VLIFTSurgical Techniqueaz621074.vo.msecnd.net/.../TLVLF_ST_1.pdf6 VLIFT System Overview End Caps Ø18 mm and Ø22 mm end caps are available in three angles: 0 , 3 , and 8 0 3 8 Note:

VLIFT®

Surgical Technique

• Vertebral Body Replacement System

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VLIFT System

• Single pre-assembled implant

• Modular end caps have awide footprint to preventsubsidence and to helpmaintain stabilization of theaffected motion segment(s)

• Large windows allow foroptional in-situ insertionof bone graft

• Evenly spaced end capspikes provide fixation tothe bony endplate

• Titanium alloy material providesmechanical integrity duringinsertion and distraction, x-rayvisibility, and biocompatibility*

• System design for ease of usein anterior and antero-lateralapproaches

• Single surgical instrument forease of insertion and distraction

• One-step locking of thedistraction mechanism with acounterclockwise turn of thepre-assembled locking screw

*Data on file at Stryker Spine

• Optional static extensionsincrease height flexibility forconstruct sizing

• Large open architecture tomaximize bone-to-bonegraft contact

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Contents

Contents

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 7

Surgical Technique

Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Preoperative Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Patient Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Surgical Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Step 1: Implant Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Step 2: Implant Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Step 3: End Cap Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 - 15

Step 4: Bone Graft Packing (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Step 5: Implant Insertion and Distraction . . . . . . . . . . . . . . . . . . . . . . 17 - 19

Step 6: Locking the Distraction Mechanism . . . . . . . . . . . . . . . . . . . . . . . . 20

Step 7: In situ Bone Graft Packing (optional) . . . . . . . . . . . . . . . . . . . . . . . 21

Step 8: Supplemental Fixation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Standard Set and Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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VLIFT System Overview

System Description

The VLIFT Vertebral Body ReplacementSystem consists of a Distractible In Situ(DIS) implant, which enables thesurgeon to customize the height of theimplant after implantation. Extensions(if needed) and modular end caps snapinto each end of the implant for quickassembly. The end caps are available in0° or with angulation to match eitherthe lordosis or kyphosis of the spinalsegment. The implants, extensions, andend caps are composed of titaniumalloy.

System Indications

Stryker Spine’s VLIFT System isintended to replace a vertebral body oran entire vertebra. It is for use in thethoracolumbar spine (T1-L5) to replacea collapsed, damaged or unstablevertebral body or vertebra resected orexcised during total and partialcorpectomy and vertebrectomyprocedures due to tumor or trauma(i.e., fracture). The VLIFT System isintended to be used with supplementalinternal fixation. The supplementalinternal fixation systems that may beused with VLIFT include, but are notlimited to, Stryker Spine plate or rodsystems (Xia Spinal System, SpiralRadius 90D and Trio). The use of bonegraft with the VLIFT System is optional.

Note: Case study courtesy of MichaelWich, MD, Director of the TraumaClinic, Umfallkrankenhaus Berlin,Berlin, Germany

Pre-op sagittal of CT-scan showing T8 and T9 Fractures

Treatment

The patient underwent treatment of this injury in two stages. On post-injury day 1,the patient was taken to the OR for posterior fixation and fusion (T6-T12) andreduction of the kyphosis. After stabilizing the patient in intensive care for one week,anterior spinal surgery was performed on day 7 via an anterior approach. A rightsided thoracotomy was performed resecting the 8th rib. Corpectomies of bothvertebral bodies (T8 and T9) were performed using the resected bone as bone graft.After positioning the VLIFT implant and expanding it into final position theautologous bone was placed around the implant. Use of the VLIFT expandableimplant was particularly helpful in achieving stable anterior device placement sinceintraoperative distraction between T7 and T10 was not possible because of theposterior fixation.

VLIFT Case Study

Trauma patient presented with unstable fractures of the vertebral bodies of T8and T9 with acute kyphosis of 20° and rupture of the dorsal ligamentousstructures. Patient also had right sided pneumothorax and a fracture of the 7thrib on the right side and lung contusions bilaterally.

Intraoperative x-ray with c-armpicture prior to full distraction of the

VLIFT implant (43 mm)

And after distraction of the VLIFTimplant (61 mm)

Ten days after the traumatic injury, the patient was able to walk without brace andwith crutches and full weight bearing on the left leg (due to a hip dislocation duringthe injury).

Note: Patient results may vary.

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VLIFTTM Extensions

Extensions press fit onto both ends of the VLIFT implant to build a longer implantconstruct when necessary. A mallet may be used to assemble the extensions.

