SURGICAL TECHNIQUE ROI-C TM ANTERIOR CERVICAL CAGE

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Dana Underwood
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1 SURGICAL TECHNIQUE ROI-C TM ANTERIOR CERVICAL CAGE

SURGICAL TECHNIQUE ROI-C TM Table of Contents page 1 - Disc location............................................................................................ 3 2 - Discectomy.

............................................................................ 4 5 - Cage selection......................................................................................... 6 6 - Cage preparation.

2 SURGICAL TECHNIQUE ROI-C TM Table of Contents page 1 - Disc location Discectomy Freshening the vertebral endplates Trial implant selection Cage selection Cage preparation Loading the cage on the implant holder Cage positioning Anchoring plates positioning Implant holder removal and final control

1 Discectomy and endplates preparation Disc location The approach to the intersomatic space is realised after locating the affected level under fluoroscopy.

Place the distractor on the pins. 8 mm 8 mm Distract the intersomatic space, then start disc resection with a thin, long scalpel and disc forceps.

3 1 Discectomy and endplates preparation Disc location The approach to the intersomatic space is realised after locating the affected level under fluoroscopy. The surgical protocol and the technique used for the exposure of the intersomatic space are the same as for the standard anterior approach for cervical vertebral surgery. 2 Discectomy Place the Caspar pins 8mm from the superior and inferior endplates of the treated level in order to not impede insertion of the implant. Place the distractor on the pins. 8 mm 8 mm Distract the intersomatic space, then start disc resection with a thin, long scalpel and disc forceps. Continue the discectomy to the back of the endplates. Remark: It is not necessary to remove all the annular disc tissue laterally. It is sufficient to remove only the amount corresponding to the cage (between the uncus); maintaining the lateral annular layers optimizes cage stability and facilitates arthrodesis

4 Trial implant selection Trial implant selection The trial implants vary in: depth x width and height.

4 SURGICAL TECHNIQUE ROI-C TM 3 Freshening the vertebral endplates Prepare the implant space and the grafting surfaces with a curette and a rasp. Thorough freshening of the endplates favours the fusion. 4 Trial implant selection Trial implant selection The trial implants vary in: depth x width and height. They are identifiable due to a colour code: each colour representing a size (depth x width) 12x14mm 12x15,5mm 14x14mm 14x15,5mm 14x17mm

4a Depth selection (12 or 14 mm) Insert the chosen trial implant into the intervertebral space.

Important: The posterior side of the trial implant has to be at a minimum of 1mm from the posterior edge of the vertebra.

1 mm Remark: The trial implant hole must be visible, assuring the lack of rotation.

5 4a Depth selection (12 or 14 mm) Insert the chosen trial implant into the intervertebral space. Check under fluoroscopy correct positioning of the trial implant in depth and rotation. Important: The posterior side of the trial implant has to be at a minimum of 1mm from the posterior edge of the vertebra. If not the case, choose a trial implant of inferior depth. 1 mm Remark: The trial implant hole must be visible, assuring the lack of rotation. 4b Width selection After depth measurement, insert the chosen trial implant into the intervertebral space. Choose the trial implant that offers the best coverage of the vertebral endplate. Remark: The trial implant has to be as large as possible, while staying stable on the vertebral endplate. 4-5

SURGICAL TECHNIQUE ROI-C TM 4c Height selection (from 4,5mm) Insert the trial implant of the colour corresponding to the

Release briefly the distraction in order to make sure the trial implant is stable in the intervertebral space.

levels. Restore the distraction in order to remove the trial implant from the intervertebral space.

6 SURGICAL TECHNIQUE ROI-C TM 4c Height selection (from 4,5mm) Insert the trial implant of the colour corresponding to the previously chosen size (depth x width) into the intervertebral space. Release briefly the distraction in order to make sure the trial implant is stable in the intervertebral space. Check under fluoroscopy the consistency between the height of the selected trial implant and the discal height of the adjacent levels. Restore the distraction in order to remove the trial implant from the intervertebral space. Trial implant selection 5 Cage selection Height Colour code The colour code and the trial implant height determine the choice of the final implant. The information is located on the side of the implant boxes. Sterilisation Size (depth x width)

6 Cage preparation The fusion chamber of the cages has to be filled with

Option A Autograft Compact the graft in the fusion chamber of the ROI-C

Option B Bone substitute The BF+ bone substitute has an anatomical shape

Graft compactor Insert the superior part (dome-shaped)of the bone

7 6 Cage preparation The fusion chamber of the cages has to be filled with autograft or bone substitute. Option A Autograft Compact the graft in the fusion chamber of the ROI-C cage with the graft compactor. Option B Bone substitute The BF+ bone substitute has an anatomical shape and is perfectly adapted to the cage dimensions. Graft compactor Insert the superior part (dome-shaped)of the bone substitute through the inferior opening of the cage. Place the bevelled sides of the bone substitute (dome on top) in front of the cage slots to free the way for the anchoring plate. 6-7

SURGICAL TECHNIQUE ROI-C TM 7 Loading the cage on the

holder in such a way as to slot the implant holder

Hook Secure the cage on the implant holder with the

8 SURGICAL TECHNIQUE ROI-C TM 7 Loading the cage on the implant holder Bring the cage close to the implant holder in such a way as to slot the implant holder hook in the notch on the left side of the cage. Hook Secure the cage on the implant holder with the threaded axis by screwing the impaction knob. Threaded axis Impaction knob

8 Cage positioning Standard stop or Enlarged stop Set the adjustable stop to zero by screwing or unscrewing the impaction

Knurled wheel Important: During cage positioning, make sure the cage is perfectly inserted in the axis of the intersomatic

Remark: From the lateral view, the marker shows the posterior position of the cage.

