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OPAL. Oblique Posterior AtraumaticLumbar cage system.

Technique Guide

Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Bibliography 28

OPAL 2

AO Principles 4

Indications and Contraindications 5

Access and Exposure 6

Implantation 8

Implants 19

Trial Implants 20

Instruments 21

Additional Instruments 22

Filling Material 24

Additional Systems 26

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use ofthe product. Instruction by a surgeon experienced in handling this product ishighly 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

2 Synthes OPAL System Technique Guide

OPAL. Oblique Posterior AtraumaticLumbar cage system.

OPAL is an implant system for an unilateral transforaminal approach (TLIF). The design of the OPAL cage allows for self-distraction. The cage can be inserted with two different surgical techniques. The instruments are designed for mini-mally invasive surgeries.

Radiolucent– Biocompatible radiolucent polymer (PEEK) allows clear

assessment of bony fusion– Two radiographic marker pins allow for easy visualization

of the implant

Anatomic shape– OPAL implants have convex superior/inferior surfaces that

closely resemble patient anatomy and ensure accurate sizing

– Two footprints and nine heights are offered to accommo-date individual patient anatomy

– Axial canal receives filling material (bone graft or substi-tute) to allow fusion to occur through the implant

– Pyramidal teeth provide resistance to implant migration

Rotation bevel

Opal cage

Opal revolvable cage

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Two insert techniques– Traditional straight implant insertion– Revolvable implant designed for insert and revolve

technique– Implants rotated 90° in situ provide intervertebral

distraction– Revolve technique ensures that the neural structures

remain protected throughout the implantation process.– Beveled edge on revolvable implant allows for easy

rotation

Self-distracting implants– Bullet nose design allows for easy insertion and

self-distraction– Minimizes the need to remove posterior lip

Opal revolvable cage Opal cage

Bullet nose

Impact technique

Insert and revolve technique

1 See Müller et al. 19952 Ibid.3 See Aebi et al. 2007


AO Principles

In 1958, the AO formulated four basic principles, which havebecome the guidelines for internal fixation1, they are:– Anatomical reduction– Stable internal fixation– Preservation of blood supply– Early, active pain-free 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 neu-ral elements.2

AO Principles as Applied to the Spine3

Anatomical alignmentRestoration 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 mobilizationMinimization of damage to the spinal vasculature, dura, andneural elements, which may contribute to pain reduction andimproved function for the patient.

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IndicationsIndications are lumbar and lumbosacral 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 tumors– Major spinal instabilities– Primary spinal deformities

Important: OPAL must be applied in combination with posterior fixation.

Indications and Contraindications


Access and Exposure

1Position the patient

Position the patient in a restored transforaminal physiologicallordosis.

2Transforaminal approach

Recommended system

328.021– MIRA System328.025

After viewing a radiograph of the segment, make a small incision and retract the posterior anatomy.

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3Disc removal: Prepare disc space

Optional instruments

03.605.504 Bone Curette, 5.5 mm, bayoneted, black

03.605.505 Bone Curette, 45° angled, 5.5 mm, short,bayoneted, black

03.605.507 Rasp, dual-sided, bayoneted, black

03.605.508 Osteotome, straight, black

03.803.054 Curette, rectangular, bayoneted, black

389.767– Shaver for Intervertebral Discs, 777 size 7–17 mm

394.951 T-Handle with Quick Coupling

Optional system

01.605.903 Set for Minimally Invasive PosteriorInstruments

Use the curette to remove the disc through the incision window.

Shavers and excision instruments for intervertebral discs canfacilitate removal of the nucleus pulposus and the surfacelayers of the cartilaginous endplates.

Note: Appropriate cleaning of the endplates is important forthe vascularisation of the bone transplant. Excessive cleaninghowever can weaken the endplates by removing bone underthe cartilaginous layers. Removal of the entire endplate cancause subsidence and lead to loss of segmental stability.

1 2

3


Implantation

1Determine implant size

Option A: Insert and revolve technique

Instruments

03.803.011– Trial Implant Opal, 03.803.015 size 11 mm – 15 mm

Note: The insert and rotate technique can only be used forsizes 11 mm–15 mm. For all other sizes, use the impact technique.

In order to rotate the trial implant in situ, extend the T-handle.

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

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

Release the button, allowing the T-handle to lock into position (3).

