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Implantstrauma
PHLProximal Humeral Locking Plate
www.its-implant.com
All ITS plates are preformed anatomically as a matter of principle. If adjustment of the plate to the shape of the bone is required, this is possible by carefully bending gently in one direction once. Particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism. The plate must not be buckled or bent several times. This is particularly important in the case of titanium implants, to prevent material fatigue and subsequent failure. The method of bending is the conscious responsibility of the operating doctor; I.T.S. GmbH can accept no liability whatsoever for this.
1. Introduction
P. 5 PrefaceP. 6 ScrewsP. 7 PropertiesP. 8 Pre-operative planningP. 8 Indications & Contraindications P. 8 Time of operation
2. Surgical technique
P. 10 Assembly of the insertion guideP. 10 Pre-operative patient preparationP. 11 ExposureP. 11 ReductionP. 12 Plate insertionP. 13 Intraoperative identification of screw lengthP. 14 Placement of the screwsP. 18 Disassembly of the insertion guideP. 19 Optional fixation of soft tissueP. 19 Optional fixation in the shaft area with cerclageP. 19 Postoperative treatmentP. 19 Explantation
3. Information
P. 21 LockingP. 21 Dotize®P. 22 Order listP. 25 Notes
Contents
1.
Introduction
5
Preface
The newly developed Proximal Humeral Locking Plate enables the medical treatment of fractures in the joint area as well as periprosthetic fractures with an optional less invasive method.
The special feature of this implant is the free choice of screw placement.The user is able to set any desired screw in any hole (except oblong hole).
Especially with complex fractures the free choice of screw angle (+/- 15°, see page 21) has advantages in the fracture treatment.
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32351-XX
61273-220
56252-150
37422-XX-N
61253-220
56252-150
35164-260
37351-XX-N
61273-220
56252-150
Screws
Cortical Screw, D=3.5mm
Spiral Drill, D=2.7mm, L=220mm, AO Connector
Screwdriver, WS 2.5,self-holding
Cancellous Screw, locking, D=4.2mm, SH
Spiral Drill, D=2.5mm, L=220mm, AO Connector
Screwdriver, WS 2.5,self-holding
Guide Wire, Steel, D=1.6mm, L=260mm, TR, w. thread
Cortical Screw, locking, D=3.5mm, SH
Spiral Drill, D=2.7mm, L=220mm, AO Connector
Screwdriver, WS 2.5,self-holding
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Properties of the material:
• Plate material: Titanium• Material of screws: TiAl6V4 ELI• Easier removal of the implant after the
fracture has healed• Improved fatigue strength of the
implant• Reduced risk of cold welding• Reduced risk of inflammation and
allergy
Properties of the implant:
• Multi-directional locking• Anatomical plate design• 6 proximal plate holes for optimal
reconstruction of the humeral head• Oblong hole for optimal positioning
and adjustment of the humeral length• K-Wire holes for preliminary plate
fixation• Pointed distal plate end for
percutaneous insertion• Lengths: 4, 7, 10-hole
Properties
Special design of the proximal plate end to increase the range of motion and reduced risk of
subacromial impingement
6 marginal proximal holes for suture fixation of soft
tissue to the plate
Indentations in the shaft area to facilitate the use of cerclage
bands and wires
Staggered plate holes in the shaft to facilitate the screw placement for
periprosthetic fractures
Radiolucent insertion guide for minimally invasive treatment
Turn the handle 180° for proximal screw insertion
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0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 130 135 140 145 150 155 160 165 170 175 180 185 190 195 200 205 210 215 220 225 230 235 240 245 250
21133-44 holes102mm
21133-77 holes147mm
21133-1010 holes192mm
4.5
1525
Indications, Contraindications & Time of operationIndications:
• All stable and unstable humerus fractures with or without shaft involvement• Periprosthetic humerus fractures
Contraindications:
• Severe osteoporosis• Existing infections in the area of the fracture• In cases of skin and soft tissue problems• Obesity• Lack of patient compliance
Time of operation:
• Primary as well as secondary after swelling subsides and after temporary fixation
Pre-operative planning
2.
