Acutrak 2 Headless Compression Screw System
Transcription
Acutrak 2 Headless Compression Screw System
Headless Compression Screw System Acutrak 2® Headless Compression Screw Acumed® is a global leader of innovative orthopaedic and medical solutions. We are dedicated to developing products, service methods and approaches that improve patient care. Since its introduction in 1994, the Acutrak® Headless Compression Screw has revolutionized the way surgeons gain fixation. By incorporating the best features of the original Acutrak® screw with a number of system improvements, the Acutrak 2® Headless Compression Screw, has become the standard of care for multiple indications. The Acutrak 2® Headless Compression Screw is the next generation in fixation for fractures, fusions and osteotomies of the extremities. Long term surgeon feedback has helped us develop a superior implant with an innovative instrumentation set that both eases the surgical technique and increases instrumentation reliability. Contents Introducing the Acutrak 2® 2 Acutrak 2® Headless Compression Screw Features 3 Lower Extremity Indications 4 Upper Extremity Indications 5 2 Acutrak 2® Families 6 Acutrak 2® Volar Scaphoid Technique 8 Acutrak 2® Dorsal Scaphoid Technique 10 Acutrak 2® - 5.5 Technique 12 Biomechanical Data 13 Systems Compatible with Acutrak 2® 13 Indications for Acutrak 2® Standard, Mini and Micro 14 Acutrak 2® - 5.5 Indications 15 Acutrak 2® Instrumentation 16 Ordering Information 17 The Acutrak 2® System introduces expanded screw size options to fit a wider variety of fractures, including longer Acutrak 2® Standard and Acutrak 2® Mini screws and a screw sized for larger indications, the Acutrak 2® - 5.5. The system has also been extended for smaller indications with the cannulated Acutrak 2® Micro screw system. Acutrak 2® Headless Compression Screw Features Large Guide Wires 5.5 Stout guide wires make provisional stabilization of the fixation site and accurate screw placement a successful step with each surgery. Standard Mini Micro Large Hex Drivers Acutrak 2® screws accept a larger size hex driver than the traditional Acutrak®screws. The instrumentation is surgeon friendly, with an improved driver handle that maximizes comfort and compatibility. Acutrak 2® Acutrak® Self-Drilling Screw Tip After placing the guide wire and opening the near cortex with a profile drill, the self-drilling Acutrak 2® cuts its way into the bone when advanced with the hex driver, eliminating any concerns with over-drilling. Fully-Threaded Length: Biomechanical studies have shown that fully-threaded screws better handle the cyclic loading that may occur during healing. In addition, this feature allows a fracture or osteotomy site to lie almost anywhere along the length of the screw. Cannulated: Facilitates accurate percutaneous insertion with minimal soft tissue dissection. Headless: Allows the titanium screws to be implanted in and around articular regions with minimal risk of impingement or soft tissue irritation. Variable Thread Pitch: The wider thread pitch at the tip of the screw penetrates the bone faster than the finer trailing threads, compressing the two fragments gradually as the screw is advanced. 3 Lower Extremity Indications Lower Extremity Indications: • Jones Fractures • Talus Fractures • Malleolar Fractures • Midfoot Fusions • MTP Fusions • Calcaneal Osteotomy • Talonavicular Fusion • Bunionectomies The holding power of the Acutrak 2® Headless Compression Screw is extremely beneficial in the weight bearing area of the body. Its fully threaded length provides bony engagement along a greater portion of the screw. This translates into a greater ability to maintain compression once the patient begins bearing weight. All of the Acutrak 2® Headless Compression Screw Systems can be utilized in the lower extremity. Whether used for subtalar arthrodesis, bunions, Jones fractures or a wide variety of