Source: https://www.scribd.com/document/150203906/036-000-266-Oracle-Cage
Timestamp: 2017-08-24 06:24:53
Document Index: 225760117

Matched Legal Cases: ['art. 3', 'Art. 0', 'Art.273', 'Art.809', 'Art.235', 'Art. 08', 'Art.655', 'Art.809', 'Art.002']

036.000.266 / Oracle Cage | Vertebra | Electrical Connector
Oracle Cage System. Comprehensive solution for lumbar interbody fusion using the direct lateral approach.
Image intensiﬁer control Warning This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please refer to: www.synthes.com/reprocessing
Oracle Cage System AO Principles Indications and Contraindications
Preoperative Planning and Preparation Patient Positioning Access and Exposure – A. Approach spine with tissue dissector – B. Approach spine with dilators – C. Approach spine with neuromonitoring and tissue dissector or dilators Soft Tissue Retraction – A. Retraction with SynFrame – B. Retraction with Oracle access instruments Discectomy Prepare Endplates Trial for Implant Size Insert Implant – A. Insertion with implant holder – B. Insertion with lateral quick inserter distractor Supplemental Fixation
8 9 10 10 12 14
16 16 17 22 25 26 28 28 29 32
Implants Instruments Sets Additional Sets Filling Material
33 36 44 51 52
The direct lateral approach is a minimally invasive approach that avoids the anterior vessels.Oracle Cage System. Comprehensive solution for lumbar interbody fusion using the direct lateral approach. Approach The Oracle Cage system is a modular and comprehensive set of implants and instruments designed to support a direct lateral approach to the lumbar spine. Access Oracle access instruments Retractor − Provides direct minimally invasive access to operative level − Allows for fluoroscopic visualization − Blades expand distally for additional access Retractor accessories − Light clip illuminates the surgical field − Intradiscal anchor and retractor pins increase retractor stability − Blade extensions provide an additional 10 mm to the blade length in-situ 2 Synthes Oracle Cage System Technique Guide . and posterior nervous and bony structures.
ream out disc material − Bayoneted curettes ensure maximum visibility while supporting a minimal exposure − Instruments’ matte finish reduces glare from OR lighting Insertion Oracle cage insertion instruments – Trial implants’ self-distracting nose allows for easier insertion – Slide hammer minimizes force required for trial implant removal – Lateral Quick Inserter Distractor inserts and distracts in one simple step. without impaction Synthes 3 . four-fluted and twofluted.Discectomy Oracle discectomy instruments − Two styles of shavers.
Features and Benefits Oracle Cage is designed to meet the specific demands of lateral lumbar interbody fusion procedures. Anatomic shape Mimics the anatomy of the disc space Self-distracting nose Allows for ease of insertion 4 Synthes Oracle Cage System Technique Guide . and 2 sagittal profiles to accommodate various patient anatomies. The implant is available in 4 medial/lateral lengths.Oracle Cage System. Comprehensive solution for lumbar interbody fusion using the direct lateral approach. Pyramidal teeth Provide resistance to implant migration Large central canal Accommodates autogenous bone graft or bone graft substitute to allow fusion to occur through the cage Four radiographic marker pins Enable visualization of implant position The medial/lateral marker pins are located approximately 4 mm from the edges of the implant. 5 heights. The anterior/posterior marker pins are located approximately 2 mm from the edges of the implant.
The ultimate compressive strength of a vertebral body is 8.5 Compressive strength 60000 Fig. Panjabi. PA. Synthes Spine. 2006-MT06-347.4 Test results show that Oracle Cage can withstand expulsion loads of 2. to aid in stress distribution and load sharing. PA. 1 The modulus of elasticity of the polymer is approximately between cancellous and cortical bone. 1957. 1).1 Test results show that Oracle Cage can withstand compressive loads of 49. Synthes Spine. “Fracture of the Vertebral Endplate in the Lumbar Spine. 4 A. West Chester.519 ‫ ע‬9 N (see Fig.A. 25 (suppl. West Chester.Mechanical Testing Summary Testing The design of Oracle Cage is based on sound engineering principles. which enables adequate compression of autograft in and around the implant. Polyetheretherketone (PEEK) Synthes 5 . 150 N. Perry. extensive research of anatomical geometry from published literature. 2006-MT06-346. Philadelphia. and mechanical testing. Williams and Wilkins.3 Resistance to expulsion Testing was also conducted to ensure that Oracle Cage is capable of resisting expulsion at clinically relevant loads. 2 2000 1 O. Synthes Spine. which allow the surgeon to radiographically determine the exact position of the implant. Scand. 1 50000 40000 Load (N) 30000 20000 10000 0 Oracle Cage Vertebral body Pushout strength 2500 Fig. 9. 2006-MT06-416. Lippincott.) 2 Testing performed at the Mechanical Testing Laboratory.2 Additionally.” Acta Orthop. West Chester. 3 Testing performed at the Mechanical Testing Laboratory. 2). White and M. the Oracle Cage passed fatigue compression testing conducted at clinically relevant loads for 10 million cycles. 1990.000 N. Clinical Biomechanics of Spine. PA. Load (N) 1500 1000 500 0 Oracle Cage Human disc Material Oracle Cage is manufactured from a biocompatible polymer1 material embedded with four radiopaque marker pins. 7. The maximum shear force that the lumbar spine (human disc) can withstand is approx.M. Compressive strength Testing was conducted to show that Oracle Cage can withstand clinically relevant loads in the spine. 5 Testing performed at the Mechanical Testing Laboratory. both intraoperatively and postoperatively.594 ‫ ע‬35 N (see Fig.
