OPAL Spacer System TG (PDF)synthes.vo.llnwd.net/o16/Mobile/Synthes North... · the OPAL Spacer...

Instruments and implants approved by the AO Foundation

OPAL Spacer System. Oblique posterioratraumatic lumbar spacer system.

Technique Guide

Introduction

Surgical Technique

Product Information

Table of Contents

OPAL Spacer System 2

AO Principles 3

Indications 4

Preparation 5

Determine Implant Size 6

Remove Trial Spacer 8

Insert OPAL Spacer 9

Implants 14

Instruments 15

Set List 17

Image intensifier control

Synthes Spine

2 Synthes Spine OPAL Spacer System

OPAL Spacer System

OPAL Spacer, Revolve

OPAL Spacer

*Polyetheretherketone (PEEK)

Figure 1 Figure 2

Rotation bevel

The OPAL Spacer is a versatile interbody fusion device with the following features and benefits:

– Two implant offerings accommodate:

Traditional straight implant insertion

Less invasive insert and rotate technique

– Revolve Spacers designed for insert and rotate technique:

Spacers rotated 90º in situ provide intervertebral distraction

Beveled edge on Revolve Spacer allow for easy rotation

– Self-distracting implants:

Bullet nose design eases insertion

Minimizes the need to remove posterior lip

– Multiple approach options:

Bilateral posterior approach using 24 mm spacers (Figure1)

Unilateral posterior approach using 28 mm and 32 mmspacers (Figure 2)

– Axial canal intended to receive autograft to allow fusionto occur through the implant

– Pyramidal teeth provide resistance to implant migration

– Two radiographic marker pins enable visualization of implant

– Biocompatible radiolucent polymer* allows clear assessmentof fusion

Synthes Spine 3

AO Principles

In 1958, the AO formulated four basic principles, which havebecome the guidelines for internal fixation.1 They are:

– Anatomic reduction

– Stable internal fixation

– Preservation of blood supply

– Early, active mobilization

The fundamental aims of fracture treatment in the limbs andfusion of the spine are the same. A specific goal in the spineis returning as much function as possible to the injured neural elements.2

AO Principles as Applied to the Spine3

Anatomic alignmentRestoration of normal spinal alignment to improve thebiomechanics 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 mobilizationMinimization of damage to the spinal vasculature, dura, andneural elements, which may contribute to pain reduction andimproved function for the patient.

1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger. AO Manual ofInternal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.

2. Ibid.3. M. Aebi, J.S. Thalgott, J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin:

Springer-Verlag. 1998.

The OPAL Spacer is indicated for use in patients with degen-erative disc disease (DDD) at one or two contiguous levelsfrom L2 to S1 whose condition requires the use of interbodyfusion combined with supplemental fixation.* The interior ofthe OPAL Spacer should be packed with autogenous bonegraft (i.e. autograft). DDD is defined as back pain of disco-genic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should beskeletally mature and have had six months of nonoperativetreatment.

*The OPAL Spacer is intended to be used with Synthes sup-plemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click’X) and Small Stature USS.

For complete indications and contraindications, please seethe OPAL Spacer System package insert GP2650.


Indications

1Preparation

Instruments

03.605.504 Bone Curette, straight, 5.5 mm width

03.605.505 Bone Curette, reverse angle, 5.5 mm width

03.605.507 Dual-Sided Rasp, bayoneted

03.605.508 Osteotome, straight

03.803.054 Box Curette

Resect the posterior anatomy and perform the discectomy.Use a standard transforaminal approach for insertion of 28 mm and 32 mm spacers (Figure 1). Use a traditional bilateral posterior approach for insertion of 24 mm spacers(Figure 2).

Optional sets

01.605.500 Minimally Invasive Posterior Instrument Set

105.151 T-PLIF Minimally Invasive Instrument Set

105.152 T-PLIF Auxiliary Instrument Set

105.777 Posterior Lumbar Interbody FusionInstrument Set

In addition to the OPAL discectomy instruments, optionalSynthes instrument sets can be used.

