Technique Guide. NFlex. Semi-rigid rods for posterior lumbar stabilization.
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1 Technique Guide NFlex. Semi-rigid rods for posterior lumbar stabilization.
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3 Table of Contents Introduction NFlex 2 Indications and Contraindications 4 NFlex Principles 6 Surgical Technique Preoperative Planning 9 Patient Positioning 11 Insert Pedicle Screws 12 Insert Rod 13 Insert Locking Caps 18 Product Information Implants 21 Trial Implants 22 Instruments 23 NFlex Instrument Sets 24 Image intensifier control Warning This description alone does not provide sufficient background for direct use of the instrument set. Instruction by a surgeon experienced in handling these instruments is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please refer to: NFlex Technique Guide Synthes 1
4 NFlex. Semi-rigid rods for posterior lumbar stabilization. Pre-curved and straight rods for mono- and multi-segmental posterior stabilization with Click X or Pangea Dynamic 1 Solid 2 U4 3 1 Dynamic and solid ends A rod with transitional rigidity One solution for posterolateral fusion with dynamic stabilization 2 Titanium ring Allows for sliding and toggling coupled motion Sliding motion as ring slides up and down the core Toggling motion as ring toggles against the core 3 Polymer sleeve Polymer bumper that allows for controlled titanium ring motion in flexion, extension, lateral bending and axial rotation at the dynamic level 4 Titanium alloy core Tapered core design providing transitional rigidity 2 Synthes NFlex Technique Guide
5 Uninstrumented level Dynamic level Decreasing rigidity Rigid level NFlex Technique Guide Synthes 3
6 Indications and Contraindications The NFlex Stabilization System is a rod designed to be used with either the Pangea or Click X pedicle screw systems (please reference each specific Surgical Technique Guide for additional information). These pedicle screw systems are comprised of a variety of pedicle screw sizes and locking caps that can be uniquely fitted with specific instruments for each individual case. Intended purpose The NFlex Stabilization System is intended for use with pedicle screw* fixation in skeletally mature patients to provide controlled dynamic stabilization of the lumbosacral spine. Indications The NFlex Stabilization System can be used for the following indications: Spinal Stenosis with or without radiculopathy Degenerative Disc Disease (DDD) with or without retrolisthesis Soft disc protrusions Facet syndrome due to facet osteoarthritis Contraindications Do not implant in cases of: Severe osteoporosis* Spinal fracture or dislocation Spinal deformities Spinal tumor Infection Morbid Obesity (BMI > 40) Contraindications specific to the dynamic level Segmental instability Destabilizing decompression (e.g. greater than 50% facetectomy, laminectomy inducing sagittal or rotational instability) Isthmic and degenerative spondylolisthesis Previous lumbar level fusion attempt *Governed by the indications of the pertaining pedicle screw system. 4 Synthes NFlex Technique Guide
7 Patient exclusion recommendations In selecting patients for NFlex, the following exclusion criteria are important for the outcome and success of the procedure: Patients requiring multi-level correction in the sagittal or coronal plane Patients requiring corrections at the semi-rigid level Segments with gross translational or flexion/extension in stabilities at the semi-rigid level <11 mm between polyaxial screwheads at the semi-rigid level Patient s activity level, weight and musculoskeletal condition must be considered NFlex Technique Guide Synthes 5
8 NFlex Principles Principles of dynamic stabilization The NFlex Stabilization System enables dynamic stabilization of the posterior lumbar spine (1). To achieve successful outcomes with the NFlex Stabilization System, it is important to understand and consider the differences between rigid and dynamic stabilization. The principles of dynamic stabilization include: Decreased stiffness compared to traditional rigid stabilization Increased load sharing with surrounding anatomical structures 1 Dynamic constructs provide less resistance to spinal loading and motion, and warrant special patient selection and intraoperative handling consideration. The NFlex rod motion allows more load transmission to the anterior column compared to a rigid fusion. Combined posterolateral fusion with dynamic stabilization. Combined interbody fusion with dynamic stabilization. 6 Synthes NFlex Technique Guide