M.e. Early.1 They are: − Anatomical reduction − Stable internal fixation − Preservation of blood supply − Early. The ideal surgical technique and implant design minimize damage to anatomical structures. Berlin.E. 6 Synthes Oracle Cage System Technique Guide . Müller. Webb JK (2007). Arlet V. i. functional patient. and H. Willenegger: AO Manual of Internal Fixation. Stable internal fixation In the spine. Springer-Verlag 1991 2 Ibid. the AO formulated four basic principles. Stuttgart. 3 Aebi M. the biomechanics of the spine can be improved.AO Principles In 1958. active pain-free mobilization The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. but also to maintain the balance and the physiologic three-dimensional form of the spine. facet capsules and soft tissue attachments remain intact. R. Schneider. and maintains the stability of the facet joints. this means reestablishing and maintaining the natural curvature and the protective function of the spine. the goal of internal fixation is to maintain not only the integrity of a mobile segment. New York: Thieme 4 Ibid. active mobilization The ability to restore normal spinal anatomy may permit the immediate reduction of pain. which have become the guidelines for internal fixation.2 AO Principles as applied to the spine3 Anatomic alignment In the spine.4 A stable spinal segment allows bony fusion at the junction of the lamina and pedicle. AOSpine Manual (2 vols. and create a physiological environment that facilitates healing. Preservation of blood supply The proper atraumatic technique enables minimal retraction or disturbance of the nerve roots and dura. A specific goal in the spine is returning as much function as possible to the injured neural elements. and a reduction of pain can be experienced. 3rd Edition. The reduction in pain and improved function can result when a stable spine is achieved. 1 M. resulting in a more active.). By regaining this natural anatomy. Allgöwer.
Oracle implants are inserted via the lateral approach. e. e.Indications and Contraindications Intended Use The Oracle Cage is intended to replace lumbar intervertebral discs and to fuse the adjacent vertebral bodies together at vertebral levels L1 to L5. Additionally. such as: – TSLP (Thoracolumbar Spine Locking Plate with direct lateral approach) – ATB (Anterior Tension Band with the anterolateral or anterior approach) or posterior stabilization with pedicle screw systems.: – Pangea – Click’X – USS Two-level lateral view of Oracle and Pangea immediately postoperative.g.g.: – Degenerative disc diseases and spinal instabilities – Revision procedures for post-discectomy syndrome – Pseudoarthrosis or failed spondylodesis – Degenerative spondylolisthesis – Isthmic spondylolisthesis Oracle Cage is intended to be used in combination with Synthes supplemental fixation. Contraindications – Vertebral body fractures – Spinal tumors – Major spinal instabilities – Primary spinal deformities Synthes 7 . the use of autogenous bone or bone graft substitute as well as supplemental fixation is always recommended. Indications Lumbar pathologies with indicated segmental spondylodesis.
809. lumbar** Oracle Access Instrument Set Stability System Set Set for MIS Support System Oracle Discectomy Instrument Set Oracle Cage Insertion Instrument Set Optional 03. ** SynFrame RL. 8 Synthes Oracle Cage System Technique Guide . * SynFrame Basic System contains instruments that allow for direct mounting to the operating table.943 03.809.018 or 01. lumbar contains radiolucent soft tissue retractors and semitransparent bone levers.011 01. Have all sets readily available prior to surgery.609. sterile Dilation Instrument Set Set for Minimally Invasive Posterior Instuments Have all necessary imaging studies readily available to plan implant placement and visualize individual patient anatomy.002S 03.002 and 01.809.004 SynFrame Basic System in Vario Case* Set SynFrame RL.310 01.809.003 01. eight EO sterile twisted pair needle electrodes and two EO sterile single needle electrodes.Preoperative Planning and Preparation Sets 187.809.809.102 or 01. *** Kit contains a sterile pouch with a disposable monopolar stimulation probe with touchproof cable assembly and the following components in a nonsterile pouch: A nonsterile sticky pad ground electrode.903 Oracle Neuromonitoring Kit. sterile *** Retractor Pin Light Clip for Oracle Retractor.100 01.925S 01.809.612.809.605.
Secure the patient to the table. Synthes 9 . Note: If neuromonitoring is planned. It is also recommended to flex the table.809. A bolster placed underneath the hip. Caution: Prevent undue pressure points when positioning and securing the patient. Ensure that the rotational alignment is correct. to aid in opening the space between the twelfth rib and iliac crest.002S Oracle Neuromonitoring Kit. the neurophysiologist or neuromonitoring technician should apply all appropriate electrodes prior to patient positioning.Patient Positioning Optional set 03. is recommended. to aid in opening the space between the twelfth rib and iliac crest. sterile Place the patient in a lateral decubitus position.
Move the peritoneum anterior with forefinger and continue blunt dissection to palpate down to the transverse process. Slide forward to psoas muscle (2). 1 Note: Use a longitudinal incision if multiple levels will be fused. Make a skin incision targeting the anterior third of the intervertebral disc space. the oblique muscles of the abdomen should be visible. Approach spine with tissue dissector Instrument 03.Access and Exposure Locate the correct operative level and incision with fluoroscopic views. 2 10 Synthes Oracle Cage System Technique Guide .809. Separate the muscle fibers with blunt dissection and enter the retroperitoneal space (1).860 Tissue Dissector Once the skin incision is made and the subcutaneous tissue is taken down. A.
