TECHOP MOBIC INT GB:Mise en page 1 - LDR Global€¦ · CERVICAL ARTIFICIAL DISC SURGICAL TECHNIQUE Ref: MB ST 2 EN 06.2009 A France Technopôle de l’Aube BP 2 10902 Troyes Cedex

CERVICAL ARTIFICIAL DISC

S U R G I C A L T E C H N I Q U E

Ref: MB ST 2 EN

06.2009 A

FranceTechnopôle de l’Aube BP 210902 Troyes Cedex 9France+33 (0)3 25 82 32 63

ChinaUnit 08, Level 16, Building A,Beijing Global Trade Center #36North Third Ring RoadEast, Dongcheng District,Beijing, China, 100013+86 10 58256655

BrazilRua Bela Vista, 77 - CentroSão Bernardo do CampoCEP: 09715-030São PauloBrazil+55 11 43327755

United States4030 West Braker Lane, Suite 360Austin, Texas 78759512.344.3333

www.ldrmedical.com

LDR, LDR Spine, LDR Médical, BF+, BF+(ph), Easyspine, Laminotome, MC+, Mobi, Mobi-C, Mobi-L, Mobidisc, ROI, ROI-A, ROI-MC+, ROI-T andverteBRIDGE are trademarks or registered trademarks of LDR Holding Corporation or its affiliates in France, the United States or other countries.

TECHOP_MOBICCOUV_GB:Mise en page 1 29/06/09 11:58 Page 1

Pre-operative considerations� Implant height determination must be

carried out in such a way as to notexceed the height of healthy adjacentdiscs. A minimal antero-posterior depthof 14mm at the affected level must beverified by x-ray. This measurement willthen be verified intra-operatively bydirect measurement with the depthgauge. All measurements must take intoconsideration any osteophytes that willbe resected at the beginning of theprocedure.

� The surgical approach is identical with that of a classic anterior cervicalarthrodesis.

IMPORTANT: Intraoperative x-rays will be required throughout the procedureto assure accurate instrument andprosthesis positioning.

Patient positioning� Patient positioning is critical to ensure

proper orientation and alignment of theprosthesis. The patient should bepositioned in a physiological neutralposition to avoid hyperextension.

This position should be maintainedthroughout the surgery and rotation ofthe head should also be prevented.

The importance of midline placement� Although the surgical approach for the

Mobi-C is similar to that of an ACDF,certain steps are very different. More so than during a fusion, centering the prosthesis in relation to the vertebralbodies is crucial to the Mobi-C'sbiomechanical success.

Midline placement of Caspar Pins willhelp ensure midline prosthesis placementand help in placement of the CasparDistractor.

Step 1 - Partial discectomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Step 2 - Midline and width determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Centering Pin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Step 3 - Caspar retractor placement and distraction . . . . . . . . . . . . . . . . . . . . . . . . . 4

Step 4 - Complete discectomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Step 5 - Parallel distraction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Step 6 - Depth measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Step 7 - Trial implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Step 8 - Loading the prosthesis on the implant holder . . . . . . . . . . . . . . . . . . . . . . 7

Step 9 - Millimetric stop adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Step 10 - Prosthesis insertion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Step 11 - Verification of prosthesis position - lateral view . . . . . . . . . . . . . . . . 9

Step 12 - Implant holder removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Step 13 - Removal of the clamps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Step 14 - Anchorage optimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10


Table of contents page


2-3

1Step Partial discectomy

� Proceed with a classic discectomy.

� Start with the anterior portion of the disc (annular tissue)releasing as much of the uncusas possible.

� Take care to remove all anteriorosteophytes.

Centering pin

� Once the midline is located, position the centeringpin about 5mm from the inferior edge of thesuperior vertebral body.

� Use fluoroscopy to confirm proper positioning ofthe centering pin.

� Once confirmed, the centering pin is replaced by aCaspar pin using the pin holder.

2Step

� Insert the width gauge into the disc space.

� Position the width gauge flat on the inferiorendplate, in contact with the base of the uncus.

� Once the proper width is selected and the widthgauge is centered on the vertebra a referencemark can be made on the superior vertebra toidentify the midline.

Note: The center reference point, located on thewidth gauge, facilitates location of the vertebralmidline. The size of the width gauge also permitsdetermination of vertebral endplate widthbetween the two uncus.

0459

Midline and width determination

TECHOP_MOBIC_INT_GB:Mise en page 1 29/06/09 12:08 Page 1


3Step

Distraction

� Using the distraction forceps, proceed with an initial distraction ofthe disc space.

� The Caspar distractor is then attached and tightened to maintainthe desired distraction.

