SURGICAL TECHNIQUE GUIDE

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1 SURGICAL TECHNIQUE GUIDE True Spinal Fixation System Surgical Technique Guide

2 TABLE OF CONTENTS Implants & Instruments 3 Supplemental Non-Disposable Instruments 13 True Rods Overview 17 Technique for Opening of Sterile Instruments 19 Surgical Technique: Preoperative Planning and Screw Placement 21 Indications & Preoperative Planning 22 Patient positioning and C-arm Imaging 23 Pedicle Preparation 24 Screw Insertion 26 Section A: One-Level Case Using the Dual Rod 28 Section B: One-Level Case Using the NXS Starter Rod 34 Section C: Multi-Level Case Using the NXS Rod 42 Explantation / Removal of the Dual Rod 48 Explantation / Removal of the NXS Rod 52

3 Implants & Instruments

4 IMPLANTS & INSTRUMENTS Catalogue Numbers True Polyaxial Pedicle Screw Description Catalogue Number SHORT REDUCTION SCREW LONG REDUCTION SCREW 5.5mm x 25mm True Polyaxial Pedicle Screw M mm x 30mm True Polyaxial Pedicle Screw M mm x 35mm True Polyaxial Pedicle Screw M mm x 40mm True Polyaxial Pedicle Screw M mm x 45mm True Polyaxial Pedicle Screw M mm x 50mm True Polyaxial Pedicle Screw M mm x 35mm True Polyaxial Pedicle Screw M mm x 40mm True Polyaxial Pedicle Screw M mm x 45mm True Polyaxial Pedicle Screw M mm x 50mm True Polyaxial Pedicle Screw M mm x 35mm True Polyaxial Pedicle Screw M mm x 40mm True Polyaxial Pedicle Screw M mm x 45mm True Polyaxial Pedicle Screw M mm x 50mm True Polyaxial Pedicle Screw M Polyaxial Pedicle Screw (5.5mm x 45mm shown) 4

5 IMPLANTS & INSTRUMENTS Catalogue Numbers NXS Rod Catalogue Numbers NXS Rod Rod Length Catalogue Number ###mm NXS Rod Rod Length Catalogue Number ###mm NXS Rod 25mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N mm NXS Rod N NXS Cap N NXS Rod NXS Cap in Delivery Tube 5

6 IMPLANTS & INSTRUMENTS Catalogue Numbers NXS Starter Rod Rod Length 25mm NXS Starter Rod 27mm NXS Starter Rod 30mm NXS Starter Rod 32mm NXS Starter Rod 35mm NXS Starter Rod 37mm NXS Starter Rod 40mm NXS Starter Rod 42mm NXS Starter Rod 45mm NXS Starter Rod 47mm NXS Starter Rod 50mm NXS Starter Rod Catalogue Number ###mm NXS Starter Rod N N N N N N N N N N N NXS Starter Rod 6

7 IMPLANTS & INSTRUMENTS Catalogue Numbers Straight Dual Rod Catalogue Numbers Lordotic Dual Rod Rod Length Catalogue Number ###mm Dual Rod Rod Length Catalogue Number ###mm Dual Rod Straight 25mm Dual Rod Straight 30mm Dual Rod Straight 35mm Dual Rod Straight 40mm Dual Rod Straight 45mm Dual Rod Straight 55mm Dual Rod Straight 65mm Dual Rod Straight 75mm Dual Rod Straight 85mm Dual Rod Straight 95mm Dual Rod Straight 105mm Dual Rod Straight 115mm Dual Rod Straight 125mm Dual Rod Straight 135mm Dual Rod Lordotic 25mm Dual Rod Lordotic 30mm Dual Rod Lordotic 35mm Dual Rod Lordotic 40mm Dual Rod Lordotic 45mm Dual Rod Lordotic 55mm Dual Rod Lordotic 65mm Dual Rod Lordotic 75mm Dual Rod Lordotic 85mm Dual Rod Lordotic 95mm Dual Rod Lordotic 105mm Dual Rod Lordotic 115mm Dual Rod Dual Rod Cap Straight 200mm Dual Rod Straight 300mm Dual Rod Straight Dual Rod Lordotic Dual Rod 7

