Thoracolumbar Spine Locking Plate (TSLP) System. A low-profile plating system for anterior stabilization of the thoracic and lumbar spine. Technique Guide Instruments and implants approved by the AO Foundation
Table of Contents Introduction Thoracolumbar Spine Locking Plate (TSLP) System 2 AO Principles 4 Indications 5 Surgical Technique Decompress 6 Select Plate 7 Prepare to Implant Plate 8 Prepare Screw Hole 9 Measure for Screw Length 10 Insert Screws 11 Final Tightening 12 Optional Graft Screw Technique 13 Product Information Instruments 15 Set List 18 Image intensifier control Synthes Spine
Thoracolumbar Spine Locking Plate (TSLP) System The Thoracolumbar Spine Locking Plate (TSLP) is a versatile, low-profile plating system indicated for anterior stabilization of the thoracic and lumbar spine (T1 L5). The system provides a 4.5 mm construct profile, plate lengths from 40 mm to 109 mm in 3 mm increments, 5.5 mm cancellous locking screws, and instrumentation designed to simplify construct placement. 2 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
Plates Low profile (4.5 mm) Narrow AP width fits small vertebral bodies and minimizes surgical exposure and soft tissue disruption Precontoured to conform to the anatomy and restore normal spinal alignment Multiple screw hole locations Lengths in 3 mm increments (40 mm 109 mm) Convergent screw orientation maximizes resistance to construct pullout Conical screw holes allow ±5 angulation during screw insertion Made of titanium alloy (Ti -6Al -7Nb) for increased stiffness 5º 5.5 mm Titanium Cancellous Locking Screws Dual core thread design Constant outer diameter optimizes pullout strength Core diameter transition results in cortical and cancellous bone-specific threads Threads on conical screw head lock to the plate and create a fixed-angle construct Blunt, threaded tip Self-tapping design Cortical inner core diameter Transition Cancellous inner core diameter Constant outer diameter Synthes Spine 3
AO Principles In 1958, the AO ASIF formulated four basic principles, which have become the guidelines for internal fixation. 1 They are: Anatomic reduction Stable internal fixation Preservation of blood supply Early, active mobilization The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injured neural elements. 2 AO Principles as Applied to the Spine 3 Anatomic alignment Restoration of normal spinal alignment to improve the biomechanics of the spine. Stable internal fixation Stabilization of the spinal segment to promote bony fusion. Preservation of blood supply Creation of an optimal environment for fusion. Early, active mobilization Minimization of damage to the spinal vasculature, dura, and neural elements, which may contribute to pain reduction and improved function for the patient. 1. M.E. Muller, M. Allgöwer, R. Schneider, and H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin; Springer-Verlag. 1991. 2. Ibid. 3. M. Aebi, J.S. Thalgott, and J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin; Springer-Verlag. 1998. 4 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
Indications The TSLP System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1 L5) spine instability resulting from fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. Warnings: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. This device is not intended or expected to be the only mechanism of support for the spine. Regardless of the etiology of the spinal pathology for which implantation of this system was chosen, it is the expectation and requirement that a spinal fusion or arthrodesis be planned and obtained. Without solid biological support provided by spinal fusion, the device cannot be expected to support the spine indefinitely and may fall in any of several modes including bone-metal interface failure, screw fracture, or bone failure. Contraindications: Use of the Ti Thoracolumbar Spine Locking Plate (TSLP) System is contraindicated when: 1. There is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. 2. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant. 3. Metastatic tumors are present in the adjacent vertebral bodies. 4. Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative disease are relative contraindications. The decision whether to use these devices under such conditions must be made by the physician taking into account the risks versus the benefits to the patient. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure. Synthes Spine 5
