As edited by Dr. Oheneba Boachie-Adjei, Dr. Matthew Cunningham, Dr. John Kostuik, Dr. Raymund Woo and the Complex Spine Study Group et al

Similar documents
Surgical Technique FOR U.S. DOMESTIC USE ONLY

EXCELLA ll. Spinal System

operative technique Universal Application

Introduction. Our hope is that this Surgical Technique Guide enhances your knowledge and contributes to clinical success for your patients.

SURGICAL TECHNIQUE. Standard Reduction HA Coated Modular. Discover the Difference

Spinal Deformity Pathologies and Treatments

Xia 3 Spinal System. AIS surgical technique

Technique Guide. Universal Spinal System (USS). Designed to achieve the goals of scoliosis surgery.

Ref: Q400-09T1 EBI Spine. September 05/VS02. c/o BIOMET Spain Orthopaedics, S.L.

Y o u r Id e a s En g i n e e r e d t o Li f e

Maintenance of Thoracic Kyphosis in the 3D Correction of Thoracic Adolescent Idiopathic Scoliosis Using Direct Vertebral Derotation

USS Variable Axis Screw (VAS) System. For posterior fixation of the lumbar spine.

LIV selection in selective thoracic fusions

X-spine Surgical Technique

Surgical Technique. Guide and Ordering Information. Favored Angle Screw

Valencia Pedicle Screw Surgical Technique

L8 Spine System SURGICAL TECHNIQUE. Add: No.1-8, Tianshan Road, Xinbei District, Changzhou, Jiangsu, China

Dymaxeon Spine System. Simple, Streamlined, Smart. Surgical Procedure

EXPEDIUM VERSE Spinal System

HydraLok. Operative Technique. Polyaxial Pedicle Screw System


VERTEX SELECT. surgical technique. adjustability. Flexibility. adaptability. Reconstruction System

4.5 System. Surgical Technique. This publication is not intended for distribution in the USA.

Biomet Omega21 TM Spinal Fixation System

USS Variable Axis Screw

RESPONSE SURGICAL TECHNIQUE

Technique Guide. NFlex. Semi-rigid rods for posterior lumbar stabilization.

MATRIX Spine System Deformity

The Most Reliable Spinal Solution

Threshold Pedicular Fixation System Surgical Technique

Polaris Deformity System Trivium Derotation System

A U X I L I A R Y C O N N E C T O R S Surgical Technique

SURGICAL TECHNIQUE. SECURIS Pedicle Screw System for Minimally Invasive Surgery. 2 I SECURIS Pedicle Screw System

MATRIX Spine System Deformity. A posterior pedicle screw, hook, and rod fixation system.

SURGICAL TECHNIQUE GUIDE SOLANAS. Posterior Cervico-Thoracic Fixation System Adjustable Bridge System

EXCELLA MIS. Spinal System

Handling instructions. USS Low Profile. Thoracolumbar posterior fixation system.

SerratoTM. Surgical technique

LUMBAR POSTERIOR MINIMALLY INVASIVE SYSTEM. Surgical Technique

SURGICAL TECHNIQUE. Easyspine PEDICLE SCREW SYSTEM

Technique Guide. Pangea Spine System. Top loading pedicle screw and hook system for posterior stabilization and correction of spinal deformities.

POLYAXIAL SPINE SYSTEM D E G E N E R A T I V E

Dual-Opening USS. For deformity correction.

M.I.S. MAKE IT SMART IN ONE SYSTEM. Surgical Technique. Hip Knee Spine Navigation

PRODUCT SUMMARY Cobalt Chrome Tulip Multiple Options Triple Lead Thread

Technique Guide. USS Small Stature/Pediatric. A multifaceted deformity system for use in patients of small stature.

A Fusion of Versatility, Performance and Ease.

Thoracolumbar Anterior Compression (TAC) System. Allows distraction, compression, and lateral fixation of the lower thoracic and lumbar spine.

SURGICAL TECHNIQUE GUIDE TRESTLE. Anterior Cervical Plating System

Idiopathic scoliosis Scoliosis Deformities I 06

Surgical Technique. Available In Titanium And Stainless Steel

ONE SYSTEM, MULTIPLE OPTIONS. Surgical Technique. Hip Knee Spine Navigation

The CerviFix System. Including the StarLock Components. CerviFix Clamp and Screw. StarLock Clamp and Screw

VENUS SCOLIOSIS. Scoliosis System

The Versatile Polyaxial Solution for the Universal Spine Systems. USS II Polyaxial. Surgical Technique

Could Structural and Noncompensatory Lenke 3 and 4C Lumbar Curves Be Nonstructural and Compensatory?

