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LCP Medial Proximal Tibial Plate 3.5. Part of the Synthes small fragment Locking Compression Plate (LCP) system.
Surgical Technique
This publication is not intended for distribution in the USA.
Instruments and implants approved by the AO Foundation.
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 1
Introduction
Surgical Technique 6
Product Information
MRI Information 26
LCP Medial Proximal Tibial Plate 3.5 2
AO Principles 4
Indications 5
Instruments for Minimally Invasive Osteosynthesis 20
Plates 21
Screws 22
Drill Sleeves and Drill Guides 24
Sets 25
Table of contents
Image intensifier control
WarningThis 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 MaintenanceFor 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:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor 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: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
2 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
The LCP Medial Proximal Tibial Plate 3.5 is part of the Synthes small fragment LCP system, which merges locking screw technology with conventional plating techniques.
Locking Compression PlateThe Locking Compression Plate (LCP) has combi-holes in the plate shaft that combine a dynamic compression unit (DCU) hole with a locking screw hole. The combi-hole pro-vides the flexibility of axial compression and locking capabil-ity throughout the length of the plate shaft.
Note: More detailed information on conventional and locked plating principles can be found in the Synthes Locking Com-pression Plate (LCP) Technique Guide (Art. No. 036.000.019).
LCP Medial Proximal Tibial Plate 3.5. Part of the Synthes small fragment Locking Compression Plate (LCP) system.
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 3
LCP Medial Proximal Tibial PlateThe LCP Medial Proximal Tibial Plate 3.5 is available in stainless steel and titanium and has a limited-contact shaft profile. The head and neck portions of the plate accept locking screws B 3.5 mm and conical screws B 3.5 mm. The screw hole pattern allows a raft of subchondral locking screws to buttress and maintain reduction of the articular surface. This provides fixed-angle support to the tibial plateau.
Plate head – Anatomically contoured to approximate
the anteromedial proximal tibia. – Three convergent threaded screw holes
accept locking screws B 3.5 mm or conical screws B 3.5 mm.
– Two 2.0 mm holes for preliminary fixa-tion with Kirschner wires, or meniscal repair with sutures.
Plate shaft – The two angled locking holes distal to
the plate head accept locking screws B 3.5 mm or conical screws B 3.5 mm to secure the plate position. The hole angles allow the locking screws to con-verge with two of the three screws in the plate head.
– Combi-holes, distal to the angled lock-ing holes, combine a DCU hole with a threaded locking hole. The combi-holes accept locking screws B 3.5 mm or conical screws B 3.5 mm in the threaded portion of the hole and cortex screws B 3.5 mm in the DCU portion of the hole.
– Available with 4, 6, 8, 10, 12, 14, 16, 18, or 20 combi-holes in the plate shaft.
– Limited-contact profile.
Available in left and right plates.
Two 2.0 mm holes for Kirschner wires and sutures
Three locking screw holes accept locking screws B 3.5 mm or conical screws B 3.5 mm
Angled locking holes accept locking screws B 3.5 mm or conical screws B 3.5 mm and support the proximal screws
Combi-holes combine a DCU hole with a threaded locking hole
For articulated tension device
4 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
AO Principles
In 1958, the AO formulated four basic principles which have become the guidelines for internal fixation.1 Those principles, as applied to the LCP Medial Proximal Tibial Plate 3.5, are:
Anatomic reductionFacilitates restoration of the articular surface by exact screw placement using drill sleeves.
Stable fixationLocking screws create a fixed-angle construct, providing angular stability.
Preservation of blood supplyTapered end simplifies submuscular plate insertion. Limited- contact shaft profile reduces plate-to-bone contact and vascular trauma.
Early, active mobilizationPlate features combined with AO technique create an envi-ronment for bone healing, expediting a return to optimal function.
1 Müller ME, Allgöwer M, Schneider R, Willenegger (1991) AO Manual of Internal Fixation, 3rd Edition. Berlin: Springer.
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 5
The LCP Medial Proximal Tibial Plates 3.5 are intended to buttress metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibial plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia, as well as segmental fractures of the proximal tibia.
