LCP DHHS. The Dynamic Helical Hip System for Proximal Femur Fractures.

Transcription

1 LCP DHHS. The Dynamic Helical Hip System for Proximal Femur Fractures. Surgical Technique This publication is not intended for distribution in the USA. Instruments and implants approved by the AO Foundation.

2 Image intensifier control Warning This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to: For general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to:

3 Table of Contents Introduction LCP Dynamic Helical Hip System (DHHS) 2 AO Principles 4 Indications 5 Surgical Technique Preparation 6 Place Guide Wire 8 Determine Helix Blade Length 10 Ream 11 Assemble Helix Blade Inserter 12 Insert Helix Blade 14 Position Sideplate / Guide Shaft 17 Position Sideplate / Plate Impactor (optional) 18 Insert Screws 19 Lock Rotation / DHHS Impactor 19 Intraoperative Compression (optional) 20 Confirm Implant Placement 20 Implant Removal 21 Product Information Implants 22 Instruments 24 Set Lists 29 MRI Information 32 LCP DHHS Surgical Technique DePuy Synthes 1

4 LCP DHHS. The Dynamic Helical Hip System for Proximal Femur Fractures. The Locking Compression Plate (LCP) Dynamic Helical Hip System (DHHS) provides strong and stable internal fixation of a variety of intertrochanteric, pertrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. Additionally, implantation methods are simplified by minimized instrumentation. DHHS Helix Blade The LCP DHHS helix blades easily glide within the LCP DHHS plate barrel for controlled collapse and impaction of fragments. When the fracture requires additional intraoperative compression, the LCP DHHS Compression Screw can be used. Combi holes The LCP DHHS plates are low profile and have a limited-contact undersurface for minimal soft tissue irritation. The LCP DHHS plates are made of coldworked 316L stainless steel. Construct stability The helix blade improves resistance to cut-out and increases the rotational stability of the femoral head fragment when compared to traditional intertrochanteric lag screws. 1 LCP DHHS compression screw 1 M. Sommers, C. Roth, H. Hall, L. Ehmke, J. Krieg, S. Madey, and M. Bottlang, Cut-Out Resistance of Implants for Intertrochanteric Fracture Fixation, JOT, Vol 18, Number 6, July Limited-contact undersurface 2 DePuy Synthes LCP DHHS Surgical Technique

5 The LCP DHHS plate barrel contains a locking key. Two flats within the key correspond with the flats of the helix blade shaft. This enables the surgeon to manipulate the position of the sideplate prior to final fixation. Once the plate is positioned appropriately, the key may be locked, preventing any further rotation of the helix blade within the barrel. No bone is removed from the femoral head before implantation of the helix blade. This creates a more stable and mechanically sound interface between the helix blade and bone. The number of screw holes per plate length is maximized, without compromising plate strength. This allows an increased number of fixation points with a smaller incision. The Combi holes in the LCP DHHS sideplate: Combine a dynamic compression unit (DCU) hole with a locking screw hole, allowing compression in the DCU section of the hole or locking screw fixation in the threaded section Provide directional compression and fixed-angle screw purchase Allow longitudinal screw angulation for lag screw fixation of medial fragments Allow 14 of transverse cortex screw angulation Are uniformly spaced to provide greater intraoperative flexibility for screw and/or wire or cable fixation Ease of use Single-piece reamer does not need adjustment prior to use The helix blade does not have screw threads and creates its own path as it is inserted, eliminating the need for a tap and reducing overall torsional forces on the femoral head during implantation Use of the helix blade inserter assembly reduces the overall operative time to implant the helix blade when compared to implanting conventional hip lag screws The self-contained, user-activated key mechanism of the LCP DHHS sideplate eliminates the need for additional instrumentation for intraoperative insertion of separate antirotational locking devices within the barrel Plate barrel Internal key mechanism LCP DHHS Surgical Technique DePuy Synthes 3

