MEDIALMAX System SURGICAL TECHNIQUE

Transcription

1 MAXLOCK EXTREME MEDIALMAX System SURGICAL TECHNIQUE

2 Contents The MEDIALMAX Advantage Design Feature Various flex options POCKETLOCK Technology Anatomic design Advantage Provides the surgeon with multiple fixation options to create the optimal fusion position based on patient anatomy Combines the compression of an interfragmentary screw with the rigidity of a plate The contour, profile and footprint of the plates are designed to optimize the construct strength and reproducibility Table of Contents Introduction Indications for Use 3 Contraindications 3 Preoperative Planning 3 Surgical Technique MEDIALMAX Plates with POCKETLOCK Technology 4 MEDIALMAX Standard Plate 9 Medial Column Fusion Plate 13 Implants and Instruments 17 Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright Medical. Please contact your local Wright representative for product availability. 2

3 Indications for Use The MAXLOCK EXTREME Foot Plating Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. Contraindications a) Cases where there is an active infection. b) Cases with malignant primary or metastasis tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. c) Conditions which tend to retard healing, such as, blood supply limitations, previous infections, etc. d) Insufficient quantity or quality of bone to permit stabilization of the fracture complex. e) Conditions that restrict the patient s ability or willingness to follow post operative instructions during the healing process. f) Foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. g) Cases where the patient is obese. Preoperative Planning a) In MEDIALMAX cases where a cannulated pocket screw is preferred, the MAXTORQUE 4.0 mm screws should be requested in addition to the standard tray configuration. b) The MEDIALMAX POCKETLOCK plates provide a plantar-medial to dorsal-lateral compression screw trajectory. If an alternative trajectory is preferred, consider first placing a compression screw in the desired orientation, followed by a MEDIALMAX Standard Plate. c) If variable-angle locking screws may be required, the Variable Screw caddy should be requested in addition to the standard tray configuration. d) The MEDIALMAX caddy is delivered in the MAXLOCK EXTREME Auxiliary Tray for sterilization purposes. The system is designed to be used in conjuction with MAXLOCK EXTREME screws and instruments. Ensure that a standard MAXLOCK EXTREME tray is available at the time of surgery. 3

4 Surgical Technique Step 1 Perform standard exposure and prepare the metatarsocuneiform (MTC) joint according to surgeon s preferred technique for medial plating. Step 2 Temporarily fix the joint in the desired orientation. Temporary fixation is strongly recommended to maintain desired joint alignment during bone preparation and plate fixation. Note: Care must be taken when placing the k-wire in order to avoid hardware collision during the following steps. Recommended wire placement is through the dorsal aspect of the joint, directed into the plantar-lateral aspect of the medial cuneiform and into the intermediate cuneiform or second metatarsal if desired. Step 3 Select the plate template corresponding to the operative side and desired flex and place it over the medial aspect of the joint. The solid laser mark line should be placed in alignment with the joint and the template should be aligned approximately parallel to the axis of the 1st metatarsal. Plates and their corresponding templates are side-specific (Right or Left) and designed so that the pocket is on the plantarmedial aspect of the metatarsal. Note: There are three templates for each operative side: neutral, 4 past neutral, and 8 past neutral. Note that the neutral template has a slight bend to fit the natural angle of the joint. The 4 and 8 designations reflect the amount of bend past neutral and do not necessarily correspond to the total IM correction angle. 4

5 Step 4 Insert a 1.4 mm k-wire through each k-wire hole in the template. Care must be taken to keep the wires parallel during insertion as they will later facilitate plate placement. Do not bend the wires. Step 5 Select the provided countersink and drill through the template to prepare a pocket for the plate. Ensure that the template is held tightly against the bone during this step in order to fully prepare the pocket. Insert the countersink until the shoulder of the countersink hits the guide. Note: Use the provided handle to countersink by hand. It is not recommended to countersink under power. Step 6 With the k-wires still in place, slide the template off the bone. Slide the corresponding plate over the wires and position into the prepared pocket. The proximal k-wire should pass through the k-wire slot in the plate. Note: All plates and corresponding templates are marked with the flex (neutral = 0) and operative side designation (e.g. 0L, 4L, 8L, etc.). Ensure the plate selected matches the template used in the preceding steps. Note: This technique illustrates the use of the left, Neutral Flex MEDIALMAX POCKETLOCK Plate 5