Indications
AP View
Lateral View
0 10 20 30 40 50 60 70 80 90 100 mm
1.10 Magnification
For use only with the Original AO ASIF System ofInstruments and Implants
Synthes GmbHEimattstrasse 3CH-4436 Oberdorfwww.synthes.com 03
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LCP Medial Proximal Tibial Plate 3.5, right
X=2: St. SteelX=4: Titanium
X39.970 X39.968 X39.966 X39.964 X39.962 X39.960 X39.958 X39.956 X39.954 20 Holes 18 Holes 16 Holes 14 Holes 12 Holes 10 Holes 8 Holes 6 Holes 4 Holes 301 mm 275 mm 249 mm 223 mm 197 mm 171 mm 145 mm 119 mm 93 mm
0 10 20 30 40 50 60 70 80 90 100 mm
1.10 Magnification
For use only with the Original AO ASIF System ofInstruments and Implants
Synthes GmbHEimattstrasse 3CH-4436 Oberdorfwww.synthes.com
LCP Medial Proximal Tibial Plate 3.5, left
AP View
Lateral View
X39.955 X39.957 X39.959 X39.961 X39.963 X39.965 X39.967 X39.969 X39.971 4 Holes 6 Holes 8 Holes 10 Holes 12 Holes 14 Holes 16 Holes 18 Holes 20 Holes 93 mm 119 mm 145 mm 171 mm 197 mm 223 mm 249 mm 275 mm 301 mm
X=2: St. SteelX=4: Titanium 03
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6 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
Surgical Technique
1Preparation and preoperative planning
Required sets
Set for LCP Medial Proximal Tibial Plates 3.5
LCP Small Fragment Instrument Set
Small Fragment LCP Screw Set
Recommended additional sets
Large Distractor Set
Large External Fixator Set with Self-Drilling Schanz Screws
Complete the preoperative radiographic assessment and pre-pare the preoperative plan. Determine plate length and in-struments to be used.
Important: Determine proximal screw placement and screw lengths to ensure proper screw placement in the metaphysis.
Position the patient supine on a radiolucent operating table. Visualization of the proximal tibia under fluoroscopy in both the lateral and AP views is necessary.
X-ray template for right LCP Medial Proximal Tibial Plate 3.5 (Art. No. 034.000.502)
X-ray template for left LCP Medial Proximal Tibial Plate 3.5 (Art. No. 034.000.505)
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 7
2Reduce articular surface
Optional Instruments
01.301.000 Large External Fixator in Vario Case
117.700 Instrument Set for Large Distractor in Sterilization Tray
394.350 Large Distractor
Technique Tip: Prior to reduction, application of an external fixator or large distractor may facilitate visualization and re-duction of the joint.
Reduce the fracture fragments and confirm reduction using image intensification. Fragments may be reduced using inde-pendent Kirschner wires; however, Kirschner wire holes are also provided on the plate to help achieve provisional reduc-tion, plate position, or fixation.
The locking screws do not provide interfragmentary or plate-to-bone compression; therefore, any desired compression must be achieved with traditional lag screws or conical screws B 3.5 mm. The articular fragments must be reduced and compression must be obtained prior to applying the LCP Medial Proximal Tibial Plate with locking screws.
Technique Tip: To verify that independent lag screws will not interfere with plate placement, hold the plate to the bone.
Apply the distractor to assist in the visualization and reduc-tion of the joint.
8 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
Surgical Technique
3Determine plate position
Instruments
312.648 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
292.210 Kirschner Wire B 2.0 mm with trocar tip
Alternative instruments
323.027 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
Using anatomic landmarks and fluoroscopy, mount the plate on the intact or reconstructed plateau without attempting to reduce the distal portion of the fracture.
Mount the plateAttach a drill sleeve to the central hole in the head of the plate. Insert a Kirschner wire B 2.0 mm through a Kirschner wire hole.
If necessary, readjust the plate position. Place a second wire in the other Kirschner wire hole to prevent rotation of the plate and to secure provisional fixation of the plate to the tibial plateau.
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 9
4Insert proximal provisional (conical) screw
Instruments
324.214 Drill Bit B 2.8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling
319.090 Depth Gauge for Long Screws B 3.5 mm
Alternative instruments
310.284 LCP Drill Bit B 2.8 mm with Stop, length 165 mm, 2-flute, for Quick Coupling
Drill for central proximal screwWhile the plate is placed against the bone, use a B 2.8 mm drill bit to drill the hole for the locking screw through the drill sleeve attached to the central plate hole. It is imperative to use fluoroscopy while drilling in order to ensure proper screw trajectory and screw placement. Drill through to the lateral cortex or the desired screw tip location.
