Technique Guidesynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...Vertebroplasty-specific syringes Vertecem V+ Syringes have wide inte-grated wings and reinforced syringe pistons

Vertecem V+ System. Enhancedviscosity for controlled injection.

Technique Guide

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Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Bibliography 32

Vertecem V+ System 2

AO Principles 4

Indications and Contraindications 5

Preoperative Planning 6

Patient Positioning 8

Access Options 9– A Guide wire technique 9– B Direct access technique 13– C Biopsy technique 16

Cement Handling 18

Removal of the Needle 26

Postoperative Procedure 27

Notes and Warnings 28

30

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

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2 Synthes Vertecem V+ System Technique Guide

Vertebroplasty-specific syringesVertecem V+ Syringes have wide inte-grated wings and reinforced syringepistons to guarantee excellent forcetransfer, combined with good tactilefeedback.

Wide portfolio of vertebroplastyneedlesA wide portfolio with both diamondand beveled tip needles offers a solu-tion for every preference. All needlescan be used for injection of cementthrough the front or through a sideopening for better cement flow control.

Ready-to-use viscosityVertecem V+ Cement requires no wait-ing time before injectable cement vis-cosity is reached. The application timeof the ready-to-use cement is approxi-mately 27 minutes at room temperatureand offers physicians the freedom touse cement with greatly reduced timeconstraints.

Easy and efficientThe Vertecem V+ System is a closed,clean and easy-to-use vertebroplastysystem. The modularity of the availablekits enables physicians to perform sur-geries efficiently.

Vertecem V+ System. Enhancedviscosity for controlled injection.

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A B

Direction of cement trough sideopening

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Vertecem V+ Syringe Kit:Vertecem V+ Syringe Kit includes astop-cock for simple, clean and quickfilling of the 1 cc and 2 cc syringes.

Vertebroplasty Needle Kit:– 8 Ga (blue), 10 Ga (yellow) and

12 Ga (green) diamond andbeveled tip needles.

– Optional biopsy solution for 8 Gaand 10 Ga needles.

Vertecem V+ Cement KitFor the best possible visual control during cement application, the Verte-cem V+ cement contain 40% zirco-nium dioxide. A further addition of15% hydroxyapatite means that the Vertecem V+ cement contains 55% ceramic components and only 45%PMMA.

Comparison of flow behaviour between afront-opening (A) and a side-opening (B) needle.The needles are placed identically. After the injectionof 2 cc, the cement is clearly directed into the medialpart of the vertebral body with the side-openingneedle.

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AO Principles

In 1958, the AO formulated four basic principles1 which havebecome the guidelines for internal fixation. These principlesare also valid for spinal surgery:– Stable internal fixation– Preservation of blood supply– Early, active pain-free mobilization– Anatomic reduction

In Vertebroplasty (VP) these principles can beinterpreted as follows:

Stable internal fixationThe injection of Vertecem V+ Cement allows an infiltrationof the cancellous bone. Thereby, the trabecular cohesion isenhanced and micromovements within the vertebra areavoided.

Pain reliefQuick pain relief is achieved in the vast majority of vertebro-plasty procedures (80% – 90%)2 due to the restoration of themechanical properties of the vertebrae. Therefore, vertebro-plasty represents a very effective pain treatment.

Minimal invasive accessThe applied percutaneous techniques allow for a safe mini-mal invasive access to the vertebral body.

Reduction of the fracture / height restorationVertebroplasty alone does not permit an active reduction ofthe fractured vertebrae. The spontaneous reduction resultingfrom proper bodily positioning can, however, be preservedthrough augmentation. This stabilizes the fracture and stopsfurther collapse of the vertebral body.

Active height restoration in VCF can be achieved in combina-tion with the Synthes Vertrebal Body Stenting (VBS) System.For indications see the VBS Technique Guide.

Early mobilizationThe minimally invasive Vertecem V+ Cement injection tech-nique provides immediate stability that allows patients to bemobilized as soon as tolerated and to return to daily activitiesand functions.