Fluoroscopy is recommended. Remove the Kirschner wire.”. PhD: “An Anatomic Study of the Lumbar Plexus with Respect to Retroperitoneal Endoscopic Surgery. MD. Synthes 11 .1 Push a Kirschner wire through the psoas muscle in the middle of the safe zone landing and into the annulus of the desired intervertebral disc space (3). Use fluoroscopy with lateral images to determine the location of the Kirschner wire. PhD. to ensure targeting of the anterior two-thirds of the disc space of concern. PhD and Hiroyuki Yaginuma. Use fluoroscopy to determine the location of the tissue dissector. Volume 28. 3 Kirschner wire 4 Tissue dissector 1 Takatomo Moro. MD. The anterior third of the psoas muscle is the most likely safe zone for avoiding the neural elements of the lumbar plexus. Number 5. MD. Spine 2003. MD. Separate the psoas muscle using the tissue dissector and push the tissue dissector into the disc space (4). Shin-ichi Konno.Map out a safe corridor through the psoas muscle to the lumbar spine. Shin-ichi Kikuchi. pp 423-428.
large Kirschner Wire л 1.Access and Exposure B. map out a safe corridor through the psoas muscle to the lumbar spine.6 mm with blunt tip.859 02.2 Push a Kirschner wire through the psoas muscle in the middle of the safe zone landing and into the annulus of the desired intervertebral disc space.002 If sequential dilation is planned. small Oracle Dilator.001 Oracle Dilator. centred. large Oracle Dilator.858 03. length 285 mm Kirschner wire 02. not centred.809.809. Use fluoroscopy with lateral images to determine the location of the Kirschner wire. not centred. medium Oracle Dilator. The anterior third of the psoas muscle is the most probable safe zone for avoiding the neural elements of the lumbar plexus. Fluoroscopy is recommended to ensure targeting of the anterior two-thirds of the disc space of concern.809. centred. length 285 mm Kirschner Wire л 3.851 03.809.809.855 03. 12 Synthes Oracle Cage System Technique Guide . Approach spine with dilators Instruments 03. small Oracle Dilator.853 03.809.809. centred. 2 Ibid pp 423-428.0 mm with blunt tip.
859) are also available for sequential dilation.809.858 and 03. Synthes 13 .Separate the psoas muscle by inserting the smallest diameter dilator over the Kirschner wire.809. and should always be used with a 3. Use fluoroscopy to determine the location of dilator.0 mm Kirschner wire. Repeat with the next larger diameter dilator until the required dilation is achieved. Centred dilators Alternative: Not centred Oracle Dilators (03.
Probe Handle Cable 14 Synthes Oracle Cage System Technique Guide .809. Approach spine with neuromonitoring and tissue dissector or dilators Instrument 03. Attach the cable to the handle.Access and Exposure C. assemble the monopolar stimulating probe. Attach the handle and cable assembly to the proximal end of the monopolar stimulating probe. Pass the opposite end of the cable to the neurophysiologist or neuromonitoring technician. sterile If neuromonitoring is planned.002S Oracle Neuromonitoring Kit.
Map out a safe corridor through the psoas muscle to the lumbar spine by stimulating with the monopolar probe. Push the stimulating probe through the psoas muscle in the middle of the safe zone landing and into the annulus of the desired intervertebral disc space. Use fluoroscopy with lateral images to determine the location of the stimulating probe.
Caution: Do not impact on the probe.
Separate the psoas muscle using the tissue dissector. With the tissue dissector in line with the probe, push the tissue dissector into the disc space. Use fluoroscopy to determine the location of the tissue dissector. Remove the probe. Probe around the dissector to ensure avoidance of nerve structures. Tissue dissector
Alternatives 1. Remove the handle from the monopolar stimulating probe and perform sequential dilation with the not centred Oracle Dilators (03.809.858 and 03.809.859) over the stimulating probe. 2. Use a 1.6 mm Kirschner wire in combination with the centred dilators while operating the stimulating probe.
A. Retraction with SynFrame
Sets 187.310 01.609.102 SynFrame Basic System in Vario Case Set SynFrame RL, lumbar
It is recommended to use at least three radiolucent SynFrame retractors to hold the soft tissue and enable the passage of the instrumentation. Because there might be significant forces that are applied by the psoas, the retractors need to be well stabilized with the aid of the retractor holders and the SynFrame ring. For further information please refer to SynFrame Handling Technique (036.000.065).
Note: Careful positioning of the retractors is required to avoid soft tissue damage.
Oracle Cage System
B. Retraction with Oracle access instruments
Instruments 03.809.857 03.809.900 03.809.903– 03.809.915 03.809.923 03.809.941 03.809.942 388.140 Retractor Blade Screwdriver Oracle Retractor Handle Oracle Retractor Blades, 40 mm–160 mm Screwdriver, hexagonal Universal Arm Table Clamp for Universal Arm Socket Wrench л 6.0 mm, with straight handle Retractor blade Retractor handle
Optional instruments 03.612.031 03.809.925S 03.809.943 03.820.101 03.809.918 03.809.919 Fibre Optic Cable for Light Strip Light Clip for Oracle Retractor, sterile Retractor Pin Screwdriver Oracle Retractor Blade Extension Oracle Retractor Intradiscal Anchor
Retractor blade screwdriver
Determine the appropriate retractor blade lengths from the depth indicators on the tissue dissector or optional dilators. Assemble the blades to the retractor handle with the retractor blade screwdriver.
Important: Do not over-torque the screwdriver. Two-finger tightening is sufficient to retain the blades to the retractor handle.