6 AO Principles In 1958, the AO formulated four basic principles which have become the guidelines for internal fixation. 2 Those principles as applied to the LCP Dynamic Helical Hip System are: Anatomic reduction The LCP DHHS sideplate and helix blade allow controlled collapse and interfragmentary compression while maintaining rotational control of the medial fragment. Stable fixation Use of the helix blade provides improved rotational control of the femoral head fragment versus single-screw fixation, which results in improved life-to-cut-out. The number of screw holes per plate length is maximized to allow an increased number of fixation points. The locking screws in the plate shaft also create a fixed-angle construct, providing angular stability. Preservation of blood supply The limited-contact design reduces plate-to-bone contact and vascular trauma. Use of the helix blade results in reduced bone removal compared to a standard hip screw. Early, active mobilization Plate features combined with AO technique create an environment for bone healing, expediting a return to optimal function. 2 M.E. Müller, M. Allgöwer, R. Schneider, H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin; Springer-Verlag DePuy Synthes LCP DHHS Surgical Technique

7 Indications The LCP DHHS is indicated for the following fractures of the proximal femur: Intertrochanteric fractures Basilar neck fractures Pertrochanteric fractures LCP DHHS is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed. LCP DHHS Surgical Technique DePuy Synthes 5

8 Preparation 1 Preoperative planning The size and angle of the plate as well as the length of the DHHS Blade can be determined preoperatively by using the DHS Goniometer ( ). Important: For a helix blade shorter than 85 mm, use a LCP DHHS short barrel sideplate. 6 DePuy Synthes LCP DHHS Surgical Technique

9 2 Position patient Place the patient in a supine position on the operating table. 3 Reduce fracture If possible, reduce the fracture under the image intensifier by means of traction, abduction and internal rotation. 4 Access Make a straight lateral skin incision of 15 cm in length, starting two finger-widths proximal to the tip of the greater trochanter. Split the iliotibial tract lengthwise. Detach the m. vastus later alis dorsally to the intramuscular membrane, retract ventrally and, if necessary, make a slight notch in the muscle in the region of the innominate tubercle. Expose the proximal femoral shaft without retracting the periosteum. LCP DHHS Surgical Technique DePuy Synthes 7

10 Place Guide Wire 1 Place guide wire Instruments LCP DHHS Angled Guide, adjustable DHS/DCS Guide Wire B 2.5 mm with threaded tip with trocar, length 230 mm or Guide Wire B 2.5 mm with spade point tip, length 230 mm Optional instrument Drill Bit B 2.0 mm, length 100/75 mm, 2-flute Fracture reduction should be done in the same manner as for a standard DHS procedure. Determine anteversion by placing a new guide wire anteriorly along the femoral neck. Insert the wire into the femoral head. The anteversion wire will later assist in correct placement of the central guide wire in the center of the femoral head. Barrel angle The angle subtended between the femoral neck and shaft axis (C.C.D., or collum-center-diaphysis, angle) of the uninjured femur will aid in selection of the most appropriate barrel angle. The 135 barrel angle is most commonly indicated. The LCP DHHS plates are available with barrel angles of 130, 135, 140, 145 and 150. Note: Greater barrel angles may produce biomechanical advantages in unstable cases; i.e., better gliding characteristics and reduced bending stresses on the plate/barrel junction, although correct placement of the implant becomes technically more difficult as the barrel angle increases. 3 Position the DHHS angled guide at the desired angle. Align the angled guide parallel to the axis of the femoral shaft and place it on the lateral cortex of the femur. Note: The T-handle of the DHHS angled guide rotates 90 to a locked position, for easier use. 3 P. Regazzoni, Th. Rüedi, R. Winquist, and M. Allgöwer, The Dynamic Hip Screw Implant System. Berlin: Springer-Verlag, DePuy Synthes LCP DHHS Surgical Technique

11 Insert a new 2.5 mm guide wire through the angled guide, parallel to the anteversion wire and toward the center of the femoral head. The entry point varies with barrel angle. When the 135 barrel angle is used, the guide wire enters the proximal femur approximately 2.5 cm distal to the vastus ridge. Predrilling of the lateral cortex with the 2.0 mm drill bit is recommended in dense bone. Confirm placement of the guide wire under image intensification. It must lie along the axis of the femoral neck in both the anteroposterior (AP) and lateral views. The appropriate final position is in the center of the femoral head in both AP and lateral views. The tip of the guide wire should be a few millimeters short of the subchondral bony plate. When inserted, the tip of the helix blade will coincide with the tip of the guide wire. Note: This guide wire remains in place throughout the procedure. If the guide wire position is incorrect, remove the wire and insert a new 2.5 mm guide wire. Remove and discard the anteversion wire. LCP DHHS Surgical Technique DePuy Synthes 9