Synthes Spine 5

Preparation

Figure 1

Figure 2


Determine Implant Size

2 Determine implant size

Instrument

03.803.007– OPAL Trial Spacers, with T-Handle, 03.803.017 7 mm –17 mm heights

Option 1: Impact TechniqueImpact an appropriately sized trial spacer with the etch repre-senting the axial canal positioned cranial/caudal. Continue toimpact on the end of the trial spacer until the spacer is posi-tioned across the midline and 3 mm–4 mm from the anteriorlongitudinal ligament. The trial spacer shaft should be ori-ented 30º–45° from midline. Repeat using the next largersize trial spacer, sequentially distracting until adequate ante-rior height is obtained. With the segment fully distracted, thetrial spacer must fit tightly and accurately inside the discspace.

Note: The trial spacers represent the 28 mm length implants.

28 mm

30º–45º

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Figure 4 Figure 5

Option 2: Insert and Rotate TechniqueTo rotate the trial spacer in situ, the T-handle should be extended:

– Push the green T-handle out of the handle body (Figure 1)

– Press and hold the button while sliding the T-handle to theend of the instrument (Figure 2)

– Release the button, allowing the T-handle to lock into posi-tion (Figure 3)

Insert the trial spacer with the etch representing the axialcanal oriented parallel to the vertebral endplate (Figure 4).Gently impact on the end of the trial spacer until the spaceris positioned across the midline and 3 mm– 4 mm from theanterior longitudinal ligament. The trial spacer shaft shouldbe oriented 30º– 45° from midline. When the trial spacerreaches the appropriate depth, rotate it 90° clockwise to distract and assess height adequacy (Figure 5). Repeat, usingthe next larger size trial spacer, sequentially distracting untiladequate anterior height is obtained. With the segment fullydistracted, the trial implant must fit tightly and accurately in-side the disc space.

Figure 1 Figure 2

Figure 3


4Remove trial spacer

Instrument

03.803.055 Slap Hammer

When using the insert and rotate technique, it is recom-mended to rotate the trial spacer 90° counterclockwise before removal.

If removal of the trial spacer requires too much force, theslap hammer can be used. Slide the slap hammer onto theend of the trial spacer. While holding the handle of the trialspacer with one hand, apply a strong upward force to theslap hammer with the other hand. Repeat this process untilthe trial spacer is removed from the disc space. The slaphammer can be removed by pushing on the end of the shaftas shown.

Remove Trial Spacer

3 Screw/rod fixation (optional)

A screw/rod construct can be placed on the contralateral side while the trial spacer is still in position. Provisionallytighten the construct on the contralateral side to ensure that the height in the anterior column is maintained.

Figure 1

Figure 2

Figure 3

Insert OPAL Spacer

5Insert OPAL spacer

Instrument

03.803.001 OPAL Implant Holder, straightor

03.803.002 OPAL Implant Holder, pistol grip

The implant holder must be assembled before insertion ofthe OPAL spacer.

– Attach the knob to the end of the implant holder sleeveby turning the knob counterclockwise (Figure 1)

– Insert the shaft into the sleeve making sure to align the arrows on the end of the shaft with those on the sleeve (Figure 2)

– Press the button on the end of the implant holder andpush the shaft into the holder. The shaft should now betrapped inside the sleeve (Figure 3)

Synthes Spine 9

5Insert OPAL spacer continued

Select an OPAL spacer that corresponds to the size measuredusing the trial spacer in the previous steps. Attach the OPALspacer to the implant holder.

– Turn the knob at the end of the implant holder counter-clockwise to open the jaws

– Place the jaws over the posterior end of the spacer making sure that the jaws’ base is firmly seated against the implant

– Turn the knob on the end of the implant holder clockwiseuntil it is tight

– Remove the OPAL spacer from the module

The interior of the spacer should now be packed with autologous bone.