other indications in the lower extremity, the benefits of the screw consistently contribute to great results throughout the foot and ankle. With greater bending and pullout strength than its headed competitors*, the Acutrak® provides a reliable means to fix everyday indications, as well as the more challenging cases a surgeon sees in their practice. * Data on File at Acumed® 4 Upper Extremity Indications The excellent compression, holding power, and straightforward surgical instrumentation of the Acutrak® system has enabled surgeons to treat fractures, fusions and osteotomies with efficiency and effectiveness. With rigid fixation in place, patients may be able to return to normal activities sooner. Acutrak 2® Headless Compression Screws have become a highly respected solution for scaphoid fractures and non-unions. Whether a surgeon uses a dorsal or volar, percutaneous or mini-open, direct or arthroscopic approach, the Acutrak 2® provides excellent fixation for this indication. Upper Extremity Indications: • Carpal Fractures • Metacarpal Head Fractures • Proximal Pole Scaphoid Fractures • Radial Head Fractures • Scaphoid Fractures and Nonunions • Capitellum Fractures • MCP Fusions • Radial Styloid Fractures • Phalangeal Fractures Benefits of the Acutrak 2® translate equally well to a variety of other indications that are commonly seen in the upper extremity. IP fusions, carpal arthrodeses, radial head fractures, interphalangeal fractures and many others all benefit from the headless profile, strong compression and excellent holding power of the Acutrak 2® Headless Compression Screw Systems. 5 Acutrak 2® Micro Ideal For: Properties: • Phalangeal Fractures • Use in lieu of a 2.0 2.4 mm Headed Screw • Carpal Fractures • Metacarpal Head Fractures • 1.5 mm Hex Driver • .035” (.88 mm) Guide Wire • Proximal Pole Scaphoid Fractures • Radial Head Fractures 2.5 mm 20 mm 18 mm 16 mm 14 mm 13 mm 11 mm 12 mm 10 mm 9 mm 8 mm 2.8 mm Guide Wire: .035” (.88 mm) Hex Size: 1.5 mm Material: Titanium Alloy Acutrak 2® Mini Ideal For: Properties: • Scaphoid Fractures and Nonunions • Use in lieu of a 3.5 4.0 mm Headed Screw • Radial Styloid Fractures • 2.0 mm Hex Driver • Radial Head Fractures • .045” (1.1 mm) Guide Wire • Avulsion Fractures • Carpal Fusions • OCD Repair 3.5 mm • Phalangeal Fractures 30 mm 28 mm 26 mm 24 mm 22 mm 20 mm 18 mm 16 mm 3.6 mm Guide Wire: .045” (1.1 mm) 6 Hex Size: 2.0 mm Material: Titanium Alloy Acutrak 2® Standard Properties: Ideal For: • Scaphoid Fractures and Nonunions • Use in lieu of a 3.5 4.0 mm Headed Screw • Capitellum Fractures • 2.5 mm Hex Driver • Bunionectomies • .054” (1.4 mm) Guide Wire • Carpal Fusions • MCP Fusions 4.0 mm 16 mm 18 mm 20 mm 22 mm 24 mm 28 mm 26 mm 30 mm 32 mm 34 mm 4.1 mm Guide Wire: .054” (1.4 mm) Hex Size: 2.5 mm Material: Titanium Alloy Acutrak 2® - 5.5 Ideal For: Properties: • Jones Fractures • Talus Fractures • Malleolar Fractures • Midfoot Fusions • MTP Fusions • Use in lieu of a 4.5 6.5 mm Headed Screw • 3.0 mm Hex Driver • .062” (1.6 mm) Guide Wire 5.2 mm • Greater Tuberosity Fractures • Calcaneal Osteotomy • Talonavicular Fusions 25 mm 30 mm 35 mm 40 mm 45 mm 50 mm 55 mm 60 mm 5.5 mm Guide Wire: .062” (1.6 mm) Hex Size: 3.0 mm Material: Titanium Alloy 7 Surgical Technique - Acutrak 2® Volar Scaphoid Technique The key to the volar approach is to position the screw as close to the central axis as possible. This has been shown to both improve the stability of the fixation and to speed bone healing. 