SYNCAGE-LR Implant and instrument system for anterior lumbar interbody fusion

Transcription

1 SYNCAGE-LR Implant and instrument system for anterior lumbar interbody fusion Instruments and implants approved by the AO Foundation. This publication is not intended for distribution in the USA. 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 Table of Contents Introduction Overview 2 AO Principles 3 Indications and Contraindications 4 Surgical Technique Preoperative Planning 5 Access and Exposure 6 Preparation and Trial Implantation 7 Selection and Packing of Implant 11 Implant Insertion 13 Product Information Implants 17 Additional Instruments 21 Filling Material 23 Additional Recommended Sets 27 Bibliography 30 SynCage-LR Surgical Technique DePuy Synthes 1

4 Overview SynCage-LR (PEEK cage) The SynCage-LR implant and instrument system is designed for anterior lumbar interbody fusion (ALIF). Superior biocompatibility SynCage-LR is consist of pure medical grade PEEK (Polyetheretherketone). It contains no carbon fibre, thereby reducing the risk of systemic uptake and local connective tissue formation. Made of clinically proven PEEK Optima Radiolucent PEEK facilitates radiographic assessment of fusion Optimal fit An expanded range of implants including 3 profiles, 5 heights and 2 footprints to ensure an optimal fit in all patients. Specialised L5-S1 implant A specific implant for optimal fit of the L5-S1 level. 2 DePuy Synthes SynCage-LR 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 Surgical Technique DePuy Synthes 3

6 Indications and Contraindications Indications Lumbar and lumbosacral pathologies which may require anterior segmental arthrodesis, including: Degenerative disc disease and instability Revision surgery for failed decompression syndrome or pseudoarthrosis Reduced spondylolisthesis Contraindications Spinal fractures Spinal tumor Osteoporosis Infection 4 DePuy Synthes SynCage-LR Surgical Technique

7 Preoperative Planning 1 Preoperative planning Instruments X X X X-ray Template for SynCage-LR mm, 12 X-ray Template for SynCage-LR mm, 10 X-ray Template for SynCage-LR mm, 12 Determine the approximate implant size by comparing the SynCage-LR Radiographic Template (Fig. 1) with a lateral radiograph of the patient s adjacent intervertebral discs. Notes: The height indicated on the template is approximately 1 mm lower than that of the actual spacer to account for penetration of the teeth into the vertebral endplate. It is recommended to select the maximum implant size, to optimize the stability of the segment through tension in the longitudinal ligaments. (Fig. 1) SynCage-LR Surgical Technique DePuy Synthes 5

8 Access and Exposure 1 Patient positioning For an anterior approach to the lower lumbar levels, the patient is placed in a slight Trendelenburg position. 2 Anterior access and approach Recommended set Set SynFrame RL, lumbar SynFrame Basic System in Vario Case The surgical approach depends on the level to be treated. Locate the correct operative disc level and incision location by taking a lateral flouroscopic view while holding a straight metal instrument at the side of the patient. This ensures that the incision and exposure will allow direct visualization into the disc space. Expose the operative disc level through a standard retroperitoneal approach. Note: If a retraction system such as the SynFrame is used, pay attention to the positioning of soft tissue or Hohmann retractors as they may interfere with the screw insertion. 3 Exposure For anterior insertion, expose the intervertebral disc such that there is sufficient space on either side of the vertebral midline, equal to half the width of the implant. If the vessels and /or tissues cannot be retracted sufficiently, insertion from an anterolateral direction may be indicated. 6 DePuy Synthes SynCage-LR Surgical Technique

9 Preparation and Trial Implantation 1 Cut anterior window Cut a rectangular window the width of the SynCage-LR into the anterior longitudinal ligament and annulus fibrosus. A trial implant (see page 17) may be used as a template to indicate the width of the window. Retain as much of the anterolateral, lateral and posterior annulus as possible in order to provide the necessary stability of the instrumented segment. 2 Prepare disc space Recommended set Proprep Set Excise the disc material and remove the cartilaginous endplates to expose the underlying bony vertebral endplates. Adequate clearance of the endplates is important to enable the provision of a vascular supply to the bone graft. Excessive clearance or use of a rasp however, may weaken the endplate and result in subsidence of the cage. SynCage-LR Surgical Technique DePuy Synthes 7

