Oblique Posterior Atraumatic Lumbar cage system OPAL. Surgical Technique

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1 Oblique Posterior Atraumatic Lumbar cage system OPAL 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. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, 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, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to:

3 Table of Contents Introduction OPAL 2 AO Spine Principles 4 Indications and Contraindications 5 Surgical Technique Access and Exposure 6 Implantation 9 Product Information Implants 20 Trial Implants 22 Instruments 23 Additional Instruments 24 Filling Material 26 Additional Systems 28 Bibliography 30 OPAL Surgical Technique DePuy Synthes 1

4 OPAL OPAL is an implant system for a unilateral transforaminal approach (TLIF) or optionally for a bilateral posterior approach (PLIF). Multiple approach options: Unilateral posterior approach using 28 mm and 32 mm spacers (Figure 1) Bilateral posterior approach using 24 mm spacers (Figure 2) Figure 1 Figure 2 Radiolucent Biocompatible radiolucent polymer (PEEK) allows clear assessment of bony fusion Two radiographic marker pins allow for visuali zation of the implant Anatomic shape OPAL implants have convex superior/inferior surfaces designed to resemble patient anatomy Two footprints and nine heights are offered to accommodate individual patient anatomy Axial canal receives filling material (bone graft or substitute) to allow fusion to occur through the implant Pyramidal teeth are designed to provide resistance to implant migration Rotation bevel OPAL cage OPAL revolvable cage 2 DePuy Synthes OPAL Surgical Technique

5 Two insert techniques Traditional straight implant insertion Revolvable implant designed for insert and revolve technique Implants rotated 90 in situ provide intervertebral distraction Revolve technique may protect the neural structures throughout the implantation process Beveled edge on revolvable implant allows for ease of rotation Insert and revolve technique Impact technique Self-distracting implants Bullet nose design allows for ease of insertion and self-distraction Reduces the need to remove posterior lip Bullet nose OPAL revolvable cage OPAL cage OPAL Surgical Technique DePuy Synthes 3

6 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 resto ration of function to prevent disability Copyright 2012 by AOSpine 1 Aebi et al (1998) 2 Aebi et al (2007) 1 DePuy Synthes OPAL Surgical Technique

7 Indications and Contraindications Intended use OPAL is an implant system for a unilateral transforaminal approach (TLIF) or optionally for a bilateral posterior approach (PLIF). It is specially designed for small incision, resulting in a relatively atraumatic operation for the patient. Implants provide an adequate stability, restore height and lordosis to provide an optimized fusion. Indications Indications are lumbar and lumbosacral pathologies in which segmental spondylodesis is indicated, for example: Degenerative disc diseases and spinal instabilities Revision procedures for post-discectomy syndrome Pseudarthrosis or failed spondylodesis Degenerative spondylolisthesis Isthmic spondylolisthesis Contraindications Vertebral body fractures Spinal tumors Major spinal instabilities Primary spinal deformities Important: OPAL must be applied in combination with posterior fixation. OPAL Surgical Technique DePuy Synthes 1

8 Access and Exposure 1. Position the patient Position the patient in a restored physiological lordosis. 6 DePuy Synthes OPAL Surgical Technique

9 2. Preparation and discectomy Recommended system Lateral Three-blade Retractor, small Medial Three-blade Retractor, large Insight Retractor Set, Standard Configuration Resect the posterior anatomy and perform the discectomy. Use a standard transforaminal approach for insertion of 28 mm and 32 mm spacers (Figure 1). Use a traditional bilateral posterior approach for insertion of 24 mm spacers (Figure 2). Figure 1 Figure 2 OPAL Surgical Technique DePuy Synthes 7

10 Access and Exposure Optional instruments Bone Curette, 5.5 mm, bayoneted, black Bone Curette, 45 angled, 5.5 mm, short, bayoneted, black Rasp, dual-sided, bayoneted, black Osteotome, straight, black Curette, rectangular, bayoneted, black Shaver for Intervertebral Discs, size 7 17 mm T-Handle with Quick Coupling Optional system Set for Minimally Invasive Posterior Instruments Use the curette to remove the disc through the incision window. Shavers and excision instruments for intervertebral discs can facilitate removal of the nucleus pulposus and the surface layers of the cartilaginous endplates. Note: Appropriate cleaning of the endplates is important for the vascularisation of the bone transplant. Excessive cleaning however can weaken the endplates by removing bone under the cartilaginous layers. Removal of the entire endplate can cause subsidence and lead to loss of segmental stability. 8 DePuy Synthes OPAL Surgical Technique

11 Implantation 1. Determine implant size 1 2 Option A: Insert and revolve technique Instruments Trial Implant Opal, size 11 mm 15 mm Note: The insert and rotate technique can only be used for sizes 10 mm 15 mm. For all other sizes, use the impact technique. In order to rotate the trial implant in situ, extend the T-handle. Push the green T-handle out of handle body (1). Press and hold the button while sliding the T-handle to the end of the instrument (2). 3 Release the button, allowing the T-handle to lock into position (3). OPAL Surgical Technique DePuy Synthes 1

