SURGICAL TECHNIQUE ROI-T TM TLIF INTERSOMATIC IMPLANT TRANS-FORAMINAL APPROACH

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Alexis Banks
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1 TLIF INTERSOMATIC IMPLANT TRANS-FORAMINAL APPROACH

Table of Contents page Step 1 - Articular resection.................................................................................. 3 Step 2 - Pedicle screw impaction for distraction.

2 Table of Contents page Step 1 - Articular resection Step 2 - Pedicle screw impaction for distraction Step 3 - Distraction of the instrumented level Step 4 - Discectomy and endplate preparation Step 5 - Trial implant selection Step 6 - Cage preparation Step 7 - Implant insertion Step 8 - Final positioning of the cage Step 9 - Final control Step 10 - Stabilisation and compression Approach Median lateral approach, Wiltse, or mini-invasive approach.

Step 1 Articular resection In order to access the disc through the foramen, resect the articulars of the level to be instrumented, on the side of cage insertion.

Note: if access to the disc is already sufficient to perform the discectomy and the implantation, articular resection is not compulsory.

3 Step 1 Articular resection In order to access the disc through the foramen, resect the articulars of the level to be instrumented, on the side of cage insertion. Take care to use the nerve root retractors (6, 10mm) in order to protect the surrounding nerve structures. Note: if access to the disc is already sufficient to perform the discectomy and the implantation, articular resection is not compulsory. Step 2 Pedicle screw impaction for distraction Install Easyspine pedicle screws on the adjacent levels (superior and inferior) of the disc that needs to be treated. The screws will be used for the required distraction during the discectomy, during the step of trial implant selection, and during implantation of the cage. Note: a rod can be placed in the screws on the side opposite to cage insertion in order to accomplish and maintain distraction. Pre-tightening the rod ensures maintaining the distraction required for step

Step 3 Distraction of the instrumented level Several options can be

side of the implantation: First possibility: use the LDR distractor

The rod blade fits in the pedicle screw and is blocked by the locking

4 Step 3 Distraction of the instrumented level Several options can be considered for the distraction: Option A By using pedicle screws on the side of the implantation: First possibility: use the LDR distractor with the ROI-T rod blades. The rod blade fits in the pedicle screw and is blocked by the locking screw. Second possibility: place the Easyspine distraction forceps between the pedicle screws to proceed with distraction.

Option B - By using pedicle screws on the side opposite to the

Distraction Maintaining Rod Option C - By leveraging against the spinous

5 Option B - By using pedicle screws on the side opposite to the implantation: Place the Easyspine distraction forceps between the pedicle screws to proceed with the distraction. Note: In the case of a very pinched disc, a rod can be installed on the side opposite to cage insertion. After tightening, the rod will help maintain the distraction. Distraction Maintaining Rod Option C - By leveraging against the spinous processes: Place the wide spinous process distractor* between the spinous processes and distract. Wide Spinous Process Distractor* * Option: only available on order. 4-5

6 Step 4 Discectomy and endplate preparation Incise the disc in front of the foramen. Caution: the minimum width necessary for insertion of the implant is about 12mm Use the shavers, available in different sizes (8, 10 & 12mm), to continue the discectomy. Complete the discectomy by using the straight curette and/or the angled curettes. These curettes are also used for freshening the vertebral endplates. Important: During the discectomy, take into account graft placement options: anterior and/or posterior. Proper preparation of the vertebral endplates facilitates good vascularization between the vertebral endplates and the graft, but must not, in any case, weaken the cortical bone.

7 If necessary, use the box-chisels (sizes 8, 10 & 12mm) to prepare insertion of the cage at the level of the peripherical border of the end plate to a depth of about 5mm. Upper and lower cutting edges on the box-chisels. 6-7

Complete assembly by tightening the impaction knob on the implant holder until the knob contacts the handle.

8 Step 5 Trial implant selection Important: The trial implants have exactly the same dimensions as the definitive implants. They help to determine the characteristics height and lordosis the best adapted to patient anatomy. Select the trial implant that will best restore the desired disc height and lordosis. Complete assembly by tightening the impaction knob on the implant holder until the knob contacts the handle. Assemble the selected trial implant to the ROI-T implant holder sliding it on to the edge of the implant holder. The teeth and the threaded rod of the implant holder are fitted into the corresponding notches and threaded hole of the trial implant. Threaded Rod Contact Impaction Knob Teeth Notches Note: two implant holders are available in 0 and 15 angulations between the implant holder and the ROI-T implant. Appropriate choice of the implant holder the most adapted to the chosen approach will facilitate the insertion of the implant and facilitate optimal placement.

