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PLS - Pilon Locking Plates System

PLS - Pilon Locking Plates System
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PLS - Pilon Locking Plates System

Product catalog summary
Introduction
The Pilon Locking Plate System (PLS) is designed for osteosynthesis in pilon fractures, providing flexibility in screw placement and angulation. It supports both locking and non-locking screws, enhancing treatment options for complex fractures.
Specifications
The system includes titanium plates and TiAl6V4 ELI screws, featuring multi-directional locking, anatomical shaping, and percutaneous insertion options. Plates come in various lengths and strengths for optimal joint fixation.
Indications and Contraindications
PLS is indicated for tibial pilon fractures (AO classification A3, C2, C3). Contraindications include infections, osteoporosis, skin issues, obesity, and non-compliance. Surgery is ideally performed shortly after trauma or post-swelling.
Surgical Technique
Pre-operative preparation involves anesthesia and positioning, with medial access recommended. Reduction includes temporary fixation and anatomical alignment, verified by fluoroscopy. Specific drills and gauges are used for screw placement, followed by post-operative care including elevation, physical therapy, and weight-bearing guidelines.
Postoperative Treatment and Explantation
Post-surgery care involves leg elevation and physical therapy, with weight-bearing progressing from partial to full over several months. Implants can be removed after bone healing, typically 6 months to 1.5 years post-operation.
Locking Mechanism and Surface Treatment
The locking mechanism benefits from the hardness of screw material relative to the plate. Dotize® anodization enhances surface properties, reducing inflammation risk and improving fatigue resistance.
Reconditioning and Maintenance
Non-sterile implants and reusable instruments require careful handling and cleaning. Steam sterilization is recommended, with specific cleaning protocols to ensure longevity and safety.
Warnings and Precautions
Implants are single-use, and modifications are prohibited. Regular follow-ups are necessary, and MRI use with steel implants is discouraged. Proper handling and protective measures are essential during reconditioning.
Cleaning and Disinfection Procedures
Automatic cleaning is preferred for efficacy, with manual cleaning supporting heavily soiled instruments. Recommended cleaning agents have a pH of 9-11. Instruments should be fully submerged in cleaning solutions, followed by ultrasound treatment and thorough rinsing.
Manual Disinfection
If non-disinfectant cleaning agents are used, a separate disinfection step is necessary, following manufacturer instructions.
Inspection and Maintenance
Inspect instruments for visible dirt, lubricate movable parts, and ensure proper function and reassembly.
Packaging and Sterilization
Packaging is for transport only. Sterilization should use the fractionated pre-vacuum procedure as per EN 285 or EN 13060 standards, with steam sterilization at 134°C for 5 to 18 minutes.
Disposal and Responsibility
Hospital guidelines apply for disposal. Instruments returned to I.T.S. GmbH must be cleaned, disinfected, inspected, and sterilized, with decontamination confirmation.
Important Information
Instructions are validated for reconditioning medical devices. Reconditioners must ensure processes achieve desired results through validation and routine inspections. Contact I.T.S. GmbH for questions or issues.
Patient Information
Patients should be informed about post-implantation behavior and the importance of reporting any negative changes or incidents.
Symbols and Standards
Symbols indicate prescription, single use, sterilization methods, and compliance with standards like ISO 13485 and ISO 17664.
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Catalog excerpts

PLS - Pilon Locking Plates System-1

Implants trauma Pilon Locking Plates System

 Open the catalog to page 1
PLS - Pilon Locking Plates System-2

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....

 Open the catalog to page 2
PLS - Pilon Locking Plates System-3

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Indications & Contraindications P. 8 Time of operation 2. Surgical Technique P. 10 Pre-operative patient preparation P. 10 Access P. 11 Reduction P. 12 Placement of the screws P. 15 Postoperative treatment P. 15 Explantation 3. Information P. 17 Locking P. 17 Dotize® P. 18 Order list P. 20 Reconditioning Manual P. 22 Notes

 Open the catalog to page 3
PLS - Pilon Locking Plates System-5

Preface Pilon Locking Plate is a proven osteosynthesis system for various fractures of the pilon. 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, either locking or non-locking screw. The free choice of screw angulation (+/- 15°, see page 17) provides an advantage in fracture treatment, especially in the case of complex fractures.