� Remove the distraction forceps.

Caspar distractor placement

� The second Caspar pin is in turn inserted in the inferior vertebralbody about 5mm from the superior endplate.

� The pins must be parallel to themselves and parallel with thevertebral endplates in order to ensure parallel distraction.

Note: In the case of a 2-level procedure, the Caspar pin may be placedat mid-height in the vertebral body.


4Step

6Step

Complete discectomy

� A complete discectomy of thedisc space between the uncusand up to the posterior ligamentis performed.

� It is important to remove allposterior osteophytes on thesuperior and inferior endplates.

Note: To prevent weakening thevertebral endplates, use of a burris discouraged during endplatepreparation.

5Step Parallel distraction

� Insert the distraction forceps asposterior as possible. A progressiveand parallel distraction must beobtained. It is advised to alternatelylateralize the distraction forceps inorder to optimize the distraction.

� Once the desired distraction isobtained, lock the Caspar distractorin order to maintain the distraction.

� Remove the distraction forceps.

4-5

Note: Liberation of the posterior longitudinalligament (PLL) may help to obtain paralleldistraction.

Depth measurement

� Using the depth gauge, the depth ofthe vertebral endplates (superior andinferior) is determined by placing thehook of the gauge over the posterioredges of the vertebral endplates.

� The measurement is read directly fromthe instrument.



7Step

* Product availability may vary by country and market.

Trial implants

� The depth and width measurements previously taken helpdetermine the trial sizes to use. The trials will determine the finalimplant height to be used as well as implant size (width and depth).Each trial size is color coded.

� Heights are available in 4.5, 5, 6, and 7mm*. Trialing should beginwith a height that does not exceed the height of healthy adjacentdiscs.

� The trial is threaded onto the trial implant holder and, underfluoroscopy, inserted into the disc space.

Important: It is imperative to cover a maximum of the vertebralendplates without exceeding their depth.

� Release the Capsar distractor.When the Caspar distractor tension is released, take a lateral x-rayto validate height and depth selection and an A/P x-ray to assesscentral placement and width.

Note: The trial implant holder can be removed to facilitate the x-ray control. If needed, the Caspar distractor can be removed.

� For height selection, it is important to not exceed the height ofhealthy adjacent discs nor to over-distract while still obtainingstability of the trial in the intervertebral space.

Note: The holes in the trial, front and side, facilitate verification ofits position (center, rotation).

� To remove the trial, put the Caspar distractor back undertension.

Important: Take care to not over-distract the segment whileremoving the trial.


6-7

8Step Loading the prosthesis

Handling of the prosthesis is accomplished with the help of the Mobi-C implant holder.

Contact: stop threading

9Step

Note: the stop adjustment is indexed -1 turn = 1mm - in order to havesensory reference points whilethreading.

Millimetric adjustmentof the stop

The implant holder has a stop (setbeforehand on zero (0)). This stopallows for setting the insertion depthof the prosthesis from 0 to 5mm.

Figure 1

Notes: Visual control of contact can be conductedusing the window on the implant holder, the word"up", indicating the top of the prosthesis, becomesperfectly readable when the correct position isobtained.

Important: Take care to stop threading as soon as fullcontact is achieved in order to avoid opening theclamps and releasing the implant.

� Before handling, verify that the stop adjustment dial is set to the zero (0) position (Figure 1).

� The "prosthesis + clamps" assembly is loaded onto the implant holder by turning the impaction knob until the assembly is completely threaded onto and in contact withthe holder (Figure 2).

Impaction knob

Figure 2

No contact: continue threading



10Step Prosthesis insertion

� The implant holder must be positioned in the axis of the disc, the Caspar distractor maintaining the intervertebral distraction.

� The position can be verified visually: the groove on the implantholder should align with the Caspar pin.

� In order to verify the correct position in rotation of the implantholder, use the level rod as shown in the illustration below.

� The prosthesis is inserted progressively, under fluoroscopy, into the disc space by tapping lightly on the implant holder'simpaction knob with a mallet.

Note: Take care to center theprosthesis on the vertebral endplates.

� The implant holder must be pushed up against theanterior face of the superior vertebral body.

90°


8-9

11Step

12Step

Position verification – lateral view

� Fluoroscopic control facilitates assessment of correctprosthesis position.

� Release the Capsar distractor in order to put the vertebralendplates in parallel.

� The antero-posterior position of the prosthesis in the inter-vertebral space can be adjusted, if necessary, withmillimetric adjustment of the implant holder's stop.

Note: From the lateral view, visual assessment of thealignment of the tabs on the inferior plate is used to controlthe position of the prosthesis in rotation.

