uol ulna osteotomy locking plate
Transcription
uol ulna osteotomy locking plate
UOL ULNA OSTEOTOMY LOCKING PLATE emergency team for broken bones® CONTENTS Preface Surgical Technique Information Preface 3 Screws 4 Properties 5 Indications & Contraindications 5 Assembling of the instruments 6 Positioning of the patient 7 Exposure 7 Plate insertion 8 Placement of the tensile bolts 9 Shortening 12 Reduction 16 Placement of the screws 19 Removal of the instruments 22 Postoperative treatment 24 Summary 25 Order information 26 Locking 28 Dotize® 28 Sterilization guidelines 30 Preface Preface: The Ulna Osteotomy Locking Plate provides a plate system (hybrid system) to be studded with locking screws and compression screws, which is specially adapted to the anatomic and biomechanic requirements after shortening osteotomy of the distal ulna. In a single device, the Ulna Osteotomy Locking Plate allows for unique coplanar orientation of the incisions with rotation-stable shortening and the option for compression. The standardization of a plurality of surgical procedures into a single device system obtained thereby increases and secures the quality of the surgical procedure. 03 Ulna Osteotomy Locking Plate 37301-XX Cortical Screw, Locking, D=3.0mm 61243-100 Spiral Drill, D=2.4mm, L=100mm, AO Connector 56095-70 Screwdriver, Torque, T9x70 56095-70-2 Self-holding sleeve, Screwdriver, Torque 9 32271-XX Cortical Screw, D=2.7mm 61203-100 Spiral Drill, D=2.0mm, L=100mm, AO Connector 56095-70 Screwdriver, Torque, T9x70 56095-70-2 Self-holding sleeve, Screwdriver, Torque 9 37302-XX Cancellous Screw, Locking, D=3.0mm 61203-100 Spiral Drill, D=2.0mm, L=100mm, AO Connector 56095-70 Screwdriver, Torque, T9x70 56095-70-2 Self-holding sleeve, Screwdriver, Torque 9 All I.T.S. locking plates are anatomically pre-contoured. In the unlikely event that the plate has to be formed to the bone please notice that slight contouring is possible. 04 ATTENTION: Significant bending at the locking holes will reduce locking effectiveness and if bend more than once in both directions it might weaken the titanium plate strongly. Properties Properties of the implant: • • • • • • Multidirectional locking Anatomically shaped Plate length: 5-hole No dislocation of the parts of the bone due to fixation using long-bore hole Positioning of the plate prior to the osteotomy Compression instrument for simple joining of the osteotomy surfaces (compression strength freely selectable) • No loss of correction due to locking • A screw can be placed through both osteotomy surfaces as a tension or fixating screw, optionally locking Properties of the material: • • • • • • Plate material: Titanium Grade 2 Material of screws: TiAL6V4 ELI Easier removal of implant after fracture has healed Improved fatigue strength of implant Reduced risk of cold bonding Reduced risk of inflammation and allergy Indications, Contraindications Indications: Impaction syndrome of the ulnar wrist • Symptomatic, post-traumatic ulnar malposition in the distal radio-ulnar joint (DRUJ) • Degenerative ulnar wrist • Correction of the ulnar position relative to the unaffected other side up to a maximum of 6mm in one step or 13mm in two steps (see figures page 18) Extended indications: • Primary ulnar shortening in forearm fractures with insufficient reconstruction of the length of the radius • Deformities • Degenerative ulnar variant in conically shaped DRUJ according to Förstner 05 Assembling of the instruments 1 2 1 680858 680857 680853 2 680850 680856 1 680854 3 680855 680852-1 2 680851-1 680854 06 Positioning of the patient Place the patient on his back, cover the arm to be freely movable and place it on an X-ray transparent table at a shoulder abduction of 90°. Perform the operation under regional or general anaesthesia with or without using an arrest of blood supply on the upper arm. The shape of the implant allows for palmar, ulnar or dorsal positioning of the plate. The plate should be completely fitted to the bone without protruding. As the the distal palmar section of the ulna is usually curved, more proximal positioning of the plate or pre-bending of the implant are recommended. Attention: When bending the plate, make sure you bend the plate at the 2 distal bore holes only. If you bend the plate to much, it may happen that the “Locking” System doesn’t work due to deformation. Exposure The upper extremity is rotated outwards, the elbow is bent and the wrist is supported with a roll. Begin the incision of the skin approximately 2–3cm proximal of the palpable processus styloideus ulnae. It shall run 5mm palmar, parallel to the palpable margo interosseus approximately 8–9cm proximal. It is mandatory to pay attention to the ramus dorsalis n. ulnaris. 