Xia Low Profile Spinal System Ilios Application of the Xia Family. Surgical Technique

Transcription

1 Xia Low Profile Spinal System Ilios Application of the Xia Family Surgical Technique

2 Xia Ilios Application Introduction Introduction The evolution of the XIA Ilios Application is further evidence of Stryker Spine s commitment to continue to listen to the global surgeon community and to provide implants and instruments that strive to offer optimal surgical solutions. Stryker Spine s new Ilios Application was developed and built upon the success of the XIA Application. The Ilios system provides a comprehensive offering of XIA Long Screws, Offset Connectors and Rod-to-Rod Connectors to provide solutions for Sacral-Iliac fixation. Stryker Spine would like to extend their thanks to: Frank F. Rand, M.D., Boston, MA for his participation in the continued development of the Ilios Application and Surgical Technique. 2

3 Table of Contents Operative Technique A. Patient Positioning B. Surgical Access C. Pelvic Screw Path Preparation D. Pelvic Screw Placement E. Axial Connection F. Parallel Connection G. Offset Iliac Connectors H. Rod-to-Rod Connectors I. Indications J. Contraindication Implant Overview Instrument Overview Surgical Access Implants & Instruments Contraindication Indication Rod to Rod Connection Pelvic Screw Placement Axial Connection Parallel Connection Offset Iliac Connection Patient Positioning 3

4 Xia Ilios Application Patient Positioning Patient Positioning Patient Positioning Diagnosis of deformity is based upon patient history, physical findings and preoperative radiographic assessment. The patient is usually positioned prone on an appropriate spinal table. Care is taken to pad all bony prominences. The abdomen should not be compressed to help lower venous pressure. Surgical levels may be verified clinically or radiographically. To ensure adequate exposure, the incision is made to extend just beyond the length of the intended fusion. Presurgical planning defines the most appropriate implants, as well the optimal location of insertion. 4

5 Surgical Access The lumbar spine is exposed first. To begin the pelvic anchorage procedure, a separate fascial incision over the posterior iliac crest is made to allow placement of intra iliac screws. The lumbar spine exposure, surgical procedure (decompression, etc) and instrumentation are completed prior to placement of iliac/pelvic screws. Following the initial incision, a subperiosteal dissection of the outer table of the pelvis provides access to the pelvic anchorage site. The inner table is exposed to a depth of approximately 1.5cm to facilitate notching the crest and tunneling of the connector. This tunneling approach is straight forward and leaves the muscle attached, providing better coverage and a simpler closure. Surgical Access ASIS Crest Iliac Tubercle PSIS 5

6 Xia Ilios Application Operative Technique Pelvic Screw Path Preparation Pelvic Screw Placement With the posterior crest and outer table exposed the surgeon is ready to place the pelvic screw. Approximately 1.0 to 2.0 centimeters up from the tip of the spine is an ideal starting point. At this point, the crest widens and provides a wide channel for the implant. Use a rongeur to make a notch in the crest of sufficient depth and width to accept the head of the implant. The top of the implant (after insertion) should not be proud beyond the contour of the crest. Prominent implants can be a problem in this area. Use a curette to start the path between the tables of the pelvis. This curette is used for the first 1.0 to 2.0 centimeters. After the curette, use a straight probe to sound the path between the tables over the notch. Stop every few centimeters to check with a ball tip feeler to verify integrity of the canal. When the trajectory and depth are proven, measure the depth of the canal using the Xia Depth Gauge (884025). 6

7 Pelvic Screw Placement With the pelvic pathway prepared and proper screw length and diameter determined, the screw is prepared for insertion. Generally speaking, a mm diameter screw by 80mm long is used in most patients. Both the Xia Polyaxial Screwdriver ( ) and Xia Monoaxial Screwdriver ( ) provide a rigid connection between the screw and screwdriver. Pelvic Screw Placement 7

8 Xia Ilios Application Operative Technique Axial Connection The connection of the pelvic screw to the axial construct can either be direct (Main construct rod captured by the iliac screw) or with a connecting implant. Axial Connection Frequently on the convex side of the fractional lumbosacral curve, the axial rod can be easily contoured to continue from the S1 screw to the pelvic screw without the need of an additional connector. The surgeon may choose to connect to the axial rod either above or below the S1 screw with one of the Xia Offset Connectors ( , , , , , , , ). Note: When using Xia Titanium implants, the surgeon may select a Xia Vitallium Rod ( ). Vitallium Rod is recommended to be cut by the Xia Table Top Rod Cutter ( ) only. 8