1 The procedure can be carried out using the volar traction approach or using a conventional volar type approach with the arm supine on a hand table. The volar traction approach facilitates reduction of a displaced fracture and permits arthroscopy to ensure accuracy of the reduction. Fluoroscopy is used throughout. The entry point is then located using a 12 or 14 gauge IV needle introduced on the antero-radial aspect of the wrist just radial to and distal to the scaphoid tuberosity. This serves as a trochar for the guide wire and is a directional aid to establish a central path along the scaphoid. The needle is then insinuated into the scapho-trapezial joint, tilted into a more vertical position and the position is checked on the under image intensifier. By gently levering on the trapezium this maneuver brings the distal pole of the scaphoid more radial and thus ultimately facilitates screw insertion. The entry point should be approximately 1/3 the way across the scaphoid from the tuberosity in the A/P plane and central in the lateral plane. 2 Pass the guide wire through the needle and drill it across the fracture, continually checking the direction on the image intensifier and correcting as necessary, aiming for the radial aspect of the proximal pole. It is extremely important not to bend the guide wire and any adjustments in direction should be made using the needle as a guide rather than attempting to alter the line of the guide wire alone. 3 Advance the guide wire to stop just short of the articular surface and the wire should not breach it at this stage. The position, alignment and length are checked once more. Make a simple stab incision at the entry point of the wire, and deepen this down to the distal pole of the scaphoid using a small hemostat and blunt dissection. This is a relatively safe zone with minimal risk to the adjacent neuro-vascular structures. Determine the length of the screw either with the appropriate depth gauge or by advancing a second guide wire of the same length up the distal cortex of the scaphoid and subtracting the difference between the two. When using the volar approach, the correct screw size is 2-4 mm shorter than the measured length so as to ensure that the proximal tip of the screw is fully buried below the cartilage and the cortical surface. 8 Written by Nicholas Goddard, MB, FRCS 4 Advance the guide wire through the proximal pole of the scaphoid so as to exit on the dorsal aspect of the wrist. This is a precautionary measure to minimize the risk of inadvertent withdrawal of the wire during the reaming process and screw insertion and to facilitate removal of the proximal portion if the wire were to break. A second de-rotation wire can then be inserted in those cases where it is felt that there is a possibility of rotational instability of the fracture. 5 Remove the 12 gauge needle and pass the cannulated profile drill over the wire using either a power drill or hand reamer stopping 1-2 mm short of the articular surface. In hard bone it may be necessary to use the long drill to slightly expand the entry point to accommodate the trailing edge of the screw. 6 The self-tapping screw is then advanced over the guide wire and the wire removed. Compression can then be confirmed radiographically on the image intensifier. 9 Surgical Technique - Acutrak 2® Dorsal Scaphoid Technique The keys to this procedure are to place the screw as near as is feasible to the central axis of the scaphoid and to insert the longest screw possible. Both of these factors have been shown to enhance the stability of the fixation and to increase the rate of healing of the fracture. 1 The entry point in the proximal pole is at the tip of the scaphoid immediately adjacent to the sacpho-lunate ligament. This can be located either using an arthroscopy or mini open dorsal approach between the 3rd and 4th extensor compartments. Whichever approach is employed, it is essential to ensure that the guide wire does not transfix an extensor tendon. Having established the entry point, introduce the appropriate guide wire aiming for the base of the thumb and check the position on the fluoroscope. Aim to place the leading edge of the guide wire in the subchondral surface of the distal pole of the scaphoid. Confirm the wire placement and depth under imaging. Optional: A 14 gauge IV cannula is a useful aid in determining the entry point and acts as both a guide and soft tissue protector. 