Antero-posterior positioning can be adjusted millimetre by millimetre with the knurled wheel.

9 8 Cage positioning Standard stop or Enlarged stop Set the adjustable stop to zero by screwing or unscrewing the impaction knob. Remark: It is up to the surgeon to select the standard stop or the enlarged one. Knurled wheel Important: During cage positioning, make sure the cage is perfectly inserted in the axis of the intersomatic space. OK Insert the cage in the intervertebral space under fluoroscopy in order to verify correct positioning. Remark: From the lateral view, the marker shows the posterior position of the cage. The implant holder s adjustable stop comes into contact with the anterior wall of the superior vertebra space. Antero-posterior positioning can be adjusted millimetre by millimetre with the knurled wheel. Important: Each scale marked on the adjustable stop enables millimetric advancement of the cage towards the vertebral body s posterior wall. Once the antero-posterior positioning has been adjusted, release distraction and compress the segment. 8-9

SURGICAL TECHNIQUE ROI-C TM Anchoring plate positioning 9a Insertion of the first half anchoring plate Important: If the pins have not been properly placed during the discectomy,

ROI-C Anchoring plate holder When cage position is optimal and the segment put in compression, the anchoring plate (composed of two half anchoring plates) can be inserted.

The first half anchoring plate is inserted in the superior slot of the cage holder with the ROI-C anchoring plate holder (in the axis of the cage holder with a minimum of

10 SURGICAL TECHNIQUE ROI-C TM Anchoring plate positioning 9a Insertion of the first half anchoring plate Important: If the pins have not been properly placed during the discectomy, they can impede anchoring plate insertion. In this case, remove the distractor and the Caspar pins. ROI-C Anchoring plate holder When cage position is optimal and the segment put in compression, the anchoring plate (composed of two half anchoring plates) can be inserted. Impaction of the half anchoring plates is done one after another (in the inferior vertebra, then in the superior one). The first half anchoring plate is inserted in the superior slot of the cage holder with the ROI-C anchoring plate holder (in the axis of the cage holder with a minimum of obstruction). Important: During half anchoring plate insertion, make sure to push the plate all the way to the bottom of the implant holder head with the ROI-C anchoring plate holder. Impact the half anchoring plate using the ROI-C impactor (marked 1) until it reaches its mechanical stop. 1 st stage: Roi-C impactor (marked 1) Mechanical stop

11 Complete the impaction using the ROI-C final impactor (marked 2). 2 nd stage: ROI-C final impactor (marked 2) Remark: Make sure the impactions are done in the axis of the intervertebral space. Mechanical stop Note: Use fluoroscopy during each step in order to verify correct positioning of the half anchoring plate

SURGICAL TECHNIQUE ROI-C TM 9b Insertion of the second half anchoring plate The second half anchoring

second half anchoring plate is inserted in the opposite slot from the first one.

the superior vertebral body and inversely.

12 SURGICAL TECHNIQUE ROI-C TM 9b Insertion of the second half anchoring plate The second half anchoring plate is inserted and impacted following the same method used for the first one, making sure the second half anchoring plate is inserted in the opposite slot from the first one. Reminder: The half anchoring plate inserted in the implant holder s inferior guide penetrates into the superior vertebral body and inversely. 1 st stage: Roi-C impactor (marked 1) Note: Use fluoroscopy during each step in order to verify correct positioning of the half anchoring plate. 2 nd stage: ROI-C final impactor (marked 2)

13 Implant holder removal and final control 10a Implant holder removal Unscrew the impaction knob to release the cage from the threaded axis of the implant holder. Disengage the implant holder hook from the cage notch by moving the implant holder to the left. Carefully remove the implant holder in the axis of the intervertebral space. Impaction knob Remove the distractor and the Caspar pins. 10b Final control A control under fluoroscopy, from the front and lateral view, of anchoring plate position enables to ensure optimal trajectory. Final control 12-13

15 France Technopôle de l Aube BP Troyes Cedex 9 France +33 (0) China Beijing Global Trade Center #36 North Third Ring Road East, Unit 06, Level 19, Building A, Dongcheng District, Beijing, China, Brazil Av. Pereira Barreto, 1395 Torre sul - CJ Bairro Paraiso Santo André - São Paulo CEP: Brazil United States 4030 West Braker Lane, Suite 360 Austin, Texas Ref: IR-C ST 1 EN A LDR, LDR Spine, LDR Médical, BF+, BF+(ph), Easyspine, Laminotome, MC+, Mobi, Mobi-C, Mobi-L, Mobidisc, ROI, ROI-A, ROI-MC+, ROI-T, ROI-C and vertebridge are trademarks or registered trademarks of LDR Holding Corporation or its affiliates in France, the United States or other countries.

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