9 Axial Connection Use a Shindt Clamp in order to tunnel to the lumbar wound. After tunneling through the wound, pass the axial rod or connector through. The Xia Inserter ( ) can help align the Xia Universal Tightener, 5mm ( ) and the Blocker ( ) with the implant. Parallel Connection The final tightening of the Blocker is done by utilizing the Xia Anti-Torque Key ( ) and the Torque Wrench ( ). The Torque Wrench indicates the optium force which has to be applied to the implant for final tightening. Line up the two arrows to achieve this optimum torque of 12Nm. 9

10 Xia Ilios Application Operative Technique Parallel Connection The Xia Spinal System also offers a parallel connection from the main construct to the ilium. The Xia Rodto-Rod Connectors enable a surgeon to connect from the lumbar region to the ilium using one of four options: 1) Small R-R Connector (Neutral) 2) Small R-R Connector (30 degrees) 3) Large R-R Connector (Neutral) 4) Large R-R Connector (10 degrees) Axial Connection These connectors can be used for iliac fixation in a revision surgery, on a stand alone basis or can be used in conjunction with an offset rod connection to place two screws in the ilium for supplemental iliac fixation. This provides surgeons with added strength and flexibility in treating complicated spinal disorders in the lumbar and sacral regions. 10

11 Offset Connectors Four Offset Connector designs are offered in the Ilios Application. All designs are available in stainless steel and titanium. All of these connectors use a Xia Blocker for final rod fixation. 1) Long Neutral Offset Connector: This connector is 80mm long and will be perpendicular to the rod when attached. This connector can be cut and bent for additional interoperative flexibility. 2) Neutral Offset Connector: This connector is 35mm long and will be perpendicular to the rod when attached. 3) Offset Connector 75 degree bend: This connector is 35mm long and has a 75 degree angle allowing better anatomical placement of the connector in the iliac region. Offset Iliac Connection 4) Offset Connector 105 degree bend: This connector is 35mm long and has a 105 degree angle allowing better anatomical placement of the connector in the iliac region. 11

12 Xia Ilios Application Operative Technique Rod-to-Rod Connectors Four Rod-to-Rod Connectors are offered with this set. All designs are available in stainless steel and titanium. All of these connectors use the Xia Blocker for final rod fixation. 1) Small Rod-to-Rod Connector (Neutral): This open Rod-to-Rod Connector accommodates parallel rods that are 12mm apart. 2) Small Rod-to-Rod Connector (30 degrees): This open Rod-to-Rod Connector accommodates rods that are 12mm apart at angles of 30 degrees. 3) Large Rod-to-Rod Connector (Neutral): Rod to Rod Connection This open Rod-to-Rod Connector accommodates parallel rods that are 16mm apart. 4) Large Rod-to-Rod Connector (10 degrees): This open Rod-to-Rod Connector accommodates rods that are 16mm apart at angles of 10 degrees. 12

13 Xia Ilios Application Indications Indications STRYKER Spinal Fixation Systems are indicated for temporary or permanent correction or stabilization of the vertebral column from the thoracic to the sacrum and with the aim of helping consolidation or bone fusion. XIA, OPUS and DIAPASON-RPS SYSTEMS are designed for posterior fixation procedure. XIA is also designed for anterior fixation procedure. They are indicated for degenerative disc disease of the thoracic and lumbar spine, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudarthrosis or revision of failed fusion attempts. Indication 13

14 Contraindications Contraindications Contraindication Contraindications may be relative or absolute. The choice of a particular device must be carefully weighed against the patient s overall evaluation. Circumstances listed below may reduce the chances of a successful outcome: Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis. Insufficient quality or quantity of bone which would inhibit rigid device fixation. Previous history of infection. Excessive local inflammation. Open wounds. Any neuromuscular deficit which places an unusually heavy load on the device during the healing period. Obesity. An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself. Patients having inadequate tissue coverage of the operative site. Pregnancy. A condition of senility, mental illness, or substance abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. Other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count. These contraindications can be relative or absolute and must be taken into account by the physician when making his decision. The above list is not exhaustive. 14