Ø18 mm & Ø22 mm Extensions*Each extension adds 15 mm of height

20.5 mm height distracts to 27.5 mm

Ø18 mm Ø22 mm

Single, Pre-assembled Implants

Ø18 mm Implant

Ø22 mm Implant

For example:• Ø18 x 32 mm implant fully distracted + 1 extension + (2) 0° end caps = 65.5 mm• Ø18 x 32 mm implant fully distracted + 2 extensions + (2) 0° end caps = 80.5 mm• Ø22 x 37 mm implant fully distracted + 1 extension + (2) 0° end caps = 75.5 mm• Ø22 x 37 mm implant fully distracted + 2 extensions + (2) 0° end caps = 90.5 mm

25 mm height distracts to 36.5 mm 32 mm height distracts to 50.5 mm

25 mm height distracts to 36.5 mm 32 mm height distracts to 50.5 mm 37 mm height distracts to 60.5 mm

Note: Implant heights above include the assembly of two 0° end caps. Each 0° end cap adds 1 mm of height. See page 6 for all possible end cap configurations.

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End Caps

Ø18 mm and Ø22 mm end caps are available in three angles: 0°, 3°, and 8°

0° 3° 8°

Note: Each end cap adds additionalheight to the implant. 0° adds 1 mm3° adds 2.5 mm8° adds 4.5 mm15° adds 8 mm*

*15° only available for Ø22 mm implant

2.5 mm

4.5 mm

In the thoracic region, the end caps can be rotated 180° to reconstruct the thoracickyphotic alignment. Example by using two 3° end caps:

+6° -6°

Ø22 mm end caps are also available in 15° of angulationto more readily restore lumbosacral sagittal alignment.

Note: End cap diameter = distractionring diameter.

The Ø18 mm end cap footprint = 22 mm

15°

Ø22 mm

Ø26 mm

When usingangled end caps,it is important toensure theirorientation isparallel.

The 15° end caps enable thesurgeon to build additional15°, 18°, 23°, and 30° Ø22 mmimplant constructs.

Note: The angled end cap options can be interchanged to enable the surgeon tobuild a 0°, 3°, 6°, 8°, 11°, or 16° implant construct.

Ø18 mm implant

Ø22 mm implant

The Ø22 mm end cap footprint = 26 mm

Note: It is important to ensure theangled end caps are assembled to theimplant in a manner thataccommodates the surgical approach.

Example: In an anterior approach, theangled portion of the end cap shouldbe facing the gold locking screw andthus, the expander when assembled.

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Expander 48300200The VLIFTT expander is an all-in-one instrument designed to act as an inserter andan intra-operative distractor. The inside shaft threads into the implant while theouter, cannulated shaft is turned counterclockwise to distract the implant.

Screwdriver 48300300The VLIFT implant contains a pre-assembled locking screw, which is locked with thescrewdriver to secure the implant height after distraction. The screwdriver is placedinto the head of the locking screw in situ, which is then turned (backed-out) two fullturns counterclockwise to lock the distraction mechanism in place.

The screwdriver’s low-profile shaft provides ease of insertion and visualizationduring the locking step. There are laser-marks every 120° on the screwdriver shaft toprovide a reference for each revolution of the screwdriver.

Note:Only back out the locking screw with the screwdriver two full turns.

Graft Impactor 33660460, Small Graft Impactor 33660450

The VLIFT graft impactors are available in two sizes and are provided to assist inpacking the implant with bone graft. The tip of the shaft of each impactor has aknurled surface, which comes in contact with the bone graft.

After the implant is distracted and locked into its final position, any void in theimplant resulting from distraction can be filled through the large windows in theperiphery of the implant. The small graft impactor is similar to a tamp and can beused to pack additional bone graft in situ.

Note: Standard O.R. instruments such as forceps or Penfields can also be used topack bone graft.

End Cap Remover 48300450The end cap remover is a 3-in-1 instrument, which can be used to assemble endcaps, pack bone graft, and remove end caps, when necessary.

The end cap remover contains two surfaces for end cap assembly: 1. surface to impact the Ø18 and Ø22 mm 0° and 3° end caps, 2. surface to impact the Ø18 and Ø22 mm 8° end caps, as well as the Ø22 mm 15° end caps.

One side of the end cap remover disassembles the Ø18 mm end caps. The oppositeside of the end cap remover disassembles the Ø22 mm end caps.

Note: When removing the angled end caps, insert the shortest end of the end capinto the end cap remover. Extensions can be removed by hand.

End Cap Impactors 48300518 / 48300522End cap impactors are available for each implant diameter to provide a method foralignment and a surface for impaction.

The inferior portion of each end cap impactor has a cylinder with two side-by-sideprojections. The cylinder is placed into the opening of the end cap, which enablesthe projections to sit into the grooves of the end cap spikes. The projections canrotate in the groove to account for whatever end cap angulation is chosen prior toimpaction with a mallet.

