STRENGTH FROM WITHIN. Surgical Technique for Representatives

Transcription

1 STRENGTH FROM WITHIN Surgical Technique for Representatives

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3 Table of Contents PREOPERATIVE TEMPLATING... p.3 OUTRIGGER DRILL GUIDE OVERVIEW... p.4 PATIENT POSITIONING...p.5 STEP 1: REDUCE THE FRACTURE...p.5-6 STEP 2: INCISION... p.6 STEP 3: ENTRY POINT... p.7-8 STEP 4. PROXIMAL K-WIRE ADVANCEMENT... p.9 STEP 5. DISTAL FIBULA PREPARATION... p.9 STEP 6. PROXIMAL FIBULA PREPARATION... p.10 ASSEMBLY OF OUTRIGGER AND IMPLANT... p.11 STEP 7. FIBULOCK NAIL INSERTION... p STEP 8. TALON ACTIVATION... p.14 STEP 9. SCREW INSERTION... p STEP 10. END CAP PLACEMENT... p.18 APPENDIX A... p.19 FIBULOCK NAIL DIMENSIONS... p

4 PREOPERATIVE TEMPLATING The Sonoma FibuLock Nail is available in two diameters and two lengths. X-ray templates are available to determine the appropriate implant size. 4

5 OUTRIGGER DRILL GUIDE OVERVIEW PROXIMAL LATERAL SCREW GUIDE HOLE DISTAL LATERAL SCREW GUIDE HOLE.USED FOR COMPRESSION WHEN SLIDE IS SET TO COMP K-WIRE HOLE TO VERIFY LOCATION OF DISTAL SYNDESMOSIS SCREW RIGHT 3.5MM SYNDESMOSIS SCREW GUIDE HOLES ATTACHMENT KNOB COMPRESSION SLIDE K-WIRE END HOLE TO VERIFY LOCATION OF DISTAL END OF NAIL PROVISIONAL K-WIRE HOLES Top View of Outrigger RIGHT A/P SCREW GUIDE HOLE SYNDESMOSIS PREPARATION INSTRUMENTS DISTAL LATERAL SCREW PREPARATION INSTRUMENTS DISTAL A/P SCREW PREPARATION INSTRUMENTS Screw Preparation Instruments and Corresponding Screws 5

6 PATIENT POSITIONING The patient is placed in the supine position with a bump under the affected ankle. STEP 1: REDUCE THE FRACTURE Reduction Method 1: Percutaneous Generally, if fractures are less than 1-week old they may be reduced percutaneously with reduction forceps -Figure 1. In some cases, surgeons choose to make small incisions for the forceps tips to reduce surrounding skin trauma. After applying the forceps, the fibula is reduced and confirmed with fluoroscopy. The forceps are locked when reduction is achieved, and are maintained in position until distal screws are introduced. 1 Reduction Method 2: Small Incision Over Fracture For their first few surgeries, many surgeons make the reduction with towel clips or small forceps through a small incision over the fracture. This ensures visibility and helps develop comfort with the system before proceeding to smaller exposures. This small-incision technique is also frequently used if the fracture is over 1-week old and has started to fibrose. If this is the case, create a small opening over the fracture and remove any callus with a curette before reducing the fracture. For the most minimal exposure possible, two reduction instruments are available. The most commonly utilized are percutaneous forceps. However, a Hintermann distractor may also be utilized with the 2mm and 1.6mm K-wires (supplied non-sterile). 6

7 Reduction Method 3: Hintermann Taking care to avoid the anticipated implant path, drill 2mm or 1.6mm (available in 9 or 12 inches) K-wires into the fibula above the fracture and into the anterior aspect of the distal fibula below the fracture. Slide the proximal and distal arms of the Hintermann over the K-wires and use the Hintermann to re-align the bone. -Figure 2. After ensuring reduction, lock the Hintermann -Figure 3. The K-wire in the distal fragment can be driven into the talus for more secure fixation. 2 The entire operation is basically the entry point. If that is correct, the operation is a quick success Robert Tonks, MD (a surgeon designer of the Fibulock Nail) 3 STEP 2: INCISION Confirm the axis of the fibula by laying a K-wire on the surface of the skin and verifying its alignment with the fibula canal. Mark the skin in several spots along the wire to act as external alignment landmarks -Figure 4. Make a shallow 1-2cm incision aligned with the fibula axis approximately 1.5cm distal to the fibula tip. Care should be taken to avoid the peroneal tendons which are generally deeper than the incision, but may be retracted if necessary. 4 7

8 STEP 3: ENTRY POINT NOTE: Throughout the entry point and wire advancement steps, flouroscopic images should be taken regularly in both anterior-posterior (A/P) or mortise and medial-lateral (M/L) views to ensure the instruments are correctly aligned with the bone. The entry point is slightly medial to the ledge of the distal fibula tip. It is centered with the canal A/P and directed proximally to the center of the canal both M/L and A/P. Confirm the entry point fluoroscopically in both the A/P and M/L planes -Figures 5-7. Drive the 1.6mm K-wire into the bone through the drill guide -Figure 8. If the K-wire is placed slightly off-target, an offset K-wire re-drill guide is available to establish a more accurate entry point. 5 LATERAL ENTRY POINT IS SLIGHTLY MEDIAL TO THE DISTAL FIBULA TIP AND IN ALIGNMENT WITH THE AXIS OF THE FIBULAR CANAL MEDIAL Distal Fibula Tip 6 8

9 M/L Plane The entry point is generally slightly anterior to the midline of the distal fibula tip when aligned with the axis of the fibular canal. ANTERIOR MIDLINE OF THE DISTAL FIBULA TIP POSTERIOR M/L view of entry point and trajectory 7 8 A/P view of entry point in distal fibula 9

