Oblique Posterior Atraumatic Lumbar cage systemsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...SURGICAL TECHNIQUE Oblique Posterior Atraumatic Lumbar cage system Instruments

SURGICAL TECHNIQUE

Oblique Posterior Atraumatic Lumbar cage system

Instruments and implants approved by the AO Foundation.This publication is not intended for distribution in the USA.

OPAL

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.

Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, 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, 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-maintenance

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OPAL Surgical Technique DePuy Synthes 1

INTRODUCTION OPAL 2

AO Principles 4

Indications and Contraindications 5

SURGICAL TECHNIQUE Access and Exposure 6

Implantation 9

PRODUCT INFORMATION Implants 20

Trial Implants 22

Instruments 23

Additional Instruments 24

Filling Material 26

Additional Systems 28

BIBLIOGRAPHY 30

TABLE OF CONTENTS

2 DePuy Synthes OPAL Surgical Technique

OPAL

OPAL is an implant system for a unilateral transforaminal approach (TLIF) or optionally for a bilateral posterior ap-proach (PLIF). It is specially designed for small incision, resulting in a relatively atraumatic operation for the patient. Implants provide an adequate stability, restore height and lordosis to provide an optimized fusion.

Multiple approach options:• Unilateral posterior approach using 28 mm and 32 mm

spacers (Figure 1)• Bilateral posterior approach using 24 mm spacers

(Figure 2)

Radiolucent• Biocompatible radiolucent polymer (PEEK) allows clear

assessment of bony fusion• Two radiographic marker pins allow for visuali zation of

the implant

Anatomic shape• OPAL implants have convex superior/inferior surfaces

that resemble patient anatomy• Two footprints and nine heights are offered to accom-

modate individual patient anatomy• Axial canal receives filling material (bone graft or sub-

stitute) to allow fusion to occur through the implant• Pyramidal teeth are designed to provide resistance to

implant migration

Figure 1 Figure 2

OPAL cage OPAL revolvable cage

Rotation bevel


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 developed to ensure the neural

structures remain protected throughout the implanta-tion process

• Beveled edge on revolvable implant allows for easy rotation

Self-distracting implants• Bullet nose design allows for ease of insertion

and self-distraction• Reduces the need to remove posterior lip

OPAL revolvable cage OPAL cage

Bullet nose

Impact technique

Insert and revolve technique


AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become 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 and fusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injured neural 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, and neural elements, which may contribute to pain reduction and improved function for the patient.

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


INDICATIONS AND CONTRAINDICATIONS

IndicationsIndications are lumbar and lumbosacral pathologies in which segmental 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 fi xation.


1Position the patient

Position the patient in a restored physiological lordosis.

ACCESS AND EXPOSURE


2Preparation and discectomy

Recommended system

328.021– MIRA System328.025

01.615.002 INSIGHT Retractor Set, Standard Configuration

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

Figure 1

Figure 2


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, 389.777 size 7–17 mm

394.951 T-Handle with Quick Coupling

Optional system

01.605.903 Set for Minimally Invasive Posterior Instruments

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

Shavers and excision instruments for intervertebral discs can facilitate removal of the nucleus pulposus and the surface layers of the cartilaginous endplates.

Note: Appropriate cleaning of the endplates is im-portant for the vascularisation of the bone trans-plant. Excessive cleaning however can weaken the endplates by removing bone under the cartilaginous layers. Removal of the entire endplate can cause subsidence and lead to loss of segmental stability.

Access and Exposure

1 2

3


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 for sizes 10 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 the end of the instrument (2).

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

IMPLANTATION

4

5


Insert the trial implant with the etch representing the height of the trial facing the vertebral endplate (4).

Gently impact on the end of the trial implant until the implant is positioned across the midline and 3 mm–4 mm from the 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, sequen-tially distracting until adequate anterior height is ob-tained. With the segment fully distracted, the trial im-plant must fit tightly and accurately inside the disc space.

Note: The trial implants represent implants with a 28 mm length.

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 representing the axial canal positioned cranial/caudal.

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

Repeat using the next larger size trial implant, sequen-tially distracting until adequate anterior height is ob-tained. With the segment fully distracted, the trial im-plant must fit tightly and accurately inside the disc space.

Note: The trial implants represent implants with a 28 mm length.


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 200 mm, in Vario Case

For the unilateral oblique posterior approach, a screw/rod construct can be placed on the contralateral side while the trial implant is still in position. Provisionally tighten the construct on the contralateral side to ensure that the height 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° counter-clockwise before removal.

If removal of the trial implant requires too much force, the slide 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 an upward force to the slide hammer with the other hand.

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

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

1

2 3


4Prepare the implant holder


Instruments

03.803.002 Opal Implant Holder, with Pistol Grip


Instruments

03.803.001 Opal Implant Holder

The implant holder must be assembled before insertion of the cage.

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

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

Press the button on the distal end of the implant holder and push the shaft into the holder (3). The shaft should now be held inside the sleeve.

Implantation

A

B


5Select the OPAL cage

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

Turn the knob at the distal end of the implant holder counterclockwise to open the jaws. Place the jaws over the posterior end of the cage making sure that the jaw’s base is firmly seated against the implant. Turn the knob on the end of the implant holder clockwise until the jaws of the implant holder have a tight grip on the cage.


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 the appropriate packing block.

It is important to fill the implant until the filling material protrudes from its perforations in order to ensure opti-mal contact with the vertebral endplates.

Use the cancellous bone impactor to pack the filling material into the implant cavities.

Notes • The implant holder must be firmly attached to the

implant in order to avoid damage to the implant holder. The 24 mm implant must be packed manu-ally.

• For more information about the filling material chronOS, see page 26 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 for this technique. Orient the cage so that the lateral graft window is facing the vertebral endplate.