If they do not contact the disc space and/or vertebral endplates. Remove the tissue dissector or optional dilator. The MIS Support System may also be used to stabilize the retractor (refer to the MIS Support System Assembly Guide). Slide the table clamp onto the OR table rail. Turn the table clamp lever clockwise to tighten. Retractor blades should contact the disc space and/or vertebral endplates. Use an anterior/posterior fluoroscopic image to determine the position of the retractor blade tips. to minimize tissue creep.Soft Tissue Retraction Slide the retractor over the tissue dissector or optional dilator. perpendicular to the disc space. push down on the retractor to push through the psoas muscle before opening the retractor. Insert the post of the universal arm through the opening of the table clamp with the articulation of the arm facing the patient. open retractor to the desired position. Insert the universal arm into the connector of the retractor handle and turn the knob on the arm clockwise to tighten. and turn the speed nut to lock it. Retractor Tissue dissector Use the universal arm and table clamp to stabilize the retractor to the OR table. Turn the table clamp lever counterclockwise to loosen. Universal arm Table clamp 18 Synthes Oracle Cage System Technique Guide .
the cranial and caudal blades can independently provide up to 15° of cranial and caudal angulation.Retract the third blade posteriorly by turning the knob clockwise with the socket wrench. Socket wrench With the blades open and secure. Button Knob Third blade Note: If the neuromonitoring kit is used. Insert the light clip into the end of the fiber optic light cable. To release the amount of retraction. or clockwise to tighten into the desired position. Insert the light clip to increase visualization. Turn on the light source. Use the socket wrench on either the cranial or caudal knob. slide the light clip down the grooves of the cranial or caudal blades of the retractor. Turn counterclockwise to release. Knob Socket wrench 15° 15° Synthes 19 . The third blade should not be placed much beyond the posterior 1⁄3 margin of the disc space to avoid any neural structures. stimulate the exposed area with the monopolar stimulating probe to ensure that the surgical field is free of nerve structures. push the button and turn the knob counterclockwise with the socket wrench. For further retraction.
809. Tip: Remove the retractor pin before any distraction or trialing of disc space. Unscrew the driver from the anchor. attach the retractor pin to the screwdriver (03.Soft Tissue Retraction For increased retractor stability.101). For additional retractor stability. Slide the pin down the grooves of either the cranial or caudal blade and screw the pin into the vertebral body. Intradiscal anchor Retractor pin 20 Synthes Oracle Cage System Technique Guide .923).820. Slide the anchor down the grooves of the third blade. attach the intradiscal anchor to the third blade by screwing the anchor onto the hexagonal screwdiver (03.
If the psoas or soft tissue creeps beneath the cranial or caudal blades. while holding back the psoas muscle. Assemble the blade extension to the hexagonal screwdiver (03. the blade extensions provide an additional 10 mm extension.923) and slide the blade extension down the grooves of either the cranial or caudal blade.809. Hexagonal screwdriver Blade extension Blade extension Synthes 21 .
809. angled upwards.827 03. up biting or forward biting.877 Oracle Spreaders.872– 03.605. heights 9 mm–13 mm 2 Remove disc material from the intervertebral space using any of the following: periosteal elevator.809. bayoneted.809. bayoneted. The periosteal elevator can be used to loosen the disc material from the endplates. width 20 mm Oracle Shavers. length 330 mm Periosteal Elevator.5 mm denoted by the white band.809.5 mm Oracle Ring Curettes.002 Rongeur for Intervertebral Discs. The cup curettes are available in two cup sizes.809.5 or 7.004 03. Use the forward biting cup curettes to push disc material (1) and the 90° up-biting curettes to collect disc material from the disc space (2).875– 03.951 Optional Instruments 03.809. width 5.873 394. straight.870 03.809.819– 03.001/ 03.837 03.5 mm denoted by the green band. Use fluoroscopy to ensure complete removal of disc material.605.809. cup and ring curettes.Discectomy Instruments 1 03. width of tip 8 mm and 6 mm T-Handle with Quick Coupling 03.861– 03. rongeurs or shavers. 9 mm–17 mm heights Oracle Curettes. and 7.829– 03.605. widths 4 and 6 mm.809. paddle-shaped 9 mm–17 mm heights Oracle Shavers. 22 Synthes Oracle Cage System Technique Guide . 5.809.
The shavers can be used initially to ream out disc material or for final removal of the disc material and cartilaginous tissue (3). Synthes 23 . 50 mm After the discectomy is performed. break through the contralateral part of the annulus with the periosteal elevator. The height is undersized by 1 mm compared to the implant height to ensure a tight fit for final implant insertion. 3 Note: The medial/lateral dimension of the shavers is 50 mm (3: inset). Use a fluroscopic image to determine that the contralateral annulus has been perforated.
50 mm 24 Synthes Oracle Cage System Technique Guide . the lumbar plexus and/or the spinal cord. Caution – In order to prevent weakening of bony structures. The anterior and the posterior longitudinal ligaments (ALL and PLL) must stay intact in all cases. Tip: In order to prevent any risk of damaging vital structures. Turning the spreader in the wrong direction may cause damage to the bony structures. – Turn the spreader clockwise to distract the segment. shavers and/or spreaders must be avoided. use the spreaders to distract and recreate the normal disc height. it is recommended to keep intact a few millimeters of the annulus on both anterior and posterior sides. – Do not damage major vascular structures. – The anterior and posterior longitudinal ligaments (ALL and PLL) must stay intact in all cases. 4 Note: The medial/lateral dimension of the spreaders is 50 mm (4: inset). Turn the spreader counterclockwise for removal.Discectomy If the disc is severely collapsed. restore lordosis and open the neuroforamen (4). nerve roots. any damage to the vertebral endplates caused by curettes. – Avoid overdistraction in order to prevent damage to the soft tissue structures.
809. Synthes 25 . Note: The medial/lateral dimension of the rasp is 35 mm. The height is 8 mm.Prepare Endplates Instrument 03. The entire removal of the endplate may result in subsidence and a loss of segmental stability.849 Oracle Rasp When the discectomy is complete. 35 mm Important: Excessive removal of the subchondral bone may weaken the vertebral endplate. use the rasp to remove the superficial cartilaginous layers of the endplates and to expose the bleeding bone.