1 Müller ME, Allgöwer M, Schneider R, Willenegger H (1995) AO Manual ofInternal Fixation. 3rd, expanded and completely revised ed. 1991. Berlin,Heidelberg, New York: Springer

2 McGraw JK, et al. (2002): Prospective evaluation of pain relief in 100 patientsundergoing percutaneous vertebroplasty, results and follow-up. JVIR.; 13:883 –886

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Indications and Contraindications

IndicationsVertecem V+ Bone Cement is indicated for:– Vertebral compression fractures (VCF)– Progressive compression fractures of one or multiple verte-

brae with subsequent development of increasing kyphosis– Patients with persisting instability after a vertebral fracture– Combined procedures with internal fixation in osteoporosis– Osteolysis– Metastatic lesions– Aggressive type of haemangioma

Contraindications – Infections– Patients with clotting disorders– Patients with severe cardiac and / or pulmonary insuffi-

ciency– Patients with known hypersensitivity or allergy to any

of the components of Vertecem V+ Bone Cement (see Composition of Cement in the IFU)

– Vertebra plana or if safe percutaneous access to the vertebra is not guaranteed

– Unstable vertebral fractures with involvement of the posterior wall in stand alone vertebral augmentation procedures (e.g. vertebroplasty)

– Previous damage to the pedicle wall (transpedicular access)

– Fractures or neoplasia with narrowing of the spinal canal(more than 20%) and myelopathy

– Retropulsing vertebral fragments with myelopathy– A satisfactory response to conservative treatment– Asymptomatic stable vertebral fractures– Vertecem V+ Bone Cement must not be used in

arthroplasty procedures

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1Clinical

The preoperative evaluation consists of a careful assessmentof the patient, including:– Patient history (type and time of pain appearance)– Current X-ray images, if possible in standing position, of

the thoracic and lumbar spine in two planes to assess the fracture and spinal alignment

– A spinal CT or MRI scan (ideally with STIR frequency) ofthe painful region of the spine if X-rays are ambiguous. In patients with a contraindication for an MRI, a bonescan may be used alternatively.

– Pain location and pain severity– Feasibility of surgery and use of anesthesia

As recommended in the AO-Spine manual1, take into consid-eration:– Cumarine-like anticoagulants must be stopped prior to

procedure and a minimal INR value of <1.5 (= Quick >50)should be respected

– Aspirin-like medication can be continued

Preoperative Planning

1 Müller ME, Allgöwer M, Schneider R, Willenegger H (1995) Manual of InternalFixation. 3rd, expanded and completely revised ed. 1991. Berlin, Heidelberg, NewYork: Springer

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Single level

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2Instrument and implant planning

Instruments and implants

07.702.016S Vertecem V+ Cement Kit

03.702.215S Vertecem V+ Syringe Kit

03.702.216S Vertebroplasty Needle Kit, 8-Gauge, Diamond Tip


03.702.219S Vertebroplasty Needle Kit, 10-Gauge, Beveled Tip



03.702.222S Biopsy Kit, for 8-Gauge Vertebroplasty Needle Kit


The Vertecem V+ System is a modular system. All implantsand instruments are provided separately. This allows for aneconomically efficient and precise operation planning.

Single level: 1� Vertecem V+ Cement Kit 1� Vertecem V+ Syringe Kit 1� Vertebroplasty Needle Kit of choice

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1Position the patient

Place the patient in the prone position on a lumbar support.The table must be radiolucent in both planes.

The OR table should allow for free manipulation of theC-arm over the operative site in both planes.

Patient Positioning

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AGuide wire technique

The technique is based on a minimally invasive approach tothe vertebral body either trans- or parapedicular. Here afterthe transpedicular approach is described.

Instruments



The C-arm is installed in the AP projection. Plan the exact siteof incision with the C-arm.

Use the C-arm to localize the stab incision. Push the guidewire through the soft tissue until you can touch the bony sur-face of the spine. Use the C-arm for a controlled placement.Use a wire holder in order to avoid radiation exposure toyour fingers.

The orientation of the guide wire is made with the C-arm inthe AP view: Once you touch the bony surface, the tip of thewire should be located lateral of the “eye” of the pedicle atits upper third. At the thoracic spine the wire sits on thecosto-transverse process and at the lumbar spine it is sittingin the edge of the lateral facet and the transverse process.Then advance the guide wire convergent in projection of thepedicle.

Access Options

Transpedicular approach in the lumbar spine with a guide wire.

Parapedicular approach in the thoracic spine with a guide wire.

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In order to penetrate the surface of the bone, some gentleblows with a hammer are necessary. Adjust the direction ofthe guide wire as required and continuously advance it underAP C-arm control. As soon as the tip of the wire reaches themedial border of the pedicle, the depth of the wire needs tobe verified in the lateral projection.