Gently impact on the end of the implant holder, until the cage is positioned across the midline and 3 mm–4 mm from the anterior longitudinal ligament. The implant holder shaft should 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 oriented in the cranial/caudal direction.

The implant must fit tightly and accurately in order to ensure that segmental height is preserved. Using the largest possible implant maximizes segment 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 handle firmly and turn the knob counterclockwise on the end of the implant holder to release it.



Instrument

03.803.001 Opal Implant Holder

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

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

With the segment fully distracted, the implant must fit tightly and accurately, to ensure that segmental height will be preserved. Using the largest possible implant maximizes segment 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 handle firmly and turn the knob on the end of the implant holder counterclockwise to release it.

Implantation


8Supplement posterior fixation

Instruments





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

Posterior fixation with transpedicular screws (for exam-ple Pangea) is required to enhance the biomechanical stability of the motion segment and the stability of the OPAL cage.

10 mm

10 mm

28 mm

32 mm


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

Height

10 mm

9 mm

24 mm

24 mm

24 mm


OPAL Spacers, Revolve (indicated for bilateral use)

Art. No. Dimension (mm) Height (mm)

08.803.050S 9 × 24 10

08.803.051S 10 × 24 11

08.803.052S 10 × 24 12

08.803.053S 10 × 24 13

08.803.055S 10 × 24 15


TRIAL IMPLANTS

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 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


INSTRUMENTS

03.803.002 Opal Implant Holder, with Pistol Grip For 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

03.803.057 Cancellous Bone Impactor OPAL

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


ADDITIONAL INSTRUMENTS

Soft Tissue Retractor

Art. No. Width (mm)

389.857 6

389.858 8

389.859 10

389.265 Lamina Spreader for Travios

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


394.951 T-Handle with Quick Coupling

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


FILLING MATERIAL

Synthetic cancellous bone graft substitute: chronOS Bone Void FillerchronOS Bone Void Filler is a bone graft substitute con-sisting of pure ß-tricalcium phosphate. Its compressive strength is similar to that of cancellous bone once it has been incorporated and remodeled.1 Based on literature, the use of ß-tricalcium phosphate in the spinal column is a valuable alternative to allografts and autografts, even when larger amounts are required.2,3

ResorbableIt is being replaced in the human body by host bone in 6 to 18 months; depending on the indication and the patient’s conditions.2,4-6

OsteoconductiveInterconnected macropores of defined size (100–500 μm) facilitate bone formation throughout the entire implant. Interconnected micropores (< 10 μm) allow an optimal supply of nutrients.1,7

Osteoinductive with bone marrow The combination of chronOS Bone Void Filler with bone marrow accelerates and enhances osteointegration.4,5

SyntheticHaving a synthetic origin, chronOS Bone Void Filler offers the advantage of uniform quality and unlimited availabil-ity.

1 Gazdag et al. 19952 Muschik et al. 20013 Knop et al. 20064 Stoll et al. 20045 Becker et al. 20066 Wheeler et al. 20057 Lu et al. 1999


chronOS Granules Bone Void Filler

Article No. B mm Content (mL)

710.000S 0.5–0.7 0.5

710.001S 0.7–1.4 0.5

710.002S 0.7–1.4 1.0

710.003S 0.7–1.4 2.5

710.011S 1.4–2.8 2.5

710.014S 1.4–2.8 5.0

710.019S 1.4–2.8 10.0

710.021S 1.4–2.8 20.0

710.024S 2.8–5.6 2.5

710.025S 2.8–5.6 5.0

710.026S 2.8–5.6 10.0

710.027S 2.8–5.6 20.0


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 place-ment through a minimally invasive approach.

01.615.002 INSIGHT Retractor Set, Standard Configuration

Minimally Invasive Posterior Instruments (MIPI)

01.605.903 Set for Minimally Invasive Posterior Instruments

The Minimally Invasive Posterior Instruments (MIPI) set is designed to facilitate discectomy, decompression and interbody work through the smaller access ports associ-ated with atraumatic posterior lumbar procedures.


Pangea



The Pangea Degenerative Spine System is a posterior pedicle screw fixation system (T1-S2) intended to provide precise and segmental stabilization of the spine in skele-tally mature patients.

SpiRIT



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

SpiRIT is designed to minimize soft tissue trauma by using a transmuscular approach and subfascial rod inser-tion for thoracolumbar pedicle fixation.


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 vacuum like impregnation of a Beta-TCP ceramic bone substitute before 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: surgical technique, operative feasibility and preliminary clinical results. Eur Spine J. 15: 1352–9

Becker et al. (2006) Osteopromotion by a b-TCP/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine, Volume 31(1): 11–17

Gazdag AR, Lane JM, Glaser D, et al. (1995) Alternatives to autogenous bone graft: efficacy and indications. J Am Acad Orthop Surg 3(1): 1–8.

Knop C, Sitte I, Canto F, Reinhold M, Blauth M (2006) Successful posterior interlaminar fusion at the thoracic spine by sole use of b-tricalcium phosphate. Arch Orthop Trauma Surg, 126: 204–210

Lu JX, Flautre B et al. (1999) Role of interconnections inporous bioceramics on bone recolonization in vitro andvivo. J Mater Sci Mater Med 10: 111–120.

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. Eur Spine J. 10 Suppl 2: 178–84

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

Wheeler D. (2005) Grafting of massive tibial subchondral bone defects in a Caprine Model using ß-Tricalcium phosphate versus autograft. J Orthop Trauma 19(2): 85–91.

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Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

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

Documents

Oblique Posterior Atraumatic Lumbar cage systemsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...SURGICAL TECHNIQUE Oblique Posterior Atraumatic Lumbar cage system Instruments