4

5

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Insert the trial implant with the etch representing the axialcanal oriented parallel to the vertebral endplate (4).

Gently impact on the end of the trial implant until the im-plant is positioned across the midline and 3 mm – 4 mm fromthe anterior longitudinal ligament.

The trial implant shaft should be oriented 30–45° from mid-line. When the trial implant reaches the appropriate depth,rotate 90° clockwise to distract and assess height adequacy(5).

Repeat using the next larger size trial implant, sequentiallydistracting until adequate anterior height is obtained. Withthe segment fully distracted, the trial implant must fit tightlyand accurately inside the disc space.

Note: The trial implants represent implants with a 28 mmlength.


Implantation

Option B: Impact technique

Instruments

03.803.007– Trial Implant Opal,03.803.017 size 7 mm–17 mm

Impact an appropriately sized trial implant with the etch rep-resenting the axial canal positioned cranial/caudal.

Continue to impact on the end of the trial implant until thecage is positioned across the midline and 3 mm – 4 mm fromthe anterior longitudinal ligament. The trial implant shaftshould be oriented 30 – 45° from midline.

Repeat using the next larger size trial implant, sequentiallydistracting until adequate anterior height is obtained. Withthe segment fully distracted, the trial implant must fit tightlyand accurately inside the disc space.

Note: The trial implants represent implants with a 28 mmlength.

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2Screw/rod fixation (optional)

Instruments

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 200mm, in Vario Case

A screw/rod construct can be placed on the contralateral sidewhile the trial implant is still in position. Provisionally tightenthe construct on the contralateral side to ensure that theheight in the anterior column is maintained.


Implantation

3Remove trial implant

Instrument

03.803.055 Slide Hammer with Connector, short

When using the insert and revolve technique, it is recom-mended that the trial implant be rotated 90° counterclock-wise before removal.

If removal of the trial implant requires too much force, theslide hammer can be used.

Slide the slide hammer onto the end of the trial implant.While holding the handle of the trial implant with one hand,apply a strong upward force to the slide hammer with theother hand.

Repeat this process until the trial implant is removed fromthe disc space.

The slide hammer can be removed by pushing on the end of shaft.

�

� �

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4Prepare the implant holder

Instruments


03.803.002 Opal Implant Holder, with Pistol Grip


03.803.001 Opal Implant Holder

The implant holder must be assembled before insertion ofthe cage.

Attach the knob to the distal end of the implant holdersleeve by turning the knob counterclockwise (1).

Insert the shaft into the sleeve making sure to align the ar-rows on the end of the shaft with those on the sleeve (2).

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

A

B

5Select the OPAL cage

Select a cage that corresponds to the size measured usingthe trial implant in the previous steps.

Turn the knob at the distal end of the implant holder coun-terclockwise to open the jaws. Place the jaws over the poste-rior end of the cage making sure that the jaws’ base is firmlyseated against the implant. Turn the knob on the end of theimplant holder clockwise until the jaws of the implant holderhave a tight grip on the cage.


Implantation

Synthes 15

6Pack implant with bone graft

Instruments

03.803.057 Cancellous Bone Impactor OPAL

03.803.058 Packing Block OPAL, size 28�10

03.803.059 Packing Block OPAL, size 32�10

After the cage is fixed to the implant holder, insert it into theappropriate packing block.

It is important to fill the implant until the filling materialprotrudes from its perforations in order to ensure optimalcontact with the vertebral endplates.

Use the cancellous bone impactor to firmly pack the fillingmaterial into the implant cavities.

Notes – The implant holder must be firmly attached to the implant

in order to avoid damage to the implant holder. – For more information about the filling material chronOS,

see page 24 in this technique guide.


Implantation

7Insert OPAL cage


Instrument

03.803.002 Opal Implant Holder, with Pistol Grip

Use the pistol grip implant holder and the revolvable cage forthis technique. Orient the cage so that the main graft win-dow is parallel to the vertebral endplate.

Gently impact on the end of the implant holder, until thecage is positioned across the midline and 3 mm – 4 mm fromthe anterior longitudinal ligament. The implant holder shaftshould be oriented 30–45° from midline.

Once the cage is in position, rotate the implant holder 90°clockwise so that the main graft window of the cage is ori-ented in the cranial/caudal direction.