10 Preparation and Trial Implantation Once the endplates have been prepared, complete eventual additional surgical procedures (i.e. removal of a disc fragment from the spinal canal). Note: It is essential that the nucleus and the inner annulus are removed to prevent displacement of disc material into the spinal canal during spacer insertion and interference with bone in-growth. 3 Distract segment Instruments Distractor, anterior, for SynCage-LR Distractor, lumbo-sacral, for SynCage-LSR For a safe placement, verify spreader position with the help of an intraoperative lateral x-ray. Distraction of the segment is essential for restoration of disc height, opening of the neural foramina and initial stability of the SynCage-LR. To ensure that the SynCage-LR is inserted symmetrically into the disc space, the line on the blades indicating the vertebral midline is aligned with the anterior midline of the vertebral bodies. 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 itz displacement and possible injury to adjacent structures. 8 DePuy Synthes SynCage-LR Surgical Technique

11 4 Determine trial implant size Instruments SynCage-LR Trial Implant, mm SynCage-LR Trial Implant, broad, 12.0 mm, Pure Titanium SynCage-LR Trial Implant, broad, mm SynCage-LSR Trial Implant, mm Handle for SynCage Trial Implants, straight Handle for SynCage Trial Implants, angled Select the trial implant that corresponds with the SynCage- LR size determined during the pre operative planning. Attach it to the handle for trial implants. The handle must be tightened firmly to prevent loosening of the trial implant. The distractor is used to assist with guiding the trial implant into the disc space. To ensure that the implant is inserted symmetrically into the disc space, the central line on the distractor blades should be aligned with the anterior midline of the vertebral bodies. Slide the trial implant between the distractor blades into the disc space. Controlled and light hammering on the handle for trial implants may be required to bring the trial implant between the vertebral bodys. If a tight fit is not achieved, repeat the process using incrementally larger trial implants. If the trial implant cannot be inserted, repeat using incrementally smaller trial implants. SynCage-LR Surgical Technique DePuy Synthes 9

12 Preparation and Trial Implantation With the segment fully distracted, the trial implant (and final implant) must fit firmly with a tight press-fit between the endplates so that the disc height is not lost once the distractor is removed. The image intensifier may be used to check the position of the trial implant, restoration of disc and foraminal height, and overall alignment before selecting the final SynCage-LR implant size. Note: The distractor must be firmly held in place to prevent its ejection from the disc space and possible injury to adjacent structures. The trial implants are not for implantation and must be removed before insertion of the SynCage-LR. 11 DePuy Synthes SynCage-LR Surgical Technique

13 Selection and Packing of Implant 1 Select implant size Select the final SynCage-LR implant corresponding to the trial implant size. Notes: Use caution in handling the SynCage-LR. Damage to the surface finish and/or teeth can lead to fatigue failure or displacement of the SynCage-LR. The SynCage-LR is provided sterile ready for use. SynCage-LR Surgical Technique DePuy Synthes 11

14 Selection and Packing of Implant 2 Pack implant with bone graft Instruments Implant Holder, straight, for SynCage-LR Implant Holder, angled, for SynCage-LSR Packing Block for SynCage-LR, mm Packing Block for SynCage-LSR, broad Cancellous Bone Impactor, mm Cancellous Bone Impactor, mm After attaching the SynCage-LR to the implant holder, insert it into the appropriate packing block. It is important to fill the spacer until the filling material protrudes from its perforations in order to ensure optimal contact with the vertebral endplates. Use a cancellous bone impactor to firmly pack the filling material into the implant cavities. Note: The implant holder must be firmly attached to the cage in order to avoid damage to either the implant holder or the cage. Note: Implant Holder is an option for use when anatomy makes access difficult with straight instruments. 11 DePuy Synthes SynCage-LR Surgical Technique