The importance of the sagittal profile in spinal deformity surgery

EXPEDIUM 5.5 Spine System Family Product Catalogue

VTI INTERLINK PEDICLE SCREW SYSTEM

MATRIX Spine System Degenerative. A posterior pedicle screw and rod fixation system.

Surgical Technique. Occipito-Cervico-Thoracic System

Thoracolumbar Solutions. Vital Spinal Fixation System. Degenerative. Surgical Technique Guide

RESPONSE SURGICAL TECHNIQUE RESPONSE. Spine System

O PE RATIV E TE C HN IQ U E. Minimally Invasive Posterior Fixation

Zimmer Anterior Buttress Plate System. Surgical Technique

Thunderbolt. surgical technique. MIS Pedicle Screw System. Where Nimble and Secure Intersect

Thoracic Lumbar Pelvic Posterior Anterior. Universal Spine System (USS). A versatile side-loading system portfolio.

Vertical Expandable Prosthetic Titanium Rib II VEPTR II. Surgical Technique

Spinal System. Aesculap Posterior Thoracolumbar Stabilization System S 4. Aesculap Spine

100 Interpace Parkway Parsippany, NJ

Postoperative standing posteroanterior spine

Ballista Percutaneous Screw Placement System. Surgical Technique

Ballista Percutaneous Screw Placement System

Thoracolumbar Solutions. Polaris TM Deformity System. Surgical Technique Guide

T.L.I.F. Surgical Technique. Featuring the T.L.I.F. SG Instruments, VG2 PLIF Allograft, and the MONARCH Spine System.

Lowest instrumented vertebra selection in Lenke 3C and 6C scoliosis: what if we choose lumbar apical vertebra as distal fusion end?

USS II ILIO-SACRAL Modular System for Stable Fixation in the Sacrum and Illium

Synex System TECHNIQUE GUIDE. An expandable vertebral body replacement device

ACP. Anterior Cervical Plate System SURGICAL TECHNIQUE

MEDACTA UNCONSTRAINED SCREW TECHNOLOGY. Surgical Technique. Hip Knee Spine Navigation

ONE SYSTEM, MULTIPLE OPTIONS. Surgical Technique

I. II. SPINAL SYSTEM SURGICAL TECHNIQUE GUIDE

VLIFT System Overview. Vertebral Body Replacement System

Kao-Wha Chang, MD, Ku-I Chang, MD, and Chi-Ming Wu, MD

UNIQUE ANATOMIES PATIENT-MATCHED SOLUTIONS. Surgical Technique

Surgical Technique. Guide

Technique Guide. LCP Proximal Femoral Hook Plate 4.5/5.0. Part of the LCP Periarticular Plating System.

Technique Guide. Midface Distractor System. For the temporary stabilization and gradual lengthening of the cranial or midfacial bones.

Module: #15 Lumbar Spine Fusion. Author(s): Jenni Buckley, PhD. Date Created: March 27 th, Last Updated:

TSLP Thoracolumbar Spine Locking Plate

The Kickstand Rod technique for correction of coronal imbalance in patients with adult spinal deformity: theory and technical considerations

Cervical Solutions. Optio-C Anterior Cervical Plate. with Allograft/Autograft. Surgical Technique Guide

Spinal System Surgical Technique

Trio + Surgical Technique

Occipital Cervical Fusion System. Implants and instruments designed to optimize fixation to the occiput.

XRL A modular expandable radiolucent vertebral body replacement system

VERTEBRAL BODY DEROTATION MODULE. Surgical Technique. Hip Knee Spine Navigation

Surgical technique. synex. The vertebral body replacement with ratchet mechanism.

The Top-loading Pedicle Screw and Rod System Designed for the Posterior Stabilization of the Lower Back. Click X System. Surgical Technique

VENUS Hooks. Hook System

Transcription:

As edited by Dr. Oheneba Boachie-Adjei, Dr. Matthew Cunningham, Dr. John Kostuik, Dr. Raymund Woo and the Complex Spine Study Group et al

RANGE Spinal System A fusion of DENALI and MESA, offering a complete array of unique screws, rod connectors, and hooks, coupled with exciting innovations in instrumentation, this comprehensive system is poised to address the entire range of complex spinal pathologies.