Preliminarily insert the wires at all levels where cement injec-tion is planned. This is time saving and avoids problems withcontamination due to repeated change of the C-arm projec-tion. Of each vertebra where the wire has been placed pre-liminarily, store its position in your image intensifier.

The C-arm projection is now changed to lateral: In the lateralprojection, the tip of the wires must be positioned at least atthe level of the posterior wall of the vertebral body, other-wise the wire needs to be relocated by switching back to theAP view. Then cautiously advance the guide wire with gentlehammer blows and, if necessary, redirect in order to reachthe centre of the vertebral body.

Store the native pictures of the part to be injected in your C-arm and depict the picture on your right screen as a refer-ence.

Notes– First, align the X-ray beam parallel to endplates.

Plan the insertion of the guide wire based on the AP view,inject local anesthetic, advance guide wires under C-armcontrol.

– The guide wire is marked with 1 cm dashes. This allowsmonitoring the insertion progress.

Access Options

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Insert needlesSlide the side-opening needle assembled with the cannulatedtrocar together over the guide wire by rotating movements.This procedure can be painful and the anesthesiologistshould be informed to administer appropriate analgesia. Useagain C-arm control during the final needle placement.

Note: If a biopsy is needed please respect section C page 16for the biopsy technique.

The tip of the needle should be advanced until the anteriorhalf of the vertebral body is reached. As soon as the needlehas reached the final position remove the guide wire and thecannulated trocar.

Caution: Perforation of the anterior wall with the guide wiremust be avoided!

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Insert inner sleevePrior to inserting the inner sleeve ensure that all bone tissuehas been cleared out of the outer needle using the trocar.

The inner sleeve with side-opening is inserted in order toclose off the front-opening of the outer needle. Thesideopening slot enables to direct the cement flow into theneeded direction. Place the sleeve properly and check it withthe closing mechanism on the handle.

Access Options

The arrow on the handle indicates the side-opening of theneedle.

Ensure that the dash on the inner sleeve and the arrow onthe outer cannula are aligned at all times. This guaranteesthat the side-opening window is opened for cement injection.

Notes– The side-opening needle is marked with 1 cm dashes. This

allows monitoring the insertion progress.– If there is any doubt about the location, the C-arm should

be switched to the AP projection.

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BDirect access technique

The technique is based on a minimally invasive approach tothe vertebral body either trans- or parapedicular. Here afterthe transpedicular approach is described.

Instruments




The C-arm is installed in the AP projection. Plan the exact siteof incision with the C-arm.

Use the C-arm to localize the stab incision. Push the needlethrough the soft tissue until you can touch the bony surfaceof the spine. Use the C-arm for a controlled placement. Usea needle holder in order to avoid radiation exposure to yourfingers.

The orientation of the needle is made with the C-arm in theAP view: Once you touch the bony surface, the tip of theneedle should be located lateral of the “eye” of the pedicleat its upper third. At the thoracic spine the needle sits on thecosto-transverse process and at the lumbar spine it is sittingin the edge of the lateral facet and the transverse process.Then advance the needle convergent in projection of thepedicle.

Transpedicular approach in the lumbar spine.

Parapedicular approach in the thoracic spine.

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Access Options

In order to penetrate the surface of the bone, use controlledpressure combined with turning movements (also gentlehammer blows are suitable). To adjust the direction of theneedle turn the beveled tip into the desired direction andcontinuously advance it under AP C-arm control. This proce-dure can be painful and the anesthesiologist should be in-formed to administer appropriate analgesia. As soon as thetip of the needle reaches the medial border of the pedicle,the depth of the needle needs to be verified in the lateralprojection.

Preliminarily insert the needles at all levels under AP C-armcontrol where cement injection is planned. This is time savingand avoids problems with contamination due to repeatedchange of the C-arm projection. Of each vertebra where theneedle has been placed preliminarily, store its position in yourimage intensifier.

The C-arm projection is now changed to lateral: In the lateralprojection, the tip of the needle must be positioned at leastat the level of the posterior wall of the vertebral body, other-wise the needle needs to be relocated by switching back tothe AP view.

Notes– If a biopsy is needed please use article 03.702.219S and

respect section C page 16 for the biopsy technique.– First, align the X-ray beam parallel to endplates. Plan the

insertion of the beveled tip needle based on the AP view,inject local anesthetic, advance needle under C-arm con-trol.