Determine proper screw trajectory by using clinical examina-tion and fluoroscopy to confirm: – Drill bit trajectory in the proximal locking hole is parallel to
the joint and the reduction is maintained. – Screw and plate placement will be consistent with the
preoperative plan. – Alignment of the plate to the shaft of the tibia is correct
in both the AP and lateral views. Placement of the plate at this point will determine final flexion/extension.
Measure for screw lengthMeasure for screw length using the depth gauge. Remove the drill sleeve, pass the measuring hook through the hole in the plate, and read the screw length from the depth gauge.
Alternatively, read the calibration directly after drilling from the drill bit at the back of the drill sleeve. Then remove the drill bit and drill sleeve.
10 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
Surgical Technique
Insert proximal (conical) screw
Instruments
314.116 Screwdriver Shaft Stardrive 3.5, SD15, self-holding
or314.030 Screwdriver Shaft, hexagonal, small, B 2.5 mm
314.041 Screwdriver Stardrive 3.5, SD15or314.070 Screwdriver, hexagonal, small, B 2.5 mm
Insert a conical screw B 3.5 mm in the central hole in the plate head to pull the plate to the bone and gain interfrag-mentary compression through the plate by using a power tool with the screwdriver shaft.
Perform final tighteningPerform final tightening by hand using a screwdriver. Care-fully tighten the conical screw, as excessive force is not necessary to produce effective interfragmentary compres-sion.
Notes: When interfragmentary compression is desired, use conical screws B 3.5 mm or cortex screws B 3.5 mm. Lock-ing screws are not lag screws.
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 11
5Secure plate to plateau
Instruments
312.648 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
324.214 Drill Bit B 2.8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling
319.090 Depth Gauge for Long Screws B 3.5 mm
511.770 Torque Limiter, 1.5 Nm, for Compact Air Drive and for Power Drive
or511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling
314.116 Screwdriver Shaft Stardrive 3.5, SD15, self-holding
or314.030 Screwdriver Shaft, hexagonal, small, B 2.5 mm
314.041 Screwdriver Stardrive 3.5, SD15or314.070 Screwdriver, hexagonal, small, B 2.5 mm
Alternative instruments
323.027 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
310.284 LCP Drill Bit B 2.8 mm with Stop, length 165 mm, 2-flute, for Quick Coupling
Drill for anterior and posterior screws in plate headAttach drill sleeves to the anterior and posterior holes in the head of the plate. Use the drill bit to drill through the drill sleeves.
Note: Use of the drill sleeve is mandatory for screws to lock to the plate properly.
12 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
Surgical Technique
Measure for screw lengthMeasure for screw length using the depth gauge. Remove the drill sleeve, pass the measuring hook through the hole in the plate, and read the screw length from the depth gauge.
Alternatively, read the calibration directly after drilling from the drill bit at the back of the drill sleeve. Then remove the drill bit and drill sleeve.
Remove the 2.0 mm Kirschner wires.
Insert anterior and posterior locking screwsInsert the appropriate length locking screws B 3.5 mm using a power tool with the torque limiter and the screwdriver shaft.
Perform final tighteningPerform final tightening by hand using the screwdriver. Care-fully tighten the locking screw, as excessive force is not nec-essary to produce effective screw to plate locking. After one click, the optimum torque is reached.
Warning: If the torque limiter is unavailable, do not tighten the screws to the plate using power. Perform final tightening by hand.
Once both the anterior and posterior locking screws are securely locked to the plate, the central conical screw B 3.5 mm may be removed and replaced with a locking screw B 3.5 mm using the technique described on page 11.
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 13
6Reduce shaft to tibial plateau
Instruments
398.810 Bone Holding Forceps, self-centering, speed lock
or398.811 Plate Holding Forceps, with Swivel Foot
321.120 Tension Device, articulated
Reduce the tibial plateau to the shaft of the tibia, using indirect reduction techniques whenever possible. Using atraumatic technique, secure the plate to the tibial shaft with bone forceps.
Confirm rotational alignment of the extremity by clinical examination.
Once reduction is satisfactory, and if it is appropriate, based on the fracture morphology, the plate should be loaded in tension using the articulated tension device.