The end cap impactors also have two wide notches, which can be used as referencepoints when aligning angled end caps.

Container 48300001The VLIFT System consists of only one container, which contains all the implants,end caps, extensions, and associated instruments.

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VLIFT Surgical Technique

Indications

Stryker Spine’s VLIFT System isintended to replace a vertebral body oran entire vertebra. It is for use in thethoracolumbar spine (T1-L5) to replacea collapsed, damaged, or unstablevertebral body or vertebra resected orexcised during total and partialcorpectomy and vertebrectomyprocedures due to tumor or trauma(i.e., fracture). For both corpectomyand vertebrectomy procedures, theVLIFT System is intended to be usedwith supplemental internal fixation.The supplemental internal fixationsystems that may be used with VLIFTinclude, but are not limited to, StrykerSpine plate or rod systems (Xia SpinalSystem, Spiral Radius 90D and Trio).The use of bone graft is optional.

Pre-operative Planning

Use the appropriate imaging techniquesto outline the patient’s osseous anatomyand to determine the proper size andtype of the instrumentation to be used.Identify the implant components to beused for the assembly (implants, endcaps, and extensions if needed).Changes to the final implantconfiguration may become necessarybased on intra-operative findings.

Contra-indications

• The VLIFT system is not to be used forinterbody fusion.

• The VLIFT system should not beimplanted in patients with an activeinfection at the operative site.

• These devices are not intended for useexcept as indicated.

• Marked local inflammation.• Any mental or neuromusculardisorder, which would create anunacceptable risk of fixation failure orcomplications in postoperative care.

• Bone stock compromised by disease,infection or prior implantation,whichcannot provide adequate supportand/or fixation to the devices.

• Open wounds.

• Rapid joint disease, bone absorption,osteopenia, osteomalacia, and/orosteoporosis. Osteoporosis orosteopenia are relativecontraindications, since this conditionmay limit the degree of obtainablecorrection and/or the amount ofmechanical fixation.

• Metal sensitivity, documented orsuspected.

• Pregnancy.• Anytime implant utilization wouldinterfere with anatomical structures orphysiological performance.

• Inadequate tissue coverage over theoperative site.

Other medical or surgical conditionsthat could preclude the potential benefitof surgery, such as congenitalabnormalities, immunosuppressivedisease, elevation of sedimentation rateunexplained by other diseases, elevationof white blood count (WBC), or markedleft shift in the WBC differential count,must be carefully analyzed beforesurgery.

These contra-indications can be relativeor absolute and must be taken intoaccount by the physicians when makingtheir decision. The above list is notexhaustive. Surgeons must discuss allrelative contra-indications includinglimited life time of the decive whendeemed appropriate.

Pre-operative Precautions

The surgical indication and the choice ofimplants must take into account certainimportant criteria such as:• Patients involved in an occupation oractivity that applies excessive loadingupon the implant (e.g., substantialwalking, running, lifting, or musclestrain) may be at increased risk forfailure of the fusion and/or the device.

• Patients should be instructed in detailabout the limitations of the implants,including, but not limited to, theimpact of excessive loading throughpatient weight or activity, and betaught to govern their activitiesaccordingly. The procedure will not

restore function to the level expectedwith a normal, healthy spine, and thepatient should not have unrealisticfunctional expectations.

• A condition of senility, mental illness,chemical dependence or alcoholism.These conditions among others maycause the patients to ignore certainnecessary limitations and precautionsin the use of the implant, leading tofailure and other complications.

• Foreign body sensitivity. Wherematerial sensitivity is suspectedappropriate tests should be made priorto material implantation.

• Patients who smoke have been shownto have an increased incidence of non-unions. Such patients should beadvised of this fact and warned of thepotential consequences.

• Care must be taken to protect thecomponents from being marred,nicked, or notched as a result ofcontact with metal or abrasive objects.Alterations will produce defects insurface finish and internal stresseswhich may become the focal point foreventual breakage of the implant

Surgeons must discuss these precautionspre-operatively with their patients whenappropriate.

Intra-operative Precautions

The insertion of the implants must becarried out using instruments designedand provided for this purpose and inaccordance with the specificimplantation instructions for eachimplant. Those detailed instructions areprovided in the surgical techniquebrochure supplied by Stryker Spine.• Discard all damaged or mishandledimplants.

• Stryker Spine implants must not bereshaped, unless otherwise indicated inthe surgical technique instructions. Theuse of inappropriate instruments mayresult in scratches, notches, and sharpbending, causing the breakage of theimplants. Improper seating of theimplant may result in implant failure.

• Never reuse an implant, even though itmay appear undamaged.

