Part of the DePuy Synthes Locking Compression Plate (LCP ) System 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Table of Contents Introduction 3.5 mm LCP Low Bend Medial Distal Tibia Plates 2 AO Principles 4 Indications 5 Surgical Technique Preparation 6 Reduction 7 Plate Insertion 8 Screw Insertion 13 Implant Removal 17 Product Information Implants 18 Instruments 19 Set Lists 22 MR Information The 3.5 mm LCP Low Bend Medial Distal Tibia Plate 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 3.5 mm LCP Low Bend Medial Distal Tibia Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Image intensifier control 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 1
3.5 mm LCP Low Bend Medial Distal Tibia Plates The 3.5 mm LCP Low Bend Medial Distal Tibia Plate is part of the Depuy Synthes Locking Compression Plate (LCP) System that merges locking screw technology with conventional plating techniques. The Combi holes in the LCP Plate shaft combine a dynamic compression unit (DCU) hole with a locking screw hole. Combi holes provide the flexibility of axial compression and locking capability throughout the length of the plate shaft. Fixation with the 3.5 mm LCP Low Bend Medial Distal Tibia Plate has many similarities to 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. Locking capability is important for fixed-angle constructs in osteopenic bone or 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. 2 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
3.5 mm LCP Low Bend Medial Distal Tibia Plates Plate features Head of plate is low profile for minimal prominence on medial malleolus 3.5 mm cortex and 4.0 mm cancellous bone screws sit flush with plate in the nonlocking portion of distal Combi holes to minimize screw prominence Rounded edges to minimize soft tissue irritation Limited-contact shaft profile Available in stainless steel or titanium* Four to fourteen Combi holes in the shaft Combi holes in the shaft and head accept the following: 3.5 mm cortex screws 3.5 mm locking screws 4.0 mm cancellous bone screws Six round locking holes in the head accept the following: 2.7 mm cortex screws 3.5 mm cortex screws 3.5 mm locking screws 4.0 mm cancellous bone screws Two distal Combi holes Distal K-wire hole for plate placement (2.0 mm maximum diameter) Three distal locking screws diverge across subchondral bone and are parallel to joint *Implant-quality 316L stainless steel or titanium alloy (Ti-6Al-7Nb). 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 3
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 1 05.07.12 12:08 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, 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; 1991. 2. 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; 2007. Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991. 2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007. 4 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Indications The Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia, as a part of the Synthes Small Fragment LCP System. 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 5
Preparation 1 Preparation Required set 105.434 Small Fragment LCP Instrument and Implant Set, with self-tapping screws or 145.434 Small Fragment LCP Instrument and Titanium Implant Set, with self-tapping screws Optional sets 105.90 Bone Forceps Set 105.954M Small Battery Drive Set 115.700 Large Distractor Set Optional instruments 321.12* Articulated Tension Device 329.02 Bending Iron 329.30 Plate-Bending Press Warning: The direction of locking screws is predetermined by the design of the plate. If manual contouring is necessary, verify new screw angles using the screw placement verification technique on page 10. Complete the preoperative radiographic assessment and prepare the preoperative plan. Determine plate length and instruments to be used. Position the patient supine on a radiolucent operating table. Note: For information on fixation principles using conventional and locked plating techniques, please refer to the Small Fragment Locking Compression Plate (LCP) Technique Guide. *Found in the Basic Instrument Set, for LC-DCP and DCP (115.04). 6 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Reduction 2 Reduce articular surface Instruments 394.35 Large Distractor 532.010 Small Battery Drive 532.022 Quick Coupling for K-Wires Approach An open or a percutaneous approach may be used depending on the fracture. For a percutaneous approach, make an incision to access the medial malleolus and slide the plate under the soft tissue. Reduction Note: Application of an external fixator or large distractor may facilitate visualization and reduction of the joint. Reduce the fracture fragments and confirm reduction using image intensification. Methods of stabilizing reduction include the following: Independent Kirschner wires K-wires through the plate Independent lag screws Lag screws through the plate Locking screws through the plate Locking screws do not provide interfragment compression; therefore, any desired compression must be achieved with standard lag screws. The articular fractures must be reduced and compressed before fixation of the 3.5 mm LCP Medial Distal Tibia Plate with locking screws. Precaution: To verify that independent lag screws will not interfere with plate placement, evaluate placement intraoperatively with AP and lateral fluoroscopic images. 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 1