TABLE OF CONTENTS 1 NOTE: Instrumented levels are based on Surgeon preference and patient pathology. This methodology manual is intended to be used as a guideline for correction techniques with the RANGE Spinal System. Single Thoracic Exposure and Preparation 4 Screw Placement 4 Concave Left Rod Placement 4 Countertorsion 8 Thoracic Concave Translation 12 Convex Right Rod Placement 14 Final Deformity Correction 17 LIV Horizontalization 18 Additional Surgical Considerations 20 RANGE SPINAL SYSTEM Double Major Exposure and Preparation 24 Screw Placement 24 Concave Left Rod Placement 24 Countertorsion 26 Thoracic Translation 30 Convex Right Rod Placement 32 Lumbar Concave Translation 33 Final Deformity Correction 34 LIV Horizontalization 35 Additional Surgical Considerations 36 Thoracolumbar/Lumbar Exposure and Preparation 40 Screw Placement 40 Convex Left Rod Placement 40 Countertorsion 41 Concave Lumbar Translation 44 Final Deformity Correction 46 LIV Horizontalization 47 Additional Surgical Considerations 48 Kyphosis Initial Considerations 52 Screw Placement 52 Bilateral Rod Placement 53 Bilateral Compression T1-T2 (Proximal Foundation) 54 Sequential Bilateral Rod Introduction Into Deformity Crickets 56 Segmental Compression Toward Apical Vertebra 58 LIV Horizontalization 60 Additional Surgical Considerations 62 Glossary Implants 66 Instruments 67 Definitions 70

3 RANGE SPINAL SYSTEM Single Thoracic Right T4-L1 Exposure and Preparation Screw Placement Concave Left Rod Placement Countertorsion Thoracic Concave Translation Convex Right Rod Placement Final Deformity Correction LIV Horizontalization Additional Surgical Considerations

SINGLE THORACIC RIGHT T4-L1 1 2 3 NOTE: Instrumented levels are based on Surgeon preference and patient pathology. This methodology manual is intended to be used as a guideline for correction techniques with the RANGE Spinal System. Exposure and Preparation Perform facetectomies throughout. Screw Placement Use MESA Polyaxial Screws at the most proximal levels (T4 and T5) for ease of rod attachment and establishment of the proximal foundation. Otherwise, use MESA Uni-Planar or MESA 360 Screws throughout the spine. Confirm the screw heads are unlocked and all screws are at appropriate levels and aligned to accept the rod when applied. Concave Left Rod Placement Place Deformity Crickets on the concave side screws (3A). These will provide translation of screws and spine to the rod later. Pre-bend the rods in the physiological sagittal plane. For ease of rod insertion, place Deformity Crickets on only the upper half of the concave screws. After introducing rod, place Deformity Crickets over the lower half of the rod. Do not 3B

5 tighten the Deformity Crickets, as they are only meant to ensure screw capture on the rod at this point. They will be used later for translation correction of the spine and reduction of the rods to the screws. RANGE SPINAL SYSTEM Rotate the rod into the sagittal plane (3B). This is preferably performed using the Rod Rotation Wrench and a Vise Grip. Seat the rod into the proximal fixation points T4 and T5 by tightening the Deformity Crickets (3C). 3A Continued on next page 3C 3C

SINGLE THORACIC RIGHT T4-L1 3E

3 (CON T) Partially lock the T4 and T5 fixation points using the Superfly over the Deformity Crickets (3D). Fully lock the T4 and T5 fixation points with the Quick Locker to establish the proximal foundation of the deformity instrumentation (3E). The rod should be held in the physiological sagittal plane with the Rod Rotation Wrench or a Vise Grip. 7 RANGE SPINAL SYSTEM 3D

SINGLE THORACIC RIGHT T4-L1 4 Countertorsion Apply Deformity Cricket Extenders on the concave side, and Manipulators to the convex apical screws to ease manipulation maneuvers during spinal vertebral derotation and translation (4A). The Manipulators on the convex screws aid in spine translation and partial derotation. During this maneuver, maintain countertorsion of the Lowest Instrumented Vertebra (LIV) to prevent en bloc rotation and coupling of the spine. 4A

9 RANGE SPINAL SYSTEM

SINGLE THORACIC RIGHT T4-L1 NOTE: When performing countertorsion, Transverse Couplers may be used on periapical vertebrae to facilitate rotational maneuvers (4B). 4B

11 RANGE SPINAL SYSTEM

SINGLE THORACIC RIGHT T4-L1 5 Thoracic Concave Translation Translation of the concave thoracic apex to the rod is performed by gradually tightening the Deformity Crickets from either end sequentially with progression toward the apex of the deformity (5A). By performing the translation simultaneously with several Deformity Crickets, the chance of screw pull-out and loss of fixation is reduced. The rod should be held in the physiological sagittal plane with the Rod Rotation Wrench or a Vise Grip. Once all Deformity Crickets are maximally tightened, the rod will be captured in each of the screw heads. Continued on next page