Handle with Quick Coupling 26 Synthes Oracle Cage System Technique Guide .Trial for Implant Size 1 Insert trial implant Instruments 03. Each lordotic trial implant is etched with anterior and posterior markings. try the next larger or smaller size height until the most secure fit is achieved.809.237 03. 8° angle.809. heights 9–17 mm Oracle Trial Implants. heights 9–17 mm Handle with Quick Coupling Oracle Trial Implant Connect an appropriately sized trial implant to the handle.229– 03.930 Oracle Trial Implants. If the trial implant appears too small or too tight. Each trial implant has a center opening that can be visualized in an anterior/posterior fluoroscopic view. Controlled and light hammering on the trial implant handle may be required to advance the trial implant into the intervertebral disc space. ensuring that the orientation of the trial implant is correct. 0° angle. Insert the trial implant into the disc space.629– 03. Use fluoroscopy to confirm the fit of the trial implant. The bridge dividing the center opening should align with the spinous processes or be equidistant from the pedicles on an anterior/posterior fluoroscopic view.237 03.809.809.809.
The height of the trial implants is undersized by 1 mm. The trial implant.972 Oracle Slide Hammer Oracle slide hammer Slide the Oracle slide hammer onto the end of the handle with quick coupling. Repeat this process until the trial implant is removed. apply an upward force to the slide hammer with the other hand (1). and ultimately the implant. While holding the handle with one hand. 22 mm 50 mm 2 Remove trial implant 1 2 Instrument 03.809. should sit within the anterior 2⁄3 of the intervertebral disc space. Handle Synthes 27 . The trial implants’ medial/lateral dimension is 50 mm. compared to the implant. Use fluoroscopy to determine the appropriate medial/lateral dimension of the implant for the patient.Note: The anterior/posterior dimension of the trial implants is 22 mm in order to correspond with the implant. Remove the Oracle slide hammer from the handle by pushing on the end of the slide hammer (2). Take a lateral fluoroscopic image to determine the anterior and posterior position of the trial implant. to ensure a tight fit for final implant insertion.
Attach the jaws of the holder to the instrument slot of the implant and tighten the speednut.Insert Implant A: Insertion with implant holder Instruments 03. ensuring that the orientation of the implant is correct. Introduce the implant into the intervertebral disc space.809. Ensure that the implant is held flush against the neck of the implant holder and securely in the jaws of the holder. After being fixed to the implant holder. the interior of the implant can be packed with autogenous bone or bone graft substitute.809. 28 Synthes Oracle Cage System Technique Guide .881 Implant Holder for Oracle Cage Oracle Impactor Select an Oracle implant that corresponds to the height measured using the trial implant in the previous steps.874 03. Remove the implant holder and use the impactor to seat the implant in its final position.
Depth stops Synthes 29 . Pack the interior of the implant with autogenous bone or bone graft substitute.B: Insertion with lateral quick inserter distractor 1 Optional instrument 03. Turn the T-handle clockwise until the implant is engaged by both rails. and 1 mm thick. The implant is now held securely. The tips of the instrument are 35 mm in depth from the depth stops. ensuring the implant is securely seated into the pusher (2). 20 mm in width.809. place the instrument flat on the table to load the implant (1). Thread If using the Oracle lateral quick inserter distractor. To ensure proper insertion of the implant. Place the tips of the instrument into the disc space so the depth stops touch the lateral rim of the vertebral bodies.921 Oracle Lateral Quick Inserter Distractor (SQUID) T-handle Select an Oracle implant that corresponds to the height measured using the trial implant in the previous steps. Rails Pusher Tips Note: Anterior/posterior etching on the rails ensures proper loading of lordotic implants. When the thread is completely turned. take an anterior/posterior fluoroscopic image to determine that the inserter is perpendicularly oriented in the intervertebral space and that the depth stops are touching the lateral rim of the vertebral bodies. 2 Pusher Note: Ensure that the implant is centered and follows the rails between the implant teeth. Place the implant into the rails. turn the Thandle counterclockwise until the pusher stops.
Depending on surgeon preference of final implant position. The instrument is designed to leave the implant 1 mm proud to the proximal aspect of the vertebral bodies. flush or recessed). On an anterior/posterior fluoroscopic image. The inserter fully ejects and releases the implant. verify the implant’s progression and the location of the depth stops on the vertebral bodies. Continue turning the T-handle until it bottoms out on the grip. the surgeon may choose to use the Oracle impactor to seat the implant in its desired position (i. These pins should line up with the midportion of the spinous process or the lateral should be equidistant from the lateral edges of the vertebral bodies (4).Insert Implant While applying a firm and stationary force on the grip with one hand. Use fluoroscopy to determine the position of the implant. 30 Synthes Oracle Cage System Technique Guide . the two anterior/ posterior radiopaque pins of the implant should appear as one marker. turn the T-handle clockwise to advance the implant down the rails into the disc space (3). Using fluoroscopic images. 3 Note: Do not impact on the lateral quick inserter distractor.e. 4 Note: The medial/lateral marker pins of the implant are located approximately 4 mm from the edges of the implant.
Synthes 31 . middle radiopaque marker should be countersunk from the anterior edge of the vertebral bodies (5). The most anterior. the medial/lateral radiopaque pins of the implant should appear as one marker.With a medial/lateral fluoroscopic image. 5 Note: The anterior/posterior marker pins of the implant are located approximately 2 mm from the edges of the implant.
Click’X. AP view of one-level Oracle cage and TSLP. TSLP. and USS.Supplemental Fixation The Oracle Cage is intended to be used with Synthes supplemental fixation. 32 Synthes Oracle Cage System Technique Guide . ATB. Lateral view of one-level Oracle cage and Pangea. AP view of one-level Oracle cage and Pangea. e. Lateral view of one-level Oracle cage and TSLP.g. Pangea.