If the needle tip reaches the posterior wall use again C-armcontrol during the final needle placement. The tip of theneedle should be advanced until the anterior half of the ver-tebral body is reached.

Store the native pictures of the part to be injected in your C-arm and depict the picture on your right screen as a refer-ence.

Caution: Perforation of the anterior wall with the guide wiremust be avoided!

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In order to make room for the inner sleeve, it is required tocompress the bone tissue at the tip of the needle. To do this,turn the needle together with the trocar assembly 360°.Then remove the trocar. This needs to be done if the innersleeve is used for cement injection.

Insert inner sleevePrior to inserting the inner sleeve ensure with the trocar thatall bone tissue has been cleared out of the outer cannula.

The inner sleeve with side-opening is inserted in order toclose off the front-opening of the outer needle. The sideopening slot enables to direct the cement flow intothe needed direction. Place the sleeve properly and check itwith the closing mechanism on the handle.

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Access Options

CBiopsy technique

Instruments



When the inserted needle (here shown for the beveled 10 gauge needle) has passed the posterior wall, remove thebeveled trocar.

Note: This technique is also applicable using the 8 or 10 gauge diamond tip needle. Instead of removing only thebeveled trocar, as described above, the cannulated trocar together with the guide wire needs to be removed.

Insert the biopsy needle and lock it into the handle of theouter cannula. Advance the outer cannula assembled withthe biopsy needle to the final position in the vertebral body(see page 17). During this insertion bone tissue is captured inthe biopsy needle. Rotate the assembly at least one full turn(360°). This will help to loosen the biopsy.

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Attach a luer lock syringe (1–3 cc) to the biopsy needle andcreate a vacuum to retain the bone biopsy in the needle. Remove the biopsy needle with the attached syringe fromthe outer needle.

Remove the syringe and use the stylet to push the collectedbone tissue out of the biopsy needle.

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�

�

�


1Prepare cement

Implant

07.702.016S Vertecem V+ Cement Kit

Hold the Vertecem V+ Cement Kit upright and gently slatwith the finger tip at the top of the mixing device in order toensure no cement powder sticks to the cartridge and trans-portation lid.

Note: During preparation, mixing and injection make sure toalways handle the mixing device by gripping the blue part located directly below the transparent cartridge. If the trans-parent part is used as gripping surface, the excess body heatprovided by the users hand might result in a shorter workingtime than intended.

Open the glass ampoule by breaking off its neck with theplastic cap �. Then remove the transportation lid (seen inpicture above) from the mixing device and dispose of it. Pourthe full content of the ampoule � into the mixer and close ittightly with the separate mixing and transfer lid �. Makesure that both mixing lid and the small sealing plug on top ofit are securely tightened.

Notes– Entire content must always be mixed.– Using only one part of the components is not permitted.– See also the quick step preparation technique on the inner

packaging of the Vertecem V+ Cement Kit.

Cement Handling

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�

�

�

�

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Grip the mixer by the blue part �. Start mixing the VertecemV+ cement by pushing and pulling the handle � from end-point to endpoint � for 20 seconds (1-2 strokes per second).Perform the first few mixing strokes slowly with an oscillat-ing-rotating movement (� and � combined). Once properlymixed, the handle � must be left in its outmost position.

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2Fill Injection syringes

Instrument

03.702.215S Vertecem V+ Syringe Kit

Once cement has been mixed using the “Vertecem V+ Cement Kit” remove the sealing plug and connect the stopcock. Use the side without the funnel when connecting thestop-cock to the mixer.

The handle in the initial position is turned 90° away from themixer and the “off” sign is on the opposite side from thefunnel. Ensure a tight fit between the stop-cock and mixingdevice, but avoid breakage of the stop-cock due to the appli-cation of excessive torque.

First, the air has to be removed from the system. Hold the ce-ment mixer in a vertical position and gently turn its handleclockwise.

Note: Turn the handle clockwise to extrude cement from themixer, do not push.

You will see the piston of the mixer advancing in the translu-cent cartridge and a steady flow of cement moving into thestop-cock. As soon as the cement is visible at the funnel endof the stop-cock, close the stop-cock by turning the handle(“off”) toward the mixer (90°).

Cement Handling

open closed

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Attach a syringe to the stop-cock (funnel side). We highlyrecommend using the 2 cc syringes first.Open the stop-cock by turning the handle (90° turn), back toits original position.