12 Determine Helix Blade Length 2 Determine helix blade length Instrument Measuring Device for adjustable LCP DHHS Angled Guide 25 mm 38 mm Attach the measuring device to the angled guide. Read the required helix blade length directly from the measuring device. No subtraction is necessary, a direct measurement should be used for best results. When the proper helix blade length, position, and plate angle have been determined, remove the angled guide. Select a standard- or short-barrel plate, with an appropriate number of shaft holes, based on the requirements dictated by the fracture pattern. The standard 38 mm barrel length is most commonly indicated. Choose the 25 mm short barrel for specific clinical situations, including: Use of a helix blade shorter than 85 mm Cases in which the standard barrel may not provide sufficient glide for the helix blade; i.e., a long impaction distance is expected A medial displacement osteotomy An unusually small femur Combine these selections with the required plate angle as determined in Step 1. Note: The short-barrel plate MUST be used with helix blades shorter than 85 mm to allow for proper sliding of the helix blade in the plate barrel, and for fracture compression. 11 DePuy Synthes LCP DHHS Surgical Technique

13 Ream 3 Ream Instrument LCP DHHS Reamer, length 60 mm Quick Coupling for DHS/DCS Triple Reamers The DHHS reamer does not ream into the femoral head and is designed to prevent over-reaming. Insert the 60 mm reamer into the Compact Air Drive (or similar drill) using the quick coupling attachment. Slide the reamer over the guide wire to ream for the helix blade inserter assembly and countersink for the plate/barrel junction. When reaming in dense bone, use of continuous irrigation is recommended to prevent thermal necrosis. Control guide wire migration during reaming. Alternative instrument * LCP DHHS Reamer, length 56 mm For smaller stature patients, the 56 mm reamer may be used for standard- and short-barrel plates with barrel angles up to 135. For the placement of a DHS Screw, please refer to the technique guide Standard DHS Lag Screw with LCP DHHS Sideplate ( ) Precaution: Temporary fixation of the femoral head is recommended in order to prevent any inadvertent rotation. *Also available LCP DHHS Surgical Technique DePuy Synthes 11

14 Assemble Helix Blade Inserter 4 Assemble helix blade inserter Instruments align flats LCP DHHS Guide for Blade Insertion LCP DHHS Connecting Screw, length 324 mm LCP DHHS Spiral Inserter for Blade Insertion Place the spiral inserter fully into the guide for blade insertion. When assembling the helix blade inserter, align the flats of the helix blade with the flats on the sides of the guide. Insert the spiral inserter (back end) of the selected helix blade into the tip of the guide and orient the hexagonal recess of the helix blade onto the hexagonal tip of the spiral inserter. 11 DePuy Synthes LCP DHHS Surgical Technique

15 Insert the connecting screw into the back of the spiral inserter (Figure 1) until the connecting screw knob is visible in the window at the back of the spiral inserter (Figure 2). Finger-tighten the connecting screw. Note: Hold the helix blade and inserter assembly together with one hand, tilting the assembly downward. Use the free hand to insert and tighten the connecting screw. Figure 1 Figure 2 Helix blade Inserter guide Coupling screw Inserter shaft LCP DHHS Surgical Technique DePuy Synthes 11

16 Insert Helix Blade 5 Insert helix blade Instruments LCP DHHS Guide for Blade Insertion LCP DHHS Spiral Inserter for Blade Insertion Hammer, 700 g helix, starting position swivel plate Before placing the insertion instrument into the reamed cavity, pull back on the spiral inserter so that only the helix is exposed. This ensures the helix blade is inserted to the proper depth and orientation. Place the inserter assembly over the guide wire and into the reamed cavity. Note: Depending on whether the left or right hip is being treated, the corresponding etch on the helix inserter instrumentation should be visible. Note: The swivel plate on the guide must be parallel with, and flush to, the shaft of the femur. This will determine the final position and depth of the helix blade. 11 DePuy Synthes LCP DHHS Surgical Technique