9 Function of the NFlex rod The main goal of the NFlex surgical technique is to implant the rod so that the patient can utilize the full range of motion and load-sharing capabilities of the device. To accomplish this: Implant the dynamic end in an unstressed, unloaded state to achieve a passive rod fit. Position the rods to complement the motion of the segment. 2 Preloading the dynamic end of the NFlex rod could compromise the dynamic performance of the titanium ring and polymer sleeve construct and overload the titanium core, causing the rod to fail. Both patient pathology and intraoperative technique can contribute to preloading the NFlex rod. The NFlex rod is in an unloaded (passive) state when there is no ring toggling and/or sliding relative to the core (2). Unloaded state Loaded state The NFlex rod should be inserted in an unloaded, passive state. NFlex Technique Guide Synthes 7
10 NFlex Principles Appropriate use of the NFlex rod Semi-rigid Level (Dynamic) Adjacent rigid level (Solid) 2nd rigid level (Solid) Correction of kyphosis (flat back) No Yes, if correction does not preload dynamic unit Yes, if correction does not preload dynamic unit Correction of sagittal or coronal alignment No Yes, if correction does not preload dynamic unit Yes, if correction does not preload dynamic unit Spondylolisthesis or retrolisthesis reduction No Yes, if correction does not preload dynamic unit and with anterior support only Yes Rod persuasion No Minimal Yes Segmental compression or distraction No Yes, if correction does not preload dynamic unit Yes Hypermobility (assessed by surgeon) No Yes Yes Facetectomy or facet insufficiency No No Yes Laminectomy No No Yes, only if adjacent segment is also fused Laminotomy Yes, but segment must be stable prior to implantation Yes Yes Disc height restoration Yes, with anterior support only Yes, if correction does not preload dynamic unit Yes Contributors to excessive rod loading: Patient pathology factors Sagittal or coronal spinal deformities Spondylolisthesis Facet insufficiency at the dynamic level Hypermobility at the dynamic level Intraoperative factors Improper patient positioning Rod persuasion Compression or distraction at the semi-rigid level Instability induced by laminectomy or facetectomy 8 Synthes NFlex Technique Guide
11 Preoperative Planning A detailed and correct assessment of the indication is the key for successful results using the NFlex stabilization system. If conservative treatment methods have failed to yield positive results, a diagnosis can be made on the basis of indication profile as to whether the use of NFlex could be a promising option for the patient in question. Basic diagnosis X-ray, anterior/posterior (AP) and lateral X-ray, flexion/extension and lateral inclination (patient standing) NFlex rods should be placed bilaterally only. The segment intended for semi-rigid stablization must provide enough stability to load share with the NFlex rod postoperatively. A solid rod should be used to stabilize any segment with questionable load sharing capabilities. A-P Lateral Note: Candidates for the NFlex rod should not require multilevel spinal correction in the sagittal or coronal plane or isolated correction at the semi-rigid level. Adult patients with surgically corrected spinal deformities are predisposed to return to their preoperative spinal alignment.* Using the NFlex rod to correct spinal deformities can cause excessive loading at the dynamic level and increase the risk of rod failure. Flexion Extension *C. Ponder, J. H. Dickson, P. R. Harrington, W. D. Erwin. (1975) Results of Harrington instrumentation and fusion in the adult idiopathic scoliosis patient. The Journal of Joint and Bone Surgery. 57: NFlex Technique Guide Synthes 9
12 Preoperative Planning Segmental instability The dynamic end of the NFlex rod is not designed to withstand the extreme loads that could be produced in highly unstable segments and should not be applied to segments with significant instability. 3 Instability may be associated with pre-existing degenerative conditions or induced intraoperatively. Examples of instability include: Facetectomy or significant facet insufficiency Laminectomy inducing sagittal or rotational instability Hypermobility (3) Extension Flexion Important: Surgeons should carefully consider if the spinal segment intended for dynamic stabilization will provide enough stability to load share with the NFlex rod postoperatively. Translational hypermobility. White lines represent translation of the superior body from extension to flexion. 10 Synthes NFlex Technique Guide
