For anterolateral and lateral approach. SynCage-LR 45 /90. Surgical Technique

Transcription

1 For anterolateral and lateral approach SynCage-LR 45 /90 Surgical Technique

2 Image intensifier control This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended. Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, please contact your local sales representative or refer to: For general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, please consult the Important Information leaflet (SE_023827) or refer to:

3 Contents Introduction 4 AO Spine Principles 5 Indications/Contraindications 6 System Overview 7 SynCage-LR 45 /90 Cage and Trial Implant Overview Chart 9 Essential Instruments for SynCage-LR 45 /90 10 Surgical Technique for Anterolateral and Lateral Approach 12 Additional Instruments 24 A Comprehensive Solution for ALIF Surgery 25 Implants 27 Instruments 29 Literature 34 SynCage-LR 45 /90 Surgical Technique DePuy Synthes 3

4 Introduction The SynCage system is the Synthes implant and instrumentation solution for anterior lumbar interbody fusion (ALIF), designed in accordance with the AO/ASIF Principles of Interbody Fusion: 1. Provide adequate stability 2. Restore disc height 3. Restore lordosis 4. Maintain the integrity of the endplates 5. Provide an optimised fusion bed 6. Atraumatic technique 4 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

5 AO Spine Principles The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum: Stability Alignment Biology Function. 1, 2 Stability Stabilization to achieve a specific therapeutic outcome axial sagittal coronal Alignment Balancing the spine in three dimensions Biology Etiology, pathogenesis, neural protection, and tissue healing Function Preservations and restoration of function to prevent disability Copyright 2012 by AOSpine 1 Aebi et al (1998) 2 Aebi et al (2007) SynCage-LR 45 /90 Surgical Technique DePuy Synthes 5

6 Indications/Contraindications Indications Lumbar and lumbosacral pathologies that may require anterior segmental arthrodesis, including: Degenerative disc disease and instability Revision surgery for failed decompression syndrome or pseudarthrosis Reduced spondylolisthesis Contraindications Spinal fractures Spinal tumour Osteoporosis Infection Note: The SynCage-LR is not designed or intended to be used as a stand-alone device; the use of supplementary posterior instrumentation is therefore strongly recommended. When used in the treatment of spondylolisthesis, posterior pedicle screw assisted reduction is usually performed prior to the insertion of the SynCage-LR. 6 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

7 System Overview The SynCage-LR 45 /90 is an evolutionary development of the proven SynCage concept The titanium SynCage system s wedge-shaped, bi-convex design offers: Reduced risk of subsidence The optimal anatomical shape and supportive superior and inferior surface design reduces the risk of subsidence into the adjacent vertrebrae. Enhanced fusion The perforated structure allows for bony ingrowth through the cage, and the bi-convex design ensures optimal implantto-endplate contact. Stability SynCage is designed to fit snugly into the natural concavity between two adjacent vertebral bodies. The tension of the longitudinal ligaments and annulus fibrosus provide stability; the teeth on the superior and inferior surfaces provide additional initial stability. SynCage-LR 45 /90 Surgical Technique DePuy Synthes 7

8 System Overview The PEEK SynCage-LR 45 /90 offers all the benefits of the titanium version, plus: Radiolucency PEEK facilitates radiographic assessment of the fusion. Superior biocompatibility SynCage-LR 45 /90 consists of pure medical grade PEEK (Polyetherether ketone). It contains no carbon fibre, thereby reducing the risk of systemic uptake and local connective tissue formation. Bone integration The injection-moulded PEEK SynCage-LR 45 /90 has a roughened surface to promote bone integration and ongrowth. Optimal fit An expanded range of implants including 5 heights and 2 footprints ensures an optimal fit in most patients. Easy access to anatomy The slots on the superior and inferior surfaces of the implant offer a guiding channel for easy implant insertion over the distractor. 8 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

9 SynCage-LR 45 /90 Cage and Trial Implant Overview Chart The implant s sterile packaging and trial implants are colour-coded to avoid mismatching. SynCage-LR Trial Implant 45 /90 Dimensions: 24 mm (depth) 30 mm (width) For smaller and normal vertebral bodies Anterior Cat. no. Cat. no. Colour height Implant Trial implant code 12 mm S mm S mm S mm S mm S SynCage-LR Trial Implant 45 /90, broad Dimensions: 28 mm (depth) 38 mm (width) For larger vertebral bodies Anterior Cat. no. Cat. no. Colour height Implant Trial implant code 12 mm S mm S mm S mm S mm S SynCage-LR 45 /90 Surgical Technique DePuy Synthes 9

