2.7 mm/3.5 mm LCP Distal Fibula Plate

Transcription

1 Part of the DePuy Synthes Locking Compression Plate (LCP ) System 2.7 mm/3.5 mm LCP Distal Fibula Plate Surgical Technique

2 Table of Contents Introduction 2.7 mm/3.5 mm LCP Distal Fibula Plates 2 AO Principles 4 Indications 5 Surgical Technique Preparation 6 Reduce Distal Fibula 8 Insert and Position Plate 9 Distal Screw Insertion 10 Shaft Screw Insertion 13 Confirm Reduction and Fixation 15 Implant Removal 16 Product Information Implants 17 Instruments 19 Set List 20 MR Information The 2.7 mm/3.5 mm LCP Distal Fibula Plates System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the 2.7 mm/3.5 mm LCP Distal Fibula Plates System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Image intensifier control 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 1

3 2.7 mm/3.5 mm LCP Distal Fibula Plates. Part of the DePuy Synthes Locking Compression Plate (LCP) System. The 2.7 mm/3.5 mm LCP Distal Fibula Plates are part of the DePuy Synthes locking compression plate system that merges locking screw technology with conventional plating techniques. The plates are available in stainless steel and titanium and feature an anatomic shape and profile, both distally and along the fibular shaft. The Combi holes in the LCP Plate shaft combine a dynamic compression unit (DCU) hole with a locking screw hole. Combi holes provide maximum flexibility with the options of axial compression and locking capability throughout the length of the plate shaft. K -wire holes accept K- wires (up to 2.0 mm) to temporarily fix the plate to the distal fibula, to temporarily reduce articular fragments, and to confirm the location of the plate, relative to the distal fibula. Fixation with the 2.7 mm/3.5 mm LCP Distal Fibula Plates provides the same benefits of traditional plate fixation methods, with a few important improvements. Locking screws provide the ability to create a fixed-angle construct while using standard AO plating techniques. The ability to place locking screws is especially important in osteopenic bone, short bone fragments, and multifragment fractures, where screw purchase is compromised. These screws do not rely on plate- to- bone compression to resist patient load, but function similarly to multiple, small, angled blade plates. Note: For information on fixation principles using conventional and locked plating techniques, please refer to the Small Fragment Locking Compression Plate (LCP) Technique Guide. 2 DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

4 2.7 mm/3.5 mm LCP Distal Fibula Plates. Part of the DePuy Synthes Locking Compression Plate (LCP) System. 2.7 mm/3.5 mm LCP Lateral Distal Fibula Plate Five coaxial distal holes accept 2.4 mm and 2.7 mm locking and cortex screws to provide multiple screw options Anatomically shaped Combi holes in shaft accept 3.5 mm locking screws, 3.5 mm cortex screws, and 4.0 mm cancellous bone screws Recesses for screwheads in coaxial holes minimize screw prominence to create a low-profile construct Four K-wire holes in the head accept 2.0 mm K-wires 2.7 mm/3.5 mm LCP Posterolateral Distal Fibula Plate Six round locking holes and two coaxial holes accept 2.4 mm and 2.7 mm locking and cortex screws to provide multiple screw options Combi holes in shaft accept 3.5 mm locking screws, 3.5 mm cortex screws, and 4.0 mm cancellous bone screws Anatomically shaped Recesses for screwheads in coaxial holes minimize screw prominence to create a low-profile construct Screw profiles in coaxial hole 2.4 mm cortex screw 2.7 mm cortex screw 2.7 mm locking screw 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 3

5 AO Principles AO PRINCIPLES In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation. 1,2 In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation 1, 2. 4_Priciples_03.pdf :08 Anatomic Anatomic reduction reduction Fracture Fracture reduction reduction and and fixation fixation to to restore restore anatomical anatomical relationships. relationships. 1 2 Stable Stable fixation fixation Fracture Fracture fixation fixation providing providing absolute absolute or relative or relative stability, stability, as required as by the required patient, by the the injury, patient, and the the injury, personality and the personality of the fracture. of the fracture. Early, Early, active mobilization Early Early and and safe safe mobilization and rehabilitation of of the injured part and and the the patient as as a whole. 4 3 Preservation Preservation of of blood blood supply supply Preservation Preservation of of the the blood blood supply supply to to soft soft tissues tissues and and bone bone by by gentle reduction gentle reduction techniques techniques and and careful careful handling. handling. 1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer-Verlag; Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal 2nd ed. Stuttgart, New York: Thieme; Fixation. 3rd ed. Berlin Heidelberg New York: Springer Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

6 Indications The 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies and nonunions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone. 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 5

