implants and instruments for interbody fusion available in ...synthes.vo.llnwd.net/o16/llnwmb8/int...

Implants and Instruments for Interbody Fusion Available in both PEEK and ProTi 360º™ Titanium Integrated Technology

ACIS® – Anterior Cervical Interbody SpacerSurgical Technique

Image intensifier control

This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenancehttp://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

Surgical Technique ACIS® – Anterior Cervical Interbody Spacer DePuy Synthes 1

Table of Contents

Introduction ACIS® – Anterior Cervical Interbody Spacer 2

AO Spine Principles 4

Surgical Technique Preparation 5

Patient Positioning 6

Exposure and Discectomy 7

Segment Distraction 8

Endplate Preparation 9

Implant Size and Shape Determination 10

Implant Insertion 13

Supplemental Fixation 21

Implant Removal 22

Indications and Contraindications 23

Bibliography 24

For Product Catalog contact your local DePuy Synthes representative.

*PEEK-Optima® is a registered trademark of Invibio Ltd.

2 DePuy Synthes ACIS® – Anterior Cervical Interbody Spacer Surgical Technique

The implant is available in three footprints, multiple heights, and three sagittal profiles

ACIS® – Anterior Cervical Interbody Spacer Implants and Instruments for Interbody Fusion

Pyramidal teethSuperior and inferior surface of implant

Central lumenAccommodates bone graft

Sagittal profilesConvex, lordotic, and parallel implants

Lateral windowsWindows on the lateral walls of the cage (PEEK implants only)

Available materialsAvailable in two material options: PEEK-Optima* and ProTi 360°TM Titanium Integrated Technology

Implant-Instrument interface

Midline markers


ACIS® – Anterior Cervical Interbody Spacer Implants and Instruments for Interbody Fusion

Trial Implants• Preassembled and

double-sided• Color-coded by sagittal

profile

Insertion Device• Multiple shaft options

with and without depth stops

Implant Holder• Alternative implant inser-

tion option


AO Spine Principles

The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum: Stability – Alignment – Biology – Function.1,2

StabilityStabilization to achieve a specific therapeutic outcome

AlignmentBalancing the spine in three dimensions

BiologyEtiology, pathogenesis, neural protection,and tissue healing

FunctionPreservations and resto-ration of function to pre-vent disability

Copyright © 2012 by AOSpine

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1. Preparation

Required set

01.841.101 ACIS Standard Set in Vario Case

Optional sets

187.797 Cervical Retractors and Distractors

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

Have all necessary sets readily available prior to surgery.

Preparation

2. Assemble insertion device

Instrument

03.841.050 ACIS Insertion Device

Assemble the insertion device prior to use according to the assembling instruction shown here.


Position the patient in a supine position on a radiolucent operating table. Ensure that the neck of the patient is in a sagittally neutral position and supported by a cushion. When treating C6–C7 make sure that the shoulders do not limit the x-ray monitoring. For all cases, both vertebrae should be completely visible on radiographic imaging.

Patient Positioning


1. Access

Optional set


Locate the correct operative level using radiographic imaging.

Expose the intervertebral disc and the adjacent vertebralbodies through a standard anterior approach to the cer-vical spine.

Precaution: Careful positioning of the retractor is required to protect against soft tissue damage.

2. Discectomy

Prepare the fusion site following the appropriate tech-nique for the given indication.

Exposure and Discectomy


Optional set


Perform segmental distraction.

Note: Distraction of the segment is essential for restoring disc height and for providing access to the intervertebral space.

Segment Distraction


Endplate Preparation

Optional instrument

03.841.150 Endplate Rasp

When the discectomy is complete, remove the superficial cartilaginous layers of the endplates to expose bleeding bone.

Warnings:• Adequate cleaning of the endplates is important for

vascular supply of the autologous bone graft or bone graft substitute. Excessive cleaning, however, may result in removal of bone underlying the carti-laginous layers and weaken the endplates.

• The removal of any osteophytes is crucial for achieving complete decompression of the neural structures and for reducing the risk of partial com-pression after implant insertion.