07 Plate insertion After opening the forearm fascia, mobilize bluntly the belly of the FCU (M. flexor carpi ulnaris) at its insertion point at the ulna and retract it medial using Hohmann retractors. Define the optimal position of the plate and incise the dorsal forearm fascia in the designated osteotomy area. 08 Placement of the tension bolts Place the assembled osteotomy system upon the ulna osteotomy plate, which is attached to the ulna using the plate holes alternatingly from the outside centrad; distally with D=3.0mm locking cancellous screws (37302-XX) or D=3.0mm locking cortical screws (37301-XX) (spiral drill, D=2.0mm, L=100mm, AO Connector (61203-100) for locking cancellous screw / spiral drill, D=2.4mm, L=100mm, AO Connector (61243-100) for locking cortical screw), proximally with 2 tension bolts (680859) after inserting the drill guide, D=2.0mm (62208) for the tension bolt and a D=2.0mm bore (optionally D=2.4mm for hard bone). 09 The bore diameter depends on the choice of the screw. (spiral drill, D=2.0mm, L=100mm, AO Connector (61203-100) for locking cancellous screw / spiral drill, D=2.4mm, L=100mm, AO Connector (61243-100) for locking cortical screw). 10 D=2.0 mm D=2.0 mm 11 Shortening Incise the periosteum at the osteotomy site and retract it minimally before performing, using the incision gage and producing as little heat as possible, two atraumatic, parallel cuts according to the measured shortening. The maximum recommended osteotomy length is 6mm. Caution: In osteoporotic bones, traction bolts may tilt due to high traction forces (malformation of drilled holes in osteoporotic bone). The thickness of the saw blade may amount to 0.7mm maximally. We recommend a thickness of the saw blade amounting to 0.5–0.7mm in order to achieve precision. 12 13 14 15 Reduction After removal of the dissecate, the osteotomy surfaces must be cleaned meticulously of bone or soft tissue remnants before, after loosening the tension bolts (1/2 to 3/4 turn), shortening is performed using the setscrew. If there are excessive tensions and shortening difficulties, this is usually the consequence of an interponate. After contact of the osteotomy surfaces, prior to a desired compression the reduction may be additionally secured using holding tongs. After that, tighten the tension bolts firmly. 1/2 to 3/4 turn (loosening) 16 1/2 to 3/4 turn (loosening) 17 If shortening of more than 6mm is desired, two subsequent osteotomies may be performed. For recommended OT-widths please refer to table stated below. Shortening in mm First Osteotomy Second Osteotomy 0-6 required length - 7 4 3 8 5 3 9 6 3 10 6 4 11 6 5 12 6 6 13 7 6 Any desired shortening of 7-13mm may be performed following the initial OT by manual support and protected against rotation using a clamp, without using the adjusting screw on compression (for OT-widths, please see table above). As a result, the drill holes will stay undeformed to the greatest extent even in osteoporotic bone, while the shortening is still protected against rotation. After successful shortening, the instrument is attached to the ulna in a stable manner, and the second OT is performed according to existing standards. Due to the stepwise approach, no extended implant is required, even with enhanced shortenings, and the length of the surgical incision will be unchanged. Caution: At OT-widths of 11 to 13mm, we recommend not to use hole G (see figure beside), since the bridge between the drilled hole for the proximal traction bolt and the drilled hole in G will be too narrow thus, a safe fixation cannot be guaranteed, particularly not in osteoporotic bone. Shortening in mm A B C D E F G H A B C D E F G H A B C D E F G H A B C D E F G H A B C D E F G H A B C D E F G H A B C D E F G H 0 8 9 10 11 12 13 18 Displacement of the bores Placement of the screws After making a bore with the spiral drill, D=2.0mm, L=100mm, AO Connector (61203-100), place a D=2.7mm cortical screw (32271-XX) as a fixation screw into the oblique bore. The cortical screw may optionally be used as a tension screw (bore into the corticalis near the plate using a spiral drill, D=2.7mm, L=100mm, AO Connector (61243-100)). D=2.0 mm 19 Loosen the pre-tension and replace first the tension bolt in the slide hole close to the osteotomy site, second the one at the end of the plate with a D=2.7mm cortical screw (32271-XX). Subtract 4 mm from the length measured. 