• Do not mix metals.

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Figure 1: Example of a corpectomy of the L5 vertebral body.

Figure 2: Example of a vertebrectomy of a thoracic vertebra.

Post-operative Precautions

Physician instructions regarding fullweight-bearing activities must becomplied with until maturation of thefusion mass is confirmed. Failure tocomply with physician instructions mayresult in failure of the implant, thefusion, or both.

Caution for Patients

Based on the fatigue testing results, thephysician/surgeon should consider thelevels of implantation, patient weight,patient activity level, other patientconditions, etc., which may impact theperformance of the system. In theUnited States, Federal law restricts thisdevice to sale by or on the order of alicensed physician.

Patient Positioning

Patient positioning on the operatingtable is dependent on the level(s) to beoperated. For levels T1-T3 and L5, thepatient is typically placed in the anteriorsupine position. For levels T4-L4, thepatient is typically placed in the lateraldecubitus position.

Surgical Approach

Through a trans-sternal, trans-thoracic,retroperitoneal, or combined thoraco-lumbar approach, the lateral or anterioraspect of the spine column is exposed.X-ray or fluoroscopy should be used toconfirm the appropriate level.

A total or partial corpectomy orvertebrectomy procedure as needed isperformed, see Figures 1 and 2.

The bony endplates are prepared forimplant insertion using standardsurgical procedures andinstrumentation.

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+6° -6°

Figure 4: The end caps can be rotated 180° to reconstruct either a thoracickyphotic or a lumbar lordotic curve. Above example uses two 3° end caps.

Figure 3: Confirm the height of the defect in situ by measuring from theposterior aspect of the motion segment(s).

STEP 1: Implant Measurement

The appropriate size implant can bedetermined preoperatively, by measuringthe defect from the patient’s films or CTscans. However, the measurementshould be confirmed in situ with acaliper or ruler. It is recommended tomeasure in situ from the posterior aspectof the inferior endplate of the vertebralbody above the affected level to theposterior aspect of the superior endplateof the vertebral body below the affectedlevel, see Figure 3.

STEP 2: Implant Selection

Depending on the spinal region andpatient’s anatomy, either an Ø18 mm orØ22 mm implant should be chosen. TheØ18 mm implant has a Ø22 mmfootprint and the Ø22 mm implant has aØ26 mm footprint. An end cap or animplant can be used as a template toconfirm the appropriate diameter in situ.The measured implant height can becross-referenced with a sizing templateto choose the appropriate implantconstruct, depending on diameter.

STEP 3: End Cap Assembly

The VLIFT System offers varying endcap angles of 0°, 3°, 8° for both the Ø18mm or Ø22 mm implants. The angledend caps are available for those cases inwhich lordosis or kyphosis providesenhanced sagittal alignment andincreased stabilization of the implantconstruct, see Figure 4.

The end caps are assembled to theimplant utilizing a combination of anend cap impactor and the end capremover, which is also used as an endcap assembly station. The end capremover contains two surfaces for endcap assembly, see Figure 5:• SURFACE 1: to impact the Ø18 mm,0° and 3° end caps, and Ø22 mm, 0°and 3° end caps

• SURFACE 2: to impact the Ø18 mm,8° end caps, and Ø22 mm, 8° and 15°end caps Figure 5: Assembly Surfaces of the VLIFT End Cap Remover.

Surface 1Surface 2

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To assemble the first end cap to theimplant, it is recommended to firstplace the end cap onto the appropriatesurface of the end cap remover, seeFigure 6.

Next, the chosen implant should beplaced into the end cap remover, on topof the first end cap, see Figure 7.

After the implant and the first end capare appropriately aligned, a mallet canbe used to impact the implant to theend cap, see Figure 8. When angled endcaps are used, it is important toassemble the end caps to the implant ina manner that accommodates thesurgical approach and the sagittalalignment to be restored.

Figure 6: Example of A.) Ø22 mm x 0° end cap placed on surface 1 and B.) Ø22 mm x 15° end cap placed on surface 2.

Figure 7: Example of the Ø22 x 32 mm implant placed on top of the Ø22 mm x 15° end cap.

Figure 8: A mallet is used to assemble the implant to the first end cap.

A. B.

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To assemble the second end cap to theimplant construct, two end capimpactors are available to provide amethod for alignment and a surface forimpaction for each end cap diameter.An example of the Ø22 mm end capimpactor is shown in Figure 9.

The inferior portion of each end capimpactor has a cylinder with two side-by-side projections. The cylinder isplaced into the opening of the end cap,which enables the projections to sit intothe grooves of the end cap spikes, seeFigure 9. The projections can rotate inthe grooves of the end cap spikes toaccount for whatever end capangulation is chosen prior to impactionwith a mallet. The end cap impactorsalso have two wide notches, which canbe used as reference points whenaligning angled end caps. Refer toFigure 10, which outlines the features ofthe end cap impactor.