Surgical technique
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3 4
1 2
Assembly of the insertion guide
Treatment of periprosthetic fractures• The proximal humeral plate facilitates the screw placement for
periprosthetic fractures due to staggered plate holes in the shaft.• Take care to avoid collision with the prosthesis resp. nail by choosing the
appropriate plate holes and screws.• In addition, indentations in the shaft enables a proper hold of cerclages.
11
ExposureAnterolateral access:
• Skin incision parallel to the anterior acromion and extension 5cm distally in fiber direction of the M. deltoideus.
• Detachment of the pars acromialis of the M. deltoideus.
ATTENTION: The axillary nerve quits the lateral armpit dorsally moves around the surgical neck (collum chirurgicum) of the humerus.
ReductionAnatomical reduction of the fracture under fluoroscopy.
Pre-operative patient preparation• Positioning on a radiolucent surgical table• Semi-sitting angle of about 30° - 40°, shoulder should be freely moveable (optional
shoulder table)• The arm should be freely moveable to allow fracture reduction• General anaesthesia, regional anaesthesia or combination can be used
12
Plate insertion• Insert the plate, assembled on the insertion guide (recommended in Z position)• Remain plate in constant contact with the bone and slide distally• Align the proximal end of the plate on the Tuberculum majus• Verify the correct plate position. Optionally temporary fixation with guide wires,
steel, D=1.6mm, L=260mm, TR, w. thread (35164-260) into proximal guide wire holes.
ATTENTION: Take care to avoid injuring the axillary nerve when inserting the plate.
13
21
Intraoperative identification of screw length1. Insert the depth gauge for humeral systems (59222) after drilling screw holes. Then, hook into the far medial cortices and read off the required screw length.2. Drill screw holes under fluoroscopy guidance through the far medial cortices. Then, read off the required screw length at the calibrated spiral drill D=2.7mm, L=220mm (61273-220).
Note: In the proximal area, the screw length is determined using the depth gauge, solid small fragment screws (59022).
14
Placement of the screwsFix the plate temporarily to the bone and drill with the spiral drill, D=2.7mm, L=220mm, AO Connector (61273-220) in the oblong hole. Drilling is performed through the D=2.8mm drill sleeve (118005-10) that was placed in the tissue protection sleeve (118005-8). Then, the drill sleeve is removed and a D=3.5mm cortical screw (32351-XX) (appropriate length measured before) is inserted through the tissue protection sleeve.
Advice: For optimal positioning and adjustment of the humeral length, we recommend to first fill the oblong hole.Therefore it is a centric and eccentric sleeve available.(centric sleeve (118005-7): after placing the screw, the plate can be slid 3.5mm in both directions; eccentric sleeve (118005-6): after placing the screw, the plate can be slid 7mm in one direction).
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Unscrew the clamping nut (118005-16) up to the non-threaded part (see picture below), rotate the handle 180° and tighten the clamping nut by hand.Then using the spiral drill, D=2.5/2.7mm, L=220mm, AO Connector (61253-220/61273-220) to drill through the drill guide, D=2.7/2.0mm (62202) into a proximal hole.Use the screwdriver, WS 2.5 (56252-150) to insert a D=3.5mm locking cortical screw (37351-XX-N) or a D=4.2mm locking cancellous screw (37422-XX-N) of appropriate length determined previously with the depth gauge, solid small fragment screws (59022).
16
Following unscrew the clamping nut (118005-16) up to the non-threaded part (see picture below), rotate the handle 180° and tighten the clamping nut by hand.Then the shaft holes are occupied, optionally with locking or non-locking screws.Use the screwdriver, WS 2.5 (56252-150) to insert D=4.2mm locking cancellous screws (37422-XX-N) or D=3.5mm cortical screws, optionally locking or non-locking (37351-XX-N/ 32351-XX) of appropriate lengths determined previously.