13 RANGE SPINAL SYSTEM 5A

SINGLE THORACIC RIGHT T4-L1 5 (CON T) 6 Partially lock all of the concave fixation points using the Superfly over the Deformity Crickets (5B). The Deformity Crickets may now be removed from the concave screws. Unlock all convex apical screws whose manipulators have been applied. Convex Right Rod Placement Place Deformity Crickets on the convex screws. The convex rod is introduced using the technique similar to the concave/corrective rod (6A). The proximal fixation points, T4 and T5, are partially locked using the Superfly over the Deformity Crickets and the rod is checked for proper sagittal plane alignment. Next, fully lock the T4 and T5 screws using the Quick Locker. The Deformity Crickets are then tightened sequentially to reduce the rod into the screws. Continued on next page 5B

15 RANGE SPINAL SYSTEM 6A

SINGLE THORACIC RIGHT T4-L1 6 (CON T) The Superfly is used to create a partial lock of each of the convex rod fixation points (6B). If necessary, the rod contour may be adjusted using the Medial/Lateral or In-situ Benders. 6B

7 Final Deformity Correction The final deformity correction is now performed using a variety of compression/ distraction and direct vertebral derotation (DVD) maneuvers. For compression/distraction, begin proximal to the apex. Compress or distract against a screw that has been buttressed with a DC Ring or a Vise Grip (7A & 7B). Remove the applied DC Rings. 17 RANGE SPINAL SYSTEM NOTE: The surgeon may also perform compression and/or distraction prior to partial locking by releasing the Deformity Cricket one to two turns to achieve final deformity correction. This method employs a similar technique to that of a standard set screw system. 7A 7B

SINGLE THORACIC RIGHT T4-L1 8 LIV Horizontalization Confirm horizontal position of the Lowest Instrumented Vertebra (LIV) and fully lock these fixation points using the Quick Locker. Repeat final locking of each screw with the Quick Locker to confirm rigid fixation throughout (8A). Transverse Connector(s) may be applied to the construct if indicated. Confirm at least 5 mm of rod length extends beyond the most proximal and distal screws. 8A

19 RANGE SPINAL SYSTEM

Additional Surgical Considerations Include: a. Do not attempt to forcefully derotate spine using the Deformity Crickets. The majority of the force should be applied to the Manipulators and rib hump on the convex side of the thoracic deformity, while simultaneously derotating the Deformity Crickets around the rod. b. Screws are more resistant to plowing through the pedicle during compression/ distraction maneuvers if the screw is moved caudally against the thicker bone of the caudal/foraminal aspect of the pedicle. c. Optional: In-situ bending of rod(s): i. Beginning at curve apex, Medial/Lateral Benders may be used to segmentally correct the deformity. ii. Minimize focal bending around a single screw to reduce the risk of bone failure. Placing Medial/ Lateral Benders around at least two screws is preferred. iii. The pear-shaped screwdriver handle can be placed between the pivot points of the Medial/Lateral Benders to improve leverage when bending across a long segment. d. For rigid deformities consider coronal bending of the concave rod at the apex while the rod is partially locked. Maintain final rod position with the coronal benders and simultaneously apply the Quick Locker to final lock the screws.

21 RANGE SPINAL SYSTEM

23 RANGE SPINAL SYSTEM Double Major T4-L3; Right Thoracic, Left Lumbar Exposure and Preparation Screw Placement Concave Left Rod Placement Coutertorsion Thoracic Translation Convex Right Rod Placement Lumbar Concave Translation Final Deformity Correction LIV Horizontalization Additional Surgical Considerations

DOUBLE MAJOR T 4 - L 3 R I G H T T H O R A C I C, L E F T L U M B A R 1 2 3 NOTE: Instrumented levels are based on Surgeon preference and patient pathology. This methodology manual is intended to be used as a guideline for correction techniques with the RANGE Spinal System. Exposure and Preparation Perform facetectomies throughout. Screw Placement Use MESA Polyaxial Screws at the most proximal levels (T4 and T5) for ease of rod attachment and establishment of the proximal foundation. Otherwise, use MESA Uni-Planar or MESA 360 Screws throughout the spine. Confirm the screw heads are unlocked and all screws are at appropriate levels aligned to accept the rod when applied. Concave Left Rod Placement Place Deformity Crickets on the concave side screws (3A). These will provide translation of screws and spine to the rod later. Pre-bend the rods in the physiological sagittal plane. 3A 3B

25 For ease of rod insertion, place Deformity Crickets on only the upper half of the concave screws. After introducing rod, place Deformity Crickets over the lower half of the rod. Do not tighten the Deformity Crickets, as they are only meant to ensure screw capture on the rod at this point. They will be used later for translation correction of the spine and reduction of the rods to the screws. Rotate the rod into the sagittal plane (3B). This is preferably performed by using the Rod Rotation Wrench and a Vise Grip. Seat the rod into the proximal fixation points T4 and T5 by tightening the Deformity Crickets (3C). Continued on next page RANGE SPINAL SYSTEM 3C

