KneeAlign System Surgical Technique Guide

Transcription

1 KneeAlign System Surgical Technique Guide

2 Table of Contents Step 1 System Assembly... 1 Step 2 System Assembly... 2 Step 3 System Assembly... 2 Step 4 System Assembly... 2 Step 5 Sensor Pairing... 2 Step 6 Sensor Confirmation... 3 Step 7 Sensor Taring... 3 Step 8 Sensor Taring... 4 Step 9 System Placement... 4 Step 10 System Placement... 5 Step 11 System Verification... 5 Step 12 Landmark Registration... 6 Step 13 Landmark Registration... 6 Step 14 Landmark Registration... 7 Step 15 Resection Navigation... 7 Step 16 Resection Navigation... 8 Step 17 Completion... 8

3 Step 1 System Assembly Open instrument tray and assemble the metal instruments of the KneeAlign tibial jig as follows: Lift out the tibial jig body (a) and set the fixation arm (b) centered and pointing down. Ensure that the tibial jig is locked in neutral (0-0) position for varus/valgus and posterior slope: Neutral (0-0) position for varus/valgus: upper bars of jig are in line with lower bar. Neutral (0-0) position for posterior slope: upper bar of jig is pressed flat against middle bar. j Resection Stylus i Tibial Cutting Block c Midline Probe Attach the midline probe (c) to proximal end of the tibial jig. The midline probe should not be used to lift instrument. a KneeAlign Tibial Jig Body b Fixation Arm Attach the shin spacer (d) to tibial jig. Shin spacer may already be attached. h Reference Sensor Attach ankle tube (e) to distal end of the tibial jig and lock it in place by pressing the lever down. Attach malleolar probe (f) to ankle tube. Only use the curved malleolar probe (g) for extremely long or short tibias (see back cover). Remove reference sensor (h) from tray. Sensor battery will come packaged with the pre-sterile navigation unit. V Rest d Shin Spacer Unit Button Function Back button: moves to previous screen Blank button: no function Forward button: turns KneeAlign unit on and advances to next screen e Ankle Tube Back button and blank button: turns KneeAlign unit off f Malleolar Probe 1

4 Step 2 System Assembly Open the KneeAlign unit package and pass the inner sterile blister package into operative field. Step 5 Sensor Pairing Step 3 System Assembly Remove KneeAlign unit and reference sensor battery from blister pack. Insert battery into reference sensor and close cover. Reference sensor LED will slowly flash yellow to indicate battery has been inserted correctly. KneeAlign unit will move to the next screen when the reference sensor is found. Step 4 System Assembly Attach reference sensor to the tibial jig on the two pins, with reference sensor LED facing up. It is recommended to attach the reference sensor so that it is on the lateral side of the tibial jig during operation. Attach the KneeAlign unit to the tibial jig. Ensure that KneeAlign unit is firmly attached to tibial jig. Press the forward button to turn KneeAlign unit on. Step Four 2

5 Step 6 Sensor Confirmation Step 7 Sensor Taring The reference sensor LED should now display a solid green light. If it does, push button on KneeAlign unit for Yes. If it does not display a solid green light, push button on KneeAlign unit for No, remove and reinsert battery into reference sensor and repeat step. The Use Count number displayed on the KneeAlign unit screen indicates the number of times the reference sensor has been powered up. Press the center button on the KneeAlign unit to confirm the reference sensor is green. KneeAlign unit will beep and move to the next screen when pairing confirmed. Reference sensor LED will flash green several times if KneeAlign unit and reference sensor are correctly paired. If reference sensor LED does not flash green, press back arrow button on KneeAlign unit to move back to prior screen, remove and reinsert reference sensor battery and repeat Step 5. Repeat this process until reference sensor LED flashes green to indicate correct pairing. Hold tibial jig level with the KneeAlign unit screen facing up, keeping bubble level screen green in color. Ensure that the tibial jig is in neutral (0/0) position for varus/valgus and posterior slope (see Step 1). The malleolar probe may be adjusted to assist in leveling the tibial jig. Do not adjust tibial jig levers. Press the center button on KneeAlign unit when ready and maintain steady, level position until this step is complete. If tibial jig is not maintained in a steady position, a red hand will flash on the KneeAlign unit screen. 3

6 Step 8 Sensor Taring Step 9 System Placement Lift the tibial jig at an angle of approximately 80, keeping bubble level screen green in color. If tibial jig is not maintained in a steady position, a red hand will flash on the KneeAlign unit screen. Press the center button on KneeAlign unit when ready and maintain this position steady until this step is complete. Set the fixation arm on the proximal body of the tibial jig to Left or Right for the leg being operated on. Confirm and press button to select corresponding L or R on KneeAlign unit. Left leg fixation arm setting Right leg fixation arm setting System is now ready to be handed off to the surgeon. Hold the jig centrally while handing off as shown in Step 8. 4