Insert OPAL Spacer continued

Option 1: Impact Technique

Instrument

03.803.001 OPAL Implant Holder, straightor


Using either the straight or pistol grip implant holder, orientthe spacer with the main graft window in the cranial/caudaldirection. Gently impact on the end of the implant holder,until the spacer is positioned across the midline and 3 mm–4 mm from the anterior longitudinal ligament. The implantholder shaft should be oriented 30º–45° from midline.

With the segment fully distracted, the implant must fit tightlyand accurately, to ensure that segmental height will be pre-served. Using the largest possible implant maximizes segmentstability by creating ligamentous tension.

Use AP and lateral fluoroscopy to confirm appropriate place-ment and trajectory.

When the spacer is in the proper location, hold the handlefirmly and turn the knob on the end of the implant holdercounterclockwise to release it.

Synthes Spine 11


Insert OPAL Spacer continued

5Insert OPAL spacer continued

Option 2: Insert and Rotate Technique

Instrument


Use the pistol grip implant holder and the revolve OPALspacer for this technique. Orient the spacer with the maingraft window parallel to the vertebral endplate. Gently impact on the end of the implant holder, until the spacer is positioned across the midline and 3 mm– 4 mm from the anterior longitudinal ligament. The implant holder shaftshould be oriented 30º–45° from midline. Once the spacer is in position, rotate the implant holder 90° clockwise so that the main graft window of the spacer is oriented in thecranial/caudal direction. The implant must fit tightly and ac-curately to ensure that segmental height is preserved. Usingthe largest possible implant maximizes segment stability bycreating ligamentous tension.

Use AP and lateral fluoroscopy to confirm appropriate place-ment and trajectory.

When the spacer is in the proper location, hold the handlefirmly and turn the knob on the end of the implant holdercounterclockwise to release it.

6Supplement posterior fixation

Posterior fixation with transpedicular screws (Click’X, VAS,Pangea or USS) is required to enhance the biomechanicalstability of the motion segment and the stability of the OPAL spacer.

Synthes Spine 13

Implants


OPAL Spacers, 10 mm x 28 mm

Height (mm)

08.803.107 7

08.803.108 8

08.803.109 9

08.803.110 10

08.803.111 11

08.803.112 12

08.803.113 13

08.803.115 15

08.803.117 17

OPAL Spacers, 10 mm x 32 mm

Height (mm)

08.803.207 7

08.803.208 8

08.803.209 9

08.803.210 10

08.803.211 11

08.803.212 12

08.803.213 13

08.803.215 15

08.803.217 17

OPAL Spacer, Revolve, 9 mm x 28 mm

Height (mm)

08.803.130 10

OPAL Spacer, Revolve, 9 mm x 32 mm

Height (mm)

08.803.230 10

OPAL Spacers, Revolve, 10 mm x 28 mm

Height (mm)

08.803.131 11

08.803.132 12

08.803.133 13

08.803.135 15

OPAL Spacers, Revolve, 10 mm x 32 mm

Height (mm)

08.803.231 11

08.803.232 12

08.803.233 13

08.803.235 15

28 mm

10 mm

32 mm

9 mm

10 mm Height

28 mm 32 mm

28 mm 32 mm

9 mm

10 mm 10 mm

Spacers shown actual size.