Once the second end cap is chosen, it isplaced on top of the implant construct,which remains in the end cap assemblystation, see Figure 11.

If the second end cap is angled, it isimportant to ensure the end cap isaligned to the implant construct in amanner that accommodates the surgicalapproach and sagittal angulation to berestored.

Note: If two angled end caps are used,ensure the laser-marks on the secondend cap are parallel with the laser-marks on the first end cap.

Figure 9: The Ø22 mm end cap impactor can accommodate all angles of the22 mm end caps. Example is shown with the 15° end cap.

Figure 10: Key features of the end cap impactor.

Figure 11: Second Ø22 mm end cap is placed on top of implant construct.

Projection

Two wide notches

+5 mm

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The appropriate diameter end capimpactor is then placed into the secondend cap. If angled end caps are chosen,the end cap impactors have notches,which can be used to aid in alignment.A mallet can be used to impact thesecond end cap to the implantconstruct, see Figure 12.

As previously described, it is importantto assemble angled end caps in amanner that accommodates the surgicalapproach and sagittal angulation to berestored, refer to example below.

Example: Always use the gold lockingscrew as your reference point whendetermining how to orient angled endcaps to the implant. The expander willalways be assembled to the implant inthe threaded hole underneath the goldlocking screw, see Figure 13.

Example #1:• Patient is undergoing a lumbarprocedure, such as a L5 corpectomy • Surgeon is performing an anteriorapproach • Implant needs to provide asignificant amount of lordosis,especially at the lumbosacral region • Surgeon chooses to use angled endcaps superiorly and inferiorly

Result: The end caps need to bepositioned to the implant so that theend cap laser mark is oriented parallelwith gold locking screw for properassembly, see Figure 14.

Example #2:• Patient is undergoing a lumbarprocedure, such as a L3 corpectomy • Surgeon is performing a left-sidedanterolateral approach • Implant needs to restore lumbarlordosis • Surgeon chooses to use angled endcaps superiorly and inferiorly

Result: The end caps need to bepositioned to the implant so that theend cap laser mark is oriented 90° to theleft of the gold locking screw for properassembly, see Figure 15.

Figure 12: A mallet is used in conjunction with the Ø22 mm end cap impactorto impact the second Ø22 mm end cap to the implant construct.

Figure 13: The threaded hole in the implant for the expander assembly islocated below the gold locking screw.

Figure 14 Figure 15 Figure 16

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Figure 17a: Assemble the extension(s) prior to 17b: Assembling the end caps.

Note: If an extension is needed,assemble the extension to the implantprior to assembling the end caps, seeFigures 17a and 17b. Two extensionscan also be used if needed. No specificorientation is necessary for theextensions. The end cap remover canalso be used as an assembly station forthe extensions.

The Ø22 mm implants have anadditional angled end cap of 15°, whichis part of the standard set configuration.Additional lordosis may be necessary insituations such as restoring lumbosacralsagittal alignment, see Figure 18.

The end caps add height to the overallimplant height, which will need to betaken into consideration duringconstruct assembly. Table 3 shows howmuch height each individual end capand each end cap combination adds.

Figure 18: Sagittal reconstruction of a L5 corpectomy using a 15° end capplaced superiorly and a 20° end cap placed inferiorly on a Ø22 x 32 mm implant.

Note: 20° end caps are special order. It is anticipated that they will only be usedin rare cases. See page 19 for ordering information.

Table 3: End cap and end cap combination heights

End cap(s) Ø18 mm & Ø22 mm End cap(s) Ø22 mm

0° adds 1 mm 15° adds 8 mm

0° + 0° adds 2 mm 0° + 15° adds 9 mm

3° adds 2.5 mm 3° + 15° adds 10.5 mm

0° + 3° adds 3.5 mm 8° + 15° adds 12.5 mm

3° + 3° adds 5 mm 15° + 15° adds 16 mm

8° adds 4.5 mm

0° + 8° adds 5.5 mm

3° + 8° adds 7.0 mm

8°+ 8° adds 9.0 mm

Example #3:• Patient is undergoing a thoracicprocedure, such as a T7 corpectomy • Surgeon is performing a left-sidedanterolateral approach • Implant needs to restore thoracickyphosis • Surgeon chooses to use angled endcaps superiorly and inferiorly

Result: The end caps need to bepositioned to the implant so that theend cap laser mark is oriented 90° tothe right of the gold locking screw forproper assembly, see Figure 16 onpage 13.

