Position trial implant

If trial implant does not pivot automatically, turn the applica-tor handle medially to initiate pivoting upon impaction (1).After pivoting is initiated the applicator handle must beturned back to an angle of 10 –15° from the sagittal planeto pivot the trial implant into final position (2).

Important: Maintain 10 –15° between the applicator handleand the sagittal plane for final trial implant insertion.



1 24Remove non detachable trial implant

Instruments

03.809.972 Oracle Slide Hammer


Optional instrument


Important: The applicator must be in the pivoting positionto remove the trial implant.

Slide the slide hammer onto the end of the applicator knobwith quick coupling (1). While holding the handle with onehand, apply an upward force to the slide hammer with theother hand. Repeat this procedure until the trial implant is removed (2).

Optionally the combination hammer may also be used to remove the trial implant.

Remove the slide hammer from the handle by pushing onthe end of the slide hammer.


43

5


To detach the trial implant from the applicator pull the secu-rity ring down simultaneously turn the knob counterclock-wise until it stops (3). Push the small button on the applica-tor knob and remove the trial implant (4).

Insert the applicator inner shaft into the applicator outershaft making sure that the arrow on the outer shaft isaligned with the distal opening of the inner shaft (5). The applicator inner shaft should now be trapped inside theouter shaft. The applicator is know ready to accept the im-plant.

Note: If the security ring cannot be pulled down, turn theknob clockwise a quarter turn. The ring can now be pulleddown.


1 2Optional: Remove trial implant

Instrument


Optional instrument


Important: The applicator must be in the pivoting positionto remove the trial implant.

Slide the slide hammer onto the end of the applicator knobwith quick coupling (1). While holding the handle with onehand, apply an upward force to the slide hammer with theother hand. Repeat this procedure until the trial implant is removed (2).

Optionally the combination hammer may also be used to remove the trial implant.

Remove the slide hammer from the handle by pushing onthe end of the slide hammer.


43


To detach the trial implant, pull the security ring down andsimultaneously turn the applicator knob counterclockwiseuntil it stops (3). The trial implant can now be removed fromthe applicator (4).



Implant Preparation

1Select Implant

Implants and Instruments

08.812.007S– T-PAL Small Implant, size 7–17 mm, 08.812.017S PEEK

08.812.207S– T-PAL Large Implant, size 7–17 mm, 08.812.217S PEEK

04.812.007S – T-PAL Small Implant, size 7–17 mm, 04.812.017S Titanium

04.812.207S– T-PAL Large Implant, size 7–17 mm, 04.812.217S Titanium

03.812.044 Packing Block for T-PAL

Select the T-PAL implant that corresponds to the height andsize measured using the trial implant in the previous steps.

Insert the selected implant into the appropriate packingblock place.


1

2

3

2Pack implant with bone graft

Instrument

03.812.043 Cancellous Bone Impactor for T-PAL

Turn the packing block on its side and use the cancellousbone impactor to firmly pack the filling material into the im-plant cavities (1).

Make sure the implant is well placed in the packing block toavoid implant damage while bone graft filling (2).

It is important to fill the implant until the filling material protrudes from its perforations in order to ensure optimalcontact with the vertebral endplates (3).

For more information about the filling volumes, see page 38in this technique guide.


Implant Preparation


1

3

23Connect implant to the applicator

Instruments




To connect the implant to the applicator turn the packingblock upwards again. Pull the security ring down and simul-taneously turn the knob at the proximal end of the applica-tor counterclockwise. The applicator jaws open (1). Place thejaws over the proximal end of the implant making sure toalign the arrows on the end of the applicator with those onthe implant (2).

Turn the applicator knob clockwise to close the jaws. Duringthis closing procedure the security ring moves upwards,so that the green color band is visible. Continue to turn theknob until it is tightened (3).

Note: When the applicator knob is tightened, the implantcan not pivot or detach.

Important: Ensure the arrows on the end of the applicatoralign with those on the implant. The contact surfaces betweenthe implant and the applicator should have no gap (2).


10 –15°

1

2

3

1Insert implant

Optional Instrument


Recheck the firm connection of implant to applicator. Insertthe implant into the disc space, ensuring that the orientationof the implant is correct. The implant tip should be orien-tated medial. Maintain 10 –15° between the applicator han-dle and the sagittal plane during implant insertion (1). Controlled and light hammering on the applicator may be required to advance the implant into the intervertebral discspace.Use fluoroscopy to confirm position and fit of the implant.The tip should be positioned near the anterior edge of theadjacent vertebral bodies (2).

Notes:– Firm connection of implant to applicator can be checked

manually by applying pressure on the lateral side of theimplant with the thumb. Implant should not pivot.

– Use soft tissue retractor 389.857 –389.859 to protect softtissue.

