Surgical Technique Guide
DESIGNING SURGEONS Darrel Brodke, M.D. University of Utah Medical Center Dept. of Orthopedic Surgery Salt Lake City, Utah Iain Kalfas, M.D., F.A.C.S The Cleveland Clinic Foundation Dept. of Neurosurgery Cleveland, Ohio Dezsö Jeszensky, M.D. Kantonsspital St. Gallen Klinik fur Orthopadische Chirurgue St. Gallen, Switzerland Harry Shufflebarger, M.D. Miami Children s Hospital Miami, Florida INTRODUCTION/ PHILOSOPHY Building upon decades of cumulative design history, sound surgical philosophy, clinical experience and biomechanical performance of the MOSS, MOSS MIAMI and MOSS MIAMI SI Systems, the EXPEDIUM Spine System represents a true advance in the treatment of thoracolumbar pathologies. The EXPEDIUM Spine System incorporates technique-simplifying designs, including a state of the art internal closure mechanism and a comprehensive set of implants designed in harmony with the instruments, which maximize performance and meet the challenge of even the most difficult pathologies.
Contents EXPEDIUM Polyaxial Screws 2 EXPEDIUM Reduction Screws 13 EXPEDIUM Hooks 15 EXPEDIUM Translation Hooks 20 EXPEDIUM Dual Innie Polyaxial Screws 22
EXPEDIUM Polyaxial Screws Pedicle Screw Preparation Pedicle preparation is performed utilizing a selection of Awls, Pedicle Probes, Ball Tip Feelers and Bone Taps. Probes and Bone Taps are marked to indicate the appropriate length Polyaxial Screw. Polyaxial Screws have a fully threaded, tapered tip minimizing the need to tap. However, taps are provided for surgeon preference. 2
SURGICAL TECHNIQUE GUIDE Polyaxial Screwdriver Application Step 1 Place the tip of the Polyaxial Screwdriver into the head of the screw. Step 2 Thread the Screwdriver into the head of the screw, making sure the screw shank is straight. Step 3 Slide the Screwdriver sleeve down into the head of the screw. 3
EXPEDIUM Polyaxial Screws Step 4 To adjust the screw height, rotate the outer sleeve counter-clockwise. Step 5 To disengage, retract the Screwdriver sleeve and unthread the driver from the head of the screw. 4
SURGICAL TECHNIQUE GUIDE Quick-Connect Screwdriver Application Step 1 Place the T20 Driver tip into the T20 feature in the screw shank. Step 2 Slide the Screwdriver sleeve down and thread into the head of the screw. Step 3 To adjust the screw height, rotate the handle counter-clockwise. Step 4 To disengage the screw, unthread the Screwdriver sleeve. 5
EXPEDIUM Polyaxial Screws Monoaxial Screws Polyaxial Screw Insertion Polyaxial Screws are inserted using the Polyaxial Screwdriver. NOTE: See Polyaxial Screwdriver application (Page 3). Monoaxial Screws may be used according to surgeon preference. The Polyaxial Screw head can be adjusted and positioned using the Head Adjuster. Head Adjuster Rod Insertion Choose the appropriate length rod with the desired lordosis. Place the rod into the Polyaxial Screw heads. 6
SURGICAL TECHNIQUE GUIDE Single Innie Insertions Using the Single Innie Inserter, pick up an Innie from the caddy. The Single Innie will self-retain on the inserter. Alignment Guide Align with the screw head. Thread into the screw head to capture the rod. Rod Capture Capture the rod into the implant by inserting the Single Innie. The Alignment Guide can be used to help position the head and reduce the chance of cross-threading. 7
EXPEDIUM Polyaxial Screws Rod Reduction Clip-On Rod Approximator Attach the Clip-On Device to the TOP NOTCH feature at the top of the Polyaxial Screw head. Load the Single Innie from the caddy onto the combination Reduction Tube/SI Inserter. 8
SURGICAL TECHNIQUE GUIDE Thread the Reduction Tube into the Clip-On Device to fully seat the rod. Capture the rod by threading the Single Innie into the implant head until tight. Remove the Reduction Tube and Clip-On Device. 9
EXPEDIUM Polyaxial Screws Rod Reduction Using the Squeeze-Down Rod Approximator Attach the Squeeze-Down Device to the TOP NOTCH feature at the top of the Polyaxial Screw head. Fully seat the rod by squeezing the handles together. Load the Single Innie from the caddy and thread into the implant head through the guide in the Squeeze-Down Device. Disengage the device from the TOP NOTCH feature. 10
SURGICAL TECHNIQUE GUIDE Compression/Distraction Once the rod has been captured into all of the Polyaxial Screw heads, compression and distraction maneuvers can be easily accomplished by simply loosening and tightening the Single Innie. 11
EXPEDIUM Polyaxial Screws Final Tightening T-Handle Torque Wrench Final tightening is performed with the Hexlobe Shaft inserted into the T-Handle Torque Wrench, set to 80 in-lb. The shaft is inserted through the Rod Stabilizer and into the Single Innie. The Stabilizer is then slid down over the head of the Polyaxial Screw and onto the rod. The Stabilizer handle can be held either perpendicular or parallel to the rod. The T-Handle is rotated clockwise until it clicks and resistance is no longer evident. T-Handle Torque Wrench set to 80 in-lb. 12