7 Preparation The techniques for implanting the lateral and posterolateral distal fibula plates are similar. The following describes implantation of a lateral plate. 1 Preoperative planning Required set / Small Fragment LCP Instrument and Implant Set, with self-tapping screws (stainless steel or titanium) Complete the preoperative radiographic assessment and plan. Determine plate length and distal screw locations to ensure proper plate selection and position, and screw placement in the distal fibula. 6 DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

8 Preparation 2 Position patient Position the patient supine with a sandbag (bump) underneath the buttock of the affected side. This allows the foot to lie in a neutral position and prevents the normal external rotation of the leg. Elevate the leg on a padded rest with the knee slightly flexed to assist placement in a neutral position. Visualization of the distal fibula under fluoroscopy in both the lateral and AP views is recommended. Note: The direction of the locking screws is determined by the design of the plate, based on the average anatomy of the distal fibula. If manual contouring of the plate in the metaphyseal area is necessary, or if the patient s normal anatomy is not well matched by the implant, the distal screw trajectories will be altered. The screw trajectories can be confirmed using the K-wire screw placement verification technique. 3 Approach Make a straight lateral or posterolateral surgical incision to expose the fibular fracture, the distal fibula, and the fibular diaphysis. A lateral incision directly over the fibula can accentuate plate prominence and the wound closure will be directly over the implant. Alternatively, the incision can be placed along the posterolateral border of the fibula where there is improved soft tissue coverage. Precaution: Be careful not to damage the superficial peroneal nerve proximally and anteriorly, or the sural nerve posteriorly. Deep dissection allows exposure of the fibula along its length. An extraperiosteal approach to the fibula proximal to the fracture is usually preferred. 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 7

9 Reduce Distal Fibula 4 Reduce fibular fracture Expose and clean the fracture site and reduce the fracture. It is critical that fibular length, alignment and rotation are accurately restored. In spiral or oblique fracture patterns, a clamp can be applied for reduction. Provisional reduction can be maintained with pointed reduction forceps or K-wires. Alternatively, in some fracture patterns, the plate can be used to assist with and guide the reduction. This may be especially important in comminuted fractures where a bridging technique is used. Note: Application of an external fixator or distractor may facilitate obtaining fibular length, fracture reduction and visualization of the distal tibiofibular joint. Confirm the reduction with image intensification. Temporary reduction can be obtained with clamps, multiple Kirschner wires, or independent lag screws if the fracture pattern allows. K-wires can be placed through the distal end of the plate to assist with temporary maintenance of the reduction and for plate placement. Options for maintaining the reduction depend on the fracture configuration and include: Independent lag screws Lag screws through the plate Locking screws through the plate Locking screws do not provide interfragmentary compression; compression must be achieved with standard lag screws or by using the plate itself to compress the fracture. The fracture must be reduced and compressed before fixation of the LCP Distal Fibula Plate with locking screws in simple fracture configurations. If a bridge plate technique is planned, the implant can be secured proximally and distally using locking screws, if the fibular length, alignment and rotation are correct. 8 DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

10 Insert and Position Plate 5 Insert plate Expose the fibula proximally as needed for plate application. In the majority of circumstances, an open approach for plate application will be performed. Occasionally, a submuscular plate insertion will be performed using a minimally invasive technique. The plate can be slid along the lateral fibular shaft and positioned with the distal end of the plate approximately 5 mm from the tip of the fibula. Note: The 2.7 mm/3.5 mm posterolateral fibula plate is typically positioned 8 10 mm from the tip of the fibula. 6 Position plate and fix provisionally Temporarily hold the plate in position using any of the following options. These options also prevent plate rotation while inserting the first locking screw: Standard plate holding forceps K-wires placed through the plate distally and/ or proximally 2.7 mm cortex screw placed in one of the distal holes 3.5 mm cortex screw placed in a Combi hole After plate insertion, check plate placement and alignment using fluoroscopy. Ensure proper reduction before inserting the first locking screw. Once locking screws are inserted, further reduction is not possible without loosening the locking screws. Verify plate placement under image intensification to determine if final screw and plate placement are acceptable. 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 9

11 Distal Screw Insertion 7 Distal screw insertion Determine the combination of screws to be used for fixation. If a combination of locking and cortex screws will be used, cortex screws should be inserted first. Note: To secure the plate to the fibula before locking screw insertion, it is recommended to pull the plate to the bone using a cortex screw. Nonlocking screw insertion fixation with 2.7 mm cortex screws Instruments Handle, with quick coupling * 2.7 mm Three-Fluted Drill Bit, quick coupling, 125 mm Depth Gauge mm Drill Bit with depth mark, quick coupling, 140 mm * 2.7 mm Universal Drill Guide Use the 2.0 mm drill bit through the 2.7 mm universal drill guide to predrill the bone. Measure for screw length using the depth gauge. Select and insert the appropriate 2.7 mm cortex screw using the small hexagonal screwdriver. * Found in the Small Fragment LCP Instrument and Implant Set 10 DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