10 Essential Instruments for SynCage-LR 45 /90 Handle for SynCage Trial Implants, angled ( ) The trial implant is screwed onto the trial implant handle at a position corresponding to 45 or 90 of the vertebral midline. The choice of position depends on the surgical approach. Distractor for SynCage-LR ( ) anterolateral approach The distractor permits simultaneous distraction and implant insertion without compromising the space available within the intervertebral disc region for placement of the implant. Implant Holder for SynCage-LR 45º/90º ( ), for smaller and normal vertebral bodies anterolateral approach only Permits secure control of the SynCage-LR 45 /90 during implantation. The instrument grasps the implant on the anterior and lateral faces. For use with small footprint cages ( S S) only. 11 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

11 Implant Holder for SynCage-LR 45 /90, broad ( ), for larger vertebral bodies anterolateral approach only An alternative to the version mentioned above, the implant holder for SynCage-LR 45 /90 for broad implants is specifically designed to ensure an optimal fit in larger anatomies. For use with large footprint cages ( S S) only. Implant Holder for SynCage-LR 45 /90 ( ) lateral approach Permits secure control of the SynCage-LR 45 /90 during implantation. The instrument grasps the implant on the lateral face. Used for both cage sizes Packing Block for SynCage-LR mm Packing Block for SynCage-LSR, broad Cancellous Bone Impactor, mm Cancellous Bone Impactor, mm SynCage-LR 45 /90 Surgical Technique DePuy Synthes 11

12 Surgical Technique for Anterolateral and Lateral Approach 1. Preoperative planning The surgical approach is dependent on the level to be treated and the surgeon s preference. Determine the optimal implant size by comparing the relevant SynCage-LR radio graph template with a lateral radiograph of the adjacent intervertebral discs. Note: The height indicated on the template is approximately 1 mm lower than that of the actual cage to account for penetration of the teeth into the vertebral bone. With the segment fully distracted, the SynCage-LR 45 /90 must fit firmly with a tight press-fit between the endplates. It is therefore recommended that the maximum size SynCage-LR 45 /90 is selected to optimise the stability of the segment through tension in the annulus fibrosus and/or longitudinal ligaments. Use with SynCage-LR 45 /90 large and with SynCage-LR 45 /90 (small footprint). 11 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

13 2. Patient positioning For both lateral and anterolateral approaches, the patient is either placed in lateral or supine decubitus position. 3. Approach The anterolateral approach preserves the longitudinal ligament. The lateral approach avoids the retraction of the great vessels. SynCage-LR 45 /90 Surgical Technique DePuy Synthes 11

14 Surgical Technique for Anterolateral and Lateral Approach 4a. Cut the anterolateral window Cut a rectangular window the width of the SynCage-LR 45 /90 into the longitudinal ligament and the anterolateral part of the annulus fibrosus. A trial implant may be used as a template to indicate the required width of the annular window. Care is taken to retain as much of these structures as possible as they are important for the stability of the instrumented segment. Anterolateral approach 4b. Cut the lateral window Cut a rectangular window of the width of the SynCage-LR 45 /90 into the lateral part of the annulus fibrosus. A trial implant may be used as a template to indicate the required width of the annular window. Care is taken to retain as much of these structures as possible as they are important for the stability of the instrumented segment. Lateral approach 11 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

15 5. Prepare the disc space Through the window prepared in step 4, the disc material is excised and the superficial layers of the cartilaginous endplates removed such that bleeding bone is attained. Adequate cleaning of the endplate is important to enable the provision of a vascular supply to the bone graft; excessive cleaning or use of a rasp may, however, weaken the endplate and result in subsidence of the cage. Once the endplates have been prepared and any additional surgical procedures completed, the SynCage-LR 45 /90 is introduced into the vertebral space as per the following steps. Note: It is essential that all nuclear material and the inner annulus is removed to prevent interference with bone ingrowth and displacement of disc material into the canal as the cage is inserted. SynCage-LR 45 /90 Surgical Technique DePuy Synthes 11