20 21 Removal of the instruments Remove the osteotomy system from the ulna osteotomy plate, and insert D=3.0mm locking cancellous screws (37302-XX) or D=3.0mm locking cortical screws (37301-XX) into the remaining plate holes. The bore diameter depends on the choice of the screws. (spiral drill, D=2.0mm, L=100mm, AO Connector (61203-100) for locking cancellous screw / spiral drill, D=2.4mm, L=100mm, AO Connector (61243-100) for locking cortical screw) 22 To avoid collision of the fixation/tension screw with screw A (see figure), it must be installed with an angle of up to 15° proximal. The direction of the bore is to be selected so that the opposite corticalis is not weakened. Monocortical installation with an angle-stable screw is likewise possible. A A 23 The repositioned periosteum should cover the osteotomy area. After verifying the rotation and radiologically controlling the osteotomy gap, plate position and screw length, suture the fascia and the skin. Drainage as required. Postoperative treatment Forearm splint for 3 weeks. Concomitant physiotherapy aiming at freely closing the fist and bending/ stretching of the elbow joint. During this period, rotation of the forearm should be restricted to R: 30/0/30. From the 5th postoperative week on, this is to be focused upon in accordance with the clinical and radiological follow-up examination results. 24 Summary The Ulna Osteotomy Locking Plate provides a plate system (hybrid system) to be studded with locking screws and compression screws, which is specially adapted to the anatomic and biomechanic requirements after shortening osteotomy of the distal ulna. In a single device, the Ulna Osteotomy Locking Plate allows for unique coplanar orientation of the incisions with rotation-stable shortening and the option for compression. The standardization of a plurality of surgical procedures into a single device system obtained thereby increases and secures the quality of the surgical procedure. 25 Order information Ulna Osteotomy Plate, 5-Hole 21231-5 Cancellous Screw, Locking, D=3.0mm, L=10mm Cancellous Screw, Locking, D=3.0mm, L=12mm Cancellous Screw, Locking, D=3.0mm, L=14mm Cancellous Screw, Locking, D=3.0mm, L=16mm Cancellous Screw, Locking, D=3.0mm, L=18mm Cancellous Screw, Locking, D=3.0mm, L=20mm Cancellous Screw, Locking, D=3.0mm, L=22mm Cancellous Screw, Locking, D=3.0mm, L=24mm 37302-10 37302-12 37302-14 37302-16 37302-18 37302-20 37302-22 37302-24 Cortical Screw, D=2.7mm, L=10mm Cortical Screw, D=2.7mm, L=12mm Cortical Screw, D=2.7mm, L=14mm Cortical Screw, D=2.7mm, L=16mm Cortical Screw, D=2.7mm, L=18mm Cortical Screw, D=2.7mm, L=20mm Cortical Screw, D=2.7mm, L=22mm Cortical Screw, D=2.7mm, L=24mm Cortical Screw, D=2.7mm, L=26mm 32271-10 32271-12 32271-14 32271-16 32271-18 32271-20 32271-22 32271-24 32271-26 Cortical Screw, Locking, D=3.0mm, L=8mm Cortical Screw, Locking, D=3.0mm, L=10mm Cortical Screw, Locking, D=3.0mm, L=12mm Cortical Screw, Locking, D=3.0mm, L=14mm Cortical Screw, Locking, D=3.0mm, L=16mm Cortical Screw, Locking, D=3.0mm, L=18mm Cortical Screw, Locking, D=3.0mm, L=20mm Cortical Screw, Locking, D=3.0mm, L=22mm Cortical Screw, Locking, D=3.0mm, L=24mm 37301-8 37301-10 37301-12 37301-14 37301-16 37301-18 37301-20 37301-22 37301-24 Screwdriver, WS 2.5 Screwdriver, Torque, T9x70 Self-holding sleeve, Screwdriver, Torque 9 56252 56095-70 56095-70-2 Depth Gauge, PROlock 59023 Drill Guide, D=2.7/2.0mm Drill Guide, D=2.0mm 62202 62208 Spiral Drill, D=2.0mm, L=100mm, AO Connector Spiral Drill, D=2.4mm, L=100mm, AO Connector 61203-100 61243-100 Instruments, Ulna Osteotomy Plate Transection Gauge, Right, Ulna Transection, Left, Ulna 26 680851-1 680851-2 Support for Transection Gauge Right Support for Transection Gauge Left 680852-1 680852-2 Carrier Unit 680850 Set-screw guide 680853 Fixing Screw 680854 Fixing Screw for Transection Gauge 680855 Setscrew 680856 Crossbolt 680857 Slide 680858 Tension Bolt 680859 Sterilization Tray, Ulna Osteotomy Plate 50199 27 Locking Locking works because of: • 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 Re-setting of screw (up to 3 times) 30° Dotize® Chemical process - anodization in a strong alkaline solution * Type III anodization Dotize Type II anodization Layer thickness 60-200nm Layer thickness 2000-10 000nm + Different colors + Film become an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration - No visible cosmetical effect Dotize® Type - II Type - III Ti-Oxid Anodization Type II leads to following benefits* • • • • • • • • 28 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 * White Paper: Ti6Al4V with Anodization Type II: Biological Behavior and Biomechanical Effects; Axel Baumann, Nils Zander Notes 29 Sterilization Guidelines The following remarks should serve as a guideline in the sterilization of medical products. IMPORTANT INDICATIONS FOR DOCTORS AND OPERATING THEATRE PERSONNEL This instruction leaflet refers to all supplied nonsterile implants and all reusable instruments from I.T.S. GmbH. Detailed information for the identification of the product (such as system classification, cat. no.) can be found in the product identification code and/ or on the package label. Make sure that you are familiar with the possibilities of application, combinability and correct handling of the product. Please note that product systems can undergo modifications which can affect the combinability of the implant with other implants or