DOUBLE MAJOR T 4 - L 3 R I G H T T H O R A C I C, L E F T L U M B A R 3 (CON T) 4 Partially lock the T4 and T5 fixation points using the Superfly over the Deformity Crickets (3D). Fully lock the T4 and T5 fixation points with the Quick Locker to establish the proximal foundation of the deformity instrumentation (3E). The rod should be held in the physiological sagittal plane with a Rod Rotation Wrench or a Vice Grip. Maintain rod sagittal alignment with the Rod Rotation Wrench. Countertorsion Apply the Deformity Crickets and Cricket Extenders to the periapical concave thoracic and convex lumbar screws. Apply the Manipulators to the periapical convex thoracic and concave lumbar screws. This will ease manipulation maneuvers during spinal vertebral derotation and translation (4A). Advance Deformity Crickets to make contact with rods prior to Direct Vertebral Derotation. Simultaneous convex and concave direct vertebral derotation or countertorsion is carried out (4B). Continued on next page 3D 3E 4A

27 RANGE SPINAL SYSTEM 4B

DOUBLE MAJOR T 4 - L 3 R I G H T T H O R A C I C, L E F T L U M B A R (CON T) NOTE: When performing countertorsion, Transverse Couplers may be used on periapical vertebrae to facilitate rotational maneuvers (4C). 4C

29 RANGE SPINAL SYSTEM

DOUBLE MAJOR T 4 - L 3 R I G H T T H O R A C I C, L E F T L U M B A R 5 Thoracic Translation Translation of the concave thoracic and convex lumbar apices to the rod is performed gradually by tightening the Deformity Crickets from either end sequentially with progression toward the apex of the deformity (5A). By performing the translation simultaneously with several Deformity Crickets, the chance of screw pull-out and loss of fixation is reduced. The rod should be held in the physiological sagittal plane with the Rod Rotation Wrench or a Vise Grip. Once all of the Deformity Crickets are maximally tightened, the rod will be captured in each of the screw heads. 5A

31 Partially lock all fixation points on the left rod using the Superfly over the Deformity Crickets (5B). The Deformity Crickets may now be removed from the left side. Unlock all apical screws whose Manipulators have been applied. Place Deformity Crickets on the right side. RANGE SPINAL SYSTEM 5B

DOUBLE MAJOR T 4 - L 3 R I G H T T H O R A C I C, L E F T L U M B A R 6 Convex Right Rod Placement The convex right rod is introduced using the technique similar to the concave/ corrective rod (6A). The proximal fixation points, T4 and T5, are partially locked using the Superfly over the Deformity Crickets and the rod is checked for proper sagittal plane alignment (6B). Next, fully lock the T4 and T5 screws using the Quick Locker (6C). 6A 6B 6C

7 Lumbar Concave Translation The Deformity Crickets are then tightened sequentially to reduce the rod into the screw and the Superfly is used to create a partial lock of each of the convex rod fixation points (7A). If necessary, the rod contour may be adjusted using the Medial/Lateral or In-situ Benders. 33 RANGE SPINAL SYSTEM 7A

DOUBLE MAJOR T 4 - L 3 R I G H T T H O R A C I C, L E F T L U M B A R 8 Final Deformity Correction The final deformity correction is now performed using a variety of compression/ distraction and direct vertebral derotation (DVD) maneuvers. For compressions/distraction maneuvers, begin with compression of the convex lumbar apex to the Lowest Instrumented Vertebra (LIV). Next, begin compression of the convex thoracic apex. Finally, perform distraction on the concave lumbar apex to achieve horizontalization of the LIV. Compress or distract against a screw that has been buttressed with a DC Ring or a Vise Grip (8A & 8B). Remove the applied DC Rings. NOTE: The surgeon may also perform compression and/or distraction prior to partial locking by releasing the Deformity Cricket one to two turns to achieve final deformity correction. This method employs a similar technique to that of a standard set screw system. 8A 8B

9 LIV Horizontalization Confirm horizontal position of Lowest Instrumented Vertebra (LIV) and fully lock these fixation points using the Quick Locker. Repeat final locking of each screw with the Quick Locker to confirm rigid fixation throughout (9A). Transverse Connector(s) may be applied to the construct, if indicated. Confirm at least 5 mm of rod length extends beyond the most proximal and distal screws. 35 RANGE SPINAL SYSTEM 9A