Insert the chosen trial implant into the inter-vertebral space as close as possible to the desired final position without removing the trial implant from the

Check the correct positioning of the trial implant under X-Ray fluoroscopy.

9 Insert the chosen trial implant into the inter-vertebral space as close as possible to the desired final position without removing the trial implant from the implant holder. Release the distraction temporarily to ensure the trial implant is stable in the inter-vertebral space. Check the correct positioning of the trial implant under X-Ray fluoroscopy. Restore the distraction to withdraw the trial implant from the inter-vertebral space. Important: Take care to not separate the trial implant from the implant holder before the trial implant/implant holder assembly has been completely withdrawn from the inter-vertebral space. 8-9

Step 6 Cage preparation The fusion chamber of the implant must be filled with

Assemble the cage to the implant holder as done previously with the trial

Fusion Chamber Secure the implant by pushing the holding plate down, ensuring

chamber, and then tighten the screw knob.

ensure that it is in contact with the handle of the implant holder.

10 Step 6 Cage preparation The fusion chamber of the implant must be filled with autograft or bone substitute. Assemble the cage to the implant holder as done previously with the trial implant. Fusion Chamber Secure the implant by pushing the holding plate down, ensuring the pins on the holding plate s underside are positioned inside the graft chamber, and then tighten the screw knob. Screw Knob Holding Plate Important: After tightening the impaction knob, ensure that it is in contact with the handle of the implant holder. Place bone graft in the funnel of the holding plate and compact it with the graft compactor. Place the cage and implant holder assembly on the graft support, taking care to position the centering pin in the graft chamber. Base Implant Holder Centering Pin

Step 7 Implant insertion Note: Bone graft can be

insertion and placement of the cage using the

Position the implant in the inter-vertebral

Check correct final positioning of the implant

Loosen the impaction knob of the implant holder

11 Step 7 Implant insertion Note: Bone graft can be inserted anteriorly into the disc space before insertion and placement of the cage using the Anterior Graft Spatula. Position the implant in the inter-vertebral space as close as possible to the final position. Check correct final positioning of the implant under X-Ray fluoroscopy. Loosen the impaction knob of the implant holder in order to release the cage and then carefully remove the implant holder gently and in a straight line

Step 8 Final positioning of the cage Use the secondary impactor to place the cage in its final position (anterior, and centered on the vertebral endplate).

12 Step 8 Final positioning of the cage Use the secondary impactor to place the cage in its final position (anterior, and centered on the vertebral endplate). ❶ to ❹ ❶ ❷ Note: it is recommended to do this positioning under X-Ray fluoroscopy to avoid an insertion too anterior of the implant. Remark: The introduction angle of the secondary impactor in the inter-vertebral space permits adjustment of the implant s rotation between the vertebral endplates. ❸ ❹

Step 9 Final control Conduct a final control under X-Ray fluoroscopy of the implant s

body. OPTION It is possible to fill the inter-vertebral space posterior to the cage

13 Step 9 Final control Conduct a final control under X-Ray fluoroscopy of the implant s position to validate correct positioning of the cage (anterior and centered position on the inferior vertebral endplate). - Anterior control: the median radio-opaque marker must be centered on the vertebral body. OPTION It is possible to fill the inter-vertebral space posterior to the cage with bone graft using the posterior graft spatula. - Profile control: the vertical radio-opaque markers must be aligned in the sagittal plane

pedicle screws and the rods installed during step 2.

14 Step 10 Stabilisation and compression After the ROI-T cage is implanted, place the treated segment under compression using the pedicle screws and the rods installed during step 2. Important: Ensure that compression of the cage does not compromise the nerve roots.

15 France Technopôle de l Aube BP Troyes Cedex 9 France +33 (0) China Unit 08, Level 16, Building A, Beijing Global Trade Center #36 North Third Ring Road East, 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-T 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 and vertebridge are trademarks or registered trademarks of LDR Holding Corporation or its affiliates in France, the United States or other countries.

SURGICAL TECHNIQUE ROI-C TM ANTERIOR CERVICAL CAGE

SURGICAL TECHNIQUE ROI-C TM ANTERIOR CERVICAL CAGE SURGICAL TECHNIQUE ROI-C TM Table of Contents page 1 - Disc location............................................................................................