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If the patient’s anatomic demandsrequire an adjustment in the end capangulation, the end caps can bedisassembled from the implant with theend cap remover. It is recommended toremove the end caps from the implantwhile the implant is assembled to theexpander, see Figure 19. Step 5 on page 17 describes how to assemble theexpander to the implant.

One side of the end cap removerremoves the Ø18 mm end caps. Theopposite side of the end cap removerremoves the Ø22 mm end caps, seeFigure 20. For example, the appropriatetechnique to remove an Ø18 mm endcap is as follows:

• Retain the implant construct on the tipof the expander

• Drop the implant construct into thecenter of the end cap remover, thenposition the Ø18 mm end cap to bedisassembled in the Ø18 mm removalside.

• Gently pull up and down on theexpander until the end capdisassembles from the implant.

The same technique should be usedwhen disassembling a Ø22 mm end cap,except the Ø22 mm end cap will need tobe positioned in the Ø22 mm removalside of the end cap remover. It ishelpful to hold the end cap removersturdy on the back surgical table withone hand while gently leveraging theexpander to disassemble an end capwith the other hand.

Note: When disassembling the angledend caps, it is recommended to insertthe shortest end of the end cap into theappropriate end cap removal side first.Extensions can be disassembled byhand.

Figure 20: The end cap remover, made of stainless steel, can disassemble alldiameter and angled end caps.

Figure 19: Implant should be retained on the expander during removal.

Ø18 mmremoval side

Ø22 mmremoval side

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STEP 4: Bone Graft Packing(optional)

The VLIFT System can be packed withbone graft. The use of bone graft withthe VLIFT System is optional.

Depending on surgeon preference, bonegraft can be packed into the VLIFTimplant before or after end capassembly. However, it is recommendedto assemble the end caps first in orderto check the implant construct fit andsagittal alignment in situ prior to bonegraft packing.

Note: The end cap opening = insidediameter of the implant. Thus, theassembly of the end caps does notimpede the continuous opening in theimplant construct to maximize bonegraft packing.

The VLIFT System includes small andstandard graft impactors, which can beused to pack bone graft into theimplant, see Figure 21. Both graftimpactors have knurled tips for moreprecise packing of the bone graft, seeFigure 22.

Note: The end cap remover can beused as a bone graft packing station ifneeded.

Prior to implantation, it isrecommended to pack additional bonegraft into the opening of the superiorend cap, see Figure 23. “Overstuffing”the implant with bone graft will morereadily prevent a void of no bone graftin the implant, which may result afterdistraction.

The implant is now ready to be inserted.

Note: Depending on surgeonpreference, the implant can beexpanded to a height within 3 mm ofthe final implant height during bonegraft packing to maximize the amountof bone graft in the implant prior toinsertion.

Figure 21: Initial bone graft packing with the graft impactors.

Figure 22: Small graft impactor, standard graft impactor, and knurled tips of each.

Figure 23: “Overstuffing” the implant with bone graft after assembly of both endcaps.

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STEP 5: Implant Insertion

After assembly of the implant construct(implant + end caps + extension(s) ifneeded) and packing of bone graft(optional), the implant is ready forinsertion.

Note:Visually check the implant toensure all extensions and end caps areproperly seated prior to insertion.

The expander is used to insert theimplant and distract the implant to itsfinal height. The expander has threecomponents: a main shaft, an insidethreaded shaft, and an outer cannulatedshaft, see Figure 24.

The inside threaded shaft retains theimplant to the end of the expander byengaging the threaded hole of theimplant, see Figure 25.

The threaded hole of the implant islocated just below the gold lockingscrew, see Figure 26.

Note: Be sure the gold locking screw isflush with the implant prior toassembling the expander. This willallow the distraction ring to rotatefreely during distraction.

Once the inside threaded shaft fullyengages the implant, the outercannulated shaft will come into contactwith the implant. The perforated tipsof the outer cannulated shaft of theexpander must properly line up inbetween the scallops of the outerdistraction ring of the implant, seeFigure 27.

Outer CannulatedShaft

Main Shaft withSilicon Handle

Inside Threaded Shaft

Figure 24: Three components of the expander.

Figure 27: Placement of the perforatedtips of the outer cannulated shaft ofthe expander in between the scallopsof the outer distraction ring.

Perforations ofthe outerdistraction ring

Figure 25: Assembly of the implant onto the inside threaded shaft.

Figure 26: Threaded hole of theimplant, which receives the insidethreaded shaft of the expander.

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Note: During assembly of theexpander, ensure the T-handle of theexpander is perpendicular to theimplant, see Figure 28.

The end of the main shaft of theexpander is curved, see Figure 29. Thisunique tip geometry conforms to thediameter of each implant, allowing formaximum contact of the expander andimplant during insertion to reduce anyplay. To ensure this snug fit, it isimportant to orient the silicon T-handle of the expander perpendicularto the implant during assembly.