Please note that the width of all cages is 22 mm.5 5.8 3.8 4.2 2. heights and lordotic angulations.3 11 2.5 4.2 0° 8° Synthes 33 .6 5.7 7.1 15 3.1 13 3.5 6.5 5.4 2.0 2.8 2.5 2.4 4.0 3.7 9 1.7 3.0 4.9 5.0 4.8 6.7 6.7 17 4.6 15 4.9 5.Implants Graft volume The table below shows the approximate graft volume that Oracle implants will hold.5 3.5 7.8 4.9 11 2.6 5.4 4.5 6. depending on the dimensions.1 4. Medial / lateral length Width Height Lordotic angle Filling volumes in cc Lordotic angulation Height (mm) Medial/lateral length (mm) 9 40 45 50 55 2.1 17 4.2 3.5 13 3.
55 mm‫ן‬22 mm Art. 0° angle. no.209S 08.269S 08.809. 0° angle. 50 mm‫ן‬22 mm Art.273S 08.809.233S 08.809.809. 08.215S 08.809.213S 08. 08.237S Height (mm) 9 11 13 15 17 45 mm 22 mm Oracle Cage. 0° angle.809. no.277S Height (mm) 9 11 13 15 17 55 mm 22 mm Note: Total combined height of teeth is 2 mm. no.Implants Oracle Cage.809.809.251S 08. 40 mm‫ן‬22 mm Art.809.809.271S 08.809.809.809.249S 08.809.253S 08. 08.809. 34 Synthes Oracle Cage System Technique Guide .217S Height (mm) 9 11 13 15 17 40 mm 22 mm Height Oracle Cage.231S 08.211S 08.257S Height (mm) 9 11 13 15 17 50 mm 22 mm Oracle Cage.809. 08.809. no.809.275S 08.809.255S 08.809.229S 08. 0° angle. 45 mm‫ן‬22 mm Art.235S 08.
673S 08.809.Oracle Cage. 08.609S 08.629S 08.809.809. 50 mm‫ן‬22 mm Art. no. 8° angle.809.613S 08.675S 08. no.809.649S 08.809.809.651S 08.633S 08.809.809.809.809.611S 08.809.809.677S Height (mm) 9 11 13 15 17 Posterior height (mm) 6 8 10 12 14 55 mm 22 mm Note: Total combined height of teeth is 2 mm. no.809.669S 08. 08.617S Height (mm) 9 11 13 15 17 Posterior height (mm) 6 8 10 12 14 40 mm Angle 22 mm Height Posterior height Oracle Cage.671S 08. 55 mm‫ן‬22 mm Art. 08.809. 45 mm‫ן‬22 mm Art.655S 08. no. 8° angle.637S Height (mm) 9 11 13 15 17 Posterior height (mm) 6 8 10 12 14 45 mm 22 mm Oracle Cage. 08. 8° angle.631S 08.809.809.809.653S 08.635S 08. 40 mm‫ן‬22 mm Art.809.615S 08. 8° angle.809.657S Height (mm) 9 11 13 15 17 Posterior height (mm) 6 8 10 12 14 50 mm 22 mm Oracle Cage. Synthes 35 .
605.629– 03. 0º.809.031 Fibre Optic Cable for Light Strip 03. heights 9 mm–17 mm (2 mm increments) 36 Synthes Oracle Cage System Technique Guide .001 Rongeur for Intervertebral Discs. angled upwards. paddle-shaped.002 Rongeur for Intervertebral Discs.004 Periosteal Elevator.Instruments 03.237 Oracle Trial Implants. 8º.809.637 Oracle Trial Implants. heights 9 mm–17 mm (2 mm increments) 03. angled upwards. heights 9 mm–17 mm (2 mm increments) 03. length 330 mm 03.819– 03.809.229– 03.605.809.612. width 4 mm. width 6 mm. length 330 mm 03.827 Oracle Shavers.605.809.809. width 20 mm 03.
862 03. width 7. up biting Synthes 37 .837 Oracle Shavers. down biting angled.809.03.849 Oracle Rasp 03. bayoneted.829– 03.809.809.809. up biting angled.857 Screwdriver Retractor Blade Oracle Curettes.809.867 03.865 03.866 03.868 straight.5 mm 03.809.809.809.861 03.809. forward biting straight.809. forward biting straight.864 straight. down biting angled. up biting Oracle Curettes.863 03.809. bayoneted. up biting angled. width 5.809. height 9 mm–17 mm (2 mm increments) 03.5 mm 03.
809.874 Implant Holder for Oracle Cage Oracle Spreaders 03. up biting. width 5.876 03.809.875 03. width of tip 8 mm 03.873 Oracle Ring Curette.Instruments 03.809.869 Oracle Curette.872 Oracle Ring Curette.870 Oracle Curette.809. 90° angled. bayoneted.809.809.5 mm 03.5 mm 03.809. up biting. bayoneted.877 9 mm height 11 mm height 13 mm height 38 Synthes Oracle Cage System Technique Guide . 90° angled. width 7.809. bayoneted. width of tip 6 mm 03. bayoneted.
919 Oracle Retractor Intradiscal Anchor 03.921 Oracle Lateral Quick Inserter Distractor Synthes 39 . 03.900 03.809.809.809.03.900 Oracle Retractor Handle 03.809.918 Oracle Retractor Blade Extension 03.809.809. 40 mm–160 mm. (10 mm increments) for No.881 Oracle Impactor 03.809.809.903– 03.915 Oracle Retractor Blades.
