Surgical Technique INTERSOMATIC CERVICAL CAGE

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1 R INTERSOMATIC CERVICAL CAGE

2 NEOCIF IMPLANTS NEOCIF is an implant designed to make anterior cervical interbody fusion (ACIF) easier and to remove the need for structural autologous graft. The cage is made of PEEK OPTIMA (Poly- Ether-Ether-Ketone). The primary fixation is improved by titanium alloy (Ti6A14V) spikes. The core of the cage can be filled with autologous cancellous bone or synthetic bone substitute. Two sizes and four heights are available in order to match the different configuration of interbody spaces. Furthermore, the wedge-shaped design restores cervical lordosis, foraminal cross sectional area and disc height. INDICATIONS Degenerative cervical disc disease (C3-C7). Cervical instability and pseudoarthrosis: These indications may require additional plating. BENEFITS AND FEATURES PEEK OPTIMA * features an elastic modulus between cortical and cancellous bone (3.6 GPa), providing immediate load bearing capacity and biocompatibility. Allows for assessment of fusion via X-ray, MRI or CT scan due to its radiolucency. Surfaces with retentive teeth and three anchoring pins provide a secure cage fixation to the endplates. Furthermore, the pins allow for an exact placement of the implant under fluoroscopic control. Plating is recommended in cases of traumatic instability or whenever severe kyphotic malalignment has to be corrected. The central cavity offers maximum filling volume for bone or granular bone substitute (up to 634,002 mm 3 ). The goal is a faster and more complete bony ingrowth. Simple and user friendly instrumentation. Precise selection of the implant size with radiopaque trials. Safe insertion of the implant with a slim inserter featuring a depth stop. E. B. I. SPINE, a Biomet company does not practice medicine and does not recommend this or any other surgical technique for use in a specific patient. The surgeon, in the course of his surgical duties, is responsible for deciding upon and using an appropriate technique in each patient. E. B. I. SPINE, a Biomet company, is not responsible for the choice of an appropiate surgical technique for use in any particular case. The surgical technique has been revised and aproved by a Medical Doctor. * PEEK-OPTIMA polymer is a trademark of INVIBIO.LTD

3 CONTENTS 2pag. SURGICAL APPROACH 3pag. DISTRACTION 4pag. DISCECTOMY AND DECOMPRESSION 4pag. SELECTION OF THE CAGE 5pag. FILLING THE CAGE 5pag. INSERTION OF THE IMPLANT 6pag. AXIAL COMPRESSION AND CLOSURE NEOCIF Intersomatic Cervical Cage 1

4 NEOCIF SURGICAL APPROACH (General anaesthetic) 1 The patient is in supine position (Fig. 1). The head may be slightly extended. The shoulders are pulled in order to improve fluoroscopy of the lower cervical spine. The skin incision is centered on the radiographic labeling of the target level(s) (Fig. 2). Fig.1 A classical antero-lateral approach is normally used; right sided approaches are often avoided in order to avoid the recurrent laryngeal nerve. Fig.2 2 NEOCIF

5 DISTRACTION Once the target area is confirmed with the image intensifier, temporary distraction pins (Cyclops instrument as optional ref ) are screwed in with the pin inserter (Cyclops instrument as optional ref ) (Fig. 3 and Fig. 4), in the vertebrae above and below the disc to be removed. 2 Fig.3 The sleeves of the distractor (Cyclops instrument as optional ref ) are inserted on the pins. Following the incision of the annulus, distraction is provided by turning the wing nut clockwise (Fig. 5 and Fig. 6). 3 Fig.4 Depending on the pathology to be treated, a single or multi-level discectomy can be carried out. 4 Fig.5 Fig.6 3

6 NEOCIF DISCECTOMY AND DECOMPRESSION Fig.7 5 A complete discectomy should leave the adjacent vertebral endplates cleared from all the disc material and the cartilaginous layer. A parallel shape of the endplates is achieved by burring the anterior and posterior rim of the cranial vertebra and only of the posterior rim of the caudal vertebra. In this way the contact area between cage and vertebral endplates is maximized (Fig. 7). SELECTION OF THE CAGE Fig.8 6 The NEOCIF trial cage (ref /06/08/10/12/14/16/18) is connected to the insertion handle (ref ) and the safety stop is adjusted (Fig. 8). 7 The trial is then introduced into the intervertebral space under fluoroscopic control (Fig. 9, Fig. 10 and Fig. 11). Make sure the handle is on cranial position (etched on the instrument) when inserting the trial. The size of the trials corresponds to the NEOCIF permanent cage, but without spikes! Fig.9 Note: the trial should never be left in situ. Fig.10 Fig.11 4 NEOCIF

7 FILLING IN THE CAGE The selected NEOCIF cage is connected to the insertion instrument (ref ) and placed on the graft table (ref ). Autologous bone or biomaterials in granules mixed with local blood, are options for filling the NEOCIF cage (Fig. 12). 8 Fig.12 The graft table compactor (ref ) is used for this purpose (Fig. 13). The graft table has one of the two footprints in each side of the device. 9 Fig.13 INSERTION OF THE IMPLANT The NEOCIF cage is inserted into the disc space under fluoroscopic guidance (Fig. 14 and Fig. 15). The adjustable depth stop prevents pushing of the implant into the spinal canal. 10 Fig.14 Fig.15 5

8 NEOCIF 11 A lateral and AP fluoro-print will indicate the correct position of the NEOCIF cage (Fig. 16).Once the implant is in a satisfactory position, the implant holder is released. Fig.16 Fig.17 AXIAL COMPRESSION AND CLOSURE 12 Releasing distraction and performing axial compression (Cyclops instrument as optional ref ) improves the penetration of the anchoring pins into the vertebral endplates. After removal of the distraction screws the wound is closed by layers. 6 NEOCIF

9 INTERSOMATIC CERVICAL CAGE ORDERING INFORMATION IMPLANTS Size Reference Description (L / H)* (mm) NEOCIF Intersomatic Cervical Cage 13 / NEOCIF Intersomatic Cervical Cage 13 / NEOCIF Intersomatic Cervical Cage 13 / NEOCIF Intersomatic Cervical Cage 13 / NEOCIF Intersomatic Cervical Cage 15 / NEOCIF Intersomatic Cervical Cage 15 / NEOCIF Intersomatic Cervical Cage 15 / NEOCIF Intersomatic Cervical Cage 15 / 8 L H INSTRUMENTS Size Reference Description (L / H)* (mm) Qty / Set *Image not in actual size IQL NEOCIF Empty Instrumentation Case 1 includes: NEOCIF Complete Instrumentation Case NEOCIF Insertion instrument NEOCIF Graft Table NEOCIF Graft Table Compactor NEOCIF trial 13 / NEOCIF trial 13 / NEOCIF trial 13 / NEOCIF trial 13 / NEOCIF trial 15 / NEOCIF trial 15 / NEOCIF trial 15 / NEOCIF trial 15 / CYCLOPS Distractor ** ( Optional ) CYCLOPS Pin Inserter ** ( Optional ) CYCLOPS Temporary Pin ** ( Optional ) * Length and Height ** The following instruments (CYCLOPS Cervical Plate System) can be used to achieve distraction / compression. - To be ordered separately - No room in the empty case ( Ref IQL)

10 NOTES

11 NOTES

12 Ref: Q460-09T1 EBI Spine - Jan. 06 / Rev. FEB 06 c/o Biomet Spain Orthopaedics S.L. Spain mail: ebispine@biomet.es

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