Once the expander is in properalignment with the implant, the implantcan be placed into the defect anddistracted to the appropriate height.

To distract the implant, simply rotate the outer cannulated shaft of theexpander counterclockwise as indicatedby the directional arrow, which is lasermarked on the outside of the shaft. Thecounterclockwise rotation of the outercannulated shaft will turn the outerdistraction ring of the implant andresult in distraction of the implant, seeFigure 30.

Note: Prior to maximum distraction ofthe implant, it is recommended thesurgeon stop distraction when: • The deformity of the defect iscorrected. • The end caps subside or embed intothe bony endplate. It is also suggested to monitordistraction with fluoroscopy to preventany progressive distraction of the facetjoints and disruption of the ligaments.

CAUTION: Carefully monitor foroverdistraction, especially in cases ofspondylectomy and trauma.

Figure 28: The silicon T-handle of the expander must be perpendicular to theimplant during the assembly.

Figure 29: The end of the expander’s main shaft is curved to provide maximumcontact to the implant during insertion.

Figure 30: Distraction of the implant by rotating the outer cannulated shaft ofthe expander counterclockwise.

Main shaft

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Figure 33: An outer cannulated shaft “groove” should face superior, as shownin this picture, at the completion of distraction to provide access to the goldlocking screw.

The implant has reached its finaldistraction height once the threadedbase “arms” of the implant are nolonger visible, see Figure 31.

After the appropriate height of theimplant is achieved, disassemble theexpander from the implant construct byfirst unthreading the inside threadedshaft from the threaded hole of theimplant and then removing the entireexpander.

It is important to ensure the scallops ofthe outer distraction ring line up oneither side of the gold locking screwafter distraction, see Figure 32.

Grooves on the tip of the outercannulated shaft of the expander aid inalignment of the distraction ringscallops, see Figure 33.

As the surgeon is completingdistraction of the implant, it isrecommended that one of the grooveson the tip of the outer cannulated shaftof the expander be positionedsuperiorly.

Following these steps will aid inproviding maximum access of thelocking screw to complete the lockingstep of the procedure, as described inStep 6 on page 20.

Figure 31: Full distraction of the implant is reached once the threads are nolonger visible in the implant windows.

At full distraction,the threads are notvisible in the window

Threadedbase “arm”

Figure 32: Scallops of the distraction ring.

Outer cannulatedshaft “grooves”

20


Figure 34: The screwdriver engages the pre-assembled locking screw. Twocounterclockwise turns of the locking screw with the screwdriver will lock theimplant height in place.

STEP 6: Locking the DistractionMechanism

Once the optimal implant height isreached via in situ distraction, the outerdistraction ring can be locked with apre-assembled gold locking screw toprevent the implant height fromchanging, see Figure 34.

To lock the outer distraction ring andthe implant height, place the head ofthe screwdriver into the head of thelocking screw. Rotate the screwdrivercounterclockwise two full turns, whichwill cause the head of the locking screwto protrude out (back-out) of theimplant and contact the outerdistraction ring.

Note: The locking screw was notdesigned to provide any tactilefeedback during the locking step. Thelocking screw should back-out of theimplant freely with rotation of thescrewdriver. The screwdriver was alsodesigned to be low-profile topotentially eliminate unnecessarytorque transmission to the lockingscrew.

If the surgeon backs-out the lockingscrew past two full turns and reaches apoint where the screw can no longerback-out, the surgeon should stoprotating the screwdriver. At thispoint, the implant height is locked andany further rotation of the lockingscrew may compromise its integrity.

120° oriented laser-marks are locatedon the shaft of the screwdriver, seeFigure 35. Each laser-mark (circle,square, triangle) provides the surgeonwith a visual reference to maintainorientation during screwdriverrotation. The screwdriver only needs torotate counterclockwise two full turnsto lock the implant height.

Once the locking screw is backed-outtwo full turns, the implant height isnow locked and the surgeon canproceed with the remaining part of theoperative procedure.

Figure 35: The screwdriver shaft contains 120° oriented laser-marks to providea visual reference during the locking step.

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STEP 7: In-situ Bone GraftPacking (optional)

After the implant is distracted andlocked into its final position, a void maybe present between the bone graft insidethe implant and the bony endplate ofthe vertebral body. The void can befilled through the large windows in theperiphery of the implant. The smallgraft impactor acts similar to a tampand can be used to pack additional bonethrough the large implant windows, seeFigure 36. Standard O.R. instrumentssuch as forceps or Penfields may also beused.