8 IMPLANTS & INSTRUMENTS Catalogue Numbers Basic Instrument Kit Description Catalogue Number Basic Instrument Kit Tube Handle Driver T Handle Driver Pedicle Feeler Probe Rod Measuring Ruler Push Rod Basic Instrument Kit 8

9 IMPLANTS & INSTRUMENTS Tube Handle Driver T Handle Driver Pedicle Feeler Probe Rod Measuring Ruler Push Rod 9

10 IMPLANTS & INSTRUMENTS Catalogue Numbers Cannulated Tap Description Catalogue Number Cannulated Tap (6.5mm shown) 5.5mm Cannulated Tap mm Cannulated Tap mm Cannulated Tap Catalogue Numbers Pedicle Preparation Straight Paddle Description Gearshift Probe Straight Lenke Catalogue Number SL Curved Paddle Gearshift Probe Curved Lenke CL Straight Lenke Gearshift Probe Straight Paddle Gearshift Probe Curved Paddle SP CP Curved Lenke Jamshidi Needle SC J MIS Pedicle Prep Instrument MI Gearshift Probe (Curved Lenke shown) MIS Pedicle Prep Instrument Jamshidi Needle 10

11 IMPLANTS & INSTRUMENTS Long Guide Wire- 495mm Rod Benders Short Guide Wire- 267mm Catalogue Number True Rod Benders Catalogue Number Extended Guide Wire Description Catalogue Number Description Catalogue Number Rod Benders Short Guide Wire 267mm (2 pcs) Long Guide Wire- 495mm (2 pcs)

12 IMPLANTS & INSTRUMENTS Catalogue Numbers Removal Instrument Kit Description Catalogue Number Removal Instrument Kit Removal Instrument Removal Instrument Kit Torque Breaker Shaft Driver Torque Breaker Shaft Driver Removal Instrument 12

13 Supplemental Non-Disposable Instruments

14 APPENDIX: NON-DISPOSABLE INSTRUMENTS Catalogue Numbers Supplemental Non-Disposable Instrument Tray Non-Disposable True Instrument Kit Description Supplemental Non- Disposable Instrument Tray Catalogue Number N Non-Disposable Screw Handle Socket Drive Non Disposable Tube Handle Driver Non-Disposable T Handle Driver Non-Disposable Breakaway T-Handle 5.5 mm Non-Disposable Cannulated Tap 6.5 mm Non-Disposable Cannulated Tap 7.5 mm Non-Disposable Cannulated Tap Non-Disposable Pedicle Feeler Probe Non-Disposable Extended Shaft Driver Non-Disposable Rod Measuring Ruler Non-Disposable Extended Torque Breaker 1-4 SQ Drive Palm Ratchet Handle Driver 1-4 SQ Drive Torque Limited T Handle Driver Guide Wire 559mm (2 pcs) Bone Compass 14

15 IMPLANTS & INSTRUMENTS Non-Disposable Screw Handle Socket Drive Non-Disposable T Handle Driver Non-Disposable Pedicle Feeler Probe Non Disposable Tube Handle Driver Bone Compass Non-Disposable Rod Measuring Rule 15

16 IMPLANTS & INSTRUMENTS Non-Disposable Cannulated Tap (6.5mm shown) 1-4 SQ Drive Torque Limited T Handle Driver Non-Disposable Extended Shaft Driver Non-Disposable Extended Torque Breaker 1-4 SQ Drive Palm Ratchet Handle Driver 16

17 True Rods Overview

18 True Rod Options Dual Rod Dual Rod Caps loaded on Dual Rod See Section A: Placement of Dual Rod NXS Starter Rod Unthreaded on both ends See Section B: Placement of NXS Starter Rod NXS Rod Threaded on one end, unthreaded on the opposite end See Section C: Placement of NXS Rods 18