2 3 10 If the fracture is unstable it may be helpful to place a second parallel guide wire using the parallel wire guides which are available for all three Acutrak 2® screw families. Measure guide wire length using either the percutaneous screw sizer, or by placing a second wire at the entry point and subtracting the difference. The screw sizer cannot be used with the arthroscopic technique due to the limited access. 4 mm should be subtracted from the measured length to ensure that both ends of the screw are buried within the bone. 4 Written by Nicholas Goddard, MB, FRCS Advance the guide wire through the far cortex so that it lies in the subcutaneous tissues. This minimizes the risk of accidental withdrawal of the guide wire while drilling and facilitates wire removal if it should break. Tip: For most adult males the screw should not be longer than 26 mm, and in females 22 mm. 5 Open the near cortex with the appropriate profile drill. 6 Next, drill into the far fragment with the long drill. To be effective the drill only has to advance 4-5 mm past the fracture site. Tip: The long drill is recommended to mitigate the effects of varying bone density and distraction upon screw insertion. 7 Insert the correctly sized screw with the appropriate hex driver. If resistance is met upon insertion or if distraction occurs, stop, remove the screw, redrill with the long drill and re-insert the screw. Confirm placement and length of the screw on imaging, ensuring that both leading and trailing edges of the screw are beneath the articular surfaces. Finally remove the guide wires. 11 Surgical Technique - Acutrak 2® - 5.5 1 2 Insert a guide wire at desired screw placement location and advance through the near cortex and into the medullary canal. Check for proper guide wire placement and continue advancing guide wire to desired depth. Measure wire depth to indicate screw length. Tip: Measure off laser mark closest to the end of the guide wire. 3 Advance the guide wire past desired drill depth prior to drilling. 4 Open the near cortex with the profile drill. An optional long, straight drill is available with the Acutrak 2® - 5.5 for use in dense bone. 5 12 Install screw with the 3.0 mm hex driver provided in the set. Biomechanical Data The biomechanical properties of the Acutrak® Headless Compression Screw System have contributed to the systems overall success. The Acutrak 2® offers a next generation headless compression screw. In addition to improved instrumentation and a straightforward surgical technique, laboratory results demonstrate that the Acutrak 2® Headless Compression Screw System offers surgeons biomechanical advantages. The Acutrak 2® is an example of innovation and function combined into one versatile system for both the upper and lower extremities. The Acutrak 2® Headless Compression Screw exceeds the biomechanical properties of the traditional Acutrak® Screw in pull-out strength. The Acutrak 2® Standard offers more pull-out strength than the Original Acutrak® Standard while continuing to maintain excellent compression. Pull-Out Resistance* 100 * Data on File at Acumed® Average Load (lbs.) 80 Average Compression (lbs.) Compression* 15 10 60 40 20 5 0 0 Acutrak 2® Standard Acutrak® Standard Acutrak 2® Standard Acutrak® Standard Systems Compatible with Acutrak 2® • • • • • • • • • Anatomic Radial Head Acu-loc® 2 Distal Radius Plates Polarus® PHP® Elbow Plating System Calcaneal Plating System Fibula Rod System Locking Ankle Plating System Forefoot/Midfoot Plating System Lower Extremity Modular System Scaphoid and Acu-Loc® VDR Plate 13 Indications for Acutrak 2® Standard, Mini and Micro Four Corner Fusion DIP Fusion Radial Head Fracture Proximal Pole Scaphoid Fracture 14 Ulnar Osteotomy Phalangeal Fracture Radial Styloid & Provisional Fixation for Scaphoid Lunate Instability