13 Patient Positioning Position the patient prone on the operating table, with the lumbar spine in a neutral position. Use a standing plain film to establish the appropriate spinal alignment. Lateral fluoroscopy may be used to confirm that the spinal alignment matches the preoperative film. Maintain this spinal alignment for the duration of the procedure. Verify the correct operative level(s) and expose using a standard approach to the posterior spine. Notes When implanting the NFlex rod, the patient s position on the operating table should match his / her natural pre - operative standing position. This allows the rod to remain in an unloaded passive state when the patient resumes a standing position postoperatively. When the NFlex rod is used as a standalone device to achieve fusion, do not attempt to alter spinal alignment through patient positioning. NFlex Technique Guide Synthes 11
14 Insert Pedicle Screws Care should be taken when inserting the screws to maximize the function of the dynamic end of the rod. 4 Guidelines for inserting screws at all levels: Use the longest appropriate screw lengths to allow for screw height adjustment during the rod insertion step. Place the screws as deep into the vertebral body as possible. Ensure that the polyaxial screwhead remains free to rotate in all planes. Guidelines for inserting screws at the dynamic level (4): Preserve the facet joints to ensure stability of the segment. Place the screws lateral to the facet joints, at a latero - medial trajectory. Screw positioning should be similar on both sides of the seg ment and facilitate parallel rod placement at the dynamic level. A minimum of 11 mm of spacing is required between the screwheads that form the semi-rigid level. When properly placed, screwheads should follow the natural spinal contour (a) and screws are perpendicular (b) to the contour (5). Confirm screw placement under fluoroscopy. 5 a Note: Use only Pangea and Click X implants and instruments with the NFlex rods. Use of other screw systems could cause failure. b Synthes NFlex Technique Guide
15 Insert Rod 1 Prepare rod Careful rod planning and preparation is essential for proper function of the NFlex rod. 2a Use NFlex trial implants to prepare NFlex curved rods, 40 mm 85 mm Instruments NFlex Trial Implants, 45 mm 85 mm Note: NFlex rods should be placed bilaterally only. Note: NFlex trial implants are for sizing only. Do not implant! c 6 The four NFlex trial implants correspond to the ten NFlex rods ranging in length from 40 mm to 85 mm. The colored bands on the trial implants (a) represent the implant sizes. Refer to the number above the colored band to determine the corresponding implant size (6). b b a The two thicker portions of the trial (b) represent the PCU (polycarbonate urethane) section of NFlex that cannot be placed within the screw heads. The area between corresponds to the titanium ring on the NFlex rod (c) where the screw head should be placed. NFlex Technique Guide Synthes 13
16 Insert Rod Select the appropriate NFlex trial rod that will span the screwheads. Insert the trial rod into the screwheads in the desired orientation. The trial rod should rest passively within each screwhead (7). 7 The screw height(s) may be adjusted to match the contour of the trial implant. Once a passive trial implant fit is achieved, determine the appropriate implant length. Select the shortest implant length that will fit entirely within the last screwhead of the construct, as indicated by the colored bands on the trial implant (d). If a passive trial implant fit cannot be achieved after the screw height(s) have been adjusted, use the alternative technique for preparing the rod using the NFlex bending template and NFlex straight rod, 150 mm (step 2b). Note: The NFlex straight rod, 150 mm should be used if rod bending is required to create a passive fit. d 14 Synthes NFlex Technique Guide
17 2b Use NFlex bending template to prepare NFlex straight rod, 150 mm a a 12 mm 11 mm Instrument Bending Template, for NFlex rods Contour template The NFlex bending template is designed to establish the contour for the NFlex straight rod, 150 mm. b The solid portion of the bending template represents the dynamic portion of the NFlex rod that cannot be contoured. The two thicker portions of the trial (a) represent the PCU section of NFlex that cannot be placed within the screw heads. The area between corresponds to the titanium ring (b) on the NFlex rod where the screw head should be placed. Place the bending template into the screw heads, taking care that the titanium ring fits freely Note: If adequate screwhead placement cannot be achieved at the dynamic level, the NFlex rod should not be implanted; a solid rod should be used. NFlex Technique Guide Synthes 15