The implant must fit tightly and accurately in order to ensurethat segmental height is preserved. Using the largest possibleimplant maximizes segment stability by creating ligamentoustension.

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

When the cage is in the proper location, hold the handlefirmly and turn the knob counterclockwise on the end of theimplant holder to release it.


Instrument

03.803.001 Opal Implant Holder

Using the implant holder, orient the cage with the main graftwindow in the cranial/caudal direction.

Gently impact on the distal end of the implant holder, untilthe cage is positioned across the midline and 3 mm –4 mmfrom the anterior longitudinal ligament. The implant holdershaft should be oriented 30 –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 seg-ment stability by creating ligamentous tension.

Use AP and lateral fluoroscopy to confirm appropriate placement and trajectory.

When the cage 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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8Supplement posterior fixation

Instruments

01.620.015 Pangea Polyaxial Basic Instruments in Vario Case

01.620.018 Pangea Polyaxial Implants in Vario Case



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

Posterior fixation with transpedicular screws (for examplePangea) is required to enhance the biomechanical stability ofthe motion segment and the stability of the OPAL cage.

Implantation

10 mm

10 mm

28 mm

32 mm

Height

Implants

Dimension, 10�28 mm

Art. No. Height (mm) Insertion technique

Insert and revolve Impact

08.803.107S 7 X

08.803.108S 8 X

08.803.109S 9 X

08.803.110S 10 X

08.803.131S 11 X X

08.803.132S 12 X X

08.803.133S 13 X X

08.803.135S 15 X X

08.803.117S 17 X

Dimension, 10�32 mm

Art. No. Height (mm) Insertion technique


08.803.207S 7 X

08.803.208S 8 X

08.803.209S 9 X

08.803.210S 10 X

08.803.231S 11 X X

08.803.232S 12 X X

08.803.233S 13 X X

08.803.235S 15 X X

08.803.217S 17 X

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Trial Implant Opal

Art. No. Size (mm) Insertion technique


03.803.007 7 X

03.803.008 8 X

03.803.009 9 X

03.803.010 10 X

03.803.011 11 X X

03.803.012 12 X X

03.803.013 13 X X

03.803.015 15 X X

03.803.017 17 X

Trial Implants

Instruments

03.803.002 Opal Implant Holder, with Pistol GripFor use only with the insert and revolve technique.

03.803.001 Opal Implant HolderFor use with the impact technique

03.803.055 Slide Hammer with connector, short

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03.803.057 Cancellous Bone Impactor OPAL

03.803.058 Packing Block OPAL, size 28�1003.803.059 Packing Block OPAL, size 32�10


Soft Tissue Retractor

Art. No. Width (mm)

389.857 6

389.858 8

389.859 10

03.605.504 Bone Curette, 5.5 mm, bayoneted, black

03.605.505 Bone Curette, 45° angled, 5.5 mm, short,bayoneted, black

03.605.507 Rasp, dual-sided, bayoneted, black

03.803.054 Curette, rectangular, bayoneted, black

03.605.508 Osteotome, straight, black

Additional Instruments

389.265 Lamina Spreader for Travios

Shaver for Intervertebral Discs

Art.No. Size (mm)

389.767 7

389.768 8

389.769 9

389.770 10

389.771 11

389.772 12

389.773 13

389.775 15

389.777 17

394.951 T-Handle with Quick Coupling

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Filling Material

chronOS: Synthetic cancellous bone graft substitutechronOS is a fully synthetic and resorbable bone graft substi-tute consisting of pure ß-tricalcium phosphate. Its compres-sive strength is similar to that of cancellous bone. Based onliterature, the use of ß-tricalcium phosphate in the spinal column is a valuable alternative to allografts and autografts,even when larger amounts are required.1

Opal, 10�28 mm

Art. No. Height (mm) Filling Volume

[mm3] [cm3]

08.803.107S 7 375 0.38

08.803.108S 8 460 0.46

08.803.109S 9 540 0.54

08.803.110S 10 620 0.62

08.803.131S 11 665 0.67

08.803.132S 12 765 0.77

08.803.133S 13 840 0.84

08.803.135S 15 995 1.00

08.803.117S 17 1225 1.23

Opal, 10�32 mm

Art. No. Height (mm) Filling Volume

[mm3] [cm3]