Scaphoid Fracture with Callos® Bone Void Filler Indications for Acutrak 2® 5.5 Bi-Lateral Malleolar Fracture The fully threaded, headless features of the Acutrak 2® - 5.5 screws are ideal for malleolar fractures. This X-ray (right) shows a combination of the Acutrak 2® - 5.5 screws with the Acumed Fibula Rod. Jones Fracture The cannulated, headless features of the Acutrak 2® - 5.5 screws are ideal for Jones Fractures. Based on clinical evidence*, Acutrak® and Acutrak® 2 screws have become the “gold” standard for many surgeons. * Data on File at Acumed® 15 Unmatched Tray Versatility The Acutrak 2® Headless Compression Screw System is available in a modular format, allowing it to be placed inside multiple Acumed plating sets for ease of use. Our newest Acutrak 2® Standard, Mini and Micro tray can be used in any of our universal trays, making it easy to bundle the Acutrak 2® system with other cases. The Acutrak 2® - 5.5 Screw System is housed in a separate satellite tray and can also be used in the Acutrak 2® family tray. Other instruments including the ratcheting handle, screw sizer, cannula and probe can also be placed within the Acutrak 2® family tray. Acutrak 2® - 5.5 Satellite Tray Universal Acutrak 2® Std, Mini & Micro Instrument Platter Ratcheting Handle Ratcheting handles are available to assist with screw insertion. The ergonomic handle and precision ratcheting mechanism reduce user fatigue during screw insertion. Updated Surgical Instrumentation Extensive surgeon feedback has helped Acumed develop an innovative instrumentation set that both facilitates the surgical technique and increases instrumentation reliability. The Acutrak 2® Screw System contains specialized instrumentation to accommodate the versatility of the screw and aid the surgeon during each procedure. All drills and drivers are quick release, featuring a driver handle that is designed for surgeon comfort. The Plunger holds the guide wire in place as the drill is removed. Arthroscopic Instrumentation is included for all screw families. 16 Ordering Information Acutrak 2® Micro Implants Acutrak 2® Mini Implants Sterile 8 mm Micro Acutrak 2® AT2-C08-S Sterile 16 mm Mini Acutrak 2® AT2-M16-S Sterile 9 mm Micro Acutrak 2® AT2-C09-S Sterile 18 mm Mini Acutrak 2® AT2-M18-S Sterile 10 mm Micro Acutrak 2® AT2-C10-S Sterile 20 mm Mini Acutrak 2® AT2-M20-S Sterile 11 mm Micro Acutrak 2® AT2-C11-S Sterile 22 mm Mini Acutrak 2® AT2-M22-S Sterile 12 mm Micro Acutrak 2® AT2-C12-S Sterile 24 mm Mini Acutrak 2® AT2-M24-S Sterile 13 mm Micro Acutrak 2® AT2-C13-S Sterile 26 mm Mini Acutrak 2® AT2-M26-S Sterile 14 mm Micro Acutrak 2® AT2-C14-S Sterile 28 mm Mini Acutrak 2® AT2-M28-S Sterile 16 mm Micro Acutrak 2® AT2-C16-S Sterile 30 mm Mini Acutrak 2® AT2-M30-S Sterile 18 mm Micro Acutrak 2® AT2-C18-S Non Sterile 16 mm Mini Acutrak 2® AT2-M16 Sterile 20 mm Micro Acutrak 2® AT2-C20-S Non Sterile 18 mm Mini Acutrak 2® AT2-M18 Non Sterile 8 mm Micro Acutrak 2® AT2-C08 Non Sterile 20 mm Mini Acutrak 2® AT2-M20 Non Sterile 9 mm Micro Acutrak 2® AT2-C09 Non Sterile 22 mm Mini Acutrak 2® AT2-M22 Non Sterile 10 mm Micro Acutrak 2® AT2-C10 Non Sterile 24 mm Mini Acutrak 2® AT2-M24 Non Sterile 11 mm Micro Acutrak 2® AT2-C11 Non Sterile 26 mm Mini Acutrak 2® AT2-M26 Non Sterile 12 mm Micro Acutrak 2® AT2-C12 Non Sterile 28 mm Mini Acutrak 2® AT2-M28 Non Sterile 13 mm Micro Acutrak 2® AT2-C13 Non Sterile 30 mm Mini Acutrak 2® AT2-M30 Non Sterile 14 mm Micro Acutrak 2® AT2-C14 Acutrak 2® Mini Instruments Non Sterile 16 mm Micro Acutrak 2® AT2-C16 Non Sterile 18 mm Micro Acutrak 2® AT2-C18 Non Sterile 20 mm Micro Acutrak 2® AT2-C20 Acutrak 2® Micro Instruments Micro AT2 Parallel Wire Guide Assy .035" x 6.0" K-Wire Micro Acutrak 2® Profile Drill AT2-3500 WS-0906ST AT2-4500 .045" x 6.0" K-Wire WS-1106ST Mini Acutrak 2® Profile Drill AT2M-1813 Mini AT2 Long Drill 2.0 mm Cannulated Hex Driver At2 Mini X-ray Template