16 Surgical Technique for Anterolateral and Lateral Approach 6. Distract the segment Distraction of the segment is essential for restoration of disc height, opening of the neural foramina and stability of the SynCage-LR 45 /90. Distraction is achieved prior to insertion of the SynCage-LR 45 /90 using the appropriate distractor. Note: Distractor for SynCage-LR must be used. The same instrument is used for both large and small cages. Ensure that the distractor is positioned correctly. The blades of the distractor must correspond with the chosen approach angle and the slots on the implant to ensure symmetrical insertion of the device. Anterolateral approach Compressing the distractor handle opens the disc space. Note: Due to the wedge-shaped configuration of the disc and the distractor blades, the distractor must be held in place during distraction and the insertion of the trial or implant to prevent its displacement and possible injury to adjacent structures. Lateral approach 11 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

17 7. Trial for implant size Select the trial implant that corresponds to the SynCage-LR 45 /90 size determined during the preoperative planning and attach it to the handle for trial implants. Anterolateral approach Note: There is one handle for trial implants: Handle for Trial Implants, straight. For the anterolateral approach mount the handle for trial implants on the antero lateral face of the trial implant. For the lateral approach mount the handle for trial implants on the lateral face of the trial implant. The trial implant is then slid between the distractor blades into the disc space. If a tight fit is not achieved, repeat the process using incrementally larger sizes of trial implants. Conversely, if the trial implant cannot be inserted, repeat using incrementally smaller sizes of trial implants. With the segment fully distracted, the SynCage-LR 45 /90 or trial implant must fit firmly with a tight press-fit between the endplates such that disc height is not lost once the distractor is removed. Lateral Anterolateral Lateral Anterolateral Once the optimal size of SynCage-LR 45 /90 has been determined, the distraction is temporarily relaxed. The image intensifier can now be used to check the trial implant position. Note: The trial implants are not for implantation and must be removed before insertion of the SynCage-LR 45 /90. Lateral approach SynCage-LR 45 /90 Surgical Technique DePuy Synthes 11

18 Surgical Technique for Anterolateral and Lateral Approach 8. Select the implant The SynCage-LR 45 /90 corresponding to the trial implant is then selected and attached to the appropriate implant holder. The trial implants are laser-etched with the nominal height of the cages, and both trial implant and cage packaging are colour-coded. SynCage-LR 45 /90, large Note: Use caution in handling the SynCage-LR 45 /90. Damage to the surface finish and/or teeth can lead to fatigue failure or displacement of the SynCage-LR 45 /90. SynCage-LR 45 /90 11 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

19 9. Pack implant with bone graft It is recommended to fill the cage with autologous graft material. To assist packing the graft, the SynCage-LR 45 /90 with the implant holder attached is inserted into the appropriate packing block. The Cancellous Bone Impactors ( and ) are used to firmly pack the harvested graft material into the implant. It is important to fill the cage until the graft protrudes from the perforations in the cage to ensure optimal contact with the vertebral endplates. Notes: The implant holder must be firmly attached to the cage in order to avoid damage to either the implant holder or the cage. There are two Packing Blocks: Packing Block for for SynCage-LR, mm (Standard) Packing Block for SynCage-LSR, broad SynCage-LR 45 /90 Surgical Technique DePuy Synthes 11

20 Surgical Technique for Anterolateral and Lateral Approach 10. Insert implant With the SynCage-LR 45 /90 ready for insertion, the segment is again distracted. The distraction is fixed by tightening the locking nut on the handle. The SynCage-LR 45 /90 is then introduced into the disc space by sliding it between the distractor blades. The SynCage-LR 45 /90 will require light hammering to fully introduce it into the disc space. Note: The distractor should be held firmly in place during this stage of the procedure. Anterolateral approach Lateral approach 22 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

21 11. Remove instruments Once the SynCage-LR 45 /90 is positioned in the centre of the vertebral endplate, the locking nut on the distractor handle is loosened and the distraction released. The distractor is gently removed while the SynCage-LR 45 /90 is held in position by the implant holder. Additional hammering will ensure a secure fit. The implant holder is then released from the SynCage-LR 45 /90 by loosening the locking nut, leaving the Syn- Cage-LR 45 /90 in its optimal position. Anterolateral approach Lateral approach Once the distractor has been removed, the Positioner for SynCage ( ) may be used to manipulate the cage within the disc space, if required. SynCage-LR 45 /90 Surgical Technique DePuy Synthes 22

22 Surgical Technique for Anterolateral and Lateral Approach 12. Verify placement The optimal position for the SynCage-LR 45 /90 is centred within the periphery of the vertebral endplate. 3 4 mm Depending on the size of the vertebrae, the anterior edge of the SynCage-LR 45 /90 will usually be approximately three to four millimetres posterior from the anterior edge of the vertebrae. The location of the SynCage-LR 45 /90 relative to the vertebral bodies in the AP direction should be verified using an image intensifier. Three X-ray markers are incorporated into the implant to allow for an intra-operative assessment of the position of the cage. 22 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