17 Drive the helix blade into position using even and steady blows with the hammer. The spiral inserter assembly controls the depth and rotation of the helix blade. Monitor the advancement of the helix blade under image intensification to ensure proper placement. When the helix blade is fully inserted, the inserter assembly will prevent any further advancement. Additionally, the circumferential etch around the spiral inserter will align with the back edge of the guide sleeve when the helix blade is fully implanted (Figure 1). etch Figure 1 LCP DHHS Surgical Technique DePuy Synthes 11

18 Insert Helix Blade 5 Insert helix blade After full insertion of the helix blade, the inserter assembly can be removed by unscrewing the connecting screw and retracting the inserter assembly. The guide wire and the helix blade remain in the femur. Optional instrument Screwdriver, hexagonal, large, B 3.5 mm The connecting screw may be loosened with a large (3.5 mm) hexagonal screwdriver, if necessary. 11 DePuy Synthes LCP DHHS Surgical Technique

19 Position Sideplate/Guide Shaft 6 Position sideplate / guide shaft Instruments LCP DHHS Guide Shaft LCP DHHS Impactor, cannulated LCP DHHS Cap for Impactor To place the LCP DHHS sideplate over the helix blade, the guide shaft must be used. Align the flats on the guide shaft with the flats of the internal key of the sideplate, then insert the guide shaft through the plate barrel. Note: For a helix blade shorter than 85 mm, use an LCP DHHS short barrel sideplate. Slide the sideplate and guide shaft over the guide wire. Insert the guide shaft into the back of the helix blade. The guide shaft has a hexagonal tip that mates with the end of the helix blade, to ensure that the internal sideplate key and the helix blade shaft are properly aligned. Slide the sideplate down the guide shaft and onto the shaft of the helix blade. Note: If the plate does not slide easily into the reamed cavity, gently moving the guide shaft up and down can assist in the placement. After the plate has been fully seated into the reamed cavity, it may be aligned with the axis of the femur as needed. The internal plate key is free to rotate with no movement of the helix blade, until keyed. When the barrel of the plate is fully inserted in the reamed cavity, remove the guide shaft. If the sideplate is not completely flush against the lateral cortex, use of the LCP DHHS impactor with plastic cap may be necessary. LCP DHHS Surgical Technique DePuy Synthes 11

20 Position Sideplate/Plate Impactor (optional) 7 Position sideplate/plate impactor (optional) Instruments LCP DHHS Impactor, cannulated LCP DHHS Cap for Impactor Hammer, 700 g Alternative instrument LCP DHHS Guide Shaft To use the cap for impactor, slide it onto the tip of the cannulated impactor until fully seated. A positive click will be noticed when assembling. Place the cap for impactor and shaft assembly over the 2.5 mm guide wire and seat it directly into the barrel hole of the sideplate. Use of light blows with the hammer is recommended until the sideplate is seated completely against the lateral cortex. Precaution: Do not use the cap for impactor and shaft guide to seat the plate if the plate is more than 5 mm off the bone. If the plate appears to be more than 5 mm off the bone, the flats on the helix blade and the internal flats on the key may not be properly aligned. Impacting the plate in this condition could cause further unwanted advance ment of the helix blade. 11 DePuy Synthes LCP DHHS Surgical Technique

21 Insert Screws and Lock Rotation/ Key Impactor 8 Insert screws 5.0 mm locking screw Remove and discard the guide wire. Affix the LCP DHHS sideplate to the bone with 4.5 mm cortex screws, 5.0 mm locking screws, or a combination of both.* 4.5 mm cortex screw 9 Lock rotation/dhhs impactor Instruments LCP DHHS Impactor, cannulated Hammer, 700 g Once the desired placement of the LCP DHHS sideplate has been achieved, the surgeon can use the cannulated impactor to advance the internal sideplate key and permanently lock rotation of the helix blade. Note: Make sure to remove the plastic impactor tip before proceeding. Insert the cannulated impactor into the barrel of the sideplate until it is fully seated. Moderate taps with the hammer will lock rotation, rendering the helix blade rotationally stable, but still allow dynamic collapse. * For information on fixation principles using conventional and locked plating techniques, please refer to the LCP Locking Compression Plate Instructions for Use ( ). LCP DHHS Surgical Technique DePuy Synthes 11