STEP 8: Supplemental Fixation

If supplemental fixation was not appliedprior to the insertion of the VLIFTimplant, it must be applied once theimplant is in place. The supplementalinternal fixation systems that may beused with VLIFT include, but are notlimited to, Stryker Spine plate or rodsystems (Xia Spinal System, SpiralRadius 90D and Trio), see Figure 37.

Figure 37: Addition of the Xia� Anterior Spinal System to supplement the VLIFTimplant.

Figure 36: Insertion of bone graft with the small graft impactor through thelarge implant windows.

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REMOVAL

If fusion / bone graft growth occurs, thedevice will be deeply integrated into thebony tissues. As a result, the VLIFTsystem is not intended for removalunless the management of acomplication or adverse event requiresremoval. Standard instruments may beused to hold and disengage the devicefrom the vertebrae. Any decision by aphysician to remove the device shouldtake into consideration such factors asthe risk to the patient of the additionalsurgical procedure as well as thedifficulty of removal.

The following steps can be used if theVLIFT device must be removed:

1. Insert the VLIFT screwdriver into thehead of the locking screw. Rotate theset screw with the screwdriverclockwise until the gold locking screwis flush with the implant (lockingscrew will reach an end point and willno longer be able to be rotatedclockwise) see Figure 38. Once thegold locking screw is flush with theimplant, the distraction mechanism isunlocked. Remove the screwdriverfrom the defect.

2. Insert the expander into the defectand ensure the silicon handle isperpendicular to the implant. Threadthe inside shaft of the expander intothe threaded hole of the implant.The threaded hole of the implant islocated just below the gold lockingscrew, see Figure 13 on page 13.

3. Once the inside shaft is fully insertedinto the threaded hole of the implant,ensure the perforated tips of theouter cannulated shaft of theexpander properly line up in betweenthe scallops of the outer distractionring. Rotate the outer cannulatedshaft clockwise to reduce the heightof the implant until it is possible toremove the implant from the defect,see Figure 39.

Figure 38: Rotate the screwdriver clockwise to unlock the distractionmechanism.

Figure 39: To reduce the height of the implant for removal, rotate the outercannulated shaft of the expander clockwise.

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VLIFT Standard Set and Ordering Information

ImplantsPart Number Description #/Set

48291820 Ø18 mm x 20 mm Implant 1

48291825 Ø18 mm x 25 mm Implant 2

48291832 Ø18 mm x 32 mm Implant 2

48292225 Ø22 mm x 25 mm Implant 2

48292232 Ø22 mm x 32 mm Implant 2

48292237 Ø22 mm x 37 mm Implant 2

ExtensionsPart Number Description #/Set

48291800 Ø18 mm 1

48292200 Ø22 mm 1

End CapsPart Number Description #/Set

48291180 Ø18 mm End Cap, 0° 3

48291183 Ø18 mm End Cap, 3° 3

48291188 Ø18 mm End Cap, 8° 3

48291220 Ø22 mm End Cap, 0° 3

48291223 Ø22 mm End Cap, 3° 3

48291228 Ø22 mm End Cap, 8° 3

48292215 Ø22 mm End Cap, 15° 2

48290220 Ø22 mm End Cap, 20° 0*

48290225 Ø22 mm End Cap, 25° 0*

48290230 Ø22 mm End Cap, 30° 0*

Implants

InstrumentsPart Number Description #/Set

48300200 Expander 1

48300210 Auxiliary Inside Shaft 0*

48300300 Screwdriver 1

33660450 Small Graft Impactor 1

33660460 Graft Impactor 1

48300450 End Cap Remover 1

48300518 Ø18 mm End Cap Impactor 1

48300522 Ø22 mm End Cap Impactor 1

48300001 Container 1

*Special order item, not part of standard set

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use aparticular product when treating a particular patient. Stryker does not dispense medical advice and recommendsthat surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon mustalways refer to the package insert, product label and/or instructions for use before using any Stryker product.Products may not be available in all markets because product availability is subject to the regulatory and/or medicalpractices in individual markets. Please contact your Stryker representative if you have questions about theavailability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the followingtrademarks or service marks: Spiral Radius 90D, Stryker, Trio, VLift, Xia. All other trademarks are trademarks oftheir respective owners or holders.

TLVLF-ST-1 SC/GS 01/16

Copyright © 2016 StrykerPrinted in USA

Stryker Spine2 Pearl Court Allendale, NJ 07401-1677 USAt: 201-760-8000www.stryker.com

VLIFTSurgical Techniqueaz621074.vo.msecnd.net/.../TLVLF_ST_1.pdf6 VLIFT System Overview End Caps Ø18 mm and Ø22 mm end caps are available in three angles: 0 , 3 , and 8 0 3 8 Note:

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