17
The remaining plate holes are then filled, with either locking or non-locking screws.Subsequent control of plate position under fluoroscopy.
18
Disassembly of the insertion guideFor disassembling the insertion guide (118005A) unscrew the retaining screw (118005-15) and remove the entire guiding instrument.
19
Postoperative treatmentAs a rule, physical therapy immediately after surgery (passive motion exercices). Active motion exercices after 3-9 weeks.I n case of poor bone quality or insecure fixation, immobilization for a maximum of 3 weeks.
Explantation• Removal is possible, if desired by the patient. This is facilitated by the fact that cold
welding never occurs.• Implant removal is performed 6 months post-operative and if the fracture has healed• Vice versa of implantation• Skin incision following the old scar• Assemble the insertion guide onto the plate• Stab incision and remove the screws with the screwdriver, WS 2.5 (56252-150)• The problem of cold welding was resolved by using a special surface treatment (for
further information see page 21)
Optional fixation of soft tissueSoft tissue can be sutured to the marginal holes in the proximal area of the plate with special suture material (see picture below - red marked).
Optional fixation in the shaft area with cerclageMillings in the shaft area of the plate facilitate the optional use of cerclage wire (see picture below - red marked).
3.
Information
21
Locking
Dotize®
Ti-Oxid
30°
* White Paper: Ti6Al4V with Anodization Type II: Biological Behavior and Biomechanical Effects; Axel Baumann, Nils Zander
• Oxygen and silicon absorbing conversion layer• Decrease in protein adsorption• Closing of micro pores and micro cracks• Reduced risk of inflammation and allergy• Hardened titanium surface• Reduced tendency of cold welding of titanium implants• Increased fatigue resistance of implants• Improved wear and friction characteristics
Chemical process - anodization in a strong alkaline solution*
Type - IIIDotize® Type - II
Anodization Type II leads to following benefits*
Locking works because:
• Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2)
• Screw head forms thread into the plate (no cutting)
Benefits:
• ± 15° and Locking• No pre threading• No cold welding• No debris• You can re-set the screw up to 3 times
Type III anodization
• Layer thickness 60-200nm + Different colors - Implant surface remains sensitive to: Chipping
Peeling Discoloration
DotizeType II anodization
• Layer thickness 2000-10 000nm + Film becomes an interstitial part of the titanium - No visible cosmetic effect
22
Order listProximal Humeral Plate, 4-hole 21133-4 Proximal Humeral Plate, 7-hole 21133-7Proximal Humeral Plate, 10-hole 21133-10
Cortical Screw, Locking, D=3.5mm, L=18mm, SH 37351-18-N Cortical Screw, Locking, D=3.5mm, L=20mm, SH 37351-20-NCortical Screw, Locking, D=3.5mm, L=22mm, SH 37351-22-NCortical Screw, Locking, D=3.5mm, L=24mm, SH 37351-24-NCortical Screw, Locking, D=3.5mm, L=26mm, SH 37351-26-NCortical Screw, Locking, D=3.5mm, L=28mm, SH 37351-28-NCortical Screw, Locking, D=3.5mm, L=30mm, SH 37351-30-NCortical Screw, Locking, D=3.5mm, L=32mm, SH 37351-32-NCortical Screw, Locking, D=3.5mm, L=34mm, SH 37351-34-NCortical Screw, Locking, D=3.5mm, L=36mm, SH 37351-36-NCortical Screw, Locking, D=3.5mm, L=38mm, SH 37351-38-NCortical Screw, Locking, D=3.5mm, L=40mm, SH 37351-40-N