22 Intraoperative Compression (optional) and Confirm Implant Placement 10 Intraoperative compression (optional) For further intraoperative compression of the trochanteric fracture, the LCP DHHS compression screw may be inserted in the helix blade. The LCP DHHS compression screw may be used in unstable fractures to prevent disengagement of the helix blade from the plate barrel in non-weightbearing patients. 9.7 mm LCP DHHS Enhanced Compression Screw 2.6 mm LCP DHHS Compression Screw Note: Use of the compression screw may cause the helix blade to pull out of osteoporotic bone. 11 Confirm implant placement Take final C-arm images or x-rays to confirm proper implant placement. 22 DePuy Synthes LCP DHHS Surgical Technique

23 Implant Removal Implant Removal Instruments * Combined Hammer 400 g * Hammer Guide for Combined Hammer 400 g Screwdriver Stardrive, T25, self-holding Screwdriver, hexagonal, large, B 3.5 mm, with Groove Connecting Screw B 5.2 mm Use either the hexagonal or StarDrive screwdriver to remove any 4.5 mm cortex screws or 5.0 mm locking screws from the LCP DHHS sideplate. Remove the LCP DHHS sideplate to expose the end of the helix blade. Once the sideplate has been removed, thread the connecting screw onto the end of the shaft of the helix blade. Thread the hammer guide for combined hammer onto the connecting screw. Use the combined hammer to extract the helix blade. Instrument options for removal System DHS DHS/DCS Wrench ( ) Connecing Screw, long ( ) DHS One-Step DHS/DCS Wrench, with octagonal coupling ( ) Connecting Screw ( ) DHHS Combined Hammer, 400 g ( ) Hammer Guide ( ) Connecting Screw B 5.2 mm ( ) Will remove: DHS DHS One-Step DHHS DHS One-Step DHHS DHHS Note: If the DHHS Connecting Screw has external threads on the back-end, for removal use: Inserter-Extractor ( ) and Slotted Hammer ( )* * The slide/fixed hammer and hammer guide can be found in the Titanium Humeral Nail-EX Instrument and Titanium Implant Set ( ). LCP DHHS Surgical Technique DePuy Synthes 22

24 Implants LCP DHHS Sideplates, standard barrel (38 mm barrel) Shaft Shaft length Barrel angle holes (mm) N/A N/A N/A N/A N/A N/A N/A mm 38 mm LCP DHHS Sideplates, short barrel (25 mm barrel) Shaft Shaft length Barrel angle holes (mm) Helix Blades Length Length (mm) (mm) Note: For a helix blade shorter than 85 mm, use an LCP DHHS short barrel sideplate. 22 DePuy Synthes LCP DHHS Surgical Technique

25 LCP DHHS Compression Screws LCP DHHS Compression Screw, enhanced LCP DHHS Compression Screw DHS Trochanter Stabilizing Plate, universal, locking LCP DHHS Surgical Technique DePuy Synthes 22

26 Instruments Drill Bit B 3.2 mm, length 145/120 mm Drill Bit B 4.3 mm, length 180 mm Drill Bit B 4.5 mm, length 145/120 mm T-Handle with Quick Coupling Tap for Cortex Screws B 4.5 mm Threaded Drill Guide DePuy Synthes LCP DHHS Surgical Technique

27 Double Drill Guide 4.5/ Drill Sleeve Insert 4.5/ Holding Sleeve, large Screwdriver Stardrive, T25, self-holding Screwdriver Shaft Stardrive 4.5/5.0, T Screwdriver Shaft, hexagonal, large, B 3.5 mm LCP DHHS Surgical Technique DePuy Synthes 22

28 Instruments Screwdriver, hexagonal, large, B 3.5 mm Depth Gauge for Screws B 4.5 to 6.5 mm Screw Forceps, self-holding Universal Drill Guide 4.5/ LCP DHHS Angled Guide, adjustable 22 DePuy Synthes LCP DHHS Surgical Technique

29 Connecting Screw B 5.2 mm Measuring Device for adjustable LCP DHHS Angled Guide LCP DHHS Reamer, length 60 mm LCP DHHS Guide for Blade Insertion LCP DHHS Guide Shaft LCP DHHS Connecting Screw, length 324 mm LCP DHHS Surgical Technique DePuy Synthes 27