15 Implant Insertion 1 Insert implant Instruments Distractor, anterior, for SynCage-LR Distractor, lumbo-sacral, for SynCage-LSR Insert the implant into the disc space. The distractor is used to assist with guiding the implant into the disc space. To ensure that the implant is inserted symmetrically into the disc space, the central line on the distractor blades should be aligned with the anterior midline of the vertebral bodies. Slide the implant between the distractor blades and into the disc space. Controlled and light hammering on the implant holder may be required to bring the implant between the vertebral bodies. The implant must fit firmly with a tight press-fit between the endplates. The image intensifier may be used to check the implant position, restoration of disc and foraminal height, and overall alignment. Note: The distractor must be firmly held in place to prevent its ejection from the disc space and possible injury to adjacent structures. Ensure the implant holder remains tightened to the implant during the entire implant insertion procedure. Precautions: The trial implants are not for implantation and must be removed before insertion of the SynCage-LR. Damage to the surface finish and/or teeth can lead to fatigue failure or displacement of the SynCage. It is essential that enough material is removed from the intervertebral disc to accommodate the SynCage-LR, otherwise disc material may be displaced posteriorly during insertion of the implant. SynCage-LR Surgical Technique DePuy Synthes 11

16 Implant Insertion 2 Remove instruments When the implant is correctly positioned, loosen the locking nut on the distractor handle in order to release the distraction. Gently remove the distractor while the implant holder holds the implant in position. After the distractor is removed, ensure a secure fit by lightly hammering on the implant holder. 11 DePuy Synthes SynCage-LR Surgical Technique

17 3 Verify final implant position The optimal position for the cage is centered within the periphery of the vertebral endplate. Depending on the size of the vertebrae, the anterior edge of the SynCage-LR will usually be approximately 3 4 mm posterior from the anterior edge of the adjacent vertebrae. Verify the location of the cage relative to the vertebral bodies in the AP and lateral directions using an image intensifier. Three x-ray markers are incorporated into the implant to allow accurate intraoperative and postoperative radiographic assessment of the position of the implant. The posterior x- ray marker is located approximately 3 mm from the posterior wall of the cage. SynCage-LR Surgical Technique DePuy Synthes 11

18 Implant Insertion 4 Additional stabilization Anterior or posterior stabilization The SynCage-LR is not designed or intended to be used as a stand-alone device. The use of additional anterior fixation (e.g. ATB) or posterior fixation (e.g. Pangea) is required. When used in the treatment of spondylolisthesis, 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. 11 DePuy Synthes SynCage-LR Surgical Technique

19 Implants SynCage-LR Cage and Trial Implant Overview Implant sterile packaging and trial implants are colour coded to avoid mismatching. SynCage-LR Dimensions: 24 mm (depth) 30 mm (width) for smaller and normal vertebral bodies Anterior Cat. no. Cat. no. Corresponding Trial Implant Colour Height Implant Trial Implant code 12 mm S mm S mm S mm S mm S SynCage-LR, large Dimensions: 28 mm (depth) 38 mm (width) for larger vertebral bodies Anterior Cat. no. Cat. no. Corresponding Trial Implant Colour Height Implant Trial Implant code 12 mm S mm S mm S mm S mm S SynCage-LSR Dimensions: 28 mm (depth) 38 mm (width) for application in L5-S1 Anterior Cat. no. Cat. no. Corresponding Trial Implant Colour Height Implant Trial Implant code 12 mm S mm S mm S mm S mm S SynCage-LR Surgical Technique DePuy Synthes 11

20 Instruments Handle for SynCage Trial Implant, straight Handle for SynCage Trial Implant, angled Holder for Trial Implants, straight, detachable Distractor, anterior, for SynCage-LR Distractor, lumbo-sacral, for SynCage-LSR Implant Holder, straight, for SynCage-LR Implant Holder, angled, for SynCage-LSR 18 DePuy Synthes SynCage-LR Surgical Technique

21 Packing Block for SynCage-LR, mm Packing Block for SynCage-LSR, broad Cancellous Bone Impactor, mm Cancellous Bone Impactor, mm Cancellous Bone Impactor B 8.0 mm, round Handle with Quick Coupling Cancellous Bone Impactor, straight SynCage-LR Surgical Technique DePuy Synthes 11