Cortical Screw, D=3.5mm, L=18mm 32351-18 Cortical Screw, D=3.5mm, L=20mm 32351-20Cortical Screw, D=3.5mm, L=22mm 32351-22Cortical Screw, D=3.5mm, L=24mm 32351-24Cortical Screw, D=3.5mm, L=26mm 32351-26Cortical Screw, D=3.5mm, L=28mm 32351-28Cortical Screw, D=3.5mm, L=30mm 32351-30Cortical Screw, D=3.5mm, L=32mm 32351-32Cortical Screw, D=3.5mm, L=34mm 32351-34Cortical Screw, D=3.5mm, L=36mm 32351-36Cortical Screw, D=3.5mm, L=38mm 32351-38Cortical Screw, D=3.5mm, L=40mm 32351-40
Cancellous Screw, Locking, D=4.2mm, L=24mm, SH 37422-24-N Cancellous Screw, Locking, D=4.2mm, L=26mm, SH 37422-26-NCancellous Screw, Locking, D=4.2mm, L=28mm, SH 37422-28-NCancellous Screw, Locking, D=4.2mm, L=30mm, SH 37422-30-NCancellous Screw, Locking, D=4.2mm, L=32mm, SH 37422-32-NCancellous Screw, Locking, D=4.2mm, L=34mm, SH 37422-34-NCancellous Screw, Locking, D=4.2mm, L=36mm, SH 37422-36-NCancellous Screw, Locking, D=4.2mm, L=38mm, SH 37422-38-NCancellous Screw, Locking, D=4.2mm, L=40mm, SH 37422-40-NCancellous Screw, Locking, D=4.2mm, L=42mm, SH 37422-42-NCancellous Screw, Locking, D=4.2mm, L=44mm, SH 37422-44-NCancellous Screw, Locking, D=4.2mm, L=46mm, SH 37422-46-NCancellous Screw, Locking, D=4.2mm, L=48mm, SH 37422-48-NCancellous Screw, Locking, D=4.2mm, L=50mm, SH 37422-50-NCancellous Screw, Locking, D=4.2mm, L=55mm, SH 37422-55-NCancellous Screw, Locking, D=4.2mm, L=60mm, SH 37422-60-N
23
Screwdriver, WS 2.5, conical head 56252-150
Depth Gauge, Solid Small Fragment Screws 59022 Depth Gauge, F. Humeral Systems 59222
Drill Guide, D=2.0/2.7mm 62202 Drill Guide, Centered, D=2.7mm 62207
Spiral Drill, D=2.5mm, L=220mm, AO Connector 61253-220 Spiral Drill, D=2.7mm, L=220mm, AO Connector 61273-220
Guide Wire, Steel, D=1.6mm, L=260mm, TR, w. thread 35164-260
Insertion Guide, Proximal Humeral Plate 118005A
Sterilization Tray 50249
Spare Parts List Insertion Guide / Optional (on request)
Jig Part 1, Proximal Humeral Plate 118005-12
Jig Part 2, Proximal Humeral Plate 118005-13
Fixing Screw, Jig, Proximal Humeral Plate 118005-14
Handle, Proximal Humeral Plate 118005-3
Clamping Nut 118005-16
Retaining Screw 118005-15
Sleeve, eccentric 118005-6 Sleeve, centric 118005-7
Tissue Protection Sleeve 118005-8
Drill Sleeve, D=1.7mm 118005-9 Drill Sleeve, D=2.8mm 118005-10
Retaining Sleeve 118005-11
Clamping Screw 118003-12
For detailed cleaning and sterilization instructions, please refer to package insert.
24
Tray configuration
25
Notes
26
27
ITS. GmbHAutal 28, 8301 Lassnitzhöhe, Austria
Tel.: +43 (0) 316 / 211 21 0Fax: +43 (0) 316 / 211 21 [email protected]
www.its-implant.com
Order No. PHL-OP-0218-PREdition: February/2018
© ITS. GmbH Graz/Austria 2018. Subject to technical alterations, errors and misprints excepted.
I.T.S. Latin AmericaPO Box 2500 Guaynabo
PR 00970
Tel.: 787 - 622 - 6836Fax: 787 - 622 - 6839