23 Supplemental posterior procedure The SynCage-LR is not designed or intended to be used as a stand-alone device; the use of supplementary posterior instrumentation is therefore strongly recommended. When used in the treatment of spon dylolisthesis, posterior pedicle screw assisted reduction is usually performed prior to the insertion of the SynCage-LR. Postoperative care Patients can usually be mobilized once they regain muscular control of their trunk on the same day or one day after surgery. However, patients should be cautioned against activities that place unreasonable stress on the lower back until solid bony union has been achieved. Excessive physical activity and trauma may result in failure, with subsidence of the implant and/or the development of a non-union. SynCage-LR 45 /90 Surgical Technique DePuy Synthes 22

24 Additional Instruments Other instruments that may be useful during the SynCage-LR procedure include: Cancellous Bone Impactor ( ) and Handle with Quick Coupling ( ) A larger version of the Cancellous Bone Impactor ( ) Bone Spreaders ( , ); can be used to distract the vertebral segment Hammers ( , ); for final seating of the implant and for packing bone graft into the implant SynFrame 22 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

25 A Comprehensive Solution for ALIF Surgery More than just an implant system Synthes provides an entire range of complementary material to further enhance and simplify the SynCage-LR procedure for the surgical team. Click X Transpedicular Screw System The Synthes solution for the required supplementary posterior fixation. SynFrame Retractor system for the minimally open approach. SynCage-LR 45 /90 Surgical Technique DePuy Synthes 22

26 A Comprehensive Solution for ALIF Surgery chronos TM The approved AO/ASIF bone substitute. b-tcp Granules for supplementing autologous bone graft material. Item no. Granule size Quantity S mm 5cc S mm 10cc S mm 20cc 22 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

27 Implants S SynCage-LR 45º/90º, mm, PEEK, sterile S SynCage-LR 45º/90º, mm, PEEK, sterile S SynCage-LR 45º/90º, mm, PEEK, sterile S SynCage-LR 45º/90º, mm, PEEK, sterile S SynCage-LR 45º/90º, mm, PEEK, sterile S SynCage-LR 45º/90º, wide, mm, PEEK, sterile S SynCage-LR 45º/90º, wide, mm, PEEK, sterile S SynCage-LR 45º/90º, wide, mm, PEEK, sterile S SynCage-LR 45º/90º, wide, mm, PEEK, sterile S SynCage-LR 45º/90º, wide, mm, PEEK, sterile SynCage-LR 45 /90 Surgical Technique DePuy Synthes 22

28 Implants Trial Implants SynCage-LR Trial Implant 45 /90, 12.0 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, 13.5 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, 15.0 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, 17.0 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, 19.0 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, broad, 12.0 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, broad, 13.5 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, broad, 15.0 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, broad, 17.0 mm, Pure Titanium SynCage-LR Trial Implant 45 /90, broad, 19.0 mm, Pure Titanium 22 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

29 Instruments Positioner for SynCage Laminectomy Punch, 40 angled upwards, width 2 mm, length 400 mm Laminectomy Punch, 40 angled upwards, width 4 mm, length 400 mm Laminectomy Punch with Reservoir, mm Laminectomy Punch with Reservoir, mm Laminectomy Punch with Reservoir, mm Laminectomy Punch with Reservoir, mm Laminectomy Punch with Reservoir, mm Laminectomy Punch with Reservoir, mm Rongeur for Intervertebral Discs, width 2 mm, length 400 mm Rongeur for Intervertebral Discs, width 4 mm, length 400 mm Rongeur for Intervertebral Discs, width 6 mm, length 400 mm Periosteal Elevator for End Plates, width 10 mm, length 480/250 mm Periosteal Elevator for End Plates, width 15 mm, length 480/250 mm Periosteal Elevator for End Plates, width 20 mm, length 480/250 mm SynCage-LR 45 /90 Surgical Technique DePuy Synthes 22