6 Step 7 Using the fixed drill guide and the 2.4 mm drill bit, drill a pilot hole for the most distal 3.5 mm screw. Take care to not move the plate after drilling for a locking screw in order to maintain the proper pilot hole alignment and prevent locking screw cross-threading. Note: The threaded screw holes in the plate are compatible with a variety of screw options; 2.7 mm non-locking screws (gold), 3.5 mm non-locking or fixed-angle locking screws (magenta) and 4.0 mm non-locking screws (teal). These screws are included in the MAXLOCK EXTREME Tray. Depending on surgeon preference, a combination of screw types can be used. Use the appropriate size drill guide and drill bit to prepare for each screw. Instruments are color-coded to match the corresponding screw size. 3.5 mm variableangle locking screws may also be used in the plates; however, the variable screw caddy must be present at the time of surgery. Reference the variable-angle locking screw technique guide (MXE ) if variable-angle locking screws are desired. WARNING: Do not use any other manufacturer s screws with Wright Medical plates. Step 8 Determine the screw length required using the depth gauge provided in the MAXLOCK EXTREME tray. Note: The depth gauge reading corresponds to the working length of the screw (from distal tip to underneath the screw head). Step 9 Remove the desired screw from the screw caddy using the HEXSTAR driver. For all screws used throughout the procedure, verify the screw length using the gauge provided on the screw caddy. Step 10 With the HEXSTAR driver, insert the selected screw into the hole and drive the screw. Step 11 Follow the same technique for the remaining distal screw hole. Note: It is recommended that at least one of the two distal screws is a 3.5 mm fixed-angle locking screw. 6

7 Step 12 Select the pocket wire guide and place the nose into the plate pocket, aligning the solid line on the guide with the dashed line on the plate. Take care to fully seat the guide tip in the pocket. Step 13 With the guide fully seated in the plate pocket, insert a 1.4 mm guide wire through the guide at the desired trajectory. This wire determines the trajectory of the pocket screw. The pocket wire guide allows for 12 of planar angulation within the slot. Verify wire placement with fluoroscopy in multiple views to ensure trajectory and screw purchase will be adequate. Step 14 Remove the pocket wire guide and use the provided pocket depth gauge to measure over the wire and determine the required screw length. Note: Subtract at least 2 mm from the depth gauge reading. Up to 4 mm of subtraction may be required based on compression generation. Step 15 Use the provided 2.7 mm cannulated drill bit to drill over the wire for the 4.0 mm pocket screw. Note: The MAXLOCK EXTREME 4.0 mm partially threaded screw (pocket screw) is blunttipped. Drill past the end of the wire to prepare a complete pilot hole. Step 16 Remove the 1.4 mm guide wire from the pocket in order to insert a MAXLOCK EXTREME 4.0 mm partially threaded solid screw. Leave any other provisional fixation in place to maintain proper alignment. 7

8 Step 17 Using the MAXLOCK EXTREME HEXSTAR Driver, insert the appropriate length MAXLOCK EXTREME 4.0 mm partially threaded screw through the pocket until almost fully seated in the pocket. Note: If preferred, a 4.0 mm MAXTORQUE cannulated screw maybe used in the pocket hole. Use the MAXTORQUE 4.0 mm driver to insert the pocket screw. Do not use MAXTORQUE screw in any other plate holes. Step 18 Remove any provisional fixation wires that cross the joint and fully tighten the pocket screw. The proximal k-wire should remain in place during screw insertion to maintain plate alignment; the slot will allow plate translation during pocket screw insertion. Step 19 Remove all remaining wires. Drill and insert the proximal screws using the technique described in Steps 8 10 above. Fully tighten all screws. Verify final plate and screw placement with fluoroscopy to ensure correct joint alignment and screw trajectory. 8

9 Step 1 Perform standard exposure and prepare the first metatarsocuneiform (MTC) joint according to surgeon s preferred technique for a medial approach. Step 2 Temporarily fix the joint in the desired orientation using the provided k-wires. Step 3 Select the MEDIALMAX Standard Plate that corresponds to the correct operative side. The MEDIALMAX Standard Plate is pre-contoured with a neutral flex to fit the natural angle of the first MTC joint, reducing the need for intraoperative plate bending. If plate bending is required, use the bending pliers in the MAXLOCK EXTREME tray to contour the plate to the bone surface. Neutral flex WARNING: Bending should only be done in one direction. Avoid excessive bending through the locking holes. If the plate is bent through a locking hole, a non-locking screw is recommended to avoid cross-threading of a locking screw. Note: This technique illustrates the procedure using the Neutral Left plate. Step 4 Place the plate over the medial aspect of the joint. The compression slot should be located distally, over the first metatarsal, as shown. If desired, the plate may be provisionally fixed using a combination of olive wires and/ or k-wires. The k-wire hole in the plate is compatible with the 1.4 mm k-wires included in the MEDIALMAX caddy. 9