19 Technique for Opening of Sterile Instruments

20 TECHNIQUE FOR OPENING OF STERILE INSTRUMENTS True Sterilization The True Spinal Fixation System is a single-use, pre-sterilized spinal fixation system True is sterilized using gamma irradiation and is packaged in either Tyvek pouches or PETG trays. Sterile Package Opening The recommended technique for transferring the instruments to the surgical field is for a nurse or surgical technician outside of the sterile field to open the tray and present the sterile contents to a second nurse or surgical technician inside the sterile field will remove the tray contents in a sterile fashion. Dumping the tray contents onto the sterile field is not recommended. 20

21 Surgical Technique Preoperative Planning and Screw Placement

22 INDICATIONS & PREOPERATIVE PLANNING Indications The True Spinal Fixation System is intended for posterior, non-cervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion. Preoperative Planning Preoperative planning should include determination of the size and inclination angle of each pedicle in the surgical construct through a careful review of the patient s plain radiographs, CT, and/or MRI studies. The length and diameter of each pedicle screw in the surgical construct should be determined. In addition, the overall number of pedicle screws and approximate size and number True Rods should also be determined. The surgeon should verify the availability of all the required surgical implants and single-use instrument kits prior to commencing with surgery. Fig. 1a Fig. 1b Fig. 1a and Fig. 1b The width and inclination angle of each pedicle in the planned surgical construct can be measured from preoperative imaging studies (i.e. CT or MRI scans). 22

23 POSITIONING & C-ARM IMAGING Patient Positioning & Setup The patient is positioned prone on a radiolucent spinal frame. The abdomen should be free of compression and all bony prominences should be padded. Access for the C-arm mobile fluoroscopy unit should be ensured. Fluoroscopic Views The fluoroscopic views used for implantation of the True Spinal Fixation System include the true anteroposterior (AP) view, the true lateral view (Lat) and the en face view (en face). Fig. 2a True AP View In a properly aligned true AP view, the superior endplate appears as a single radiopaque line and the pedicles are located immediately caudal to the superior endplate. The spinous process is equally spaced between the right and left pedicles (see Fig. 2a). In a properly aligned true lateral view, the pedicles are superimposed and the posterior and superior cortex of the vertebral body project as a single radiopaque lines (see Fig. 2b). Fig. 2b True Lateral View To obtain the en face view, begin with a properly aligned true AP view and then rotate the C-arm towards the side of the pedicle of interest until beam is aligned with the central axis of the pedicle. In a properly aligned en face view, the medial border of the pedicle lines up with the medial border of the superior articular process (see Fig. 2c). Fig. 2c En Face View 23

24 PEDICLE PREPARATION SURGICAL TECHNIQUE Pedicle Preparation Establishing a Pedicle Passage The True Spinal Fixation System contains a Gearshift Probe available in the following styles: Straight Lenke Curved Lenke Straight Paddle Curved Paddle After exposure of the bony anatomy at the pedicle entry site, a small pilot hole can be made with an appropriate instrument such as a high speed drill. The tip of the Gearshift Probe is inserted into the pilot hole and aligned with the trajectory of the pedicle (see Fig. 3). Fluoroscopic imaging can be utilized to confirm the position of the Gearshift Probe. Using gentle downward pressure and simultaneous back and forth rotation of the Gearshift Probe, the instrument is advanced through the pedicle into the vertebral body. The instrument should traverse the pedicle in a smooth fashion with moderate resistance. The depth of insertion of the Gear Shift Probe can be determined from the depth marks on the shaft of the instrument. Correct position of the Gearshift Probe can be confirmed with fluoroscopy. Fig. 3 Preparing a pedicle passage with the Gearshift Probe. 24

25 PEDICLE PREPARATION SURGICAL TECHNIQUE Verify Pedicle Passage The Pedicle Feeler Probe is used to palpate the walls and floor of the pedicle passage to ensure the bony pedicle passage is intact. Continuous bony walls and an intact pedicle floor should be confirmed during this step (see Fig. 4). Tap the Pedicle Passage (Optional) Although the True Polyaxial Pedicle Screws are self-tapping, some surgeons prefer to tap the pedicle passage, especially when the patient is found to have hard bone. The True system contains 5.5mm, 6.5mm, and 7.5mm Cannulated Taps to assist in preparation of the pedicle passage. Fig. 4 Palpation of the walls and floor of the pedicle passage with the Pedicle Feeler Probe. The Cannulated Tap is threaded into the pedicle passage, maintaining the trajectory of the pedicle (see Fig. 5). Tapping can be done over the long guide wire (495mm) if desired. Depth of tapping can be determined by depth marks on the side of the tap or by lateral fluoroscopy. Fig. 5 Tapping the pedicle passage using the Cannulated Tap. 25