– Use fluoroscopy during the insertion to confirm anteriorposition of the implant.

– The anterior marker pins of the implant are located approximately 2 mm from the edge of the implant.

Important: – The implant tip marker pin indicates approximate final

anterior position of implant (3).– Maintain 10 –15° between the applicator handle and the

sagittal plane during implant insertion.

PEEK Implant Insertion


10 –15°

10 –15°1

2

2 Position implant

Optional Instrument


Turn the applicator knob counterclockwise until it stops (1).

Note: Ensure applicator knob is turned counterclockwise un-til it stops to avoid deformation of the applicator outershaft.

Controlled and light hammering on the applicator may be -required to pivot the implant into final position (2). Use fluo-roscopy during the pivoting procedure and confirm fit andposition of the implant. With a medial/lateral fluoroscopic image of the cage in thefinal position, the two anterior pins of the implant should appear as one line.

In an anterior/posterior fluoroscopic image, the two anteriorpins should be equidistant to the pedicles. The tip pin indicates the lateral edge of the implant.

Note: If bone graft or bone graft substitutes are placed intothe disc space after trialing, the implant may not reach thesame position as the trial.

Important: Maintain 10 –15° between the applicator handleand the sagittal plane during implant insertion.


10 –15°

1 2

Optional: Position implant

If implant does not pivot automatically, turn the applicatorhandle medially to initiate pivoting upon impaction (1). Afterpivoting is initiated the applicator handle must be turnedback to an angle of 10 –15° from the sagittal plane to pivotthe implant into final position (2).

Important: Maintain 10 –15° between the applicator handleand the sagittal plane for final implant insertion.

PEEK Implant Insertion


3Detach implant

To detach the implant, pull the security ring down and simul-taneously turn the applicator knob counterclockwise until itstops. The applicator can now be removed from the implant.

Use fluoroscopy to verify final position of the implant. Witha medial/lateral fluoroscopic image, the two anterior pinsof the implant should appear as one line and the tip markeras a dot.


Note: If the applicator does not disengage from the implantturn the applicator handle laterally to free the instrument.


10 –15°

2

3

Titanium Implant Insertion

1Insert implant

Optional instrument


Recheck the firm connection of implant to applicator. Insertthe implant into the disc space, ensuring that the orientationof the implant is correct. The implant tip should be orien-tated medial. Maintain 10 –15° between the applicator han-dle and the sagittal plane during implant insertion (1). Controlled and light hammering on the applicator may be required to advance the implant into the intervertebral discspace.Use fluoroscopy to confirm position and fit of the implant.The tip should be positioned near the anterior edge of theadjacent vertebral bodies (2).

Notes:– Firm connection of implant to applicator can be checked

manually by applying pressure on the lateral side of theimplant with the thumb. Implant should not pivot.

– Use soft tissue retractor 389.857 –389.859 to protect softtissue.

– Use fluoroscopy during the insertion to confirm anteriorposition of the implant.

Important: – The implant tip indicates approximate final anterior

position of implant (3).– Maintain 10 –15° between the applicator handle and the

sagittal plane during implant insertion.


10 –15°

10 –15°

1

2

2 Position implant

Optional instrument


Turn the applicator knob counterclockwise until it stops (1).

Note: Ensure applicator knob is turned counterclockwise un-til it stops to avoid deformation of the applicator outershaft.

Controlled and light hammering on the applicator may be required to pivot the implant into final position (2). Use fluoroscopy during the pivoting procedure and confirmfit and position of the implant. Each implant has a medial/lat-eral and an anterior/posterior opening for position control.

Note: If bone graft or bone graft substitutes are placed intothe disc space after trialing, the implant may not reach thesame position as the trial.

Important: Maintain 10 –15° between the applicator handleand the sagittal plane during implant insertion.


10 –15°

1 2

Optional: Position implant

If trial implant does not pivot automatically, turn the applica-tor handle medially to initiate pivoting upon impaction (1).After pivoting is initiated the applicator handle must beturned back to an angle of 10 –15° from the sagittal planeto pivot the implant into final position (2).

Important: Maintain 10 –15° between the applicator handleand the sagittal plane for final implant insertion.

Titanium Implant Insertion


3Detach implant

To detach the implant, pull the security ring down and simul-taneously turn the applicator knob counterclockwise until itstops. The applicator can now be removed from the implant.

Use fluoroscopy to verify final position of the implant. With a medial/lateral fluoroscopic image, lateral opening of the titanium T-PAL implant should be visible.


Note: If the applicator does not disengage from the implantturn the applicator handle laterally to free the instrument.


1Pack disc space

Instrument


After the T-PAL cage is implanted, fill the posterior discspace and the lateral disc space with bone graft or bonegraft substitute to create optimal conditions for fusion.