Synthes Spine 15

Instruments

03.803.001 OPAL Implant Holder, straight


03.605.504 Bone Curette, straight, 5.5 mm width, bayoneted

03.605.505 Bone Curette, reverse angle, 5.5 mm width,short, bayoneted




Instruments continued

Intervertebral Disc Shavers

389.767 7 mm height

389.768 8 mm height

389.769 9 mm height

389.770 10 mm height






OPAL Trial Spacers, with T-Handle

03.803.007 7 mm height

03.803.008 8 mm height

03.803.009 9 mm height

03.803.010 10 mm height

03.803.011 11 mm height

03.803.012 12 mm height

03.803.013 13 mm height

03.803.015 15 mm height

03.803.017 17 mm height



394.951 Quick Release T-Handle

OPAL System Set (01.803.100)

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Graphic Cases and Modules60.803.001 Graphic Case, for OPAL Spacer Discectomy

Instruments

60.803.002 Graphic Case, for OPAL Spacer Implants

Instruments03.605.504 Bone Curette, straight, 5.5 mm width,

bayoneted

03.605.505 Bone Curette, reverse angle, 5.5 mm width,short, bayoneted



03.803.001 OPAL Spacer Implant Holder, straight

03.803.002 OPAL Spacer Implant Holder, pistol grip

OPAL Trial Spacers, with T-Handle

03.803.007 7 mm height

03.803.008 8 mm height

03.803.009 9 mm height

03.803.010 10 mm height

03.803.011 11 mm height

03.803.012 12 mm height

03.803.013 13 mm height

03.803.015 15 mm height

03.803.017 17 mm height



Intervertebral Disc Shavers

389.767 7 mm height

389.768 8 mm height

389.769 9 mm height







394.951 Quick Release T-Handle, 2 ea.

For additional information, please refer to package insert.

60.803.001

60.803.002

OPAL System Set (01.803.100) continued


Implants OPAL Spacers, 10 mm x 28 mm, 2 ea.

08.803.107 7 mm height

08.803.108 8 mm height

08.803.109 9 mm height

08.803.110 10 mm height

08.803.111 11 mm height

08.803.112 12 mm height

08.803.113 13 mm height

08.803.115 15 mm height

08.803.117 17 mm height

OPAL Spacers, 10 mm x 32 mm, 2 ea.

08.803.207 7 mm height

08.803.208 8 mm height

08.803.209 9 mm height

08.803.210 10 mm height

08.803.211 11 mm height

08.803.212 12 mm height

08.803.213 13 mm height

08.803.215 15 mm height

08.803.217 17 mm height

OPAL Spacers, Revolve, 2 ea.

08.803.130 9 mm x 28 mm, 10 mm height

08.803.131 10 mm x 28 mm, 11 mm height

08.803.132 10 mm x 28 mm, 12 mm height

08.803.133 10 mm x 28 mm, 13 mm height

08.803.135 10 mm x 28 mm, 15 mm height

08.803.230 9 mm x 32 mm, 10 mm height

08.803.231 10 mm x 32 mm, 11 mm height

08.803.232 10 mm x 32 mm, 12 mm height

08.803.233 10 mm x 32 mm, 13 mm height

08.803.235 10 mm x 32 mm, 15 mm height

60.803.101

60.803.102

Also Available

Sets and Modules01.605.500 Minimally Invasive Posterior Instrument Set

105.151 Minimally Invasive T-PLIF Instrument Set

105.152 T-PLIF Auxiliary Instrument Set

105.777 Posterior Lumbar Interbody FusionInstrument Set

60.803.101 Module, for OPAL Spacers (10 mm x 28 mm and 10 mm x 32 mm)

60.803.102 Module, for OPAL Spacers, Revolve (10 mm x 28 mm and 10 mm x 32 mm)

60.803.103 Module, for OPAL Spacers, Revolve

(10 mm x 24 mm)

ImplantsOPAL Spacers, Revolve*

08.803.050 9 mm x 24 mm, 10 mm height

08.803.051 10 mm x 24 mm, 11 mm height

08.803.052 10 mm x 24 mm, 12 mm height

08.803.053 10 mm x 24 mm, 13 mm height

08.803.055 10 mm x 24 mm, 15 mm height

*24 mm OPAL Revolve spacers are indicated for bilateral use.

Synthes Spine 19

Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2008 Synthes, Inc. or its affiliates. All rights reserved. Antegra, Click’X, Pangea and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 8/08 J7671-B

www.synthes.com

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