30 Instruments Bone Lever, straight, width 15 mm, length 410/250 mm Bone Lever, straight, width 25 mm, length 410/250 mm Bone Lever, curved, width 15 mm, length 375/218 mm Bone Lever, curved, width 25 mm, length 375/218 mm Bone Curette, angled, oval edge, mm, length 480/250 mm Bone Curette, angled, oval edge, mm, length 480/250 mm Bone Curette, angled, oval edge, mm, length 480/250 mm Bone Curette, angled, oval edge, mm, length 480/250 mm Bone Curette, angled, oval edge, mm, length 410/250 mm Bone Curette, angled, oval edge, mm, length 480/250 mm Osteotome, straight, width 5 mm, length 480/250 mm Osteotome, straight, width 10 mm, length 480/250 mm 33 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

31 Cancellous Bone Impactor, mm, length 480/250 mm Cancellous Bone Impactor, mm Cancellous Bone Impactor, mm Handle for SynCage Trial Implants, straight Handle for SynCage Trial Implants, angled Distractor, anterior, for SynCage-LR Implant Holder, straight, for SynCage-LR Implant Holder for SynCage-LR 45º/90º Implant Holder for SynCage-LR 45º/90º, broad Distractor, lumbo-sacral, for SynCage-LRS SynCage-LR 45 /90 Surgical Technique DePuy Synthes 33

32 Instruments Packing Block for SynCage-LR, mm Packing Block for SynCage-LSR, broad 33 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

33 Additional Instruments Cancellous Bone Impactor, straight Handle with Quick Coupling Cancellous Bone Impactor B 8.0 mm, round Bone Spreader, speed lock, width 8 mm, length 210 mm Bone Spreader, speed lock, width 12 mm, length 270 mm Hammer 500 g Hammer 700 g SynCage-LR 45 /90 Surgical Technique DePuy Synthes 33

34 Literature Aebi M., Arlet V., Webb J.K.: AO Spine Manual (2 vols), Stuttgart, New York: Thieme Aebi M, Thalgott JS, Webb JK (1998). AO ASIF Principles in Spine Surgery. Berlin: Springer. Heiden, E.A., Montesano, P.X. Translaminar Facet Screw Fixation in Manual of Internal Fixation of the Spine, eds. Jacobs, R.R., Montesano, P.X., Jackson, R.P. Enhancement of Lumbar Spine Fusion by Use of Translaminar Facet Joint Screws. Spine 14(1):12 15, J.S. Thalgott, M. Aebi. Lippincott-Raven Publishers, Philadelphia, Heggeness, M.H., Esses, S.I. Translaminar Facet Joint Screw Fixation for Lumbar and Lumbosacral Fusion. A Clinical and Biomechanical Study. Spine 16(6S): , Lund T., Oxland T.R., Jost B., Cripton P., Grassmann S., Etter C., Nolte L.P.; Interbody cage stabilisation in the lumbar spine: biomechanical evaluation of cage design, posterior instrumentation and bone density. J. Bone Joint Surg Br 1998 Mar; 80(2): Müller, M.E., Allgöwer, M., Schneider, R., Willenegger, H.: Manual of Internal Fixation. 3 rd, exp. a. completely rev. ed Corr. 3 rd printing. Berlin, Heidelberg, New York: Springer Müller, M.E., Allgöwer, M., Schneider, R., Willenegger, H. Manual of Internal Fixation. Techniques Recommended by the AO/ASIF Group. Third edition, Springer-Verlag, Berlin, Oxland T.R., Hoffer Z., Nydegger T., Rathonyi G.C., Nolte L.P.; A comparative biomechanical investigation of anterior lumbar interbody cages: central and bilateral approaches; J. Bone Joint Surg Am 2000 Mar; 82(3): Rüedi T.P., Murphy W.M.; AO Principles of Fracture Management; Thieme Stuttgart New York Schlegel, J., Green, S. Polyetheretherketone (PEEK) A Biocompatible High Performance Plastic. Medical Plastics 2000, vol. 14, , Hexagon Holding ApS, DK-1460 Copenhagen, Denmark. Steffen T., Tsantrizos A., Aebi M.; Effect of implant design and endplate preparation on the compressive strength of interbody fusion constructs. Spine 2000 May; 25(9): Watkins, R.G. Anterior Lumbar Interbody Fusion: Surgical Technique in Lumbar Interbody Fusion, eds. P.M. Lin, K. Gill. Aspen Publishers, Inc., Rockwille. 33 DePuy Synthes SynCage-LR 45 /90 Surgical Technique

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36 DSEM/SPN/0814/0165(1) 10/16 Synthes GmbH Eimattstrasse Oberdorf Switzerland Tel: Fax: Not all products are currently available in all markets. This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at DePuy Synthes Spine, a division of Synthes GmbH All rights reserved