10 Step 5 In order to generate compression across the fusion site, the proximal screws should be inserted first. Using the fixed drill guide and the 2.4 mm drill bit, drill a pilot hole for the first proximal 3.5 mm screw. Take care to not move the plate after drilling for a locking screw in order to maintain the proper pilot hole alignment and prevent locking screw cross-threading. Note: The threaded screw holes in the plate are compatible with a variety of screw options; 2.7 mm non-locking screws (gold), 3.5 mm non-locking or fixed-angle locking screws (magenta) and 4.0 mm non-locking screws (teal). These screws are included in the MAXLOCK EXTREME Tray. Depending on surgeon preference, a combination of screw types can be used. Use the appropriate size drill guide and drill bit to prepare for each screw. Instruments are color-coded to match the corresponding screw size. 3.5 mm variableangle locking screws may also be used in the plates; however, the variable screw caddy must be present at the time of surgery. Reference the variable-angle locking screw technique guide (MXE ) if variable-angle locking screws are desired. WARNING: Do not use any other manufacturer s screws with Wright Medical plates. Step 6 Determine the screw length required using the depth gage provided in the MAXLOCK EXTREME tray. Note: The depth gauge reading corresponds to the working length of the screw (from distal tip to underneath the screw head). Step 7 Remove the desired screw from the screw caddy using the HEXSTAR driver. For all screws used throughout the procedure, verify the screw length using the gauge provided on the screw caddy. 10

11 Step 8 With the HEXSTAR driver, insert the selected screw into the hole and drive the screw. Do not fully tighten the screw to the plate. Step 9 Follow the same technique for the remaining proximal screw hole. Fully tighten both proximal screws. Step 10 Drill a pilot hole through the distal region of the compression slot using the appropriate size offset drill guide tip and drill bit. Ensure that the arrow on the drill guide tip is oriented in the same direction as the arrow on the plate. Step 11 Determine the screw length required using the depth gauge provided in the MAXLOCK EXTREME tray. Step 12 Use the HEXSTAR driver to insert the desired length non-locking screw. Ensure any temporary fixation wires are removed prior to final screw tightening. As the screw is tightened, it will drive compression toward the fusion site. The compression slot in the MEDIALMAX Standard Plates offers 2 mm of compression. 11

12 Step 13 Fill the remaining screw holes as desired using the technique described above. Verify final plate and screw position using fluoroscopy. 12

13 Step 1 Perform standard exposure and prepare the first metatarsocuneiform (MTC) and naviculocuneiform (NC) joints according to surgeon preferred technique for a dorsomedial plate. Step 2 Temporarily fix the joints in the desired orientation using the provided k-wires. Step 3 Select the Medial Column Fusion Plate that corresponds to the correct operative side. The Medial Column Fusion Plate is anatomically contoured to fit the dorsomedial aspect of the MTC NC joint complex, reducing the need for intra-operative plate bending. WARNING: If plate bending is required, use the bending pliers in the MAXLOCK EXTREME tray to contour the plate to the bone surface. Bending should only be done in one direction. Avoid excessive bending through the locking holes. If the plate is bent through a locking hole, a non-locking screw is recommended to avoid cross-threading of the locking screw. Note: This technique illustrates the procedure using the Left plate. Step 4 Place the plate over the joint complex, as shown. If desired, the plate may be provisionally fixed using a combination of olive wires and/ or k-wires. The k-wire holes in the plate are compatible with the 1.4 mm k-wires included in the MEDIALMAX caddy. 13

14 Step 5 The Medial Column Fusion plate features two opposing compression slots. In order to generate compression across both joints, the middle screws in the cuneiform should be inserted first. Using the fixed drill guide and the 2.4 mm drill bit, drill a pilot hole for the first 3.5 mm center screw. Take care to not move the plate after drilling for a locking screw in order to maintain the proper pilot hole alignment and prevent locking screw crossthreading. Note: The threaded screw holes in the plate are compatible with a variety of screw options; 2.7 mm non-locking screws (gold), 3.5 mm non-locking or fixed-angle locking screws (magenta) and 4.0 mm non-locking screws (teal). These screws are included in the MAXLOCK EXTREME Tray. Depending on surgeon preference, a combination of screw types can be used. Use the appropriate size drill guide and drill bit to prepare for each screw. Instruments are color-coded to match the corresponding screw size. 3.5 mm variableangle locking screws may also be used in the plates; however, the variable screw caddy must be present at the time of surgery. Reference the variable-angle locking screw technique guide (MXE ) if variable-angle locking screws are desired. WARNING: Do not use any other manufacturer s screws with Wright Medical plates. Step 6 Determine the screw length required using the depth gauge provided in the MAXLOCK EXTREME tray. Note: The depth gauge reading corresponds to the working length of the screw (from distal tip to underneath the screw head). Step 7 Remove the desired screw from the screw caddy using the HEXSTAR driver. For all screws used throughout the procedure, verify the screw length using the gauge provided on the screw caddy. 14