Plate Insertion 3 Insert plate Instrument 324.031 Threaded Plate Holder Saphenous vein Saphenous nerve Percutaneous insertion For a percutaneous approach, insert the plate through the medial incision. Carefully push the plate under the soft tissue. Note: Thread a threaded plate holder into one of the distal holes as a handle for percutaneous insertion. Open insertion Open the area as necessary to expose the joint. Carefully push the plate under the soft tissue for placement on the shaft. Center the plate on the medial malleolus. Precaution: When choosing a percutaneous approach take care not to damage the saphenous nerve or saphenous vein. 8 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Plate Insertion 4 Position plate and fix provisionally After plate insertion, check alignment on the bone using fluoroscopy. Make any adjustments before inserting screws. Note: This locking plate is precontoured to fit the medial distal tibia. If the plate contour is changed, it is important to check the position of the screws relative to the joint, using the screw placement verification technique. Optional instrument 324.024 Push-Pull Reduction Device The plate may be temporarily held in place using any of the following options: Push-pull reduction device 4.0 mm cancellous bone screw in a distal Combi hole Standard plate-holding forceps K-wires through the plate Any of these options will allow moving the plate into final position, and will also prevent plate rotation while inserting the first locking screw. Note: Ensure proper reduction before inserting the first locking screw. Once the locking screws are inserted, further reduction is not possible without loosening the locking screws. 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 9
Plate Insertion Optional technique: Screw placement verification Instruments 292.71 1.6 mm Kirschner Wire with Thread 310.288 2.8 mm Drill Bit 312.648 2.8 mm Threaded Drill Guide 323.023 1.6 mm Wire Sleeve 323.025 Direct Measuring Device 532.010 Small Battery Drive 532.022 Quick Coupling for K-Wires Since the direction of the locking screw depends on the contour of the plate, final screw position may be verified with a K-wire before insertion. This becomes especially important when the plate has been manually contoured or applied near the joint. 10 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Plate Insertion With the 2.8 mm threaded drill guide in the desired locking hole, insert the 1.6 mm wire sleeve into the threaded drill guide. Insert a 1.6 mm threaded K-wire through the wire sleeve and drill to the desired depth. Verify K-wire placement under image intensification to determine if final screw placement will be acceptable. Precaution: The K-wire position represents the final position of the locking screw. Confirm that the K-wire does not enter the joint. 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 11
Plate Insertion Optional technique: Screw placement verification continued Measure for screw length by sliding the tapered end of the direct measuring device over the K-wire down to the wire sleeve. Remove the direct measuring device, K-wire and 1.6 mm wire sleeve, leaving the threaded drill guide in place. Use the 2.8 mm drill bit to drill. Remove the threaded drill guide. Insert the appropriate length locking screw. 12 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Screw Insertion 5 Insert distal screws 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 to pull the plate to the bone. If a locking screw will be used as the first screw, ensure the plate is held securely to the bone to prevent plate rotation as the screw is locked to the plate. In distal Combi holes: For nonlocking screws, use the standard AO screw insertion technique. The two Combi holes in the plate head accept 3.5 mm cortex, 3.5 mm locking or 4.0 mm cancellous bone screws. When using a cortex or cancellous bone screw in these Combi holes, the screwhead will be recessed in the hole. For distal locking screws: Instruments 310.288 2.8 mm Drill Bit 312.648 2.8 mm Threaded Drill Guide 314.115 StarDrive Screwdriver, T15 314.116 StarDrive Screwdriver Shaft, T15 319.01 Depth Gauge Thread the 2.8 mm threaded drill guide into a distal locking 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. 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 13
Screw Insertion 5 Insert distal screws continued Instruments 511.770* Torque Limiting Attachment, 1.5 Nm or 511.773 Torque Limiting Attachment, 1.5 Nm, quick coupling Insert the locking screw under power, using the torque limiting attachment and the StarDrive TM Screwdriver shaft, or insert manually, using the StarDrive Screwdriver. Be sure the plate is held securely to the bone to prevent plate rotation as the screw is locked to the plate. Notes: When using the torque limiting attachment, the screw is securely locked into the plate when a click is heard. Always use a torque limiting attachment when using power with the StarDrive Screwdriver shaft. *Also available. 14 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Screw Insertion Optional technique: Direct measuring with calibrated drill bits For locking screws: Instruments 03.122.001 2.8 mm LCP Drill Guide 03.122.002 2.8 mm Calibrated Drill Bit, quick coupling 314.115 StarDrive Screwdriver Shaft, T15 314.16 StarDrive Screwdriver shaft, T15 Determine where locking screws will be used. Thread the 2.8 mm LCP Drill Guide into a threaded hole until fully seated. Use the 2.8 mm calibrated drill bit to drill to desired depth. Determine the screw length directly from the drill bit. Insert the screw. **Found in the Basic Instrument Set, for LC-DCP and DCP (115.04). 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 15
