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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.
4 Synthes Spine OPAL Spacer System
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.
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Preparation
Figure 1
Figure 2
6 Synthes Spine OPAL Spacer System
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
8 Synthes Spine OPAL Spacer System
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.
10 Synthes Spine OPAL Spacer System
Insert OPAL Spacer continued
Option 1: Impact Technique
Instrument
03.803.001 OPAL Implant Holder, straightor
03.803.002 OPAL Implant Holder, pistol grip
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.
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12 Synthes Spine OPAL Spacer System
Insert OPAL Spacer continued
5Insert OPAL spacer continued
Option 2: Insert and Rotate Technique
Instrument
03.803.002 OPAL Implant Holder, pistol grip
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.
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Implants
14 Synthes Spine OPAL Spacer System
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
03.803.002 OPAL Implant Holder, pistol grip
03.605.504 Bone Curette, straight, 5.5 mm width, bayoneted
03.605.505 Bone Curette, reverse angle, 5.5 mm width,short, bayoneted
03.605.507 Dual-Sided Rasp, bayoneted
03.605.508 Osteotome, straight
16 Synthes Spine OPAL Spacer System
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
389.771 11 mm height
389.772 12 mm height
389.773 13 mm height
389.775 15 mm height
389.777 17 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
03.803.054 Box Curette
03.803.055 Slap Hammer
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
03.605.507 Dual-Sided Rasp, bayoneted
03.605.508 Osteotome, straight
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
03.803.054 Box Curette
03.803.055 Slap Hammer
Intervertebral Disc Shavers
389.767 7 mm height
389.768 8 mm height
389.769 9 mm height
389.770 10 mm height
389.771 11 mm height
389.772 12 mm height
389.773 13 mm height
389.775 15 mm height
389.777 17 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
18 Synthes Spine OPAL Spacer System
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