instruments. Detailed user information can be found in the respective surgical instructions. Intended Use of the Implant The implant temporarily stabilises bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed. Indications and Contra-Indications of the Implant Indications and contra-indications are determined by current medical practice. Side Effects of the Implant Up to now, no allergic reactions have been known with titanium implants. Allergic reactions to steel implants cannot be excluded. Warnings and Preventive Measures • Pay attention to the instructions on the package. • Implants are only to be used once. • Always treat implants carefully to avoid surface damage or geometric alterations. • Any alterations to the design of implants of I.T.S. GmbH are prohibited. • Regular postoperative follow-up examinations (e.g. X-ray check-ups) are to be carried out. • For metallurgical, mechanical and design reasons, never combine implants from different producers. Materials used are stated in the product catalogue or on the label. • The length, angle and right or left version of an implant of a particular type can differ. • The precise positioning and fastening of a properly made connection between implant and instrument must be repeatedly checked during the course of an operation. 30 • In the case of magnetic resonance imaging (MRI), it is generally recommended to check back with the manufacturer of the MR scanner. The use of MRI with steel implants is prohibited by I.T.S. GmbH, and in such cases the user must contact the manufacturer of the MRI scanner. • Staff who come into contact with contaminated or potentially contaminated medical products should follow the generally recognised preventive measures. Due care is to be taken when handling medical products with sharp points or edges. • Appropriate protective measures must be taken to ensure safe handling when dealing with contaminated or potentially contaminated medical products (e.g. gloves, etc.) • In countries with stricter safety requirements regarding recycling medical products, these safety requirements apply and are to be adhered to. • Supplied non-sterile medical products must be thoroughly prepared according to these instructions before use. • No metal brushes or abrasive cleaning materials are to be used for manual cleaning purposes. The use of these materials can lead to damage of surfaces and coatings. Instead, soft brushes made of nylon should be used. • Steam (damp heat) is the recommended sterilization method of medical products of I.T.S. GmbH. • All the following described steps for cleaning and sterilization are made easier when contaminants (e.g. blood) are not allowed to dry beforehand. Restrictions • Unless otherwise stated, repeated preparation of re-usable instruments of I.T.S. GmbH has minimal effects on them when following the procedures mentioned below. • The end of the product service life is usually determined by wear and damage caused by use. • Instruments containing aluminium or anodised aluminium are damaged by alkaline (pH > 7) cleaning agents and solutions. INSTRUCTIONS FOR RECONDITIONING Preparation at the Location of Use • Remove surface dirt using a disposable cloth or paper towel. Storage and Transport • No special requirements. • It is recommended to recondition medical products as soon as possible after their previous use. Cleaning/ Disinfection/ Drying Cleaning automatic Recommended equipment: commercially available disinfector authorized for use with medical products, with tested efficiency; commercially available cleaning agent authorized for use with medical products (alkaline – with pH value < 11). Step 1 Each instrument that can be dismantled should be taken apart for cleaning. Jointed instruments are to be opened so that water can flow out of cannulae and blind holes. Step 2 Set the cycle. Adhere to the guidelines of the manufacturer of the disinfector. Step 3 After removing the instruments from the disinfector, check cannulae, blind holes, etc, for visible dirt. If required, repeat cycle or clean by hand. Cleaning manual Recommended equipment: commercially available cleaning agent authorized for medical products (alkaline – with a pH value < 11); soft brushes made of nylon; running water Step 1 Each instrument that can be dismantled should be taken apart for cleaning. Rinse off surface dirt from instrument. Step 2 Apply cleaning agent solution to all surfaces using a brush. Make sure that jointed instruments are cleaned in both open and closed positions. N.B.: A suitable brush must be used for cleaning cannulae and blind holes so that every part can be reached. The concentration and residence time as stated by the cleaning agent manufacturer must be adhered to unconditionally. Step 3 Rinse the medical product for a minimum of 1 minute with clean water. Openings and other areas which are