26 SCREW INSERTION SURGICAL TECHNIQUE Screw Insertion Initial Insertion of the Pedicle Screw After removing the Polyaxial Pedicle Screw from the sterile tray, the pedicle screw can be threaded into the prepared pedicle passage for the first few turns using the ribbed top end of the screw assembly. Final Insertion of the Pedicle Screw Using the Tube Handle Driver When resistance is encountered during initial insertion of the pedicle screw, the surgeon should attach the Tube Handle Driver to the back end of the Pedicle Screw Assembly (see Fig. 6). Using the Tube Handle Driver, additional torque can be applied to the pedicle screw for final seating of the screw. A useful technique is to rotate the larger diameter portion of the handle with one hand while holding the thinner diameter (top section) of the Tube Handle Driver with the other hand to assist in alignment of the screw during insertion. Fig. 6 Assembly of the Tube Handle Driver onto the Polyaxial Pedicle Screw. 26

27 SCREW INSERTION SURGICAL TECHNIQUE Insert the Pedicle Screw Insert the pedicle screw to the desired depth by rotating the Tube Handle Driver in a clockwise direction while maintaining the proper trajectory of the pedicle passage (see Fig. 7). Remove the Tube Handle Driver by stabilizing the plastic assembly of the pedicle screw with one hand while gently rocking the Tube Handle Driver back and forth with the other hand to release the instrument. This sequence of pedicle preparation and screw insertion is repeated for each pedicle screw in the construct. When the pedicle screws have been placed, the surgeon should choose the True System rod option that best fits the patient s individual anatomy. Fig. 7 Insertion of the pedicle screw using the Tube Handle Driver. 27

28 Surgical Technique Section A: Placement of the Dual Rod

29 ROD MEASUREMENT, SELECTION, & CONTOURING SURGICAL TECHNIQUE Rod Measurement Measure the correct rod size by holding the Breakaway Shafts of the pedicle screws perfectly parallel. Place the Rod Measuring Ruler over the Breakaway Shafts with one Breakaway Shaft through the hole and the second Breakaway Shaft through the slot of the Rod Measuring Ruler. Read the correct rod length from the ruler using the Dual Rod scale (see Fig. 8). Rod Selection Select the rod size that is closest to the measured length from the Rod Measuring- Ruler. Lordotic Dual Rods are available in 5 mm increments from 35 mm to 55 mm and 10 mm increments from 65 mm to 115 mm. In addition, straight Dual Rods are available in 5 mm increments from 35 mm to 55 mm and 10 mm increments from 65 mm to 135 mm, as well as 200 mm and 300 mm lengths. Fig. 8 Measuring the rod size with the Rod Measuring Ruler. Open sterile packaged Dual Rod Caps in a sufficient quantity to match the pedicle screws in the construct. Rod Contouring Dual Rods may be contoured as needed to accommodate the sagittal contour of the construct using the True Rod Benders (Fig. 9). NOTE Dual Rod Caps must be off the Dual Rod prior to rod contouring. Fig. 9 Dual Rods contouring with Rod Benders 29

30 ROD PLACEMENT SURGICAL TECHNIQUE Construct with Dual Rod The Dual Rod Caps should be loaded onto the Dual Rod in equivalent quantity for the pedicle screws on one side of the construct. The Dual Rod and Caps should be top loaded onto the Breakaway Shafts. Start with the Breakaway Shafts in a roughly parallel orientation. Insert one Breakaway Shaft through each of the Caps (see Fig. 10). With the soft tissues properly retracted, the Dual Rod is pushed down over the Breakaway Shafts until the Caps meet the threaded portion of the Breakaway Shafts. A useful tip is to use the T Handle Driver to push down over the Breakaway Shaft onto the top of each Cap sequentially to assist with delivery of the Dual Rod. Fig. 10 Placement of the Dual Rod over the Breakaway Shafts. 30