 Open the catalog to page 5
PLS - Pilon Locking Plates System-6

Cortical Screw, Locking, D=3.5mm, SH Spiral Drill, D=2.7mm, L=IOOmm,AO Connector self-holding sleeve ^^^^^^^HfiMAfl^yUai. 61273-100 Spiral Drill, D=2.7mm, L=l00mm, AO Connector self-holding sleeve 37422-xx-N Cancellous Screw, locking, D=4.2mm, SH 61253-180 Spiral Drill, D=2.5mm, L=l80mm, AO Connector self-holding sleeve

 Open the catalog to page 6
PLS - Pilon Locking Plates System-7

Properties Properties of the implant: • 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 • Multi-directional Locking • Anatomically shaped • 5 resp. 6 distal plate holes for fixation close to joint • Pointed proximal plate end for percutaneous insertion Pilon Plate small: Pilon Plate: • 5 distal plate holes for optimal fixation close to joint • Lengths: 4, 6, 8-hole • Strength: 2.5mm • 6 distal plate holes...

 Open the catalog to page 7
PLS - Pilon Locking Plates System-8

Indications, Contraindications & Time of operation Indications: • Fractures of the tibial pilon of AO classification A3, especially groups C2 and C3 Existing infections in the fracture zone and operation area Common situations that do not allow osteosynthesis With advanced osteoporosis In cases of skin and soft tissue problems that prevent a tension-free skin closure Obesity Lack of patient compliance Time of operation: • Primarily in the first hours after trauma • Secondarily after swelling has subsided. Intermediate fixation by means of a external fixator or by means of extension.

 Open the catalog to page 8
PLS - Pilon Locking Plates System-9

Surgical Technique

 Open the catalog to page 9
PLS - Pilon Locking Plates System-10

Pre-operative patient preparation • General anaesthesia, local anaesthesia or combination can be used • The patient is in the supine position with the leg raised slightly on a pedestal • Application of a tourniquet Access Medial Access: • Skin incision is made via the inner side of the ankle • The incision should be made 1-2cm away from the fracture so that the suture is not directly over the plate. • If necessary, the flexor retinaculum (laciniate ligament) can be severed. • Remove the tendon of the tibialis posterior muscle and the flexor tendons from their compartments and hold aside in the...

 Open the catalog to page 10
PLS - Pilon Locking Plates System-11

Reduction • Temporary fixation of the plate to the pilon using guide wires • Anatomical reduction of the articular block and fracture segments to the plate (varus/valgus, ante-/retroversion)a • Subsequent control under fluoroscopy Optionally, the plate can be stabilized using the ITS. Temporary Plate Holder (58164-150).

 Open the catalog to page 11
PLS - Pilon Locking Plates System-12

Placement of the screws With the spiral drill, D=2.7mm, L=100mm, AO Connector (61273-100), drill through the drill guide, D=2.7/2.0mm (62202) into a proximal plate hole. Determine appropriate length using the depth gauge, solid small fragment screws (59022). Insert the D=3.5mm cortical screw (32351-XX) with the screwdriver, WS 2.5, self-holding sleeve (56252).

 Open the catalog to page 12
PLS - Pilon Locking Plates System-13

Then using the spiral drill, D=2.5mm, L=100mm, AO Connector (61253-100) to drill through the drill guide, D=2.7/2.0mm (62202) into a distal plate hole. Determine appropriate length using the depth gauge, solid small fragment screws (59022). Insert the D=4.2mm locking cancellous screw (37422-XX-N) with the screwdriver, WS 2.5, self-holding sleeve (56252).

 Open the catalog to page 13
PLS - Pilon Locking Plates System-14

The remaining plate holes are then filled, with either locking or non-locking screws. Subsequent control of plate position under fluoroscopy. Pilon Plate Pilon Plate small

 Open the catalog to page 14
PLS - Pilon Locking Plates System-15

Postoperative treatment • Keep leg raised for 2 to 5 days and take decongestant actions • Physical therapy immediately following surgery (no immobilization required) • Partial toe touch weight-bearing - at week 6-8 (depends on wound healing): 10-15kg • Full weight-bearing - after about 3 months (depends on consolidation of the joint) • When a locking screw connection has been used, it is necessary to be aware that a diagnosis of non-union may be very delayed. Explantation If desired by the patient, the implant can be removed. Removal should be performed at the earliest 6 months - 1 1/2 years...

 Open the catalog to page 15
PLS - Pilon Locking Plates System-17

Locking Locking works because: • Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) ± 15° and Locking No pre threading No cold welding No debris You can re-set the screw up to 3 times Dotize® Chemical process - anodization in a strong alkaline solution* Dotize Type II anodization • Layer thickness 2000-10 000nm + Film becomes an interstitial part of the titanium + Different colors - Implant surface remains sensitive to: Chipping Peeling Discoloration - No visible cosmetic effect Dotize® Type - II Anodization Type...

 Open the catalog to page 17

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.