not easily accessible should be thoroughly rinsed. Disinfection Equipment: Commercially available disinfectants authorized for use with medical products e.g.. MEDICLEAN FORTE) can be used (but only according to the instructions of the disinfectant producer). In the case of automatic cleaning, a final rinse cycle at 90 °C for 5 minutes can be finally carried out to provide thermal disinfection. Drying Drying as part of the cleaning/ disinfection cycle should not exceed 110 °C. Checking, Maintenance and Inspection • Each instrument or implant is to be inspected carefully to make sure that all visible dirt has been removed. If any ingrained dirt is found, the cleaning/ disinfection cycled should be repeated. • Any instruments with an attached movable mechanism should be treated with a commercially available lubricant authorized for sterilisable surgical instruments. • The mobility of movable parts should be checked to ensure that the planned sequence of motion can be completely carried out. • In the case of instruments which can be reassembled into larger units, check whether the single parts can be put together easily. Package The delivery package is purely for transport use and not suitable for sterilization. Sterilization • The hospital is responsible for in-house procedures regarding assembly, inspection and packaging of instruments. Furthermore, the hospital should recommend protective measures covering sharp or potentially dangerous parts of the instruments. • All instruments and implants should be laid out in such a way that the steam should reach all the surfaces. • Each instrument that can be dismantled should be taken apart for sterilization. • Sterilization by means of heat/ steam is the preferred method for instruments and implants of I.T.S. GmbH. • Manufacturer’s recommendations regarding sterilization appliances should always be followed. When several instruments are sterilised in one sterilization cycle, care must be taken not to exceed the maximum amount of items to be sterilised in the appliance as stated in the manufacturer’s instructions. Cycle Duration of sterilization Temperature Pressure Duration of drying Prevacuum 5 minutes 134°C 273°F 3,04 bar 27 psi 30 minutes Prevacuum² 18 minutes 134°C 273 °F 3 bar 28,5 psi 30 minutes ² From the World Health Organization’s (WHO) recommended disinfection/ steam sterilization parameters for the reconditioning of instruments when there is a risk of TSE/CJD contamination Important Note • The above-mentioned instructions have been validated by the manufacturer of medical products for the preparation of a medical product whose reuse is deemed SUITABLE. It is the responsibility of the reconditioner to ensure that reconditioning actually carried out using the equipment, materials and staff in the preparation facility achieves the desired results. For this, validation and routine inspections of the preparation process are usually necessary. Likewise, any deviation from the provided instructions by the preparer should be evaluated for its efficiency and possible disadvantageous consequences. • In the case of questions or problems, please contact us at the address above. Symbols Single use Expiry date (year/month) Disposal The valid guidelines of the hospital operator apply for disposal. Charge number Sterilization by steam Sterilization by radiation Sterilization by ethylene oxid Patient Information Order number Implantation has consequences for the discomfort, mobility and general life circumstances of the patient. For this reason, the patient should be given instructions for appropriate behaviour after implantation, and it should be explained to him or her the necessity of reporting negative changes in the area of the implant as well as any falls and accidents which may appear not to have damaged the implant nor the site of the operation. Package content (no. of items) Material used Size Pay attention to instructions RL 93/42/EWG ÖNORM EN ISO 13485 ISO 17664 Responsibility of the Hospital for Instruments lent by I.T.S. GmbH • Surgical instruments generally have a long service life. But their life expectancy can be quickly reduced due to misuse or insufficient protection. Instruments which no longer work correctly, whether due to wear, misuse or improper care, have to be disposed of. • Medical products which are returned to I.T.S. GmbH must undergo cleaning, disinfection, inspection and a final sterilization. Products returned to I.T.S. GmbH must be accompanied by a confirmation of the decontamination they were subjected to. 31 I.T.S. GmbH part of the MED-HOLD GROUP Autal 28, 8301 Lassnitzhöhe, Austria Tel.:+43 | 316 | 211 21 0 Fax:+43 | 316 | 211 21 20 [email protected] www.its-implant.com Order No. UOL-OP-0112-E Edition: January/2012 © I.T.S. GmbH Graz/Austria 2012. Subject to technical alterations, errors and misprints excepted.