12 Implantation Insert the trial implant with the etch representing the height of the trial facing the vertebral endplate (4). 4 Gently impact on the end of the trial implant until the implant is positioned across the midline and 3 mm 4 mm from the anterior longitudinal ligament. The trial implant shaft should be oriented from mid-line. When the trial implant reaches the appropriate depth, rotate 90 clockwise to distract and assess height adequacy (5). Repeat using the next larger size trial implant, sequentially distracting until adequate anterior height is obtained. With the segment fully distracted, the trial implant must fit tightly and accurately inside the disc space. Note: The trial implants represent implants with a 28 mm length DePuy Synthes OPAL Surgical Technique

13 Option B: Impact technique Instruments Trial Implant Opal, size 7 mm 17 mm Impact an appropriately sized trial implant with the etch representing the axial canal positioned cranial/caudal. Continue to impact on the end of the trial implant until the cage is positioned across the midline and 3 mm 4 mm from the anterior longitudinal ligament. The trial implant shaft should be oriented from midline. Repeat using the next larger size trial implant, sequentially distracting until adequate anterior height is obtained. With the segment fully distracted, the trial implant must fit tightly and accurately inside the disc space. Note: The trial implants represent implants with a 28 mm length. OPAL Surgical Technique DePuy Synthes 11

14 Implantation 2. Screw/rod fixation (optional) For the unilateral oblique posterior approach, a screw/ rod construct can be placed on the contralateral side while the trial implant is still in position. Provisionally tighten the construct on the contralateral side to ensure that the height in the anterior column is maintained. 11 DePuy Synthes OPAL Surgical Technique

15 3. Remove trial implant Instrument Slide Hammer with Connector, short When using the insert and revolve technique, it is recommended that the trial implant be rotated 90 counterclockwise before removal. If removal of the trial implant requires too much force, the slide hammer can be used. Slide the slide hammer onto the end of the trial implant. While holding the handle of the trial implant with one hand, apply an upward force to the slide hammer with the other hand. Repeat this process until the trial implant is removed from the disc space. The slide hammer can be removed by pushing on the end of shaft. OPAL Surgical Technique DePuy Synthes 11

16 Implantation 4. Prepare the implant holder Option A: Insert and revolve technique Instruments Opal Implant Holder, with Pistol Grip Option B: Impact technique Instruments Opal Implant Holder The implant holder must be assembled before insertion of the cage. Attach the knob to the distal end of the implant holder sleeve by turning the knob counterclockwise (1). Insert the shaft into the sleeve making sure to align the arrows on the end of the shaft with those on the sleeve (2). 2 3 Press the button on the distal end of the implant holder and push the shaft into the holder (3). The shaft should now be held inside the sleeve. 11 DePuy Synthes OPAL Surgical Technique

17 5. Select the OPAL cage A Select a cage that corresponds to the size measured using the trial implant in the previous steps. Turn the knob at the distal end of the implant holder counterclockwise to open the jaws. Place the jaws over the posterior end of the cage making sure that the jaw s base is firmly seated against the implant. Turn the knob on the end of the implant holder clockwise until the jaws of the implant holder have a tight grip on the cage. B OPAL Surgical Technique DePuy Synthes 11

18 Implantation 6. Pack implant with bone graft Instruments Cancellous Bone Impactor OPAL Packing Block OPAL, size mm Packing Block OPAL, size mm After the cage is fixed to the implant holder, insert it into the appropriate packing block. It is important to fill the implant until the filling material protrudes from its perforations in order to allow strong contact with the vertebral endplates. Use the cancellous bone impactor to pack the filling material into the implant cavities. Notes The implant holder must be firmly attached to the implant in order to avoid damage to the implant holder. The 24 mm implant must be packed manually. For more information about the filling material chronos, see page 26 in this technique guide. 11 DePuy Synthes OPAL Surgical Technique

19 7. Insert OPAL cage Option A: Insert and revolve technique Instrument Opal Implant Holder, with Pistol Grip Use the pistol grip implant holder and the revolvable cage for this technique. Orient the cage so that the lateral graft window is facing the vertebral endplate. Gently impact on the end of the implant holder, until the cage is positioned across the midline and 3 mm 4 mm from the anterior longitudinal ligament. The implant holder shaft should be oriented from midline. Once the cage is in position, rotate the implant holder 90 clockwise so that the main graft window of the cage is oriented in the cranial/caudal direction. The implant must fit tightly and accurately in order to ensure that segmental height is preserved. Using the largest possible implant enhances segment stability by creating ligamentous tension. Use AP and lateral fluoroscopy to confirm appropriate placement and trajectory. When the cage is in the proper location, hold the handle firmly and turn the knob counterclockwise on the end of the implant holder to release it. OPAL Surgical Technique DePuy Synthes 11