18 Insert Rod 3 Contour rod 8 Instrument Rod Bender Hold the NFlex rod bender with the instrument markings facing toward you. Open the handles of the rod bender as wide as possible and insert the solid end of the rod into the left side of the bender (8). The rod will not advance into the bending head past the collar. This prevents bending of the dynamic end, which could damage the rod. Using the contoured bending template as a guide, position the portion of the rod to be contoured into the bending head (9). Slowly squeeze the handles of the rod bender together to contour the rod (10). 9 Open the handles to release the rod and reposition in increments down the rod to contour the rod to match the bend of the bending template. Do not reverse bend. Do not bend the rod by pulling the handles apart. Note: Use the NFlex rod bender to contour the NFlex rod. Contour only the solid end of the NFlex rod; contouring the dynamic end of the rod will damage the rod Synthes NFlex Technique Guide
19 4 Insert rod 11 Place the NFlex rod into the pedicle screwheads, ensuring that the screwheads do not contact the polymer sleeve. Fluoroscopy may be used to confirm proper alignment of the ring within the screwhead. Dynamic level The NFlex rod should rest passively in the screwheads that form the dynamic level and adjacent level to achieve a passive rod fit (11). If additional adjustment is required to achieve a passive fit, remove the rod and: adjust the screw height to match the contour of the rod, and/or carefully re-contour the rod. If a passive rod fit cannot be achieved at the dynamic level, the NFlex rod should not be implanted. Rod placement should complement the motion of the segment at the dynamic level. The dynamic end of the rods should be as parallel to each other as the anatomy permits. Notes Do not treat/reduce spondylolisthesis at the dynamic level. The solid portion of the NFlex rod can be used to treat/ reduce spondylolisthesis as long as reduction at the rigid level does not preload the rod. Do not use persuasion instruments such as rod pushers, rocker forks or rod persuaders to insert the NFlex rod into the screws that form the dynamic level. If necessary, gently persuade the rod into the screws outside of the dynamic level with a rod persuader. The ring must sit entirely within the screwhead (12). 12 Click X pedicle screw alignment Pangea pedicle screw alignment NFlex Technique Guide Synthes 17
20 Insert Locking Caps 1 Insert caps Pangea Install locking caps per the recommended Pangea surgical technique. Click X Instruments Locking Cap Insertion Tube Screw Driver for Click X Locking Cap, with knurled Handle 32 1 Using a screwdriver for the Click X locking cap, pick up a locking cap from the implant rack. Ensure the screwdriver tongs fit firmly into the slots of the locking cap. With the locking cap insertion tube in place, insert the locking cap and finger tighten with thumb and forefinger to capture the rod within the head. 2 Insertion order for locking caps. Note: Use of locking cap insertion tube ensures correct alignment and minimizes the risk of cross threading of the locking cap. Attach the locking cap to the screw that is adjacent to the ring 1, followed by the caps at the fusion levels 2. Correction manipulations at the fusion levels can now be performed. After correction has been made check that the rod sits into the saddle of the screw at the sliding ring with no preload. When this is achieved, attach the final locking cap 3, otherwise remove all locking caps and re-contour the road at the fusion levels to achieve a better fit. Note: Do not apply compression or distraction at the dynamic level. 18 Synthes NFlex Technique Guide