Note: With multifragment fractures, it may not always be possible or desirable to achieve anatomic reduction. How-ever, in simple fracture patterns, the tension device may facil-itate anatomic reduction. This device may be used to gener-ate either compression or distraction.
1 2 2 1
2 1 1 2
14 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
7Insert screws in plate shaft
In addition to having threaded locking holes, the plate func-tions similarly to DCP plates which offer the ability to axially compress fracture fragments. Therefore, a combination of cortex screws and locking screws may be used.
Important: If a combination of cortex (1) and locking screws (2) is used, a cortex screw should be inserted first to pull the plate to the bone.
Note: If locking screws (1) have been used to fix the plate to a fragment, subsequent insertion of a cortex screw (2) in the same fragment without loosening and retightening the locking screw is not recommended.
Surgical Technique
Correct
Incorrect
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 15
7aInsert cortex screws
Instruments
323.360 Universal Drill Guide 3.5
310.230 Drill Bit B 2.5 mm, length 180/155 mm
319.090 Depth Gauge for Long Screws B 3.5 mm
314.070 Screwdriver, hexagonal, small, B 2.5 mm
Insert as many self-tapping cortex screws B 3.5 mm as necessary into the distal portion of the plate.
Important: All of the cortex screws B 3.5 mm must be inserted prior to insertion of locking screws B 3.5 mm.
Drill for cortex screwUse the universal drill guide and drill bit B 2.5 mm to predrill for the cortex screws B 3.5 mm. Drill through both cortices. 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 drill guide’s spring-loaded tip.
Measure for screw lengthMeasure for screw length using the depth gauge.
Insert cortex screwSelect and insert the appropriate length cortex screws B 3.5 mm.
Perform final tighteningPerform final tightening by hand using the hexagonal screw-driver.
16 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
7bInsert locking screws
Instruments
312.648 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
324.214 Drill Bit B 2.8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling
319.090 Depth Gauge for Long Screws B 3.5 mm
511.770 Torque Limiter, 1.5 Nm, for Compact Air Drive and for Power Drive
or511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling
314.116 Screwdriver Shaft Stardrive 3.5, SD15, self-holding
or314.030 Screwdriver Shaft, hexagonal, small, B 2.5 mm
For final tightening and locking
397.705 Handle for Torque Limiter Nos. 511.770 and 511.771
or311.431 Handle with Quick Coupling
Alternative instruments
323.027 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
310.284 LCP Drill Bit B 2.8 mm with Stop, length 165 mm, 2-flute, for Quick Coupling
Surgical Technique
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 17
Drill for locking screwAttach the LCP drill sleeve to a locking hole in the plate shaft. Drill a hole using the LCP drill bit B 2.8 mm.
Note: Use of the drill sleeve is mandatory for properly lock-ing the screws to the plate.
Measure for screw lengthRemove the drill sleeve and determine the screw length with the depth gauge. Alternatively, read the screw length directly from the drill bit at the back of the drill sleeve. Then remove the drill bit and drill sleeve.
Insert locking screwInsert the appropriate length locking screw B 3.5 mm by us-ing a power tool with the torque limiter and the screwdriver shaft.
Perform final tighteningPerform final tightening by hand using the screwdriver shaft together with the torque limiter and the handle for torque limiter. After one click, the optimum torque is reached.
Repeat as necessary to insert additional locking screws.
Warning: If the torque limiter is unavailable, do not tighten the screws to the plate using power. Perform final tightening by hand.
Examine the limb clinically and radiographically. It is import-ant that the tibial plateau is in proper orientation to the tibial shaft.
Important: Securely tighten all locking screws again.
60 mm65 mm
18 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
8Insert locking screws in the angled holes
Repeat steps for locking screw insertion for the remaining angled holes.
Suggested screw lengths to achieve desired screw convergence.
Screw length considerationsWhen using the appropriate length screws in the angled locking holes, the screw tips should meet the proximal locking screws.
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 19
Note: Securely tighten all locking screws to lock them to the plate.
20 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
Instruments for Minimally Invasive Osteosynthesis
Hohmann Retractor HolderThe Hohmann retractor holder was developed to support minimally invasive, percutaneous plate osteosynthesis. Its design enables the easy and reliable percutaneous insertion of plates. These characteristics make the Hohmann retractor holder the ideal instrument for use in combination with modern implant systems such as LCP and LISS.