AT2M-L1813 HT-1120 ACT70-03 AT2-1509 Micro Acutrak 2® Long Profile Drill 80-0100 1.5 mm Cannulated Hex Driver HT-0915 AT2 Micro X-ray Temp Mini AT2 Parallel Wire Guide Assy ACT70-02 Additional Standard, Mini and Micro Instruments Arthroscopic Cannula Assembly AT2- Arthroscopic Probe AT2 Perc. Screw Sizer (STD, Mini, Micro) Plunger Assembly 80-0519 AT2-0402 AT2-SMCZ AT-7060 17 Acutrak 2® Standard Implants Universal Platter Standard, Mini and Micro Tray Additional Inst. Sterile 16 mm Standard Acutrak 2® AT2-S16-S Sterile 18 mm Standard Acutrak 2® AT2-S18-S 1.5 mm Easyout, QR 80-0598 Sterile 20 mm Standard Acutrak 2® AT2-S20-S 2.0 mm Easyout, QR 80-0599 Sterile 22 mm Standard Acutrak 2® AT2-S22-S 2.5 mm Easyout, QR 80-0600 Sterile 24 mm Standard Acutrak 2® AT2-S24-S Medium Ratcheting Driver Handle 80-0663 Sterile 26 mm Standard Acutrak 2® AT2-S26-S 6 mm Graft Removal Paddle Assembly BG-8064 Sterile 28 mm Standard Acutrak 2® AT2-S28-S 7 mm Bone Graft Drill Assembly PL-BG07 Sterile 30 mm Standard Acutrak 2® AT2-S30-S Sterile 32 mm Standard Acutrak 2® AT2-S32-S Universal AT2 Std, Mini & Micro Instrument Base 80-0808 Sterile 34 mm Standard Acutrak 2® AT2-S34-S Universal AT2 Std, Mini & Micro Instrument Platter Lid 80-0809 Non Sterile 16 mm Standard Acutrak 2® AT2-S16 Non Sterile 18 mm Standard Acutrak 2® AT2-S18 Non Sterile 20 mm Standard Acutrak 2® AT2-S20 Non Sterile 22 mm Standard Acutrak 2® AT2-S22 Non Sterile 24 mm Standard Acutrak 2® AT2-S24 Non Sterile 26 mm Standard Acutrak 2® AT2-S26 Non Sterile 28 mm Standard Acutrak 2® AT2-S28 Non Sterile 30 mm Standard Acutrak 2® AT2-S30 Non Sterile 32 mm Standard Acutrak 2® AT2-S32 Non Sterile 34 mm Standard Acutrak 2® AT2-S34 Acutrak 2® Standard Instruments Standard AT2 Parallel Wire Guide Assy .054” x 7.0” K-Wire Standard Acutrak 2® Profile Drill Standard AT2 Long Drill 2.5 mm Cannulated Hex Driver Acutrak 2® STD X-ray Temp AT2-5400 WS-1407ST AT2-2515 AT2-L2515 HT-1725 ACT70-01 Acutrak 2® 5.5 - Implants Sterile 25 mm Acutrak 2® - 5.5 Screw 30-0021-S Sterile 30 mm Acutrak 2® - 5.5 Screw 30-0023-S Sterile 35 mm Acutrak 2® - 5.5 Screw 30-0025-S Sterile 40 mm Acutrak 2® - 5.5 Screw 30-0027-S Sterile 45 mm Acutrak 2® - 5.5 Screw 30-0029-S Sterile 50 mm Acutrak 2® - 5.5 Screw 30-0031-S Sterile 55 mm Acutrak 2® - 5.5 Screw 30-0084-S Sterile 60 mm Acutrak 2® - 5.5 Screw 30-0085-S Acutrak 2® 5.5 Instruments .062” x 8” K-wire 80-0413 Acutrak 2® - 5.5 Profile Drill 80-0055 Acutrak 2® - 5.5 Long Drill 80-0056 3.0 mm Cannulated Driver HT-3010 3.0 mm Solid Driver HT-3012 Cannula/Tissue Protector MS-2000 Probe AP-0402 Plunger (for guide wire) AT-7060 Percutaneous Screw Sizer AP-0204 Forceps AT-7005 Acutrak 2® - 5.5 Satellite Tray Assy 80-0389 5885 NW Cornelius Pass Road Hillsboro, OR 97124 (888) 627-9957 www.acumed.net Distributed by: SPF00-02-C Effective: 12/2011 © 2011 Acumed® LLC These materials contain information about products that may or may not be available in any particular country or may be available under different trademarks in different countries. The products may be approved or cleared by governmental regulatory organizations for sale or use with different indications or restrictions in different countries. Products may not be approved for use in all countries. Nothing contained on these materials should be construed as a promotion or solicitation for any product or for the use of any product in a particular way which is not authorized under the laws and regulations of the country where the reader is located. Specific questions physicians may have about the availability and use of the products described on these materials should be directed to their particular local sales representative. Specific questions patients may have about the use of the products described in these materials or the appropriateness for their own conditions should be directed to their own physician.
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