31 CONSTRUCT TIGHTENING SURGICAL TECHNIQUE Provisional Tightening of the Construct With the Dual Rod in contact with the threaded portion of the Breakaway Shafts, the T Handle is placed over the first Breakaway Shafts and turned in a clockwise direction to capture the threads and seat the Cap to the Pedicle Screw. When seated, the Breakaway Shaft is turned 1/4 turn in a counterclockwise direction to maintain the polyaxial motion of the Breakaway shafts. This is repeated for each of the Caps in the construct. Final Tightening of the Construct Final tightening is accomplished by placing the Tube Driver over the Breakaway Shaft to capture and counter-torque the Cap, while the T Handle Driver is placed through the Tube Driver to engage and tighten the Breakaway Shaft. Hold the Tube Driver in a fixed position while turning the T Handle Driver in a clockwise direction until the Breakaway Shaft breaks free. Repeat the final tightening maneuver for each Pedicle Screw in the construct. Fig. 11 Final tightening of the construct. 31

32 SURGICAL TECHNIQUE Remove the Breakaway Shaft from the T Handle Driver In most cases, the surgeon can grasp the end of the Breakaway Shaft and remove it from the end of the T Handle Driver. If the Breakaway Shaft cannot be grasped, use the Push Rod to push the Breakaway Shaft out of the T Handle Driver until it can be grasped and removed. (see Fig. 12). Fig. 12 Use of the Push Rod to remove the Breakaway Shaft remnant. 32

33 CLOSURE & AFTERCARE SURGICAL TECHNIQUE Closure & Aftercare The surgical incisions should be closed in a routine fashion according to the surgeon s preference. Aftercare and radiographic surveillance are conducted according to the surgeon s standard protocols. Fig. 13 Completed True multi-level construct with True Dual Rods. 33

34 Surgical Technique Section B: Placement of the NXS Starter Rod

35 ROD MEASUREMENT, SELECTION, & CONTOURING SURGICAL TECHNIQUE Measure Rod Size To measure the correct size of NXS Starter Rod, the Breakaway Shafts of the pedicle screws at the adjacent levels should be held perfectly parallel. Place the Rod Measuring Ruler over the Breakaway Shafts with one Breakaway Shaft through the hole and the second Breakaway Shaft through the slot of the Rod Measuring Ruler. Read the correct rod length from the ruler using the NXS scale (see Fig. 14). Fig. 14 Measuring the rod size with the Rod Measuring Ruler. Select Rod Select the rod size that is closest to the measured length. NXS Starter Rods are available in 2.5mm increments from 25mm- 50mm sizes. NXS Rod Contouring (Optional) In most situations, contouring of the True NXS Rods is unnecessary. However, if substantial lordosis of the segment is required, contouring of the True NXS Rod can be performed. Rod contouring is achieved using the Rod Benders to enhance the sagittal contour of the rod as required (see Fig. 15). Fig. 15 Contouring True NXS Rod with the Rod Benders. 35

36 ROD PLACEMENT SURGICAL TECHNIQUE Single-Level Construct with NXS Rods Place Rod Place the selected NXS Starter Rod over the Breakaway Shafts of the Pedicle Screws (Fig 16). Next, push the Starter Rod down the Breakaway Shaft until it contacts the upper portion of the pedicle screw. The T Handle Driver may be used to provide downward pressure to push the NXS Starter Rod to the appropriate depth (see Fig. 17). Fig. 16 True NXS Starter Rod placement. Fig. 17 Use of the T Handle Driver to apply downward pressure to seat the NXS Starter Rod. 36