Note: The endplate rasp is double sided with a stan-dard depth on one side and a large depth on the other side. These are indicated by one (standard) and two (large) white bands on the shaft as well as etchings on the rear side of the rasp. The depth is limited by a stop. Depths are 14 mm for the standard and 16 mm for the large. The width is 8 mm and the height is 4 mm.

depth14 mm: standard 16 mm: large

height 4 mm

width 8 mm


Implant Size and Shape Determination

Instruments

03.841.005–011 ACIS Trial Implant, standard, lordotic, heights 5–12 mm, double-sided, blue

03.841.105–111 ACIS Trial Implant, standard, parallel, heights 5–12 mm, double-sided, purple

03.841.205–211 ACIS Trial Implant, standard, convex, heights 5–12 mm, double-sided, yellow

03.841.305–311 ACIS Trial Implant, large, lordotic, heights 5–12 mm, double-sided, blue

03.841.405–411 ACIS Trial Implant, large, parallel, heights 5–12 mm, double-sided, purple

03.841.505–511 ACIS Trial Implant, large, convex, heights 5–12 mm, double-sided, yellow

03.841.605–611 ACIS Trial Implant, small, lordotic, heights 5–12 mm, double-sided, blue

03.841.705–711 ACIS Trial Implant, small, parallel, heights 5–12 mm, double-sided, purple

03.841.805–811 ACIS Trial Implant, small, convex, heights 5–12 mm, double-sided, yellow

Optional instrument

03.820.113 Mallet


The selection of the trial implant depends on the height, width and depth of the intervertebral space, the prepa-ration technique and the patient’s anatomy. Choose a standard, large or small footprint trial implant with con-vex, lordotic or parallel sagittal shape of the appropriate height.

Notes:• The trial implants are double sided with different

heights on either side. Colored bands on the shaft indicate which side is of lesser (one band) or greater (two bands) height. In addition, heights are etched on the cranial and caudal surfaces of the trial implants.

• Trial implants are color coded by sagittal shape: yellow, blue and purple bands on the shaft indicate that a trial implant is convex, lordotic or parallel. Furthermore, the following etchings on the cranial and caudal surfaces indicate the sagittal shape: “C” for convex, “L” for lordotic, and “P” for parallel.

• The footprint is indicated by the etchings “Small”, “Standard” and “Large” on the cranial and caudal surfaces of the trial implants.

Before carefully inserting the trial implant, ensure that the orientation of the trial implant is correct. Each con-vex trial implant is etched with an arrow pointing crani-ally on the lateral walls to indicate the correct cranial/caudal alignment.

The lordotic and parallel trial implants do not have a dedicated cranial or caudal surface. They can be inserted into the intervertebral disc space with either surface pointing cranially.

Warning: Ensure that all disc material has been removed from the insertion path to avoid displacing it into the spinal canal.

lesser heightgreater height

yellow – convex

blue – lordotic

purple – parallel

lordotic convex parallel



If necessary, controlled and light hammering with the mallet can be used to help advance the trial implant into the intervertebral disc space.

Precautions:• Excessive impaction force during trial implant

insertion must be avoided.• The trial implants do not have a depth limiter; an

image intensifier should be used to check the posi-tion during insertion.

Use image intensifier to confirm the fit of the trial implant. If the trial implant appears too loose or too tight, try the next larger or smaller size height until the most secure fit is achieved.

Warnings:• The height of the trial implants is undersized by 0.5

mm compared to the implant, to help ensure a tight fit of the ACIS implant upon insertion.

• With the segment fully distracted, the trial implant must fit tightly between the endplates. To reduce potential increased risk to the patient, it is recom-mended to first trial with smaller height trial implants before trialing with taller trial implants.

• Trial implants are not for implantation and must be removed before insertion of the ACIS implant.

The mallet can be used for trial implant removal. While holding the trial implant slide the mallet over the upper part of the trial implant’s shaft and apply an upward force. Repeat this process until the trial implant has been removed.