12 Distal Screw Insertion Locking screw insertion If a locking screw will be used as the first screw, be sure the fracture is reduced and the plate is held securely to the bone. This prevents plate rotation as the screw is locked to the plate. Instruments Handle, with quick coupling Drill Guide StarDrive Screwdriver Shaft, T * Holding Sleeve for StarDrive Screwdriver Shaft, T Depth Gauge mm Threaded Drill Guide, with Depth Gauge mm Drill Bit with depth mark, quick coupling, 110 mm Torque Limiting Attachment, 0.8 Nm, quick coupling Insert the 2.0 mm threaded drill guide into a 2.7 mm locking hole until fully seated. Use the 2.0 mm drill bit to drill to the desired depth. Remove the 2.0 mm threaded drill guide. Use the depth gauge to determine screw length. Precaution: When determining appropriate screw length, ensure that the screw tip will not protrude past the articular surface. * Also available 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 11

13 Distal Screw Insertion 7. Distal screw insertion Locking screw insertion continued Alternative technique: Direct measuring with calibrated drill bit Determine where locking screws will be used. Screw the 2.0 mm threaded drill guide into a threaded hole until it is fully seated. Use the 2.0 mm drill bit with depth mark to drill to the desired depth. Determine the screw length directly from the 2.0 mm drill bit. The 2.7 mm locking screw can be inserted manually or with power. For power insertion, use the T8 StarDrive TM Screwdriver shaft attached to the 0.8 Nm torque limiting attachment. For manual insertion, use a handle with quick coupling. Use a holding sleeve, if necessary. Insert additional locking screws, as planned. 12 DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

14 Shaft Screw Insertion 8 Shaft screw insertion Nonlocking screw insertion fixation with 3.5 mm cortex screws Instruments * 2.5 mm Drill Bit * 3.5 mm Drill Bit Handle, with quick coupling * Small Hexagonal Screwdriver with Holding Sleeve or * Small Hexagonal Screwdriver Shaft * Depth Gauge * 3.5 mm Universal Drill Guide Use the 2.5 mm drill bit through the 3.5 mm universal drill guide to predrill the bone. For the neutral position, press the drill guide down in the nonthreaded hole. To obtain compression, place the drill guide at the end of the nonthreaded hole away from the fracture (do not apply downward pressure on the spring-loaded tip). Measure for screw length using the depth gauge for small screws. Select and insert the appropriate 3.5 mm cortex screw using a small hexagonal screwdriver. * Found in the Small Fragment LCP Instrument and Implant Set 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 13

15 Shaft Screw Insertion 8. Shaft screw insertion continued Locking screw insertion Instruments * 2.8 mm Drill Bit * 2.8 mm Threaded Drill Guide * StarDrive Screwdriver, T * StarDrive Screwdriver Shaft, T * Depth Gauge ** Torque Limiting Attachment, 1.5 Nm or * Torque Limiting Attachment, 1.5 Nm, quick coupling Insert the 2.8 mm threaded drill guide into a locking hole or Combi hole until fully seated. Use the 2.8 mm drill bit to drill to the desired depth. Remove the drill guide. Use the depth gauge to determine screw length. Insert screw. * Found in the Small Fragment LCP Instrument and Implant Set ** Also available 14 DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

16 Confirm Reduction and Fixation 9 Confirm reduction and fixation Carefully assess the final reduction and fixation via direct visualization and image intensification. Confirm the stability of the fixation and that there is unrestricted motion at the ankle joint. Using AP and lateral fluoroscopic visualization, confirm reduction and appropriate positioning of the plate and screws. 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 15

17 Implant Removal Implant removal Optional set Screw Removal Set Optional instrument * Conical Extraction Screw Unlock all screws from the plate, then remove the screws completely from the bone. This prevents simultaneous rotation of the plate when unlocking the last locking screw. If the screws cannot be removed with the screwdriver, insert the conical extraction screw with left-handed thread into the screwhead using a handle with quick coupling and loosen the locking screw by turning counterclockwise. * Found in Screw Removal Set DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