Reminder: The prosthesis must provide as much A/Pcoverage as possible.

Millimetric readjustment of prosthesis position under fluoroscopy.

� The implant holder is then carefully removed.

Important: Continue to turn until the screw is completely released from the clamps.

Unlocking key

Never use thisunlocking key while loading the prosthesis.

Implant holder removal

� As soon as optimal positioning of the prosthesis isconfirmed, continue to turn the implant holder'simpaction knob (in the direction of the arrow) with thehelp of the unlocking key in order to release the clampscrew.

� When the clamp screw is removed, the clamps arereleased and the implant holder can be disengaged.

Clamp screw



13Step 14Step Removal of the clamps

� Using the extractionforceps, grasp the end ofthe clamps at the notcheson the side of each clamp.

� Extract the clamps bysimply pulling back theextraction forceps alongthe axis of the disc.

Anchorage optimization

� The implant is put under compression bytightening the Caspar distractor, optimizing theanchorage of the prosthesis' plates on thevertebral endplates.

� Once the compression is achieved, remove theCaspar distractor and the two pins.

� A/P and lateral fluoroscopy will confirm correct positioning of the prosthesis.

Important :

Do not forget to extractthe clamp screw by pullingback and unscrewing theimplant holder's impactionknob.

Note: In the case of any resistance while removing the clamps, it is advised to remove them one at a time with forceps.


Pre-operative considerations� Implant height determination must be

carried out in such a way as to notexceed the height of healthy adjacentdiscs. A minimal antero-posterior depthof 14mm at the affected level must beverified by x-ray. This measurement willthen be verified intra-operatively bydirect measurement with the depthgauge. All measurements must take intoconsideration any osteophytes that willbe resected at the beginning of theprocedure.

� The surgical approach is identical with that of a classic anterior cervicalarthrodesis.

IMPORTANT: Intraoperative x-rays will be required throughout the procedureto assure accurate instrument andprosthesis positioning.

Patient positioning� Patient positioning is critical to ensure

proper orientation and alignment of theprosthesis. The patient should bepositioned in a physiological neutralposition to avoid hyperextension.

This position should be maintainedthroughout the surgery and rotation ofthe head should also be prevented.

The importance of midline placement� Although the surgical approach for the

Mobi-C is similar to that of an ACDF,certain steps are very different. More so than during a fusion, centering the prosthesis in relation to the vertebralbodies is crucial to the Mobi-C'sbiomechanical success.

Midline placement of Caspar Pins willhelp ensure midline prosthesis placementand help in placement of the CasparDistractor.

Step 1 - Partial discectomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Step 2 - Midline and width determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Centering Pin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Step 3 - Caspar retractor placement and distraction . . . . . . . . . . . . . . . . . . . . . . . . . 4

Step 4 - Complete discectomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Step 5 - Parallel distraction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Step 6 - Depth measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Step 7 - Trial implant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Step 8 - Loading the prosthesis on the implant holder . . . . . . . . . . . . . . . . . . . . . . 7

Step 9 - Millimetric stop adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Step 10 - Prosthesis insertion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Step 11 - Verification of prosthesis position - lateral view . . . . . . . . . . . . . . . . 9

Step 12 - Implant holder removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Step 13 - Removal of the clamps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Step 14 - Anchorage optimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10


Table of contents page


CERVICAL ARTIFICIAL DISC

SURGICAL TECHNIQUE

Ref:

MB

ST 2

EN

06.

2009

A

FranceTechnopôle de l’Aube BP 210902 Troyes Cedex 9France+33 (0)3 25 82 32 63

ChinaUnit 08, Level 16, Building A,Beijing Global Trade Center #36North Third Ring RoadEast, Dongcheng District,Beijing, China, 100013+86 10 58256655

BrazilRua Bela Vista, 77 - CentroSão Bernardo do CampoCEP: 09715-030São PauloBrazil+55 11 43327755

United States4030 West Braker Lane, Suite 360Austin, Texas 78759512.344.3333

www.ldrmedical.com

LDR, LDR Spine, LDR Médical, BF+, BF+(ph), Easyspine, Laminotome, MC+, Mobi, Mobi-C, Mobi-L, Mobidisc, ROI, ROI-A, ROI-MC+, ROI-T andverteBRIDGE are trademarks or registered trademarks of LDR Holding Corporation or its affiliates in France, the United States or other countries.


Documents

TECHOP MOBIC INT GB:Mise en page 1 - LDR Global€¦ · CERVICAL ARTIFICIAL DISC SURGICAL TECHNIQUE Ref: MB ST 2 EN 06.2009 A France Technopôle de l’Aube BP 2 10902 Troyes Cedex