20 Implantation Option B: Impact technique Instrument Opal Implant Holder Using the implant holder, orient the cage with the main graft window in the cranial/caudal direction. Gently impact on the distal end of the implant holder, until the cage is positioned across the midline and 3 mm 4 mm from the anterior longitudinal ligament. The implant holder shaft should be oriented from midline. With the segment fully distracted, the implant must fit tightly and accurately, to ensure that segmental height will be preserved. Using the largest possible implant enhances segment stability by creating ligamentous tension. Use AP and lateral fluoroscopy to confirm appropriate placement and trajectory. When the cage is in the proper location, hold the handle firmly and turn the knob on the end of the implant holder counterclockwise to release it. 11 DePuy Synthes OPAL Surgical Technique

21 8. Supplement posterior fixation The OPAL cage is intended to be used in combination with posterior fixation (e.g. Click X). OPAL Surgical Technique DePuy Synthes 11

22 Implants Dimension, mm Art. No. Height (mm) Insertion technique Insert and revolve Impact S 7 X S 8 X S 9 X S 10 X S 11 X X S 12 X X S 13 X X S 15 X X S 17 X 10 mm Height 28 mm Dimension, mm Art. No. Height (mm) Insertion technique Insert and revolve Impact S 7 X S 8 X S 9 X S 10 X S 11 X X S 12 X X S 13 X X S 15 X X S 17 X 10 mm 32 mm 22 DePuy Synthes OPAL Surgical Technique

23 OPAL Spacers, Revolve (indicated for bilateral use) Art. No. Dimension (mm) Height (mm) S S S S S mm 10 mm 24 mm 24 mm OPAL Surgical Technique DePuy Synthes 21

24 Trial Implants Trial Implant Opal Art. No. Size (mm) Insertion technique Insert and revolve Impact X X X X X X X X X X X X X X 22 DePuy Synthes OPAL Surgical Technique

25 Instruments Opal Implant Holder, with Pistol Grip For use only with the insert and revolve technique Opal Implant Holder For use with the impact technique Slide Hammer with Connector, short Cancellous Bone Impactor OPAL Packing Block OPAL, size Packing Block OPAL, size OPAL Surgical Technique DePuy Synthes 23

26 Additional Instruments Soft Tissue Retractor Art. No. Width (mm) Lamina Spreader for Travios Bone Curette, 5.5 mm, bayoneted, black Bone Curette, 45 angled, 5.5 mm, short, bayoneted, black Rasp, dual-sided, bayoneted, black Curette, rectangular, bayoneted, black Osteotome, straight, black 22 DePuy Synthes OPAL Surgical Technique

27 Shaver for Intervertebral Discs Art.No. Size (mm) T-Handle with Quick Coupling OPAL Surgical Technique DePuy Synthes 22

28 Filling Material Synthetic cancellous bone graft substitute: chronos Bone Void Filler chronos Bone Void Filler is a bone graft substitute consisting of pure ß-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 ß-tricalcium phosphate in the spinal column is a valuable alternative to allografts and autografts, even when larger amounts are required. 2,3 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 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 availability. 1 Gazdag et al Muschik et al Knop et al Stoll et al Becker et al Wheeler et al Lu et al DePuy Synthes OPAL Surgical Technique

29 chronos Granules Bone Void Filler Article No. B mm Content (ml) S S S S S S S S S S S S OPAL Surgical Technique DePuy Synthes 22

30 Additional Systems Minimally Invasive Retractor Access Lateral Three-blade Retractor, small Medial Three-blade Retractor, large The MIRA System is designed to allow surgeons to achieve access for decompression, interbody fusion or pedicle screw placement through a minimally invasive approach Insight Retractor Set, Standard Configuration Minimally Invasive Posterior Instruments (MIPI) Set for Minimally Invasive Posterior Instruments The Minimally Invasive Posterior Instruments (MIPI) set is designed to facilitate discectomy, decompression and interbody work through the smaller access ports associated with atraumatic posterior lumbar procedures. 22 DePuy Synthes OPAL Surgical Technique

31 SpiRIT SpiRIT Set in Vario Case SpiRIT Additional Instruments in Vario Case MIS Rods, radius 200 mm, in Vario Case SpiRIT is designed to reduce soft tissue trauma by using a transmuscular approach and subfascial rod insertion for thoracolumbar pedicle fixation. OPAL 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 Heidelberg New York: Springer Becker et al. (2006) Osteopromotion by a b-tcp/bone Marrow Hybrid Implant for Use in Spine Surgery. Spine, Volume 31(1): 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. Knop C, Sitte I, Canto F, Reinhold M, Blauth M (2006) Successful posterior interlaminar fusion at the thoracic spine by sole use of b-tricalcium phosphate. Arch Orthop Trauma Surg, 126: Lu JX, Flautre B et al. (1999) Role of interconnections inporous bioceramics on bone recolonization in vitro and vivo. J Mater Sci Mater Med 10: Muschik M, Ludwig R, Halbhubner S, Bursche K, Stoll T (2001) Beta-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 Suppl 2: Stoll et al. (2004) New Aspects in Osteoinduction. Mat.-wiss. u. Werkstofftech, 35 (4): Wheeler D. (2005) Grafting of massive tibial subchondral bone defects in a Caprine Model using ß-Tricalcium phosphate versus autograft. J Orthop Trauma 19(2): DePuy Synthes OPAL Surgical Technique

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36 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 DSEM/SPN/0215/0272(1) 08/17