Decompress 1 Decompress Perform the corpectomy/discectomy and decompress the neural elements as needed. 2 Implant graft or spacer Implant the graft or spacer device. Pack autograft or allograft material around the spacer as needed. 6 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
Select Plate 3 Select plate Instrument 324.092 Measuring Forceps Use the measuring forceps to determine plate length. Select the proper plate. The labeled plate length is the overall length of the plate. Read measurement here 4 Verify size and position Instruments 389.802 Threaded Drill Guide 389.811 Construct Holder Assemble a threaded drill guide into one of the threaded screw holes in the plate. Insert the construct holder into the threaded drill guide and position the plate over the desired site. Position the plate so that the curve of the plate best follows the spinal curvature. Using the plate as a template, remove any bony protuberances that prevent the plate from sitting flush on the vertebral bodies, and determine which holes will be used to secure the plate to the vertebral bodies. Synthes Spine 7
Prepare to Implant Plate 5 Prepare to implant plate Instrument 389.802 Threaded Drill Guide Attach threaded drill guides to all the selected screw holes. 6 Position plate Instruments 389.805 Temporary Fixation Pins 389.873 Detachable Temporary Fixation Pins 389.872 Driver Position the plate anterolaterally on the spinal column, ensuring that all screws will be placed into vertebral bodies. Lag the plate to the bone by inserting temporary fixation pins, or detachable temporary fixation pins attached to the driver, through the threaded drill guides. Light impaction on the fixation pin may be necessary to break the cortex. To improve visibility, the construct holder and associated threaded drill guide can now be removed. 8 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
Prepare Screw Hole 7 Prepare screw hole Instruments 389.801 Threaded Drill Guide Applicator 389.803 Awl Insert the threaded drill guide applicator into one of the open threaded drill guides. The drill guide applicator will serve as a guide for the awl. Insert the awl through the drill guide applicator and perforate the bony cortex of the vertebral body. Light impaction may be necessary. The awl handle will stop at the top of the drill guide applicator when it is fully inserted. The awl creates a 20 mm deep hole. Note: The awl may also be used directly through the threaded drill guide. In this case the awl creates a 23 mm deep hole. Using the drill guide applicator, loosen the threaded drill guide and remove the awl/threaded drill guide applicator/ threaded drill guide assembly in one step. Tip: Prior to removal of the assembly, retract the awl until the etched line on the shaft is visible (approximately 30 mm). The tip of the awl will be withdrawn inside the drill guide applicator to protect the soft tissue during removal. Synthes Spine 9
Measure for Screw Length 8 Measure for screw length Instrument 319.09 Depth Gauge Insert the depth gauge through the screw hole and push it through the cancellous bone to the desired depth. The depth gauge reading indicates the appropriate screw length. 9 Select screw Instruments 324.076 3.5 mm Hexagonal Screwdriver, self-retaining 389.829 3.5 mm Hexagonal Screwdriver Shaft 388.652 Ratchet T-Handle 389.814 Holding Sleeve Using the self-retaining 3.5 mm hexagonal screwdriver or the 3.5 mm hexagonal screwdriver shaft, ratchet T-handle, and holding sleeve, select the appropriate screw. Note: Screw length is measured from the beginning of the bone thread to the tip of the screw. 10 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
Insert Screws 10 Insert screws Insert the screw until the screw head engages the plate. Repeat steps 7 10 to insert the second screw. Note: It is recommended that the maximum screw length used in the anterior screw holes is 33 mm. 11 Remove temporary fixation pins Remove the temporary fixation pin(s) and then the threaded drill guide(s) using the drill guide applicator. Follow steps 8 10 to measure and insert the appropriate bone screws. Note: After removing a temporary fixation pin, use of the awl is not required before screw insertion. Remove any remaining drill guides. Synthes Spine 11