Screw Insertion 6 Insert screws in shaft If using the threaded portion of the Combi holes, repeat the steps as described for distal locking screw insertion. For nonlocking screws, use the standard AO screw insertion technique. 16 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Implant Removal Optional sets 01.240.001 Screw Removal Set 105.971 Broken Screw Removal Set 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 the handle with quick coupling and loosen the locking screw by turning counterclockwise. 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 11
Screws Used with the 3.5 mm LCP Low Bend Medial Distal Tibia Plates Stainless Steel and Titanium 2.7 mm Cortex Screws* May be used in the distal locking holes Compresses the plate to the bone 3.5 mm Cortex Screws* May be used in the DCU portion of the Combi holes in the plate shaft Compresses the plate to the bone or creates axial compression 3.5 mm Locking Screws* Creates a locked, fixed-angle screw/plate construct Self-tapping tip Used in the locking portion of the Combi holes or in round locking holes 4.0 mm Cancellous Bone Screws* May be used in the DCU portion of the Combi holes in the plate shaft Compresses the plate to the bone or creates axial compression Fully or partially threaded shaft *Found in the Small Fragment LCP set. 18 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Instruments 292.71 1.6 mm Kirschner Wire with thread 03.122.001 2.8 mm LCP Drill Guide, long for 3.5 mm LCP plates 03.122.002 2.8 mm Drill Bit, quick coupling, 248 mm/ 95 mm calibration 310.288 2.8 mm Drill Bit, quick coupling, 165 mm 312.648 2.8 mm Threaded Drill Guide 314.115 StarDrive Screwdriver, T15, self-retaining 314.116 StarDrive Screwdriver Shaft, T15, self-retaining, quick coupling 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 19
Instruments 319.01 Depth Gauge 323.023 1.6 mm Wire Sleeve 323.025 Direct Measuring Device 324.024 Push-Pull Reduction Device 324.031 Threaded Plate Holder, long 329.04 Bending Iron, for 2.7 mm and 3.5 mm plates, 150 mm length Used with 329.05 329.05 Bending Iron, for 2.7 mm and 3.5 mm plates, 150 mm length Used with 329.04 20 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique
Instruments 329.15 Bending Pliers, for 2.7 mm and 3.5 mm plates 394.35 Large Distractor 511.770 Torque Limiting Attachment, 1.5 Nm 511.773 Torque Limiting Attachment, 1.5 Nm, quick coupling 3.5 mm LCP Low Bend Medial Distal Tibia Plates Surgical Technique DePuy Synthes 22
3.5 mm LCP Low Bend Medial Distal Tibia Plate Sets Stainless Steel (01.112.060) and Titanium (01.112.061) Graphic Case 60.112.060 Graphic Case for 3.5 mm LCP Low Bend Medial Distal Tibia Plate Implants 3.5 mm LCP Low Bend Medial Distal Tibia Plates, right Stainless Steel Titanium Holes Length (mm) 02.112.510 04.112.510 4 109 02.112.514 04.112.514 6 135 02.112.518 04.112.518 8 161 02.112.522 04.112.522 10 187 02.112.526 04.112.526 12 213 02.112.530 04.112.530 14 239 3.5 mm LCP Low Bend Medial Distal Tibia Plates, left Stainless Steel Titanium Holes Length (mm) 02.112.511 04.112.511 4 109 02.112.515 04.112.515 6 135 02.112.519 04.112.519 8 161 02.112.523 04.112.523 10 187 02.112.527 04.112.527 12 213 02.112.531 04.112.531 14 239 Available nonsterile or sterile-packed. Add S to catalog number to order sterile product. Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to www.synthes.com/cleaning-sterilization or sterilization instructions, if provided. 22 DePuy Synthes 3.5 mm LCP Low Bend Medial Distal Tibia Plates Technique Guide Surgical Technique
Also Available Graphic Cases 690.468 3.5 mm LCP Medial Distal Tibia Plate, without tab, Set Graphic Case 60.122.001 3.5 mm Titanium LCP Medial Distal Tibia Plate, without tab, Set Graphic Case Implants 3.5 mm LCP Medial Distal Tibia Plates, without tab, right Stainless Steel Titanium Holes Length (mm) 238.700 438.700 4 116 238.702 438.702 6 142 238.704 438.704 8 168 238.706 438.706 10 194 238.708 438.708 12 220 238.710 438.710 14 246 3.5 mm LCP Medial Distal Tibia Plates, without tab, left Stainless Steel Titanium Holes Length (mm) 238.701 438.701 4 116 238.703 438.703 6 142 238.705 438.705 8 168 238.707 438.707 10 194 238.709 438.709 12 220 238.711 438.711 14 246 3.5 mm LCP Medial Distal Tibia Plates Right Left Holes Length (mm) 239.900 239.901 4 116 239.904 239.905 6 142 239.908 239.909 8 168 239.912 239.913 10 194 239.916 239.917 12 220 239.920 239.921 14 246 3.5 mm LCP Pilon Plates Holes Length (mm) 240.082 7 147 240.083 9 173 3.5 mm LCP Low Bend Medial Distal Tibia Plates Technique Guide Surgical Technique DePuy Synthes 22
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 19380 Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132 To order (USA): 800-523-0322 To order (Canada): 855-946-8999 Note: For recognized manufacturer, refer to the product label. www.depuysynthes.com DePuy Synthes 2009 2017. All rights reserved. DSUS/TRM/1016/1161 5/17 DV