SURGICAL TECHNIQUE GUIDE EXPEDIUM Reduction Screws Tab Keys or Rings are placed on the extended implant flanges to prevent distortion during rod introduction. Tab Key Reduction The EXPEDIUM Polyaxial Reduction Screw is designed to further complement the innovative design of the existing EXPEDIUM Polyaxial Screw range. These screws help to address, correct and also stabilize difficult anatomic variations. The Reduction Screw is designed with removable tabs that allow the surgeon to approximate the spine to the desired sagittal or axial profile. Tab Key Placement Tab Ring Tab Ring Placement 13
EXPEDIUM Reduction Screws Reduction Tab Remover Following the corrective reduction maneuvers, a Structural Interbody Fusion Device may be inserted via a PLIF or TLIF procedure, if required. After insertion of the Structural Interbody Fusion Device, Compression and final tightening of the Polyaxial Screws is performed. After final tightening, Extended Tabs may be removed using the Extended Tab Remover (see side panel). 14
SURGICAL TECHNIQUE GUIDE EXPEDIUM Hooks There are four possible hook placement sites in the spine: pedicle, transverse process, supra-lamina and infra-lamina. The first site is the pedicle. Pedicle Hooks are placed in the thoracic spine via the facet joint. The direction for the Pedicle Hooks is always cephalad. The facet of the appropriate level is identified and the capsule is removed. The cartilage on the inferior articular process of the next distal level should be visualized. Hook Preparation Instruments A. B. C. The facet is entered with the Pedicle Elevator. A. Thoracic Facet Finder B. Laminar Finder C. Pedicle Finder 15
EXPEDIUM Hooks The Pedicle Hook is inserted with either the Compact Hook Holder or the Hook Holding Forceps and seated flush against the facet and the pedicle. The second site is the transverse process. This is usually used in conjunction with a Pedicle Hook either at the same level or one level superior. A Wide Blade Lamina Hook or Angled Body Lamina Hook is recommended for this site. An Elevator is used to dissect around the superior surface of the transverse process. 16
SURGICAL TECHNIQUE GUIDE The Wide Blade Lamina Hook or Angled Body Lamina Hook is then placed in the required position. The third possible site is the superior lamina. The Reduced Distance Lamina Hook or the Narrow Blade Lamina Hook is recommended for this site. The direction is always caudal. These hooks may be combined with other hooks to produce a claw construct. The ligamentum flavum is divided in the midline and excised. 17
EXPEDIUM Hooks The inferior edge of the next proximal lamina is removed to permit the intra-canal placement of the hook. The appropriate lamina hook is then placed using the Hook Holding Forceps until well seated against the lamina. The fourth possible site is the inferior lamina. The Angled Blade Hook is recommended for this site in the lumbar spine. The direction is always cephalad. Similar to the Supra-Lamina Hooks, the ligamentum flavum is divided in the midline and excised. 18
SURGICAL TECHNIQUE GUIDE The inferior edge of the selected lamina is removed to permit intra-canal placement of the hook. The Angled Blade Lamina Hook is then placed using the Hook Holding Forceps until well seated against the lamina. 19
EXPEDIUM Translation Hooks The EXPEDIUM Translation Hook is designed to further complement the innovative design of the existing EXPEDIUM hook range. These hooks help to address, correct and also stabilize difficult anatomic variations. The Translation Hook is designed with removable tabs that allow the surgeon to approximate the spine to the desired sagittal or axial profile. Translation Hooks are most commonly placed at the apex of the concavity. Contour the rod to match the required spinal contours in the sagittal plane. Place the contoured rod into the spine anchors. Fully seat and secure the rod by introducing the Single Innie. The extended tabs of the Translation Hooks provide a means of capturing a rod that may have crossed the midline and would otherwise be out of reach of the anchor. 20
SURGICAL TECHNIQUE GUIDE Distraction is applied as the rod is translated into the hooks using the Single Innie. NOTE: Minimal distraction between Translation Hooks should be utilized during translation to prevent hook dislodgement. Advance the Single Innie within the flanged hook to bring the spinal anchors to the rod to correct the scoliosis. Once the rod is fully seated, the Approximation Tabs can be removed using the Tab Remover. Additionally, Cross Connectors can be used to add structural rigidity to the construct. 21
EXPEDIUM Dual Innie Polyaxial Screws Pedicle Screw Preparation Pedicle preparation is performed utilizing a selection of Awls, Pedicle Probes, Ball Tip Feelers and Bone Taps. Probes and Bone Taps are marked to indicate the appropriate length Polyaxial Screw. EXPEDIUM Dual Innie technique was developed in conjunction with Dezsö Jeszensky, M.D. Polyaxial Screws have a fully threaded, tapered tip minimizing the need to tap. However, taps are provided for surgeon preference. 22