Posterior Support

2Supplemental fixation

Sets (optional)

01.620.015 Pangea Polyaxial Basic Instruments in Vario Case

01.620.018 Pangea Polyaxial Implants in Vario Case

01.631.001 SpiRIT Set in Vario Case

01.631.005 SpiRIT Additional Instruments in Vario Case

01.631.004 MIS-Rods, radius 200 mm, in Vario Case

The T-PAL cage is intended to be used with Synthes supple-mental posterior fixation, e.g. SpiRIT with Pangea or Click’X.


Implant Removal

Implant removal with the applicator

Instruments




Ensure that the applicator is in the fully open position. Locatethe implant and close the applicator by turning the knobclockwise until the security ring is moving upwards. Thereshould be no gap between the applicator knob and the secu-rity ring. To ensure that the knob is in contact with the secu-rity ring, turn the knob counterclockwise until it stops, in thisposition the implant can pivot but not detach from the ap -plicator. The implant can now be removed. The slap hammermay be required to facilitate removal.

Note: Distraction of the segment may facilitate implant removal. However, if possible, do not distract before ensuring a firm connection between the implant and the applicator.

Important: The applicator must be in the pivoting positionto remove the implant.


Implant removal with the removal tool

Instrument

03.812.005 Removal Tool for T-PAL

Ensure that the removal tool for T-PAL is in the fully open po-sition. Locate the implant and squeeze the handle firmly. Advance the speed nut to lock the handle. The implant cannow be removed. The slap hammer may be required to facili-tate removal.

Note: When the removal tool handle is squeezed, the implant can pivot but not detach from the removal tool.

Note: Distraction of the segment may facilitate implant removal. However, if possible, do not distract before ensuring a firm connection between the implant and the removal tool.

Implant Removal



Graft volume

The table below shows the approximate graft volume that T-PAL implants will hold, depending on the footprint andheights.