Use slow, controlled turning movements on the mixer handleto fill the syringe. As soon as the syringe is filled turn thevalve of the stop-cock again (90°) towards the mixer. The“off” sign is directed toward the mixer, stopping the cementflow.

Note:To transfer cement, simply rotate the handle. Do not push.

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Disconnect the full syringe and attach the next one. Con-tinue until all syringes are filled. Always fill all syringes.

Cement Handling

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3Inject cement with side-opening needle

“Vertecem V+” is a ready to use cement (see IFU “VertecemV+ Cement Kit”). After the cement has been transferred intothe syringes an immediate injection is possible.

For the injection the C-arm is in the lateral projection.Before injecting any cement, store the images of the verte-brae to be reinforced on the image intensifier and showthem on the second screen as a reference. The anesthesiolo-gist needs to be informed of the injection in order to giveanalgesics.

Attach the syringe to the inner sleeve of the needle. Avoid aneedle displacement in anterior direction during the attach-ment.

The cement injection starts with filling of the needles. Forthis purpose, we recommend to use the 2 cc syringes.

It is important to note that the force necessary to inject thecement increases with time. Moreover, the force necessary toinject the cement with the smaller syringe is lower. It is there-fore advised to use the 2 cc syringe first and the 1 cc syringesfor the later injection phase.

Notes– Always transfer the complete cement amount from the

mixing device into the available syringes.– Optionally use the trocar for final injection of cement.

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Bilateral approachIf a bilateral approach is used, simultaneously fill the contra-lateral side as well. It is important to see the filling behaviourof both needles. Once the filling of one side is accomplished,the other side is hidden by the cement, which makes moni-toring the flowing more difficult. Therefore, when a bilateralapproach is chosen, the injection is performed stepwise andsimultaneously. Often, if one side shows cement leakage, fill-ing via the opposite pedicle is still possible.

Continue injecting after the cement appears at the openingof the needle. The cement should behave like a growingcloud. The flow of the cement needs to be monitored withcontinuous fluoroscopic control. Cement always flows in thedirection where it encounters the least resistance. If cementleakage or uncontrolled cement flow is observed, the injec-tion must be stopped immediately. By making a pause in theinjection, the cement has a chance to set further and therebyocclude the blood vessels involved in the leakage. After thispause the needle should be slightly relocated to change thecement flow direction, after which the injection of cementcan commonly be resumed. Due to the generous workingtime in comparison to other cements, the surgeon may haveto make a longer pause with Vertecem V+ before continuingthe injection.

Note: Cement flow towards the posterior wall of the verte-bral body can be monitored more reliably than lateral flow. Ifthe cement is not clearly visible, the injection must bestopped immediately. For more about cement leakage,please see “Notes and Warnings” on page 28.

It is mandatory during the whole injection procedure to havereal-time fluoroscopic control in the lateral projection. It canbe necessary to check the cement distribution in the AP pro-jection from time to time unless a biplanar control with twoC-arms is given. For this purpose the C-arm is switched backinto the AP projection.


Cement Handling

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Warning: No cement injection must be performed with anAP projection only! If a fresh fracture is reinforced, the flowalong a fracture gap toward the disc space is frequent. In thiscase, a bilateral approach may be helpful. The amount of ce-ment used to fill one level depends on the location, size andstate of the vertebral body, as well as surgeon preferenceand type of approach (uni- or bipedicular). Commonly be-tween 2 cc and 10 cc per level are used with an average ofabout 4 –6 cc. As a thumb rule, the cement in the vertebralbody should extend from the upper to the lower endplate.Any cement leakage must lead to an immediate stop of theinjection.

Notes– The following amounts of cement fits inside an empty

needle:8 Ga (∅ = 4.2 mm) 1.5 cc

10 Ga (∅ = 3.4 mm) 0.7 cc12 Ga (∅ = 2.7 mm) 0.4 cc

– The force necessary to inject the cement increases withtime. Moreover, the force necessary to inject the cementwith the smaller syringe is lower. Use the 2 cc syringesfirst. Switch to the 1 cc syringe as soon as the force withthe 2 cc syringe seems to be to low to inject the cement.At the very end of the injection phase, the trocar can beused to carefully push the cement volume present in theneedle forward. Avoid a needle displacement in anteriordirection when applying force to the trocar.

– This technique allows the application of high viscous ce-ment. Viscosity is the key for safety, as the risk for leakagedecreases with increasing viscosity.3

– We advise to check the filling pattern with an AP projec-tion control after starting the injection.