809.Instruments 03.809.809. л 2.941 Universal Arm 03. length 170 mm 03.940 Oracle Implant Remover 03.942 Table Clamp for Universal Arm 40 Synthes Oracle Cage System Technique Guide .5 mm. hexagonal. long.923 Screwdriver.809.930 Handle with Quick Coupling 03.809.
809.977 Soft Tissue Retractor Synthes 41 . long 03.809.974 Bipolar Forceps 03.809.809.973 Handle for Scalpel.03.809.975 Long Suction Instrument 03.972 Oracle Slide Hammer 03.
Instruments 03.809.809.012 Dissector.605.943 Retractor Pin. 03.809.809 Oracle Gouge.010 Ball Tip Probe.820.860 Tissue Dissector 03. length 265 mm 03.951 T-Handle with Quick Coupling SFW691R Prodisc-L Combined Hammer 03. with straight handle 394.140 Socket Wrench л 6.0 mm.605. length 300 mm 03. 3 ea. height 9 mm 42 Synthes Oracle Cage System Technique Guide . blunt.101 Screwdriver 388.
Synthes 43 .
809. without Contents Instruments 03.140 44 Synthes Oracle Cage System Technique Guide . 3 ea. 3 ea. Screwdriver.909 Retractor Blade Screwdriver Oracle Retractor Handle Oracle Retractor Blade. for No.809. 3 ea.900. hexagonal. with straight handle 03.809.809.911 03.Sets Oracle Access Instrument Set (01.900.002 Vario Case for Oracle Access Instruments.809.900.809.915 03. Oracle Retractor Intradiscal Anchor. long.0 mm. 3 ea.919 03.03. 140 mm. for No. with Lid.809.809.03.809.857 03.5 mm. length 170 mm Socket Wrench л 6. Oracle Retractor Blade.923 388.809. 160 mm. 100 mm.809.918 03. 120 mm.809.809.900 03. for No. Oracle Retractor Blade Extension. Oracle Retractor Blade.900. for No.913 03.809. 3 ea.809. Oracle Retractor Blade.002) Vario Case 68. л 2.03.03. 2 ea.
Oracle Retractor Blade. 03. 130 mm. 60 mm. 3 ea. 150 mm. 3 ea.03.900.910 03.975 03.809.809.809.900.974 03.Optional 03.03. 90 mm.03. for No.809.101 03. 3 ea.906 03.03.809.914 03. 3 ea.912 03. 40 mm. 110 mm.809. 3 ea.904 03. Oracle Retractor Blade.809. Oracle Retractor Blade.809. 80 mm. Oracle Retractor Blade.809.903 Oracle Retractor Blade.03. 3 ea. Oracle Retractor Blade. Oracle Retractor Blade.900. Bipolar Forceps Long Suction Instrument Soft Tissue Retractor Screwdriver Tissue Dissector Retractor Pin.977 03.03. 3 ea.809.900.900.809. 50 mm.905 03.809.809. 3 ea.809.809. Oracle Retractor Blade. for No.900.809. for No.900.943 Synthes 45 .908 03.809.820.907 03. for No.860 03.900. Oracle Retractor Blade. for No.809. for No. 3 ea.900.809.809. 70 mm.809.03.03.03. 3 ea.809. for No. for No.809. for No.
605.5 mm 03.809.809.010 03. bayoneted. bayoneted.605.863 03. straight. angled upwards.861 03.864 03. with Lid. up biting. up biting. width 6 mm.862 03.865 46 Synthes Oracle Cage System Technique Guide . width 7. straight.809.605.5 mm Oracle Curette. width 5. up biting. width 7. bayoneted.5 mm Oracle Curette.003) Vario Case 68.003 Vario Case for Oracle Discectomy Instruments. length 300 mm Dissector. angled. down biting.809.Sets Oracle Discectomy Instrument Set (01. angled.5 mm Oracle Curette. bayoneted. length 265 mm Oracle Curette. straight. forward biting.001 Rongeur for Intervertebral Discs.809. width 4 mm.809.002 03. without Contents Instruments 03. width 7.004 03. bayoneted.012 03. width 7. blunt. width 20 mm Ball Tip Probe. angled upwards. length 330 mm Periosteal Elevator.605.5 mm Oracle Curette.809.605. length 330 mm Rongeur for Intervertebral Discs.
11 mm.809.809. 13 mm Oracle Shaver.866 Oracle Curette.873 SFW691R Optional 03. forward biting.827 03.837 03. height 9 mm Handle for Scalpel. angled. angled. 9 mm Oracle Shaver.809. bayoneted.829 03.809. bayoneted. bayoneted. paddle-shaped Oracle Shaver. width 5. paddle-shaped Oracle Shaver.835 03. bayoneted.951 Oracle Shaver.809.809.809.5 mm Oracle Curette. 17 mm.809.5 mm Oracle Ring Curette. width of tip 8 mm Oracle Ring Curette. bayoneted.973 394.870 03. straight. down biting. 15 mm.825 03.831 03.809.869 03.809.867 03. paddle-shaped Oracle Shaver. width 5. bayoneted. 2 ea.833 03.809.872 03. long T-Handle with Quick Coupling.809.809 03. paddle-shaped Oracle Shaver.809.809. width 5. width of tip 6 mm Prodisc-L Combined Hammer 03.809.823 03. 15 mm Oracle Shaver. 17 mm Oracle Gouge. up biting.809.868 03. 11 mm Oracle Shaver.809. Synthes 47 .5 mm Oracle Curette. 90° angled. 13 mm.809. paddle-shaped Oracle Shaver.821 03. up biting. up biting.809.5 mm Oracle Curette. width 5. width 7.5 mm Oracle Curette.819 03. 90° angled.03. bayoneted. 9 mm.