22 Instruments 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 Positioner for SynCage 22 DePuy Synthes SynCage-LR Surgical Technique

23 Additional Instruments SynCage-LR 45 / Implant Holder for SynCage-LR 45º/90º Implant Holder for SynCage-LR 45 /90, broad Trial Implants 45 /90 Dimension, mm 12 mm mm mm mm mm Color code trail implant: green Dimension, mm 12 mm mm mm mm mm Color code trail implant: violet SynCage-LR Surgical Technique DePuy Synthes 22

24 Cases Syncase, for SynCage-LR 22 DePuy Synthes SynCage-LR Surgical Technique

25 Filling Material Synthetic cancellous bone graft substitute: chronos Bone Void Filler chronos Bone Void Filler is a bone graft substitute consisting of pure -tricalcium phosphate. Its compressive strength is similar to that of cancellous bone once it has been incorporated and remodeled. 1 Based on literature, the use of - tricalcium phosphate in the spinal column is a valuable alternative to allografts and autografts, even when larger amounts are required. 2,3 SynCage-LR, mm, 12 Article No. Height Filling Volume (mm 3 ) (cm 3 ) S 12 mm S 13.5 mm S 15 mm S 17 mm S 19 mm SynCage-LR, large, mm, 10 Article No. Height Filling Volume (mm 3 ) (cm 3 ) S 12 mm S 13.5 mm S 15 mm S 17 mm S 19 mm Gazdag et al Muschik et al Knop et al SynCage-LR Surgical Technique DePuy Synthes 22

26 Filling Material SynCage-LSR, mm, 12 Article No. Height Filling Volume (mm 3 ) (cm 3 ) S 12 mm S 13.5 mm S 15 mm S 17 mm S 19 mm DePuy Synthes SynCage-LR Surgical Technique

27 Resorbable It is being replaced in the human body by host bone in 6 to 18 months; depending on the indication and the patient s conditions. 2,4 6 Osteoconductive Interconnected macropores of defined size ( μm) facilitate bone formation throughout the entire implant. Interconnected micropores (<10 μm) allow an optimal supply of nutrients. 1,7 Osteoinductive with bone marrow The combination of chronos Bone Void Filler with bone marrow accelerates and enhances osteointegration. 4,5 Synthetic Having a synthetic origin, chronos Bone Void Filler offers the advantage of uniform quality and unlimited availability. chronos Granules Bone Void Filler Art. No. B (mm) Content (ml) S S S S S S S S S S S S Gazdag et al Muschik et al Knop et al Stoll et al Becker et al Wheeler et al Lu et al SynCage-LR Surgical Technique DePuy Synthes 25

28 Filling Material Synthetic cancellous bone graft substitute: chronos Putty chronos Putty is a synthetic, porous, resorbable and biocompatible bone graft substitute consisting of chronos Granules Bone Void Filler and sodium hyaluronate of non-animal origin. The synthetic sodium hyaluronate used in chronos Putty provides optimal handling properties and confers positional stability to the product during handling and use. Mixing chronos Putty with bone marrow or blood introduces blood cells, growth factors and, in the case of bone marrow, osteoprogenitor cells. Autologous bone marrow features an optimal osteogenic potential. 1,2 Perfusion of the -TCP component of chronos Putty with bone marrow aspirate has shown clear remodeling of chronos Bone Void Filler into new host bone 12 weeks postoperatively. 1,3 chronos Putty for Spine Article number Product name Liquid to add S chronos Putty, 1.0cc 0.80 ± 0.25 ml S chronos Putty, 2.5cc 2.00 ± 0.5 ml S chronos Putty, 5.0cc 4.00 ± 0.5 ml S chronos Putty, 10.0cc 8.00 ± 0.5 ml 1 Becker et al Block J E, The role and effectiveness of bone marrow in osseous regeneration. Medical Hypothesis 2005; 65: Stoll et al DePuy Synthes SynCage-LR Surgical Technique