37 ROD PLACEMENT SURGICAL TECHNIQUE Placement of Cap At each end of the construct, a NXS Cap is delivered using the Cap Delivery Tube (see Fig. 18). The Cap is first placed over the Breakaway Shaft and push down to reach the threaded portion of the shaft. Next, the T Handle Driver is placed inside the Cap Delivery Tube over the Breakaway Shaft and seated. The Cap is then held steady while the Breakaway Shaft is rotated using the T Handle Driver in a clockwise direction until the Cap tightens against the True NXS Rod. The Breakaway Shaft is then rotated 1/4 turn counter-clockwise to keep the polyaxial motion of the Breakaway Shafts intact (see Fig. 19). Fig. 18 NXS Cap & Cap Delivery Tube This sequence for NXS Cap placement is then repeated at the opposite end of the construct. Fig. 19 Tightening of the NXS Cap using the T Handle Driver placed through the Cap Delivery Tube. 37

38 CONSTRUCT TIGHTENING SURGICAL TECHNIQUE Final Tightening of the Construct Keep the Cap Delivery Tube engaged to the Cap. Place the T Handle Driver through the Cap Delivery Tube to engage the Breakaway Shaft (see Fig. 20). Ensure the T Handle Driver is fully seated prior to turning the Breakaway Shaft. The Cap Delivery Tube is held steady with firm downward pressure on the top of the Cap while the T Handle Driver is turned in a clockwise direction. When the final tightening torque has been achieved, the surgeon will feel a snap as the Breakaway Shaft is released. Both instruments are then lifted away from the construct and the Breakaway Shaft is removed. Fig. 20 Use of the T Handle Driver to final tighten the Breakaway Shaft. The surgeon should repeat this sequence for opposite end of the construct (see Fig. 21). Fig. 21 The Cap is held steady with the Cap Delivery Tube while the T handle Driver is used to turn the Breakaway Shaft clockwise. 38

39 CONSTRUCT TIGHTENING SURGICAL TECHNIQUE Correcting a Bent Breakaway Shaft If the Breakaway shaft should be bent due to turning of the Shaft when the T Handle is not fully seated, this can be corrected by turning the Breakaway Shaft is a clockwise direction while pushing downward on the T Handle Driver until the bend is aligned and the T Handle driver will fully seats on the Breakaway Shaft (see Fig. 22). With the T Handle Driver fully seated, the final tightening maneuver can be performed as described on page 38. Fig. 22 To realign a bent Breakaway Shaft, place the T Handle over the Breakaway Shaft and push downward while turning the T Handle Clockwise until the T Handle fully seats on the Breakaway Shaft. 39

40 CLOSURE & AFTERCARE SURGICAL TECHNIQUE Closure & Aftercare The surgical incisions should be closed in a routine fashion according to the surgeon s preference. Aftercare and radiographic surveillance are conducted according to the surgeon s standard protocols. Fig. 23 Completed True one-level construct with NXS Starter rods. 40

41 Surgical Technique Section C: Placement of the NXS Rods

42 NXS ROD TYPES SURGICAL TECHNIQUE There are two types of NXS rods that are used with a multi-level construct (see Fig. 24 and 25): the NXS Starter Rod and the NXS Rod. Always begin rod placement in a multi-level construct using the NXS Starter Rod. After the initial rod has been placed, all subsequent rods will be NXS Rods (see Fig 26). This arrangement will provide a Cap at each end of the construct. It is important that at each pedicle screw, the unthreaded portion of the rod is overlapped by a threaded portion of the rod (see Fig. 26) This arrangement is required for proper tightening of the construct. Fig. 24 NXS Starter Rod. notice that both ends are unthreaded. Fig. 25 NXS Rod notice that one end is threaded end and other end is unthreaded. At the ends of the construct, the unthreaded portions of the rods will be overlapped by Caps (see Fig. 26). Fig. 26 At each screw, the threaded end must overlap the unthreaded end. 42

43 ROD MEASUREMENT & SELECTION SURGICAL TECHNIQUE Measure Rod Sizes Rod measurement is identical to the technique described for a single level construct. Hold the Breakaway Shafts of the pedicle screws at the end segment of the construct perfectly parallel (see Fig. 27). Place the Rod Measuring Ruler over the Breakaway Shafts for the first segment of the construct with one Breakaway Shaft through the hole and the second Breakaway Shaft through the slot of the Rod Measuring Ruler. Read the correct rod length from the ruler (see Fig. 27). Select the rod size that corresponds to the measured length. For lumbar constructs, choose the shorter sized rod in the event that the length measurement falls between sizes. Remember that the first rod to be selected will be a NXS Starter Rod. Repeat this measuring strategy for each level of the construct to select the correct sized NXS rods. Rod contouring can be performed, if required according to the technique described herein. Fig. 27 Measuring the rod size with the Rod Measuring Ruler. 43