– The more pronounced the osteoporosis, the easier the injection.

3 Bohner M, Gasser B, Baroud G, Heini PF (2003) Theoretical and experimentalmodel to describe the injection of a polymethylmethacrylate cement into a porous structure. Biomaterials 24(16):2721–30

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The needles are removed only if the cement has completelycured. Close the side-opening window on the needle byturning the inner sleeve. This guarantees that there is nocontact between cement in the needle and vertebral body.This unique feature of the Vertecem V+ System ensures thatno cement “spikes” will result during the removal of theneedle. With a simple twist, the needle can be loosened andbe pulled out. Wound closure is done with tight suture.

Note: The setting time for Vertecem V+ at room tempera-ture is approximately 27 minutes. At body temperature thesetting time is 15 minutes. Mobilizing the patient before 15minutes after the last injection should therefore be avoided.

Removal of the Needle

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After the procedure, the patient is placed in a supine positionfor one hour for wound compression. Haematoma at thepuncture sites may occur. Subsequently, mobilization is al-lowed according to the surgeon’s decision. The effect of theprocedure can be evaluated immediately as the usual painlevel should be reduced and only the discomfort due to thepuncture should remain.

Postoperative Procedure

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Notes and Warnings

Cement leakageThe inherent risk of this technique is cement leakage. Re-specting the above mentioned technique, the risks can be re-duced and complications avoided. The second challenge thatneeds to be emphasized is fat embolism - the injected ce-ment is forcing the bone marrow into the blood circulation. Therefore the amount of cement that is injected during onesession should be limited to 25 cc4. If a patient shows se-verely compromised heart and lung capacity even less shouldbe considered. Furthermore, systemic reactions during ce-ment injection can occur as a consequence of the extravasa-tion of the toxic cement monomer.

If a significant leakage occurs, stop the procedure. Performa clinical assessment in order to clarify the neurological situa-tion.If the neurological state is not compromised, there is no ra-tionale for further surgical measures. If a severe compromiseis seen, an emergency CT scan should be performed in orderto assess the amount and location of the extravasation.If applicable, an open surgical decompression and cement re-moval might be performed as an emergency procedure.

ExtravasationIn order to minimize the risk of extravasation, it is stronglyrecommended to follow the described surgical techniquewhich means:– Have a high quality C-arm and use it in both projections– Use of side-opening needles– Use of high viscous and highly radio-opaque cement

Leakage outside the vertebraCement always flows in the direction where it encountersthe least resistance. If cement leakage or uncontrolled ce-ment flow is observed, the injection must be stopped imme-diately. By making a pause in the injection, the cement has achance to set further and thereby occlude the blood vesselsinvolved in the leakage. After this pause the needle shouldbe slightly relocated to change the cement flow direction, af-ter which the injection of cement can commonly be resumed.Due to the generous working time in comparison to othercements, the surgeon may have to make a longer pause withVertecem V+ before continuing the injection. 4 Heini PF, Orler R (2004) Vertebroplasty in severe osteoporosis. Technique and

experience with multi-segment injection. Orthopade 33(1):22–30

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Leakage into the spinal canalStop the injection. If a very small leak occurred, you may pro-ceed as described.

FractureThe risk of further fractures at adjacent levels appears to beincreased after reinforcing a vertebral compression fracturewith cement. Patients and their doctors should therefore bemade aware that if new pain occurs, a new fracture mayhave been occurred. Radiological control should be per-formed and if necessary a new reinforcement should be con-sidered. All patients with osteoporotic fractures should beevaluated and treated by an osteologist or their family doctorand if applicable get systemic treatment with vitamin D andbisphosphonates.

Pregnancy and lactationThere is no evidence of safety for the use of this material inchildren, during pregnancy or during lactation. There is inad-equate information to determine if this material might affectfertility in humans or to have teratogenic potential or otheradverse effects on the foetus.

InstrumentsBe aware that the components of different Synthes vertebro-plasty needle kits (diameter, tip style) and other Synthes ver-tebral access kits are not interchangeable. Such use couldlead to damage and loss of function of components.

The guide wire is 4 cm longer than the needle assembly. Ifthe guide wire does not instantly protrude from the handleof the needle an uncontrolled advancement of the guidewire should be suspected.