Implants

Total depthSmall implants14 mmLarge implants16 mm

Insertion depthSmall implants 10 mmLarge implants 12 mm

LengthSmall implants 28 mmLarge implants 31 mm

* 7 mm height = 0°

T-PAL Implant, 5° angle*, small footprint 10u28 mm

Heights Filling volume PEEK Implants Titanium Implants

7 mm 0.4 cc 08.812.007S 04.812.007S

8 mm 0.4 cc 08.812.008S 04.812.008S

9 mm 0.5 cc 08.812.009S 04.812.009S

10 mm 0.6 cc 08.812.010S 04.812.010S

11 mm 0.7 cc 08.812.011S 04.812.011S

12 mm 0.8 cc 08.812.012S 04.812.012S

13 mm 0.9 cc 08.812.013S 04.812.013S

15 mm 1.0 cc 08.812.015S 04.812.015S

17 mm 1.3 cc 08.812.017S 04.812.017S

T-PAL Implant, 5° angle*, large footprint 12u31 mm

Heights Filling volume PEEK Implants Titanium Implants

7 mm 0.6 cc 08.812.207S 04.812.207S

8 mm 0.7 cc 08.812.208S 04.812.208S

9 mm 0.8 cc 08.812.209S 04.812.209S

10 mm 0.9 cc 08.812.210S 04.812.210S

11 mm 1.1 cc 08.812.211S 04.812.211S

12 mm 1.2 cc 08.812.212S 04.812.212S

13 mm 1.4 cc 08.812.213S 04.812.213S

15 mm 1.7 cc 08.812.215S 04.812.215S

17 mm 2.0 cc 08.812.217S 04.812.217S


Height

Height Posterior Height

* 7 mm height = 0°

T-PAL Implant, 5° angle*, small footprint 10u28 mm

Heights Posterior height PEEK Implants Titanium Implants

7 mm 7.0 mm 08.812.007S 04.812.007S

8 mm 7.2 mm 08.812.008S 04.812.008S

9 mm 8.2 mm 08.812.009S 04.812.009S

10 mm 9.2 mm 08.812.010S 04.812.010S

11 mm 10.2 mm 08.812.011S 04.812.011S

12 mm 11.2 mm 08.812.012S 04.812.012S

13 mm 12.2 mm 08.812.013S 04.812.013S

15 mm 14.2 mm 08.812.015S 04.812.015S

17 mm 16.2 mm 08.812.017S 04.812.017S

T-PAL Implant, 5° angle*, large footprint 12u31 mm

Heights Posterior height PEEK Implants Titanium Implants

7 mm 7.0 mm 08.812.207S 04.812.207S

8 mm 7.0 mm 08.812.208S 04.812.208S

9 mm 8.0 mm 08.812.209S 04.812.209S

10 mm 9.0 mm 08.812.210S 04.812.210S

11 mm 10.0 mm 08.812.211S 04.812.211S

12 mm 11.0 mm 08.812.212S 04.812.212S

13 mm 12.0 mm 08.812.213S 04.812.213S

15 mm 14.0 mm 08.812.215S 04.812.215S

17 mm 16.0 mm 08.812.217S 04.812.217S







Instruments

03.812.307– T-PAL Small Trial Implant size 7–17 mm, 03.812.317 non detachable

03.812.507– T-PAL Large Trial Implant, size 7–17 mm, 03.812.517 non detachable









Instruments

03.605.529 Curette, rectangular, angled, right,bayoneted, black

03.605.530 Curette, rectangular, angled, left,bayoneted, black


03.605.532 Impactor, curved, standard, bayoneted,black






389.857 – Soft Tissue Retractor, width 6, 8, 10 mm389.859

389.767– Shaver for Intervertebral Discs, 389.777 size 7–17 mm



03.812.007– T-PAL Small Trial Implant, size 7–17 mm03.812.017

03.812.207– T-PAL Large Trial Implant, size 7–17 mm03.812.217

Optional Instruments


Sets

Vario Case

68.812.001 Vario Case for T-PAL

Instruments





03.812.307– T-PAL Small Trial Implant, size 7–17 mm, 03.812.317 non detachable

03.812.507– T-PAL Large Trial Implant, size 7–17 mm, 03.812.517 non detachable






Vario Case

68.812.002 Disc Removal Set for T-PAL Instruments

Instruments








03.605.529 Curette, rectangular, angled, right, bayoneted, black

03.605.530 Curette, rectangular, angled, left, bayoneted, black




389.857– Soft Tissue Retractor,389.859 width 6, 8 and 10 mm

389.767– Shaver for Intervertebral Discs, 389.777 size 7–17 mm



Attach positionPull the security ring down and simultaneously turn the knobcounterclockwise. No gap between the handle, security ring and the applicator knob should be present. The greencolor band should not be visible.

The implant or trial can be attached.

Insertion positionTurn the applicator knob clockwise to close the jaws. Duringthis closing procedure the security ring moves upwards,so that the green color band is visible. Continue to turn theknob until it is tightened.

In the insertion position; the implant or trial is fixed. The implant or trial can not pivot or detach.

Applicator Instructions

˙˙

Pivoting positionTurn the applicator knob counterclockwise until it stops. Theapplicator knob and the security ring will now be in contact.

In this position the implant or trial can pivot 80°. Implant ortrial cannot detach from applicator.

Detach positionPull the security ring down and simultaneously turn theknob counterclockwise. No gap between the handle, securityring and the Applicator knob should be present. The greencolor band should not be visible.

The implant or trial can be detached.


1

2

12

12

1

3

Applicator Outer ShaftInner ShaftKnobT-PAL Small Trial Implant, size 7–17 mm, non detachableT-PAL Large Trial Implant, size 7–17 mm, non detachable

03.812.00103.812.00303.812.004

03.812.307–31703.812.507–517

4


˙H

Possible damage– Overlaying deformation at the edge

of the groove

Prevention– none

Recommendation– Exchange instrument

Function control



Filling Material

Synthetic cancellous bone graft substitute: chronOSchronOS is a fully synthetic and resorbable bone graft substi-tute consisting of pure �-tricalcium phosphate. Its compres-sive strength is similar to that of cancellous bone. Based onliterature, the use of �-tricalcium phosphate in the spinal column is a valuable alternative to allografts and autografts,even when larger amounts are required.

ResorbableIt is remodeled to vital bone within 6–18 months

OsteoconductiveInterconnecting macropores of defined size (100–500 µm)facilitate bone ingrowth. Interconnected micropores (10–40 µm) allow an optimal supply of nutrients. The patient’sblood, blood platelet concentrate or bone marrow aspirateenhances the properties of chronOS required for fusion.

Safe100% synthetic – no risk of cross infection

chronOS Granules

Art. no. B (mm) cc

710.000S 0.5 –0.7 0.5

710.001S 0.7 –1.4 0.5

710.002S 0.7 –1.4 1

710.003S 0.7 –1.4 2.5

710.011S 1.4 –2.8 2.5

710.014S 1.4 –2.8 5

710.019S 1.4 –2.8 10

710.021S 1.4 –2.8 20

710.024S 2.8 –5.6 2.5

710.025S 2.8 –5.6 5

710.026S 2.8 –5.6 10

710.027S 2.8 –5.6 20




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This publication is not intended for distribution in the USA.

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

Documents

T-PAL. Transforaminal Posterior Atraumatic …synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...T-PAL. Transforaminal Posterior Atraumatic Lumbar Cage System. Technique Guide This