Option A. Insertion device

1. Attach implant to insertion device

Instruments

03.841.050 ACIS Insertion Deviceand03.841.057 Inner Shaft, small, with Stop, for No. 03.841.050or03.841.059 Inner Shaft, standard/large, without

Stop, for No. 03.841.050or03.841.060 Inner Shaft, standard/large, with Stop, for No. 03.841.050or03.841.061 Inner Shaft, small, without Stop,

for No. 03.841.050

Optional instruments

03.617.981 Impactor, flat

03.820.113 Mallet

Select the ACIS implant that corresponds to the foot-print, shape and height determined using the trial implant.

Refer to page 6 for ACIS insertion device assembly. If desired, the insertion device can be combined with an inner shaft with stop. It has a depth limiter that will contact the anterior edge of the vertebral body when the ACIS implant is inserted approximately 1 mm beyond the anterior edge of the vertebral body.

Attach the implant to the ACIS insertion device by align-ing the recessed grooves located on the side walls of the implant with the prolonged tabs of the instrument tip and engaging those. Turn the knob clockwise to secure the implant. Ensure that the implant is held flush against the insertion device and securely in the tabs.

Implant Insertion


Implant Insertion

2. Pack implant with autologous bone graft or bone graft substitute


03.841.054 Cancellous Bone Impactor

03.841.055 Packing Block

It is recommended to pack the ACIS implant with autol-ogous bone or bone graft substitute.

(PEEK Only) Place the ACIS implant into the packing block. Small and standard footprint implants fit into the cavity marked “Standard” while large footprint implants fit into the cavity marked “Large”.

The cancellous bone impactor can be used to firmly pack the autologous or bone graft substitute into the implant cavity.

Precaution: Excessive impaction of the implant with the cancellous bone impactor should be avoided to prevent possible implant damage.

Notes:• To ensure contact with the vertebral endplates, it is

important to fill the implant until the autologous bone or bone graft substitute protrudes from the openings of the implant.


3. Insert implant

Confirm the implant is securely attached. Carefully insert the implant into the distracted segment, ensuring that the orientation of the implant is correct. Each convex implant is etched with an arrow pointing cranially on the left lateral wall to indicate the correct cranial/caudal alignment. The lordotic and parallel implants have a symmetrical sagittal profile and therefore do not require specific orientation.

If necessary, controlled and light hammering with the mallet can be used to help advance the implant into the intervertebral disc space.

Turn the knob in a counterclockwise direction to release the implant from the insertion device. Remove the insertion device and if required use the flat impactor to seat the implant into its final position.

Use image intensifier to confirm the position of the implant.

Precautions:• If an inner shaft without stop is used then an image

intensifier should be used to check the position during insertion.

• Excessive tilting of the insertion device must be avoided to prevent implant separation or damage.

Warning: Excessive impaction must be avoided to prevent implant damage or too deep insertion.

Note: The ProTi 360˚ Implant may require additional tamping during insertion.

Implant Insertion


Warning: Verify final implant position relative to the vertebral bodies in the AP and lateral views using intraoperative imaging. The ACIS implant has three x-ray markers incorporated in the implant to enable intraoperative radiographic assessment of the implant position.

Notes:• Ø 1.0 mm diameter pins as x-ray markers. PEEK

system: Titanium Alloy (Ti-6Al-4V), ProTi 360˚ sys-tem: Tantalum.

• The distance between pins and the anterior and posterior walls of the implant is approx. 1.0 mm.

• The posterior pin is centered.

Implant Insertion


Implant Insertion

Option B. Implant holder

1. Attach implant to implant holder

Instrument

03.841.053 ACIS Implant Holder


03.617.981 Impactor, flat

03.820.113 Mallet

Select the ACIS implant that corresponds to the foot-print, shape and height determined using the trial implant.

Attach the implant to the ACIS implant holder by align-ing the recessed grooves located on the side walls of the implant with the prolonged tabs of the instrument tip. Engage the squeeze-lock by applying slight pressure on the arms of the implant holder.


Implant Insertion

2. Pack implant with autologous bone graft or bone graft substitute


03.841.054 Cancellous Bone Impactor

03.841.055 Packing Block

It is recommended to pack the ACIS implant with autol-ogous bone or bone graft substitute.

(PEEK Only) Place the ACIS implant into the packing block. Small and standard footprint implants fit into the cavity marked “Standard” while large footprint implants fit into the cavity marked “Large”.