Note: For complete warnings and precautions please refer tothe instructions for use of “Verecem V+ Cement Kit”,“Vertecem V+ Syringe Kit”, “Vertebroplasty Needle Kit” and“Biopsy Needle Kit”.

If the Vertecem V+ System is used in combination with otherSynthes products, please consult the specific techniqueguides for detailed information.

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Product Information

07.702.016S Vertecem V+ Cement Kit Containing: 1� Vertecem V+ Mixer prefilled with cement powder 1� Monomer glass ampoule

03.702.215S Vertecem V+ Syringe Kit Containing: 8� Blue 1 cc syringes 5� White 2 cc syringes 1� one-way stop cock

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03.702.216S Vertebroplasty Needle Kit, 8 Gauge, Diamond Tip, 2 units


03.702.219S Vertebroplasty Needle Kit, 10 Gauge, Beveled Tip, 2 units


03.702.221S Vertebroplasty Needle Kit, 12 Gauge, Beveled Tip, 2 units

03.702.222S Biopsy Needle Kit, 8 Gauge, 1 unit

03.702.223S Biopsy Needle Kit, 10 Gauge, 1 unit

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Bibliography

Baroud G, Nemes J, Heini PF, Steffen T (2003) Load shift ofthe intervertebral disc after a vertebroplasty: a finite-elementstudy. Eur Spine J 12(4):421–426

Belkoff SM, Mathis JM, Jasper LE, et al (2001) An ex vivo bio-mechanical evaluation of a hydroxyapatite cement for usewith vertebroplasty. Spine 26(14):1542–1546

Berlemann U, Ferguson SJ, Nolte LP, et al (2002) Adjacentvertebral failure after vertebroplasty. A biomechanical investi-gation. J Bone Joint Surg Br 84(5):748–752

Bernhard J, Heini PF, Villiger PM (2003) Asymptomatic diffusepulmonary embolism caused by acrylic cement: an unusualcomplication of percutaneous vertebroplasty. Ann RheumDis 62(1):85–86

Bohner M, Gasser B, Baroud G, Heini PF (2003) Theoreticaland experimental model to describe the injection of a polymethylmethacrylate cement into a porous structure. Biomaterials 24(16):2721–30

Deramond H, Depriester C, Galibert P, et al (1998) Percuta-neous vertebroplasty with polymethylmethacrylate. Technique, indications, and results. Radiol Clin North Am36(3):533–546

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Gangi A, Kastler BA, Dietemann JL (1994) Percutaneous ver-tebroplasty guided by a combination of CT and fluoroscopy.AJNR Am J Neuroradiol 15(1):83–86

Heini PF (2004) The current treatment-a survey of osteo-porotic fracture treatment. Osteoporotic spine fractures: the spine surgeon‘s perspective. Osteoporos Int. Heini PF,Berlemann U (2001) Bone substitutes in vertebroplasty. Eur Spine J 10 Suppl 2:205–213

Heini PF, Dain Allred C (2002) The Use of a Side-Opening Injection Needle in Vertebroplasty. Spine 27(1):105–109

Heini PF, Orler R (2004) Vertebroplasty in severe osteoporosis.Technique and experience with multi-segment injection. Orthopade 33(1):22–30

Heini PF, Walchli B, Berlemann U (2000) Percutaneoustranspedicular vertebroplasty with PMMA: operative tech-nique and early results. A prospective study for the treatmentof osteoporotic compression fractures. Eur Spine J 9(5): 445–450

Jensen ME, Evans AJ, Mathis JM, et al (1997) Percutaneouspolymethylmethacrylate vertebroplasty in the treatment ofosteoporotic vertebral body compression fractures: technicalaspects. AJNR Am J Neuroradiol 18(10):1897–1904

Kaufmann TJ, Jensen ME, Schweickert PA, et al (2001) Ageof fracture and clinical outcomes of percutaneous vertebro-plasty. AJNR Am J Neuroradiol 22(10):1860–1863

Kim SH, Kang HS, Choi JA, et al (2004) Risk factors of newcompression fractures in adjacent vertebrae after percuta-neous vertebroplasty. Acta Radiol 45(4):440–445

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Uppin AA, Hirsch JA, Centenera LV, et al (2003) Occurrenceof new vertebral body fracture after percutaneous vertebro-plasty in patients with osteoporosis. Radiology 226(1): 119–124

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Technique Guidesynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...Vertebroplasty-specific syringes Vertecem V+ Syringes have wide inte-grated wings and reinforced syringe pistons