15 Caution and Warning Caution The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. Based on the fatigue testing results, the physician/ surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc which may impact on the performance of the system. Warning The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. 15

16 Xia Ilios Application Implants REF REF Description Titanium Stainless Steel Blocker Monoaxial Screw Ø 4.5mm 25mm 45mm Monoaxial Screw Ø 5.5mm 25mm 55mm Monoaxial Screw Ø 6.5mm 30mm 100mm Monoaxial Screw Ø 7.5mm 30mm 100mm Monoaxial Screw Ø 8.5mm 30mm 100mm Monoaxial Screw Ø 9.5mm 60mm 100mm Polyaxial Screw Ø 4.5mm 25mm 45mm Polyaxial Screw Ø 5.5mm 25mm 55mm Polyaxial Screw Ø 6.5mm 30mm 100mm Polyaxial Screw Ø 7.5mm 30mm 100mm N / A Polyaxial Screw Ø 8.5mm 30mm 100mm N / A Polyaxial Screw Ø 9.5mm 60mm 100mm Implants & Instruments 16

17 REF REF Description Titanium Stainless Steel N / A Titanium Alloy Rods Ø 6.0mm 40mm 300mm N/A CP Titanium Rods Ø 6.0mm 70mm 480mm N/A Standard Rod Ø 5.5mm 480mm N/A Stiff Rod Ø 5.5mm 480mm N/A Vitallium Rod Ø 6.0mm 600mm N/A RAD Rod Ø 6.0mm 30mm 90mm N/A MAX RAD Rod Ø 6.0mm 50mm 80mm Implants & Instruments 17

18 Xia Ilios Application Implants REF REF Description Titanium Stainless Steel Rod to Rod Clamp Axial Rod to Rod Clamp Parallel Offset Connector Washer Staple N/A Sacral Block N/A Sacral Block Ø 6.5mm 25mm 35mm Bone Screw Implants & Instruments 18

19 REF REF Description Titanium Stainless Steel Small Rod-to-Rod Connector, Small Rod-to-Rod Connector, Large Rod-to-Rod Connector, Large Rod-to-Rod Connector, Offset Connector Neutral Offset Connector 75 bend Offset Connector 105 bend Long Offset Connector Neutral Implants & Instruments 19

20 Xia Ilios Application Instruments REF Description Standard Instruments Xia Rod Pusher Xia Rod Template Xia Probe-Feeler (set of 4) Xia Blunt Probe L/R Xia Bending Irons Xia French Bender Xia Tap, 4.5 / 5.5mm Xia Tap, 6.5 / 7.5mm Implants & Instruments 20

21 REF Description Standard Instruments Xia Probe-Finder Xia Awl Xia Universal Tightener, 5mm Xia Inserter Xia Rod Fork Xia Persuader Xia Torque Wrench Xia Anti-Torque Key Xia Cutting Pliers Implants & Instruments 21

22 Xia Ilios Application Instruments REF Description Standard Instruments Compressor Distractor New Xia Screwdriver, Polyaxial New Xia Polyaxial, Shaft New Xia Screwdriver, Monoxial New Xia Monoaxial, Shaft Xia Screwdriver Handle Rod Rotation Forceps Implants & Instruments 22

23 REF Description Standard Instruments Rod Insertion Forceps *Polydriver *Polyaxial Screwdriver Common Instrument Tray Xia (SS) Screw Tray Xia (SS) Hook Tray Xia (Ti) Hook Tray Xia (SS) Ilios Tray Xia (Ti) Ilios Tray Implants & Instruments * Needed for use with 8.5mm and 9.5mm polyaxial screws 23

24 Simple Way to Strong Support Spinal Systems of the Xia Family: Modern Solutions for All Your Applications Stryker SA Cité Centre Grand-Rue Montreux Switzerland t: f: This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: DIAPASON, OPUS, Stryker, XIA. All other trademarks are trademarks of their respective owners or holders. The products listed above are CE marked according to the Medical Device Directive 93/42/EEC. Literature Number: MTXTLILSST06051 MTX6779/GS 06/10 Copyright 2010 Stryker