29 Additional Recommended Sets Anterior stabilization Instrument Set for ATB Plate System in Vario Case The Anterior Tension Band Plate (ATB) is a fixation plate for stabilization of the lumbosacral spine (L1 S1). Posterior stabilization The Pangea Degenerative Spine System is a posterior pedicle screw fixation system (T1 S2) intended to provide precise and segmental stabilization of the spine in skeletally mature patients. SynCage-LR Surgical Technique DePuy Synthes 22

30 Additional Recommended Sets Anterior Lumbar Retraction System Set SynFrame RL, lumbar SynFrame Basic System in Vario Case SynFrame Basic System is a surgical approach and retraction system. It consists of a basic system (basic construction) and modules that are specially designed for the respective requirements and needs of various indications and/or approach techniques. The SynFrame basic system is always constructed in the same sequence following the same principles. The SynFrame RL is a supplementary module for the access and retraction system SynFrame. It contains radiolucent soft tissue and muscle retractors and semi transparent bone levers for minimally invasive surgery. 22 DePuy Synthes SynCage-LR Surgical Technique

31 Disc Removal System Proprep Set A clearly arranged set for intervertebral disc preparation and vertebral body resection for lumber surgery with an anterior approach: Compact but comprehensive: contains all instruments required for intervertebral disc preparation and vertebral body resection. Simplifies the entire anterior discectomy and corpectomy thanks to angled instruments with which even the posterolateral regions of the intervertebral discs can be reached. Ideal for use in extensively collapsed segments as the instruments have a low profile. The instrument length is specially designed for anterior surgery and for patients with a high BMI. Maximum instrument control thanks to silicon handles that can be gripped with two hands. SynCage-LR Surgical Technique DePuy Synthes 22

32 Bibliography Aebi M, Arlet V, Webb JK (2007): AOSpine Manual (2 vols), Stuttgart, New York: Thieme Aebi M, Thalgott JS, Webb JK (1998). AO ASIF Principles in Spine Surgery. Berlin: Springer. Arlet V, Jiang L, Steffen T, Ouellet, J, Reindl R, Max Aebi (2006): Harvesting local cylinder autograft from adjacent vertebral body for anterior lumbar interbody fusion: surgical technique, operative feasibility and preliminary clinical results. Eur Spine J. 15: Becker S, Maissen O, Ponomarev I, Stoll T, Rahn B, Wilke I (2006) Osteopromotion by a_-tricalcium Phosphate/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine 31 (1): Block J E, The role and effectiveness of bone marrow in osseous regeneration. Medical Hypothesis 2005; 65: Gazdag AR, Lane JM, Glaser D, et al. (1995) Alternatives to autogenous bone graft: efficacy and indications. J Am Acad Orthop Surg 3(1): 1 8. Lu Jx, Flautre B et al. (1999) Role of interconnections in porous bioceramics on bone recolonization in vitro and vivo. J Mater Sci Mater Med 10: Müller ME, Allgöwer M, Schneider R, Willenegger H (1995): Manual of Internal Fixation. 3rd, exp. a. completely rev. ed Corr. 3rd printing. Berlin, Heidelberg, New York: Springer Muschik M, Ludwig R, Halbhubner S, Bursche K, Stoll T (2001) -tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis preliminary results of a prospective clinical study. Eur Spine J 10: Stoll T, Maissen O, Meury T, Becker S (2004) New aspects in osteoinduction. Mat.-wiss. u. Werk stofftech 35: Wheeler D. (2005) Grafting of massive tibial subchondral bone defects in a Caprine Model using -Tricalcium phosphate versus autograft. J Orthop Trauma 19(2): Knop C, Sitte I, Canto F, Reinhold M, Blauth M (2006): Successful posterior interlaminar fusion at the thoracic spine by sole use of -tricalcium phosphate. Arch Orthop Trauma Surg, 126: DePuy Synthes SynCage-LR Surgical Technique

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36 DSEM/SPN/0316/ /16 Synthes GmbH Eimattstrasse 3 Not all products are currently available in all markets Oberdorf Switzerland This publication is not intended for distribution in the USA. Tel: Fax: All surgical techniques are available as PDF files at DePuy Synthes Spine, a division of Synthes GmbH All rights reserved