Additional Surgical Considerations Include: a. Do not attempt to forcefully derotate spine using the Deformity Crickets. The majority of the force should be applied to the Manipulators and rib hump on the convex side of the thoracic deformity, while simultaneously derotating the Deformity Crickets around the rod. b. Screws are more resistant to plowing through the pedicle during compression/ distraction maneuvers if the screw is moved caudally against the thicker bone of the caudal/foraminal aspect of the pedicle. c. Optional: In-situ bending of rod(s): i. Beginning at curve apex, Medial/Lateral Benders may be used to segmentally correct the deformity. ii. Minimize focal bending around a single screw to reduce the risk of bone failure. Placing Medial/Lateral Benders around at least two screws is preferred. iii. The pear-shaped screwdriver handle can be placed between the pivot points of the Medial/Lateral Benders to improve leverage when bending across a long segment. d. For rigid deformities consider coronal bending of the concave rod at the apex while the rod is partially locked. Maintain final rod position with the coronal benders and simultaneously apply the Quick Locker to final lock the screws.

37 RANGE SPINAL SYSTEM

39 RANGE SPINAL SYSTEM Thoracolumbar /Lumbar Exposure and Preparation Screw Placement Convex Left Rod Placement Countertorsion Concave Lumbar Translation Final Deformity Correction LIV Horizontalization Additional Surgical Considerations

THORACOLUMBAR/LUMBAR 1 2 3 NOTE: Instrumented levels are based on Surgeon preference and patient pathology. This methodology manual is intended to be used as a guideline for correction techniques with the RANGE Spinal System. Exposure and Preparation Perform facetectomies throughout. Screw Placement Use MESA Polyaxial, Uniplanar or MESA 360 Screws at all levels. Confirm the screw heads are unlocked and all screws are at appropriate levels and aligned to accept the rod when applied. Convex Left Rod Placement Place the Deformity Crickets bilaterally (3A). These will provide translation of the screws and spine to the rod later. Pre-bend the rods in the physiological sagittal plane. 3A

Introduce the convex rod through the Deformity Crickets. Apply Cricket Extenders bilaterally. Do not tighten the Deformity Crickets as they are only meant to ensure screw capture at this point. They will be used later for translation correction of the spine and reduction of the rod to the screws. 4 Countertorsion Stabilize Upper Instrumented Vertebra (UIV) and Lowest Instrumented Vertebra (LIV) to prevent en bloc rotation and coupling of the spine. Derotate periapical screws around the rod by rotating concave and convex Cricket Extenders simultaneously. Continued on next page 41 RANGE SPINAL SYSTEM Rotate the rod into the sagittal plane (3B). This is preferably performed by using the Rod Rotation Wrench and a Vise Grip. The Deformity Crickets are then tightened sequentially to reduce the rod into the screws (3C). 3B 3C

THORACOLUMBAR/LUMBAR (CON T) NOTE: When performing countertorsion, Transverse Couplers may be used on periapical vertebrae to facilitate rotational maneuvers (4A).

43 RANGE SPINAL SYSTEM 4A

THORACOLUMBAR/LUMBAR 5 Concave Lumbar Translation Introduce the concave rod through the Deformity Crickets (5A). Translation is performed gradually by tightening the concave side Deformity Crickets (5B). By performing the translation simultaneously with several Deformity Crickets, the chance of screw pull-out and loss of fixation is reduced. The rod should be held in the physiological sagittal plane with the Rod Rotation Wrench or a Vise Grip. Once all Deformity Crickets are maximally tightened, the rod will be captured in each of the screw heads. The Superfly is used to create a partial lock of each of the fixation points (5C). If necessary, the rod contour may be adjusted using the Medial/ Lateral or In-situ Benders. 5A 5B 5A

45 RANGE SPINAL SYSTEM 5C

THORACOLUMBAR/LUMBAR 6 Final Deformity Correction Compression of the periapical convex lumbar screws is achieved prior to concave lumbar distraction. Compress or distract against a screw that has been buttressed with a DC Ring or Vise Grip. Remove the applied DC Rings (6A & 6B). NOTE: The surgeon may also perform compression and/or distraction prior to partial locking by releasing the Deformity Crickets one or two turns to achieve final deformity correction. This method employs a similar technique to that of a standard set screw system. 6A

7 LIV Horizontalization Confirm horizontal position of the Lowest Instrumented Vertebra (LIV) and fully lock these fixation points using the Quick Locker. Repeat final locking of each screw with the Quick Locker to confirm rigid fixation throughout (7A). Transverse Connector(s) may be applied to the construct, if indicated. Confirm at least 5 mm of rod length extends beyond the most proximal and distal screws. 47 RANGE SPINAL SYSTEM 6B 7A

Additional Surgical Considerations Include: a. Screws are more resistant to plowing through the pedicle during compression/ distraction maneuvers if the screw is moved caudally against the thicker bone of the caudal/foraminal aspect of the pedicle. b. Optional: In-situ bending of rod(s): i. Beginning at curve apex, Medial/Lateral Benders may be used to segmentally correct the deformity. ii. Minimize focal bending around a single screw to reduce the risk of bone failure. Placing Medial/Lateral Benders around at least two screws is preferred. iii. The pear-shaped screwdriver handle can be placed between the pivot points of the Medial/Lateral Benders to improve leverage when bending across a long segment. c. For rigid deformities consider coronal bending of the concave rod at the apex while the rod is partially locked. Maintain final rod position with the coronal benders and simultaneously apply the Quick Locker to final lock the screws.