44 SURGICAL TECHNIQUE Placement of NXS Rods in a multi-level construct Rods should be placed sequentially, starting with the correct length NXS Starter Rod. Place the NXS Starter Rod over the Breakaway Shafts of the Pedicle Screws at the first segment in the construct (see Fig. 28). Push the Starter Rod down to contact the upper portion of the pedicle screws. The T Handle Driver may be placed over the Breakaway Shaft to assist in the delivery of the NXS Starter Rod. Next, a NXS Rod is placed with the threaded side of the rod on top of unthreaded end of the NXS Starter Rod at the junctional level. The NXS Rod is pushed down to contact the threaded portion of the junctional Breakaway Shaft. The junctional Breakaway Shaft is then rotated clockwise using the T Handle Driver to secure the junction of the two rods. Once the Breakaway Shaft is tight, back off 1/4 turn to maintain the polyaxial motion of the Breakaway Shaft which will assist in aligning the construct (see Fig. 29). Repeat this sequence, adding a NXS rods at each level until the construct is complete. Fig. 28 True NXS Rod placement in a multi-level construct. Notice the threaded end of the NXS rod is placed over the unthread end of the NXS Starter Rod at the junctional level. Fig. 29 Use of the T Handle Driver to rotate the Breakaway Shaft for tightening of the NXS Rod over the NXS Starter Rod. 44

45 ROD PLACEMENT SURGICAL TECHNIQUE Cap Placement At each end of the construct, a NXS Cap is delivered using the Delivery Tube. The Cap is first placed over the Breakaway Shaft and pushed down to reach the threaded portion of the shaft. Next, the T Handle Driver is placed inside the Cap Delivery Tube over the Breakaway Shaft and seated. The Cap is then held steady while the Breakaway Shaft is rotated using the T Handle Driver in a clockwise direction until the Cap tightens against the Rod. The Breakaway Shaft is then rotated 1/4 turn counter-clockwise to keep the polyaxial motion of the Breakaway Shafts intact. This sequence for NXS Cap placement is repeated on the opposite end of the construct. (see Fig. 30 and 31) Fig. 30 Placement of NXS Cap Fig. 31 Tightening of NXS Cap using the T Handle Driver 45

46 CONSTRUCT TIGHTENING SURGICAL TECHNIQUE Final Tightening of the Construct When the Rods and Caps have been delivered, the final tightening maneuver begins, working from the middle of the construct outward towards the ends of the construct (see Fig. 32). This tightening order provides the best alignment of the construct. The Tube Handle Driver is first placed over the Breakaway Shaft and engaged to the top of the NXS Rod. The T Handle Driver is placed through the Tube Handle Driver to capture the Breakaway Shaft. The Tube Handle Driver should be held steady with firm downward pressure on the top of the construct while the T Handle Driver is turned in a clockwise direction. When the final tightening torque has been achieved, the surgeon will feel a snap as the Breakaway Shaft is released. Both drivers are then lifted away from the construct and the Breakaway Shaft is removed. The surgeon should repeat this sequence for each pedicle screw in the construct, working from the center of the construct to the edges (see Fig. 32). Fig. 32 Final tightening sequence for the construct 46

47 CLOSURE & AFTERCARE SURGICAL TECHNIQUE Closure & Aftercare The surgical incisions should be closed in a routine fashion according to the surgeon s preference. Aftercare and radiographic surveillance are conducted according to the surgeon s standard protocols. Fig. 33 Completed True NXS multi-level construct. 47