SURGICAL TECHNIQUE GUIDE Polyaxial Screw Insertion Polyaxial Screws are inserted using the DI Polyaxial Screwdriver. NOTE: Polyaxial Screwdriver application is similar to the method described earlier (Page 3). The Polyaxial Screw head can be adjusted and positioned using the Head Adjuster. 23
EXPEDIUM Dual Innie Polyaxial Screws Rod Insertion Choose the appropriate length rod with the desired lordosis. Place the rod into the Polyaxial Screw heads. Dual Innie Insertions Using the Dual Innie Inserter, pick up a Dual Innie Set Screw from the caddy. The Dual Innie will self-retain on the inserter. Align with the screw head. The Alignment Guide can be used to help position the head and reduce the chance of cross-threading (see Page 7). Thread into the screw head to capture the rod. 24
SURGICAL TECHNIQUE GUIDE TLIF/PLIF using EXPEDIUM DI Polyaxial Screws Screw shank angulation can be locked by tightening the outer blue set screw of the closure mechanism using the Cannulated T-Handle Intermediate Tightener. The X-25 Hexlobe Driver should be used to center the Intermediate Tightener. Secure the rod to the proximal screw on each side of the spine by tightening the inner set screw with the X-25 Hexlobe Driver. 25
EXPEDIUM Dual Innie Polyaxial Screws Distraction along the entire vertebral body is achieved when the polyaxial mechanism is locked for all screws. Distraction is held by locking the remaining inner set screws with the X-25 Hexlobe Driver. 26
SURGICAL TECHNIQUE GUIDE With the distracted disc space temporarily held open, the intervertebral disc can be safely removed. Placement of the bone graft can be checked visually. 27
EXPEDIUM Dual Innie Polyaxial Screws Parallel compressive forces can be applied to secure the bone graft. Simply loosen the appropriate inner set screw and tighten after compression is accomplished. NOTE: The polyaxial mechanism can be released by loosening the blue outer set screw to ensure good opposition between the implant and the adjacent endplates. 28
SURGICAL TECHNIQUE GUIDE Final Tightening Final tightening of the outer set screw is performed with the Dual Innie Tightener. The shaft is inserted through the Rod Stabilizer and into the outer set screw. The Stabilizer is then slid down over the head of the Polyaxial Screw and onto the rod. The Stabilizer handle can be held either perpendicular or parallel to the rod. T-Handle Torque Wrench The T-Handle is rotated clockwise until tight. Final tightening of the inner set screw is performed with the Hexlobe Shaft inserted into the T-Handle Torque Wrench, set to 80 in-lb. The shaft is inserted through the Rod Stabilizer and into the internal set screw. T-Handle Torque Wrench set to 80 in-lb. The Stabilizer is then slid down over the head of the Polyaxial Screw and onto the rod. The Stabilizer handle can be held either perpendicular or parallel to the rod. The T-Handle is rotated clockwise until it clicks and resistance is no longer evident. 29
Removal Instructions If a decision is made to remove the implants after solid fusion occurs, the following steps should be taken after the implant is exposed. For screws with Single Innie set screw: 1. Clean debris/tissue from set screws. 2. Loosen set screw with the T-Handle Torque Wrench and the Hexlobe Shaft rotating it counter-clockwise. The 5.5 SI Rod Stabilizer should be used while loosening the set screw. 3. Remove the Single Innie set screw with the X25 Set Screw Inserter. 4. Once the set screws are removed, the rods can be removed. 5. Use the T20 Screw Driver to back the screw out of the pedicle. For screws with 5.5 DUAL Innie set screw: 1. Clean debris/tissue from set screws. 2. Loosen inner set screw with the T-Handle Torque Wrench and the Hexlobe Shaft rotating it counter-clockwise. The 5.5 DI Rod Stabilizer should be used while loosening the set screw. 3. Loosen the outer blue set screw with the DI Final Tightener. The 5.5 DI Rod Stabilizer should be used while loosening the outer set screw. 4. Remove the Dual Innie set screw with the DI Inserter. For hooks: 1. Clean debris/tissue from set screws. 5. Once the set screws are removed, the rods can be removed. 6. Use the T20 Screw driver to back the screw out of the pedicle. 2. Loosen set screw with the T-Handle Torque Wrench and the Hexlobe Shaft rotating it counter-clockwise. The 5.5 SI Rod Stabilizer should be used while loosening the set screw with Open Hooks and the Closed Hook Stabilizer should be used while loosening the set screw in Closed Hooks. 3. For Open Hooks, remove the Single Innie set screw with the X25 Set Screw Inserter. For Closed Hooks, loosen the set screw with the X25 Set Screw Inserter, in this case the set screw does not need to be removed. 4. For Open Hooks, the rods can be removed once the set screws are removed. For Closed Hooks, the rods can be removed after the set screws are loosened. 5. Use the hook holder to remove the hook from the pedicle or the lamina. 30