08.803.207S 7 475 0.48

08.803.208S 8 575 0.58

08.803.209S 9 675 0.68

08.803.210S 10 835 0.84

08.803.231S 11 830 0.83

08.803.232S 12 915 0.92

08.803.233S 13 1005 1.01

08.803.235S 15 1200 1.20

08.803.217S 17 1600 1.60

1 Muschik et al. 2001; Knop et al. 2006; Arlet et al. 2006

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Resorbable– It is remodeled to vital bone within 6–18 months

Osteoconductive– Interconnecting macropores of defined size (100–500 μm)

facilitate bone ingrowth. Interconnected micropores(10–40 μm) allow an optimal supply of nutrients. The pa-tient’s blood, blood platelet concentrate or bone marrowaspirate enhances the properties of chronOS required forfusion.2

Safe– 100% synthetic – no risk of cross infection

chronOS Granules

710.000S � 0.5 –0.7 mm, 0.5 cc

710.001S � 0.7 –1.4 mm, 0.5 cc

710.002S � 0.7 –1.4 mm, 1 cc

710.003S � 0.7 –1.4 mm, 2.5 cc

710.011S � 1.4 –2.8 mm, 2.5 cc

710.014S � 1.4 –2.8 mm, 5 cc

710.019S � 1.4 –2.8 mm, 10 cc

710.021S � 1.4 –2.8 mm, 20 cc

710.024S � 2.8 –5.6 mm, 2.5 cc

710.025S � 2.8 –5.6 mm, 5 cc

710.026S � 2.8 –5.6 mm, 10 cc

710.027S � 2.8 –5.6 mm, 20 cc

2 Allman et al. 2002; Stoll et al. 2004; Becker et al. 2006


Additional Systems

Minimally Invasive Retractor Access

328.021– MIRA System328.025

The MIRA System allows surgeons to achieve access for decompression, interbody fusion or pedicle screw placementthrough a minimally invasive approach.

Minimally Invasive Posterior Instruments (MIPI)

01.605.903 Set for Minimally Invasive Posterior Instruments

The Minimally Invasive Posterior Instruments (MIPI) set is de-signed to facilitate discectomy, decompression and interbodywork through the smaller access ports associated with atrau-matic posterior lumbar procedures.

Pangea

01.620.015 Pangea Polyaxial Basic Instruments inVario Case

01.620.018 Pangea Polyaxial Impalnts in Vario Case

The Pangea Degenerative Spine System is a posterior pediclescrew fixation system (T1-S2) intended to provide precise andsegmental stabilization of the spine in skeletally mature patients.

SpiRIT



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

SpiRIT is designed to minimize soft tissue trauma by using atransmuscular approach and subfascial rod insertion for tho-racolumbar pedicle fixation.

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Bibliography

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

Allmann M, Florias E, Stoll T, Hoerger F, Bart F (2002)Haematological evaluation of blood samples after vacuumlike impregnation of a Beta-TCP ceramic bone substitutebefore implantation (internal communication)

Arlet V, Jiang L, Steffen T, Ouellet, J, Reindl R, Max Aebi(2006) Harvesting local cylinder autograft from adjacentvertebral body for anterior lumbar interbody fusion: surgicaltechnique, operative feasibility and preliminary clinical re-sults. Eur Spine J. 15: 1352–9

Becker et al. (2006) Osteopromotion by a �-TCP/Bone MarrowHybrid Implant for Use in Spine Surgery. Spine, Volume31(1): 11–17

Knop C, Sitte I, Canto F, Reinhold M, Blauth M (2006) Suc-cessful posterior interlaminar fusion at the thoracic spine bysole use of �-tricalcium phosphate. Arch Orthop TraumaSurg, 126: 204–210

Müller ME, Allgöwer M, Schneider R, Willenegger H (1995)Manual of Internal Fixation. 3rd, exp. a. completely rev. ed.1991. Corr. 3rd printing. Berlin, Heidelberg, New York:Springer

Muschik M, Ludwig R, Halbhubner S, Bursche K, Stoll T(2001) Beta-tricalcium phosphate as a bone substitutefor dorsal spinal fusion in adolescent idiopathic scoliosis:preliminary results of a prospective clinical study. EurSpine J. 10 Suppl 2: 178–84

Stoll et al. (2004) New Aspects in Osteoinduction. Mat.-wiss.u. Werkstofftech, 35 (4): 198–202

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