809.637 03.629 03.631 03.809.809.809.235 03.229 03.809.874 height 9 mm height 11 mm height 13 mm height 15 mm height 17 mm Oracle Rasp Implant Holder for Oracle Cage 48 Synthes Oracle Cage System Technique Guide .809.Sets Oracle Cage Insertion Set (01.849 03.233 03.809. with Lid. 8° 03.809.809.809. without Contents Instruments Oracle Trial Implants.004) Vario Case 68. 0° 03.004 Vario Case for Oracle Cage Insertion Instruments.633 03.809.237 height 9 mm height 11 mm height 13 mm height 15 mm height 17 mm Oracle Trial Implants.809.809.635 03.809.231 03.
940 394.972 03.930 03.809.876 03. 1 ea.930 Oracle Lateral Quick Inserter Distractor Handle with Quick Coupling.809.809.809.951 height 9 mm height 11 mm height 13 mm Oracle Impactor Oracle Slide Hammer Handle with Quick Coupling.877 03.809.881 03.875 03.809.809. Synthes 49 .809.Oracle Spreaders 03. Oracle Implant Remover T-Handle with Quick Coupling Optional 03.809.921 03. 1 ea.
without Contents Instruments 03. with Lid.006 Vario Case for Stability System.010 Universal Arm Table Clamp for Universal Arm 03.612.014 Fibre Optic Cable for Light Strip Adapter for Three-blade Retractors.809. for No.941 03.612.031 03.018) Vario Case 68.809.612.809.942 50 Synthes Oracle Cage System Technique Guide . 03.Sets Stability System Set (01.809.
011 Instrument 03.100 01.100 01.612.925S Light Clip for Oracle Retractor.Additional Sets Note: The following are also optionally available for use with the Oracle Cage System Sets 01. sterile Synthes 51 .002S Oracle Neuromonitoring Kit.809.809.600. sterile Accessories 03.903 Set for MIS Support System Set for Minimally Invasive Posterior Instruments Proprep Set Dilation Instrument Set 01.605.809.
5 0.7–1. Becker et al. 710. Interconnected micropores (10– 40 μm) allow an optimal supply of nutrients. no.025S 710.7 0.8 1.024S 710.8 1.5 2.021S 710.8–5. 2006 52 Synthes Oracle Cage System Technique Guide .4–2.7–1. blood platelet concentrate or bone marrow aspirate enhances the properties of chronOS required for fusion.4–2. Arlet et al. Based on literature.011S 710.6 2. Stoll et al.8–5.Filling Material Synthetic cancellous bone graft substitute: chronOS chronOS is a fully synthetic and resorbable bone graft substitute consisting of pure ␤-tricalcium phosphate.027S л (mm) 0.8 2. The patient’s blood.4 0. Knop et al.1 Resorbable It is remodeled to vital bone within 6–18 months Osteoconductive Interconnecting macropores of defined size (100–500 μm) facilitate bone ingrowth.019S 710. Its compressive strength is similar to that of cancellous bone.003S 710. 2001.8–5.5 5 10 20 2. the use of ␤-tricalcium phosphate in the spinal column is a valuable alternative to allografts and autografts.6 2. 2002.6 2.4 0. even when larger amounts are required.026S 710.7–1.8–5.4 1. 2006.8 1.2 Safe 100% synthetic – no risk of cross infection chronOS Granules Art.002S 710. 2006 Allman et al.5–0.000S 710.5 1 2.4–2. 2004.001S 710.6 cc 0.014S 710.5 5 10 20 1 2 Muschik et al.4–2.
Synthes 53 .
Schneider R. Sitte I. 1957. 25 (suppl. Reindl R. Springer-Verlag 1991 Muschik M. Florias E. and Willenegger H: AO Manual of Internal Fixation. AOSPINE Manual (2 vols. Webb JK (2007). Volume 31(1): 11–17 Knop C.Bibliography Aebi M. Stoll T(2001) Beta-tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis: preliminary results of a prospective clinical study.) 54 Synthes Oracle Cage System Technique Guide . New York: Thieme Allmann M. Jiang L. Bursche K. 126: 204–210 Müller ME. Allgöwer M. Reinhold M. 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. Ouellet. Arch Orthop Trauma Surg.” Acta Orthop. 15: 1352–9 Becker et al. Stoll T. Arlet V. 3rd Edition. Eur Spine J. Max Aebi (2006): Harvesting local cylinder autograft from adjacent vertebral body for anterior lumbar interbody fusion: surgical technique. Blauth M (2006): Successful posterior interlaminar fusion at the thoracic spine by sole use of -tricalcium phosphate. 10 Suppl 2: 178–84 Perry O: “Fracture of the Vertebral Endplate in the Lumbar Spine. Spine. Ludwig R. Steffen T. Stuttgart. Halbhubner S. operative feasibility and preliminary clinical results. Berlin. Scand. Hoerger F. Canto F. Eur Spine J.). (2006) Osteopromotion by a -TCP/Bone Marrow Hybrid Implant for Use in Spine Surgery. J.
7.’. MD.Stoll et al. Shin-ichi Konno. pp 423-428 White AA and Panjabi MM: Clinical Biomechanics of Spine. Mat. MD. MD. Volume 28. Spine 2003. (2004) New Aspects in Osteoinduction. u. Shin-ichi Kikuchi.-wiss. 1990. Lippincott. PhD. MD. Number 5. PhD: ‘An Anatomic Study of the Lumbar Plexus with Respect to Retroperitoneal Endoscopic Surgery. Werkstofftech. 9 Synthes 55 . William and Wilkins. PhD and Hiroyuki Yaginuma. 35 (4): 198–202 Takatomo Moro. Philadelphia.
56 Synthes Oracle Cage System Technique Guide .
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