18 Screws Used with the 2.7 mm/3.5 mm LCP Distal Fibula Plates Stainless Steel and Titanium 4.0 mm Cancellous Bone Screws* May be used in the DCU portion of the Combi holes in the plate shaft Compress the plate to the bone or create axial compression Fully or partially threaded shaft Stainless steel or titanium 3.5 mm Cortex Screws, self-tapping* May be used in the DCU portion of the Combi holes in the plate shaft Compress the plate to the bone or create axial compression Stainless steel or titanium 3.5 mm Locking Screws, self-tapping* Used in the locking portion of the Combi holes in the plate shaft Create a locked, fixed-angle screw/plate construct Stainless steel or titanium alloy 2.7 mm Cortex Screws, self-tapping* May be used in the distal locking holes Compress the plate to the bone Stainless steel or titanium alloy 2.7 mm Locking Screws, self-tapping Used in the distal locking holes Stainless steel or titanium alloy 2.4 mm Cortex Screws, self-tapping** May be used in the distal locking holes Compress the plate to the bone Stainless steel or titanium alloy 2.4 mm Locking Screws, self-tapping** Used in the distal locking holes Stainless steel or titanium alloy Screws available in implant-quality 316L stainless steel, commercially pure (CP) titanium, or titanium alloy (Ti-6AI-7Nb) as noted. * Found in the Small Fragment LCP Instrument and Implant Set ** Found in the Modular Mini Fragment LCP Instrument and Implant Set 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 17

19 Implants 2.7 mm/3.5 mm LCP Lateral Distal Fibula Plates Right and left designs 3 to 11 shaft holes Lengths from 73 mm to 177 mm 2.7 mm/3.5 mm LCP Posterolateral Distal Fibula Plates Right and left designs 3 to 11 shaft holes Lengths from 77 mm to 181 mm Plates available in implant-quality 22Cr-13Ni-5Mn stainless steel or titanium alloy (Ti-6AI-7Nb). 18 DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

20 Instruments Handle with quick coupling Drill Sleeve for 2.0 mm Drill Bit StarDrive Screwdriver Shaft, T Depth Gauge mm Threaded Drill Guide mm Drill Bit with depth mark Torque Limiting Attachment, 0.8 Nm, quick coupling 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 19

21 2.7 mm/3.5 mm LCP Distal Fibula Plate Instrument and Implant Sets Stainless Steel ( ) and Titanium ( ) Graphic Case Graphic Case, for LCP Distal Fibula Plates Tray for 2.7 mm/3.5 mm LCP Posterolateral Distal Fibula Plates Instruments Handle, with quick coupling Drill Sleeve for 2.0 mm Drill Bit StarDrive Screwdriver Shaft, T Depth Gauge, for 2.0 mm and 2.4 mm screws mm Threaded Drill Guide, with depth gauge mm Drill Bit with depth mark, quick coupling, 2 ea Torque Limiting Attachment, 0.8 Nm, quick coupling Implants 2.7 mm/3.5 mm LCP Lateral Distal Fibula Plates Stainless Length Steel Titanium Holes (mm) right left right left right left right left right left right left right left Posterolateral plates not shown Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or sterilization instructions, if provided. 20 DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique

22 2.7 mm/3.5 mm LCP Distal Fibula Plate Instrument and Implant Sets Stainless Steel ( ) and Titanium ( ) 2.7 mm/ 3.5 mm LCP Posterolateral Distal Fibula Plates Stainless Length Steel Titanium Holes (mm) right left right left right left right left right left right left right left 2.7 mm Locking Screws, self-tapping, with T8 StarDrive Recess, 2 ea. Stainless Steel Titanium Length (mm) Required Set / Small Fragment LCP Instrument and Implant Set, with self-tapping screws (stainless steel or titanium) Also Available Modular Mini Fragment LCP Instrument and Implant Set mm/3.5 mm LCP Lateral Distal Fibula Plate Instrument and Implant Set mm/3.5 mm Titanium LCP Lateral Distal Fibula Plate Instrument and Implant Set mm/3.5 mm LCP Posterolateral Distal Fibula Plate Instrument and Implant Set mm/3.5 mm Titanium LCP Posterolateral Distal Fibula Plate Instrument and Implant Set mm/3.5 mm LCP Posterolateral Distal Fibula Plate Implant Upgrade Set mm/3.5 mm Titanium LCP Posterolateral Distal Fibula Plate Implant Upgrade Set Screw Removal Set Holding Sleeve, for StarDrive Screwdriver Shaft, T mm Universal Drill Guide Torque Limiting Attachment, 1.5 Nm Screw Rack, for 2.7 mm/3.5 mm LCP Distal Fibula Set Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or sterilization instructions, if provided. 2.7 mm/3.5 mm LCP Distal Fibula Plates Surgical Technique DePuy Synthes 21

23 Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets. Manufactured or distributed by: Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA Synthes USA, LLC 1101 Synthes Avenue Monument, CO To order (USA): To order (Canada): Note: For recognized manufacturer, refer to the product label. DePuy Synthes All rights reserved. DSUS/TRM/1016/1123 4/17 DV