– The Hohmann retractor holder allows better visualization of the inserted plate.
– Serves as a guide for the inserted plate. – Ensures that the inserted plate is centered on the bone.
For additional information see the separate Synthes publica-tion on the Hohmann retractor holder (Art. No. 036.000.219).
Soft Tissue RetractorThe offset blade facilitates an easy preparation of the epipereosteal cavity for percutaneous plate insertion.
– Adjustable blade for free choice of insertion angle and blade length
– Available in two sizes: for small and large fragment plates
For additional information see the separate Synthes publica-tion on the soft tissue retractor (Art. No. 036.000.127).
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 21
Plates
LCP Medial Proximal Tibial Plates 3.5
Steel Titanium Holes Length (mm)
239.954 439.954 4 93 right
239.956 439.956 6 119 right
239.958 439.958 8 145 right
239.960 439.960 10 171 right
239.962 439.962 12 197 right
239.964 439.964 14 223 right
239.966 439.966 16 249 right
239.968 439.968 18 275 right
239.970 439.970 20 301 right
239.955 439.955 4 93 left
239.957 439.957 6 119 left
239.959 439.959 8 145 left
239.961 439.961 10 171 left
239.963 439.963 12 197 left
239.965 439.965 14 223 left
239.967 439.967 16 249 left
239.969 439.969 18 275 left
239.971 439.971 20 301 left
All plates are available nonsterile and sterile packed. For sterile implants add suffix S to article number.
22 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
Screws
3.5 mm Locking Screw, self-tapping, with Stardrive/hexagonal recess – Threaded conical head – Fully threaded shaft – Stardrive or hexagonal recess – Self-tapping tip
Titanium Stainless Steel
413.010–413.095 213.010–213.095
412.101–412.131 212.101–212.131
3.5 mm Conical Screw, self-tapping, with Stardrive/hexagonal recess, partially threaded – Smooth conical head – Partially threaded shaft – Stardrive or hexagonal recess – Self-tapping tip
Titanium Stainless Steel
412.467–412.481 212.467–212.481
412.417–412.431 212.417–212.431
3.5 mm Conical Screw, self-tapping, with Stardrive/hexagonal recess, fully threaded – Smooth conical head – Fully threaded shaft – Stardrive or hexagonal recess – Self-tapping tip
Titanium Stainless Steel
412.367–412.381 212.367–212.381
412.317–412.331 212.317–212.331
3.5 mm Cortex Screw, self-tapping, hexagonal recess – May be used in the DCU portion of the combi-holes – Used to compress the plate to the bone or create axial
compression – Self-tapping tip
Titanium Stainless Steel
404.810–404.910 204.810–204.910
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 23
Locking and Conical Screw B 3.5 mm
Design The screw designs enhance fixation and facilitate the surgical procedure.
Screw headThe conical head simplifies alignment in the plate hole. This is of particular importance when using locking screws. The threaded screw head must align with the plate hole threads to provide a secure screw/plate construct. To ensure proper alignment and prevent cross-threading, the appropri-ate threaded drill sleeve must always be used.
Thread profileLocking screws do not rely on screw purchase in bone to achieve compression between the plate and the bone for stability. Therefore, the locking screw core diameter can be larger since its thread profile can be shallower. When re-quired, interfragmentary compression can be achieved with the partially threaded conical screws, especially when near the articular surface.
24 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
Drill Sleeves and Drill Guides
312.648 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
323.360 Universal Drill Guide 3.5
Alternative instruments
323.027 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm
LCP Medial Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 25
Sets
Plate Set LCP Medial Proximal Tibial Plates 3.5 in Vario Case
01.120.409 Stainless Steel
01.120.411 Titanium
68.120.403 Vario Case
68.120.405 Insert
689.507 Lid
Additionally required – LCP Small Fragment Instrument Set – LCP Screw Set B 3.5 mm – Insert for Screws B 3.5 mm
(included in Vario Case 68.120.403)
26 DePuy Synthes LCP Medial Proximal Tibial Plate 3.5 Surgical Technique
MRI Information
Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07Non-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 F2182-11aNon-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-clini-cal 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 under-
going MR scanning for perceived temperature and/or pain sensations.
– Patients with impaired thermo regulation or temperature sensation should be excluded from MR scanning proce-dures.
– 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.
0123
Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com
This publication is not intended for distribution in the USA.
All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©
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