21 2 Final tightening caps Perform final tightening of the caps, starting with the locking cap directly adjacent to the sliding ring 1, then tighten the remaining caps in the fusion segments 2. The cap at the sliding ring 3 should always be tightened last. Ensure that the countertorque instrument remains stationary during the final tightening procedure. Rotating the handle can damage the NFlex rod. 2 1 Top loading Note: Apply locking torque using only the torque-limiting handle and countertorque instruments specific to the Click X or Pangea system and designed for use with NFlex rods. 3 Pangea Instruments Countertorque Instrument for Pangea (NFlex) T-Handle with Ratchet Wrench and with Torque Limiter, 10 Nm Stardrive Screwdriver Shaft, T25 (Pangea) Final tightening of Pangea construct. Pangea Load the countertorque instrument for Pangea over the screwhead from the top, with the gold handle pointed medial or lateral. Attach the 10 Nm T-handle with ratchet wrench to the T25 Stardrive screwdriver shaft and load it through the cannulation of the countertorque. Hold the countertorque stationary while turning the torque limiting handle to final tighten the cap. Pangea NFlex Technique Guide Synthes 19
22 Insert Locking Caps Click X Instruments Countertorque, for Click X Torque Limiting Handle, 7 Nm Screwdriver Shaft 3.5 mm, with Hexagonal Quick Coupling 6.0 mm, for Click X Optional Instrument Screwdriver Shaft Stardrive, T25, short, with Hexagonal Coupling for Pangea (for Click X Locking Cap Stardrive) Side loading Load the Click X countertorque around the screwhead from the medial or lateral direction (13). Attach the 7 Nm torque limiting handle to the 3.5 mm hexagonal screwdriver shaft and load it through the cannu - lation of the countertorque. Hold the countertorque stationary while turning the torque limiting handle to final tighten the cap. Click X Click X Synthes NFlex Technique Guide
23 Implants NFlex rods, sterile S 40 Length (mm) straight S S S S S 65 curved S S S S S Titanium NFlex Rod, 150 mm, sterile straight NFlex Technique Guide Synthes 21
24 Trial Implants NFlex Trial Implant, monosegmental, straight, length mm NFlex Trial Implant, monosegmental, curved, length mm NFlex Trial Implant, monosegmental, curved, length mm NFlex Trial Implant, monosegmental, curved, length mm 22 Synthes NFlex Technique Guide
25 Instruments Countertorque Instrument for T25, short, for Pangea Counter Torque, short, keyed for Click X Rod Bender Bending Template for Rods 6 mm, length 150 mm, for NFlex Locking Cap Insertion Tube, for Click X NFlex Technique Guide Synthes 23
26 NFlex Instrument Sets Sets NFlex Additional Instruments in Vario Case, for use with Click'X and Pangea NFlex Additional Instruments for use with Click X NFlex Additional Instruments for use with Pangea NFlex basic equipment for Pangea and Click X Vario Case Vario Case for NFlex Instruments, with Lid, without Contents Instruments NFlex Trial Implant, monosegmental straight, length mm NFlex Trial Implant, monosegmental curved, length mm NFlex Trial Implant, monosegmental curved, length mm NFlex Trial Implant, monosegmental curved, length mm Bending Template for Rods 6.0 mm, length 150 mm, for Nflex Rod Bender S S S S S S S S NFlex, curved, monosegmental, length 55 mm, PCU/TAV-Eli, sterile NFlex, curved, monosegmental, length 60 mm, PCU/TAV-Eli, sterile NFlex, curved, monosegmental, length 65 mm, PCU/TAV-Eli, sterile NFlex, curved, monosegmental, length 70 mm, PCU/TAV-Eli, sterile NFlex, curved, monosegmental, length 75 mm, PCU/TAV-Eli, sterile NFlex, curved, monosegmental, length 80 mm, PCU/TAV-Eli, sterile NFlex, curved, monosegmental, length 85 mm, PCU/TAV-Eli, sterile NFlex, straight, monosegmental, length 150 mm, PCU/TAV-Eli, sterile NFlex additional equipment for Pangea Counter Torque Instrument for T25, short Screwdriver Shaft Stardrive, T25, short, with Hexagonal Coupling T-Handle with Ratchet Wrench and with Torque Limiter, 10 Nm Torque-limiting Handle, 10 Nm, for Pangea (optional) Implants S S S NFlex, straight, monosegmental, length 40 mm, PCU/TAV-Eli, sterile NFlex, straight, monosegmental, length 45 mm, PCU/TAV-Eli, sterile NFlex, curved, monosegmental, length 50 mm, PCU/TAV-Eli, sterile NFlex additional elements for Click X Rod Pusher/Counter Torque, short, keyed Locking Cap Insertion Tube, for Click'X Screwdriver Shaft Stardrive, T25, short, with Hexagonal Coupling Screwdriver Shaft 3.5 mm, with Hexagonal Quick Coupling 6.0 mm Torque-limiting Ratchet Handle, 7 Nm Torque-limiting T-Handle, 7 Nm (optional) Note: For additional information, please refer to the package insert. 24 Synthes NFlex Technique Guide
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28 All technique guides are available as PDF files at DePuy Synthes Spine, a division of Synthes GmbH All rights reserved DSEM/SPN/0115/ /15
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