49 RANGE SPINAL SYSTEM

www.k2m.com 2009 K2M, Inc. All rights reserved. K2-13-7021-01 Rev. 0 U.S. Patents 5,733286 amd 5,683,392 K2M, Inc. 751 Miller Drive SE, Suite F-1 Leesburg, Virginia 20175 USA PH 866.K2M.4171 (866.526.4171) FX 866.862.4144 Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands PH +31.70.345.8570 FX +31.70.346.7299

51 RANGE SPINAL SYSTEM Kyphosis (T1-L3) Scheuermann s Initial Considerations Screw Placement Bilateral Rod Placement Bilateral Compression T1-T2 (Proximal Foundation) Sequential Bilateral Rod Introduction Into Deformity Crickets Segmental Compression Toward Apical Vertebra LIV Horizontalization Additional Surgical Considerations

KYPHOSIS SCHEUERMANN S 1 2 NOTE: Instrumented levels are based on Surgeon preference and patient pathology. This methodology manual is intended to be used as a guideline for correction techniques with the RANGE Spinal System. Initial Considerations Perform wide facetectomies at all levels with excision of ligamentum flavum and multiple Ponte osteotomies symmetrically placed about the apex of the Kyphosis. Screw Placement Use MESA Polyaxial screws at the three most proximal levels (T1 to T3) for ease of rod attachment and establishment of the proximal foundation. Otherwise, use MESA Uni-Planar or MESA 360 Screws throughout the spine, particularly if scoliosis is also present. Confirm the screw heads are unlocked and all screws are at appropriate levels and aligned to accept the rod when applied. 3A

3 Bilateral Rod Placement Place Deformity Crickets bilaterally from T1 to T4. Introduce both rods utilizing the Deformity Crickets to seat the rods into the screw heads (3A). Partially lock these fixation points using the Superfly over the Deformity Crickets (3B). Remove all applied Deformity Crickets. Fully lock the T1 fixation points bilaterally with the Quick Locker to establish the proximal foundation of the deformity instrumentation (3C). 53 RANGE SPINAL SYSTEM 3B 3C

KYPHOSIS SCHEUERMANN S 4 Bilateral Compression T1-T2 (Proximal Foundation) Segmentally compress the fully locked T1 and partially locked T2 screws bilaterally (4A). Next, fully lock the T2 screws (4B). This sequence completes the proximal foundation of the reconstruction. 4A 4B

55 RANGE SPINAL SYSTEM

KYPHOSIS SCHEUERMANN S 5 Sequential Bilateral Rod Introduction Into Deformity Crickets Apply bilateral Deformity Crickets to the screws below T4 from proximal to distal to capture the rods (5A). Sequentially tighten the Deformity Crickets from proximal to distal with slow progression to translate the spine to the rod. This Deformity Cricket tightening and rod translation is completed gradually (5B). By performing the translation simultaneously with several Deformity Crickets, the chance of screw pull-out and loss of fixation is reduced. Once a given Deformity Cricket is maximally tightened, the rod will be captured in that screw head, and can be partially locked with the Superfly (5C). After partial locking is completed of four vertebral body segments, the Deformity Crickets may be removed and placed on the more distal screws to facilitate rod translation of those fixation points. 5A 5B

7 Segmental Compression Toward Apical Vertebra Fully lock apical screw with Quick Locker. Perform segmental periapical compression between fully locked screw and next partially locked screw (6A). Compress against a screw that has been buttressed with a DC Ring or Vise Grip. Work away from apex for maximum posterior vertebral shortening and closure of osteotomy sites. Remove the applied DC Rings. 57 RANGE SPINAL SYSTEM 5C

KYPHOSIS SCHEUERMANN S 6 Segmental Compression Toward Apical Vertebrae Fully lock apical screws with Quick Locker. Perform segmental periapical compression between a fully locked screw and the next partially locked screw (6A). Compress against a screw that has been buttressed with a DC Ring or Vise Grip. Work away from the apex for maximum posterior vertebral shortening and closure of osteotomy sites. Remove the applied DC Rings.