30 Instruments LCP DHHS Spiral Inserter for Blade Insertion LCP DHHS Impactor, cannulated, length 300 mm LCP DHHS Cap for Impactor Hammer 700 g Quick Coupling for DHS/DCS Triple Reamers DHS/DCS Guide Wire B 2.5 mm with threaded tip with trocar, length 230 mm or Guide Wire B 2.5 mm with spade point tip, length 230 mm 22 DePuy Synthes LCP DHHS Surgical Technique

31 LCP DHHS Implant Set ( ) Graphic Case Graphic Case for LCP DHHS Implants Implants* LCP DHHS Compression Screw Helix Blades Length Length (mm) Qty. (mm) Qty LCP DHHS Sideplates, standard barrel* Barrel Shaft Shaft Length Angle Holes (mm) Qty Note: For additional information, please refer to package insert. *For additional LCP DHHS sideplates, see page 22. LCP DHHS Surgical Technique DePuy Synthes 22

32 LCP DHHS Basic Set ( ) Graphic Case Graphic Case for LCP DHHS Instruments Instruments Drill Bit B 3.2 mm, length 145/120 mm, 2-flute Drill Bit B 4.3 mm, length 180 mm Drill Bit B 4.5 mm, length 145/120 mm, 2-flute T-Handle with Quick Coupling Tap for Cortex Screws Ø 4.5 mm Threaded Drill Guide Double Drill Guide 4.5/ Holding Sleeve, large Screwdriver Stardrive, T25, self-holding Screwdriver Shaft Stardrive 4.5/5.0, T Screwdriver Shaft, hexagonal, large, B 3.5 mm Screwdriver, hexagonal, large, B 3.5 mm Depth Gauge for Screws B 4.5 to 6.5 mm Screw Forceps, self-holding LCP DHHS Angled Guide, adjustable Connecting Screw B 5.2 mm Measuring Device for adjustable LCP DHHS Angled Guide LCP DHHS Reamer, length 60 mm LCP DHHS Guide for Blade Insertion LCP DHHS Guide Shaft LCP DHHS Connecting Screw, length 324 mm LCP DHHS Spiral Inserter for Blade Insertion LCP DHHS Impactor, cannulated, length 300 mm LCP DHHS Cap for Impactor Hammer 700 g Quick Coupling for DHS/DCS Triple Reamers DHS/DCS Guide Wire B 2.5 mm with threaded tip with trocar, length 230 mm or Guide Wire B 2.5 mm with spade point tip, length 230 mm 33 DePuy Synthes LCP DHHS Surgical Technique

33 Implants 5.0 mm Locking Screws, self-tapping, with T25 StarDrive recess Length Length (mm) Qty. (mm) Qty Also Available DHS Trochanter Stabilizing Plate, universal, locking LCP DHHS Compression Screw, enhanced Combined Hammer 400 g Hammer Guide for Combined Hammer 400 g DHS Goniometer LCP DHHS Reamer LCP DHHS Reamer, length 56 mm 4.5 mm Cortex Screws, self-tapping, with 3.5 mm hexagonal recess Length Length (mm) Qty. (mm) Qty LCP DHHS Surgical Technique DePuy Synthes 33

34 MRI Information Torque, Displacement and Image Artifacts according to ASTM F , ASTM F e1 and ASTM F Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system. Radio-Frequency-(RF-)induced heating according to ASTM F a Non-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 C with an average temperature rise of 6.6 C (1.5 T) and a peak temperature rise of 5.9 C (3 T) under MRI Conditions using RF Coils [whole body averaged specific absorption rate (SAR) of 2 W/kg for 6 minutes (1.5 T) and for 15 minutes (3 T)]. Precautions: The above mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: It is recommended to thoroughly monitor patients undergoing MR scanning for perceived temperature and/or pain sensations. Patients with impaired thermo regulation or temperature sensation should be excluded from MR scanning procedures. Generally it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible. Using the ventilation system may further contribute to reduce temperature increase in the body. 33 DePuy Synthes LCP DHHS Surgical Technique

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36 DSEM/TRM/1114/0222(2) 11/15 Synthes GmbH Eimattstrasse Oberdorf Switzerland Tel: Fax: This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at DePuy Synthes Trauma, a division of Synthes GmbH All rights reserved