SURGICAL TECHNIQUE GUIDE Notes 31
Refer to the individual system surgical technique manuals for additional important information. indications The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. The EXPEDIUM PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from L1-S1 in skeletally mature patients. CONTRAINDICATIONS Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system. Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure. See also the WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES section of this insert. WARNINGS, PRECAUTIONS, AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES Following are specific warnings, precautions, and possible adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery. WARNINGS 1. PEEK RODS AND DDD. The safety and effectiveness of the EXPEDIUM and VIPER Spine System PEEK Rods for the treatment of degenerative disc disease has not been established. 2. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape, and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. 3. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load-sharing devices which are used to obtain alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to metal fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure. 4. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, etc., which come into contact with other metal objects, must be made from like or compatible metals. 5. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure: A. The patient s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the appliance and the operation. B. The patient s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain, twisting, repetitive bending, stooping, running, substantial walking, or manual labor, he/she should not return to these activities until the bone is fully healed. Even with full healing, the patient may not be able to return to these activities successfully. C. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications. D. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary remedy. E. Foreign body sensitivity. The surgeon is advised that no preoperative test can completely exclude the possibility of sensitivity or allergic reaction. Patients can develop sensitivity or allergy after implants have been in the body for a period of time. F. Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. Additionally, smoking has been shown to cause diffuse degeneration of intervertebral discs. Progressive degeneration of adjacent segments caused by smoking can lead to late clinical failure (recurring pain) even after successful fusion and initial clinical improvement. PRECAUTIONS 1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted metal implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage. Reuse can compromise device performance and patient safety. Reuse of single use devices can also cause cross-contamination leading to patient infection. 2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of metal implants should only be done with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease the fatigue life and may cause failure. 3. CONSIDERATIONS FOR REMOVAL OF THE IMPLANT AFTER HEALING. If the device is not removed after the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery. 4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient s ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant, and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sports participation. The patient should understand that a metallic implant is not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may migrate and damage the nerves or blood vessels. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation. 5. CORRECT PLACEMENT OF ANTERIOR SPINAL IMPLANT. Due to the proximity of vascular and neurologic structures to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurologic damage with the use of this product. Serious or fatal hemorrhage may occur if the great vessels are eroded or punctured during implantation or are subsequently damaged due to breakage of implants, migration of implants or if pulsatile erosion of the vessels occurs because of close apposition of the implants. 32
Intuitive Solutions The EXPEDIUM Spine System is a comprehensive thoracolumbar system offering implant and instrument solutions designed to enhance speed, security and simplicity. Limited Warranty and Disclaimer: DePuy Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. To order in the US, call DePuy Spine Customer Service (1-800-227-6633). Not all products are currently available in all markets. DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767 USA Tel: +1 (800) 227-6633 www.depuy.com DePuy Spine, Inc. 2011 All rights reserved. POD DF17-20-002 4/11 ADDB 30% FPO