Final Tightening 12 Final tightening Instruments 389.829 3.5 mm Hexagonal Screwdriver Shaft 321.133 Torque Limiting Handle (7 Nm) For final tightening, use the 3.5 mm hexagonal screwdriver shaft with the torque limiting handle (7 Nm). 12 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
Optional Graft Screw Technique 13 Drill for graft screw Instruments 389.802 Threaded Drill Guide 389.808 3.3 mm Drill Bit Attach a threaded drill guide to the desired graft screw location. Using the 3.3 mm drill bit through the threaded drill guide, drill a hole into the graft. The 3.3 mm drill bit creates a 22 mm deep hole. Remove the threaded drill guide. 14 Tap for graft screw Instruments 388.652 Ratchet T-Handle 389.812 Tap for 5.5 mm Cancellous Locking Screws Use the tap for 5.5 mm cancellous locking screws and the ratchet T-handle to tap the drilled hole. Note: Take care to keep the tap centered in the threaded screw hole. Synthes Spine 13
Optional Technique continued 15 Insert graft screw Instrument 321.133 Torque Limiting Handle Insert the graft screw into the tapped hole until the screw head locks to the plate. Use the torque limiting handle for final tightening. 14 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
Instruments 03.600.001 Conical Extraction Screw, for 5.5 mm Locking Screws 311.425 Handle, with quick coupling 319.09 Depth Gauge 321.133 Torque Limiting Handle, quick release 324.076 3.5 mm Hexagonal Screwdriver, self-retaining 324.092 Measuring Forceps 388.652 Ratchet T-Handle Synthes Spine 15
Instruments continued 389.801 Threaded Drill Guide Applicator 389.802 Threaded Drill Guide 389.803 Awl 389.805 Temporary Fixation Pin 389.807 3.5 mm Hexagonal Screwdriver Shaft, self-retaining 389.808 3.3 mm Drill Bit, quick coupling, 248 mm 16 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
389.811 Construct Holder 389.812 Tap for 5.5 mm Cancellous Locking Screws 389.814 Holding Sleeve 389.829 3.5 mm Hexagonal Screwdriver Shaft 389.872 Driver, for Detachable Temporary Fixation Pin 389.873 Detachable Temporary Fixation Pin Synthes Spine 17
Thoracolumbar Spine Locking Plate Instrument and Titanium Implant Set (145.875) Graphic Case 690.049 Graphic Case for Thoracolumbar Spine Locking Plate Instrument and Implant Set Instruments 03.600.001 Conical Extraction Screw, for 5.5 mm locking screws, 2 ea. 311.425 Handle, with quick coupling 319.09 Depth Gauge 321.133 Torque Limiting Handle, quick release 324.076 3.5 mm Hexagonal Screwdriver, self-retaining, 2 ea. 324.092 Measuring Forceps 388.652 Ratchet T-Handle 389.801 Threaded Drill Guide Applicator, cannulated, 2 ea. 389.802 Threaded Drill Guide, 6 ea. 389.803 Awl, for 3.3 mm hole 389.805 Temporary Fixation Pin, 2 ea. 389.807 3.5 mm Hexagonal Screwdriver Shaft, self-retaining 389.808 3.3 mm Drill Bit, quick coupling, 248 mm 389.811 Construct Holder 389.812 Tap for 5.5 mm Cancellous Locking Screws, 248 mm 389.814 Holding Sleeve 389.829 3.5 mm Hexagonal Screwdriver Shaft 389.872 Driver, for Detachable Temporary Fixation Pin 389.873 Detachable Temporary Fixation Pin, 4 ea. Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://us.synthes.com/medical+community/cleaning+and+sterilization.htm or to the below listed inserts, which will be included in the shipping container: Processing Synthes Reusable Medical Devices Instruments, Instrument Trays and Graphic Cases DJ1305 Processing Non-sterile Synthes Implants DJ1304 18 Synthes Spine Thoracolumbar Spine Locking Plate (TSLP) System
Implants 5.5 mm Titanium Cancellous Locking Screws, 4 ea. Thread Length 489.142 22 mm 489.145 24 mm 489.147 26 mm 489.150 28 mm 489.154 30 mm 489.156 33 mm 489.160 36 mm 489.162 39 mm 489.165 42 mm 489.168 45 mm 489.170 48 mm 489.171 51 mm 489.174 54 mm Titanium Thoracolumbar Spine Locking Plates Length 489.440 40 mm 489.443 43 mm 489.446 46 mm 489.450 49 mm 489.453 52 mm 489.456 55 mm 489.458 58 mm 489.461 61 mm 489.463 64 mm 489.466 67 mm 489.470 70 mm 489.474 73 mm 489.475 76 mm 489.480 79 mm 489.483 82 mm 489.487 85 mm 489.489 88 mm 489.490 91 mm 489.493 94 mm 489.497 97 mm 489.500 100 mm 489.506 103 mm 489.510 106 mm 489.512 109 mm Synthes Spine 19
Synthes Spine 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.synthes.com 2004 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/11 J4903-E