7 Step 10 System Placement Step 11 System Verification a Pull the malleolar probe all the way anterior in order to avoid interference during placement of the jig. b Place the tibial jig on the anterior tibia, align the fixation arm of the jig to the medial third of the tibial tubercle, and position the tip of the midline probe just posterior to the insertion of the Anterior Cruciate Ligament (ACL). Midline probe should not be impacted into tibial plateau. If jig appears in extension relative to tibia, remove the shin spacer. This may be the case for very obese legs. c Secure fixation arm to the tibia with at least two pins. Drilling of threaded, hardened, stainless steel pins is recommended. During pinning, ensure that the midline probe is not pulling away from the main tibial jig body. If it has, push the probe down to reseat. After pinning, the fixation arm should be inspected to verify it has not pulled away from the main tibial jig body and that it is seated fully within the notch in the jig body. If the fixation arm has disengaged from the jig body, users should push the jig towards the tibia to fully reseat the fixation arm in the jig body. d Secure the mid-tibia v-rest of the tibial jig with the calf spring and adjust malleolar probe so b that v-rest sits firmly on anterior tibia. Press the center button on the KneeAlign unit when these steps are completed. c Release both side levers on tibial jig and lift upper bar of tibial jig up and out only to the right to the limit of its travel, and hold in position for at least one second. Ensure that each of the numbers on the left and right sides of the screen are within the range of If the numbers on the screen are outside the range, verify that the tibia is positioned to the horizontal and within 20 to the vertical in the coronal plane If the numbers on the screen still read outside of the range, the KneeAlign system should be re-tared. Remove the system from the tibia and repeat steps Navigate back to screen 3 by pressing the back arrow on the KneeAlign unit. Press the center button on the KneeAlign unit when this step is complete. d a 5

8 Step 12 Landmark Registration Step 13 Landmark Registration Confirm the tip of the midline probe is placed just posterior to the insertion of the ACL. Read the number on midline probe where the arrow indicates. Set matching number on the malleolar probe. Press the center button on the KneeAlign unit when this step is completed. Palpate the lateral malleolus and place the cup of the malleolar probe on its apex. Extend jig distally if necessary, by unlocking and locking ankle tube lever. Press the center button on KneeAlign unit to register the lateral malleolus. A double beep will sound on registration. Apex of lateral malleolus 6

9 Step 14 Landmark Registration Step 15 Resection Navigation Palpate the medial malleolus and place the cup of the malleolar probe on its apex. Press the center button on KneeAlign unit to register the medial malleolus. A double beep will sound on registration. Retract the malleolar probe all the way anterior. Move the distal end of the tibial jig to obtain the desired varus/valgus and posterior slope angles and lock in place with the side levers. The malleolar probe may be adjusted to assist in setting posterior slope angle. Do not use the malleolar probe to set the posterior slope angle if the posterior slope lever is locked. Press the center button on the KneeAlign unit when this step is completed and remove the midline probe. Apex of medial malleolus Levers unlocked V/V PS Levers locked 7

10 Step 16 Resection Navigation Step 17 Completion Insert the tibial cutting block and rotate into position against the tibia. Attach the resection stylus to the tibial cutting block. While setting the resection depth the stylus end should not be pressed into the tibial plateau. The resection depth measurement should be set according to the implant manufacturer s recommendations. Push the release plate of the tibial jig up to adjust the height of the tibial cutting block (locking mechanism on cutting block is in 1 mm increments). Once the tibial cutting block is at the desired position, pin in place using distal pin holes. Prior to resecting the tibia confirm that the posterior slope and varus/valgus angles still match the desired values. Use an angel wing stylus to confirm resection level and do a visual confirmation of alignment. If additional support is required, place a third pin through the tibial cutting block. In order to remove the stylus from the cutting block, it is necessary to pull the stylus central post straight up and out of its mounting hole. The horizontal stylus bar should not be used to remove the stylus. Resect the tibia. If more bone needs to be resected, move cutting block down on pins (2 mm). Recommended saw blade thickness is 1.27 mm (or in). Press the center button on KneeAlign unit when this step is completed. Use of KneeAlign unit is finished. Turn KneeAlign unit off by simultaneously pressing and holding the two outside buttons. The KneeAlign unit may be restarted for a bilateral procedure by pressing the center button if usage of the device is appropriate for the patient s other knee. 8

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12 Ordering Information Catalog Number Product Description KneeAlign Navigation Unit Instrument Specifications g f e k d a b h i j c a KneeAlign Tibial Jig Body b Fixation Arm c Midline Probe d Shin Spacer e Ankle Tube f Straight Malleolar Probe g Curved Malleolar Probe h Reference Sensor (2) i Tibial Cutting Blocks (Left & Right) j Resection Stylus k Calf Spring Instrument Features Note: For cleaning and sterilization instructions, please refer to the Instructions for Use Release plate; pivots up and down 2 Button for adjusting height of tibial cutting block. Release plate can be used to depress button when pushed up. 3 Posterior slope lever 4 Varus/valgus lever 5 Registration bar moves up and down 6 Middle bar moves side to side 7 Fixation arm can be pulled out and rotated About OrthAlign, Inc. OrthAlign is committed to providing surgeons with user-friendly, cost-effective, surgical navigation products for precise alignment. For more information about the KneeAlign system, please contact us at or info@orthalign.com. 120 Columbia, Suite 500, Aliso Viejo, CA / Rev J