59 RANGE SPINAL SYSTEM 6A

KYPHOSIS SCHEUERMANN S 7 LIV Horizontalization Confirm horizontal position of the Lowest Instrumented Vertebra (LIV) and fully lock these fixation points using the Quick Locker. Repeat final locking of each screw with the Quick Locker to confirm rigid fixation throughout (7A). Transverse Connector(s) may be applied to the construct if indicated. Confirm at least 5 mm of rod length extends beyond the most proximal and distal screws.

61 RANGE SPINAL SYSTEM 7A

Additional Surgical Considerations Include: a. For severe and rigid deformities consider the use of a transverse connector proximally prior to apical and distal rod cantilever translation. Also perform PSO or apical osteotomies to facilitate curve correction. b. Selection of fusion levels should be the first lordotic lumbar level caudally, and T1 to T2 cephald. Anterior release and interbody distraction is seldom necessary with newer posterior shortening techniques (Ponte or pedicle subtraction osteotomies). Implant selection should favor curve magnitude and flexibility.

63 RANGE SPINAL SYSTEM

65 RANGE SPINAL SYSTEM Glossary

GLOSSARY IMPLANTS MESA POLYAXIAL SCREW MESA UNI-PLANAR SCREW MESA 360 SCREW NATURAL BRIDGE LP SEMI-ADJUSTABLE TRANSVERSE CONNECTORS NATURAL BRIDGE LP ADJUSTABLE TRANSVERSE CONNECTORS 5.5 mm RODS Titanium Alloy Cobalt Chrome: RANGE Rigid Rod (R 2 Rod)

67 INSTRUMENTS RANGE SPINAL SYSTEM DEFORMITY CRICKET 801-90066 CRICKET EXTENDER 801-90073 MANIPULATOR 801-90054 SUPERFLY 801-90060 QUICK LOCKER 801-90008 ROD ROTATION WRENCH 101-90259 VISE GRIP 101-90157 ROD HOLDER 1801-90006 PROVISIONAL SCREWDRIVER HANDLE 101-90186 PROVISIONAL SCREWDRIVER SHAFT 101-90101

GLOSSARY INSTRUMENTS RATCHETING ROD CUTTER 101-90194 TELESCOPING ROD CUTTER 101-90277 ROD PULLER PLUS 801-90070 DEFORMITY ROD BENDERS 101-90284 MEDIAL / LATERAL BENDERS 101-90229, 101-90230 IN-SITU BENDERS 101-90217, 101-90218 DC RING 101-90147 PARALLEL COMPRESSOR 801-90050 PARALLEL DISTRACTOR 801-90051 WEDGE DISTRACTOR 801-90026

69 RANGE SPINAL SYSTEM GUILDING REAMER 801-90048 TORSIONAL ROD REDUCER, RIGHT 101-90024 TORSIONAL ROD REDUCER, LEFT 101-90081 ADJUSTABLE AWL 101-90114 TRANSVERSE COUPLERS SMALL 801-90090 MEDIUM 801-90091 LARGE 801-90092

GLOSSARY DEFINITIONS APICAL* In a curve, the vertebra most deviated laterally from the vertical axis that passes through the patient s sacrum. DIRECT VERTEBRAL DEROTATION (DVD) The application of forces along the transverse plane on individual vertebrae. EN BLOC DEROTATION Manipulation of several vertebrae in tandem via derotation maneuvers. INFLEXION VERTEBRAE* The localized vertebra where curves change direction from convex to concave and vise versa. LOWEST INSTRUMENTED VERTEBRA (LIV) The lowest level in a deformity reconstruction that receives an implant. NEUTRAL VERTEBRA The most cephalad vertebra below the apex of the major curve without rotation. PERIAPICAL The vertebrae forming the apex of the deformity. Usually forms the stiffest segment on bending and may be comprised of three or more vertebrae. UPPER INSTRUMENTED VERTEBRA (UIV) The uppermost level in a deformity reconstruction that receives an implant. SEGMENTAL DEROTATION Manipulation of individual vertebra via derotation maneuvers. STABLE VERTEBRA The most cephalad vertebra below the major curve which is most closely bisected by the Central Sacral Vertical Line (CSVL). *From the SRS Glossary

71 RANGE SPINAL SYSTEM

MISSION Advancement of medical science and patient care through collaborative, evidence-based research to enhance treatment of complex spinal pathologies. Methods Supported by the CSSG.

3 RANGE SPINAL SYSTEM

www.k2m.com 2009 K2M, Inc. All rights reserved. K2-13-7021-01 Rev. 0 U.S. Patents 5,733286 amd 5,683,392 K2M, Inc. 751 Miller Drive SE, Suite F-1 Leesburg, Virginia 20175 USA PH 866.K2M.4171 (866.526.4171) FX 866.862.4144 Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands PH +31.70.345.8570 FX +31.70.346.7299