The cancellous bone impactor can be used to firmly pack the autologous or bone graft substitute into the implant cavity.

Precaution: Excessive impaction of the implant with the cancellous bone impactor should be avoided to prevent possible implant damage.

Notes:• To ensure contact with the vertebral endplates, it is

important to fill the implant until the autologous bone or bone graft substitute protrudes from the openings of the implant.


Implant Insertion

3. Insert implant

Confirm the implant is securely attached, carefully insert the implant into the distracted segment, ensuring that the orientation of the implant is correct. Each convex implant is etched with an arrow pointing cranially on the left lateral wall to indicate the correct cranial/caudal alignment. The lordotic and parallel implants have a symmetrical sagittal profile and therefore do not require specific orientation.

Release the implant holder by applying slight pressure on the arms of the implant holder and disengaging the squeeze-lock. Remove the holder and if required use the flat impactor to seat the implant into its final position.

Use image intensifier to confirm the position of the implant.

Precautions:• The implant holder does not feature a depth stop.

Image intensifier control should be used to check the position during insertion.

• Excessive tilting of the implant holder must be avoided to prevent implant separation or damage.

Warning: Excessive impaction must be avoided to prevent implant damage or too deep insertion.

Note: The ProTi 360˚ Implant may require additional tamping during insertion.


Implant Insertion

Warning: Verify final implant position relative to the vertebral bodies in the AP and lateral views using intraoperative imaging. The ACIS implant has three x-ray markers incorporated in the implant to enable intraoperative radiographic assessment of the implant position.

Notes:• Ø 1.0 mm diameter pins as x-ray markers. PEEK

system: Titanium Alloy (Ti-6Al-4V), ProTi 360˚ sys-tem: Tantalum.

• The distance between pins and the anterior and posterior walls of the implant is approx. 1.0 mm.

• The posterior pin is centered.


Supplemental Fixation

For multisegmental fusions with the ACIS system, supplemental fixation is recommended (e.g. Skyline, Vectra, etc).

Complete the procedure by following the steps indicated in the respective surgical technique.


Instrument

03.841.050 ACIS Insertion Device

Optional instrument

03.820.113 Mallet Attach the ACIS insertion device to the implant in the disc space by aligning the pronged tabs of the instru-ment tip to the recessed grooves located on the side walls of the implant. Tighten the knob clockwise until the implant has a rigid connection. Ensure that the implant is held flush against the insertion device and securely in the tabs. Remove the implant from the disc space.

Warning: Take care not to push the implant towards the posterior elements.

Precautions:• Excessive tilting of the insertion device must be

avoided to prevent implant separation or damage.• Implants are single-use and should not be reused. The mallet can be used for implant removal.

While holding the insertion device, slide the mallet over the shaft of the insertion device and apply an upward force. Repeat this process until the implant has been removed.

Implant Removal


Indications and Contraindications

Please refer to the corresponding Instructions for Use for specific information on Intended use, Indications, Contraindications, Warnings and Precautions, Potential Adverse Events, Undesirable Side Effects and Residual Risks. Instructions for Use are available at www.e-ifu.com and/or www.depuysynthes.com/ifu.

ProTi 360° please refer to the corresponding Instructions for Use for specific information on its use, indications, contraindications, precautions,warnings and side effects.

ACIS PEEK


Aebi M, JS Thalgott, JK Webb. (1998). AO ASIF Princi ples in Spine Surgery. Berlin: Springer-Verlag.

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

Bibliography

For recognized manufacturer refer to product label

ACIS® SystemManufactured and Distributed by:Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11

www.jnjmedicaldevices.com

ACIS® ProTi 360º™ SystemManufactured by:Tyber Medical, LLC83 South Commerce Way, Suite 310Bethlehem, PA 18107Phone: +1 (866) 761-0933Fax: +1 (866) 889-9914

EC REP MDSS GmbHSchiffgraben 4130175 Hanover Germany

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

Surgical techniques are available as PDF files at www.depuysynthes.com/ifu

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implants and instruments for interbody fusion available in ...synthes.vo.llnwd.net/o16/llnwmb8/int...

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