48 Surgical Technique Removal of the Dual Rod

49 IMPLANT REMOVAL Implant Removal For removal of True Dual Rod implants, the Removal Instrument Kit is utilized. First, the True Dual Rod Caps should be loosened. To achieve this, the Torque Breaker is placed through the Removal Instrument and engaged to the Breakaway remnant. The Removal Instrument is engaged to the Cap (see Fig. 34). With firm downward pressure, the Torque Breaker is rotated in a counter-clockwise direction while holding the Cap steady until the Breakaway Shaft remnant begins to turn. Repeat this loosening maneuver for each Cap in the construct. Fig. 34 Sectional view showing the Torque Breaker engaging the Breakaway Shaft remnant and the Removal Instrument engaging the Cap during Cap removal. Next, the Shaft Driver is engaged to the slot in the Breakaway Shaft remnant. The Breakaway Shaft remnant is turned in a counter clockwise direction to release the Cap. Repeat this sequence for each of the Caps in the construct. The Dual Rod and Caps can now be lifted away from the pedicle screws. Fig. 35 Removal of the Cap and Rods. 49

50 IMPLANT REMOVAL Pedicle Screw Removal Remove each pedicle screw in the construct by engaging the Removal Instrument to the top of the pedicle screw and rotating the pedicle screw in a counter-clockwise direction with firm downward pressure (see Fig. 38). Fig. 38 Use of the Removal Instrument to remove the pedicle screws. 50

51 Surgical Technique Removal of the NXS Rods

52 IMPLANT REMOVAL Implant Removal For removal of True NXS Rods, the Removal Instrument Kit is utilized. The loosening sequence for the True NXS system should begin at the edges of the construct and work towards the middle of the construct. First, the True NXS Caps at each end of the construct are loosened and removed. To achieve this, the Torque Breaker is placed through the Removal Instrument and engaged to the Breakaway remnant. The Removal Instrument is engaged to the Cap (see Fig. 39). With firm downward pressure, the Torque Breaker is rotated in a counterclockwise direction while holding the Cap steady. Fig. 39 Sectional view showing the Torque Breaker engaging the Breakaway Shaft remnant and the Removal Instrument engaging the Cap during Cap removal. Fig. 40 Removal of the Cap. 52

53 IMPLANT REMOVAL Implant Removal (cont.) Next, loosen the middle levels of the construct. To achieve this, the Removal Instrument is engaged to the top of the True NXS Rod and the Torque Breaker is placed through the Removal Instrument and engaged to the top of the Breakaway Shaft remnant. Using firm downward pressure, the Torque Breaker is rotated in a counterclockwise direction while holding the Removal Instrument steady until the Breakaway Shaft remnant rotates freely (see Fig. 41). Repeat this loosening maneuver at each level of the construct working from the outside edges of the construct towards the middle of the construct. When each Breakaway Shaft remnant in the construct has been loosened with the Torque Breaker, the Shaft Driver can be used to release the True NXS Caps and True NXS Rods. The Shaft driver is engaged sequentially into the slot at the top of each of the Breakaway Shaft remnants. The Breakaway Shaft remnants are rotated counter-clockwise until the True NXS Cap and True NXS Rods have been released from the pedicle screws (see Fig. 42). Note that the True NXS Cap must be held with the Removal Instrument or another surgical instrument to prevent Cap rotation during this maneuver. The Rods and Caps are then removed from the surgical site. Fig. 41 Sectional view showing the Torque Breaker engaging the Breakaway Shaft remnant with the Removal Instrument engaged to the NXS rod during initial loosening. Fig. 42 Sectional view showing use of the Shaft Driver to release the True NXS Cap. 53

54 IMPLANT REMOVAL Pedicle Screw Removal Remove each pedicle screw in the construct by engaging the Removal Instrument to the top of the pedicle screw and rotating the pedicle screw in a counter-clockwise direction with firm downward pressure (see Fig. 43). Fig. 43 Use of the Removal Instrument to remove the pedicle screws. 54

55 Limited Warranty and Disclaimer: Innovative Surgical Designs, Inc. products are sold with a limited warranty to the original purchasers against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. This surgical technique guide is shown for instructive purposes only. The actual technique used during surgery will be determined by the surgeon using his or her medical expertise to determine the best course of treatment for each patient. Innovative Surgical Designs, Inc S. Walnut St. Bloomington, IN True Spinal Fixation System STG Rev D

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