15 Step 8 With the HEXSTAR driver, insert the selected screw into the hole and drive the screw. Do not fully tighten the screw to the plate. Step 9 Follow the same technique for the remaining screws in the cuneiform. Fully tighten all screws. Step 10 Drill a pilot hole through the distal region of the distal compression slot using the appropriate size offset drill guide tip and drill bit. Ensure that the arrow on the drill guide tip is oriented in the same direction as the arrow on the plate (proximally). Note: The compression slots may be used in either order, depending on surgeon preference. Step 11 Determine the screw length required using the provided depth gauge. Step 12 Use the HEXSTAR driver to insert the desired length non-locking screw. Ensure any temporary fixation wires are removed prior to final screw tightening. As the screw is tightened, it will drive compression toward the fusion site. The compression slots in the Medial Column Fusion Plate each offer 1.5 mm of compression. 15

16 Step 13 Fill the remaining distal screw holes as desired using the technique described earlier. Step 14 Drill a pilot hole through the proximal region of the proximal compression slot using the appropriate size offset drill guide tip and drill bit. Ensure that the arrow on the drill guide tip is oriented in the same direction as the arrow on the plate. Step 15 Use the HEXSTAR driver to insert the desired length non-locking screw. As the screw is tightened, it will drive compression toward the fusion site. Ensure any temporary fixation is removed prior to final screw tightening. Step 16 Fill the remaining proximal screw holes as desired using the technique described above. Special care should be taken when drilling and inserting the proximal screws in the Navicular. To avoid the TN joint, the use of non-locking or variable-angle locking screws may be desired depending on patient anatomy and/or plate placement. Verify final plate and screw position using fluoroscopy. 16

17 Implants and Instruments PLATES Description Part # POCKETLOCK Plate - Neutral Left MCS-002-NLP POCKETLOCK Plate - Neutral Right MCS-002-NRP POCKETLOCK Plate - 4 Left MCS-002-4LP POCKETLOCK Plate - 4 Right MCS-002-4RP POCKETLOCK Plate - 8 Left MCS-002-8LP POCKETLOCK Plate - 8 Right MCS-002-8RP Standard Plate - Neutral Left MCS-002-NL Standard Plate - Neutral Right MCS-002-NR Medial Column Plate - Left MCS-002- MCL Medial Column Plate - Right MCS-002- MCR 17

18 SCREWS 4.0mm Partially Threaded Screws Description Part # ø4.0 mm 20 mm Partially Threaded Screw MFT P-20 ø4.0 mm 22 mm Partially Threaded Screw MFT P-22 ø4.0 mm 24 mm Partially Threaded Screw MFT P-24 ø4.0 mm 26 mm Partially Threaded Screw MFT P-26 ø4.0 mm 28 mm Partially Threaded Screw MFT P-28 ø4.0 mm 30 mm Partially Threaded Screw MFT P-30 ø4.0 mm 32.5 mm Partially Threaded Screw MFT P-325 ø4.0 mm 35 mm Partially Threaded Screw MFT P-35 ø4.0 mm 37.5 mm Partially Threaded Screw MFT P-375 ø4.0 mm 40 mm Partially Threaded Screw MFT P-40 ø4.0 mm 42.5 mm Partially Threaded Screw MFT P-425 ø4.0 mm 45 mm Partially Threaded Screw MFT P-45 18

19 INSTRUMENTS Description Part # Template, Neutral Left MCS-175-NLP Template, Neutral Right MCS-175-NRP Template, 4 Left MCS-175-4LP Template, 4 Right MCS-175-4RP Template, 8 Left MCS-175-8LP Template, 8 Right MCS-175-8RP Depth Gauge MCS Wire Guide MCS Pocket Countersink MCS mm POCKETLOCK Guide Wire MXM MTP Olive Wire MFT mm Drill Bit CSS

20 1023 Cherry Road Memphis, TN Nesbitt Avenue South Bloomington, MN Trademarks and Registered marks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved. MCS Rev A ECN Apr-2016