10 STEP 4. PROXIMAL K-WIRE ADVANCEMENT NOTE: It has been found helpful for all wires and reamers used to prepare the intramedullary canal to be driven under oscillating power. This less aggressive method of advancement will help the instruments to stay in the canal and prevent breaching the bone cortex. Attempt to drive the K-wire across the fracture line while maintaining axial alignment. The wire should be medially angulated toward the center of the proximal canal to preserve the lateral cortex of the fibula during subsequent reaming -Figure 9. 9 IMPORTANT NOTE: If the K-wire is directed off-axis, a guide wire inserter is available to redirect the guide wire into the canal. To use the inserter, withdraw the guide wire and feed it into the cannulated inserter. Gently introduce the inserter into the canal; advancing with partial oscillation and frequent fluoroscopy until the desired direction is obtained -Figure

11 STEP 5. DISTAL FIBULA PREPARATION Prepare the fibula for the distal segment of the FibuLock Nail by driving the 6.2mm tapered reamer over the K-wire -Figure 11. Drive the 6.2mm reamer until the distal end of the flutes (Figure 11A) contacts the distal fibula cortex and the flutes are buried in the distal fibula. Leaving the 6.2mm tapered reamer in place, remove the K-wire and exchange it with a flexible guide wire. Drive the guide wire into the proximal fibula. Remove the 6.2mm tapered reamer while retaining the guide wire in the canal. NOTE: The guide wire can be held manually to prevent it from clinging inside the shaft of the 6.2mm reamer as the reamer is withdrawn. A 6.2mm Tapered Reamer STEP 6. PROXIMAL FIBULA PREPARATION Drive the 3.2mm x 130mm proximal reamer over the guide wire until fluoroscopy shows the depth indicator collar (Figure 12A) has reached the distal fibula cortex. If this reamer is too narrow for the canal, the 4.0mm x 130mm reamer may be utilized to prepare for the 3.8mm implant -Figure 12. If 180mm implants are warranted, long reamers are available in 3.2mm and 4.0mm diameters. After proximal reaming, remove the reamers and maintain the guide wire in the canal. NOTE: The guide wire can be held manually to prevent it from adhering inside the shaft of the proximal reamers as they are withdrawn. 11 A 3.2mm Tapered Reamer 12 11

12 ASSEMBLY OF OUTRIGGER AND IMPLANT ALIGNMENT TABS KEY INTO THE IMPLANT DIFFERENTLY ON EITHER SIDE TO ENSURE THE IMPLANT CAN ONLY BE LOADED IN THE CORRECT ORIENTATION (THE TIP OF THE IMPLANT POINTS TOWARDS THE OUTRIGGER) 12

13 STEP 7. FIBULOCK NAIL INSERTION Advance the implant insertion guide over the guide wire and into the distal fibula 10mm-20mm. Utilize fluoroscopy to confirm the guide is in the bone -Figure 13. Remove the implant insertion guide inner handle and the guide wire, retaining the guide channel -Figure Position the outrigger in a plane parallel with the axis of the foot. This will ensure the drill guide is in proper orientation for screw placement. Advance the FibuLock Nail along the guide channel and into the fibula -Figure 15. Withdraw the guide channel before advancing the distal hub of the implant into the bone. 15 Correct nail depth is verified by ensuring the syndesmosis screws are in the correct location and the nail will not sit proud distally. 13

14 Confirming Syndesmosis Screw Location Feed a 1.6mm K-wire into the hole adjacent to the distal syndesmosis drill guide hole. Lower the K-wire to the skin. If fluoroscopically viewed in the A/P plane, this K-wire will indicate the final direction and location of the syndesmosis screws -Figure 16. Generally, the syndesmosis screws are placed 5 to 10mm proximal to the mortis and level with the physeal scar of the distal tibia. Confirming Distal Position of the FibuLock Nail 16 Feed a 1.6mm K-wire into the END hole on the compression slide in the outrigger -Figure 17A. (The compression slide must be in the forward STATIC position, or it will not accept a K-wire -Figure 17B.) The point of the K-wire correlates with the distal end of the FibuLock Nail -Figure 18. Utilize A/P fluoroscopy to confirm the K-wire is not proud of the distal tip of the fibula. Light impacts may be used to seat the implant. Only strike the impact cap and do not directly strike the outrigger assembly. NOTE: If the compression feature will be utilized, the implant should be countersunk 2-3mm to ensure it is not proud after compression. After countersinking, re-confirm the reduction has been maintained. NOTE: If seating the FibuLock Nail has compacted the fracture and caused the fibula to shorten. The fibula may be brought back out to length with K-wires driven into the distal fibula fragment through the provisional holes in the outrigger -Figure 17C. After the K-wires are in the distal fibula, traction can be placed on the outrigger to correct the fibula length. Activate the talons once the fibula reaches the correct length. A C B

15 STEP 8. TALON ACTIVATION Ensure the fracture is reduced. While holding the outrigger to prevent it spinning, expand the triangulation talons by turning the activation driver clockwise for approximately 20 full rotations until it clicks -Figure 19. Opening and release of the talons can be confirmed fluoroscopically -Figure 20. The talons may not appear to open equally on all sides due to the view angle of the fluoroscopy. IMPORTANT NOTE: Once the talons are engaged, do not rotate the FibuLock Nail. This may weaken the fixation or implant. In addition, the talons may be weakened if they are de-activated and the implant is repositioned. If the FibuLock Nail requires repositioning, deactivate the talons by turning the actuation driver counter-clockwise and utilize a new FibuLock Nail. 19 CLOSED TALONS OPEN TALONS 20 15

16 STEP 9. SCREW INSERTION NOTE: Two 2.5mm hex drivers are available: captured and cannulated. The captured driver features a split tip that captures the hex head of the screw. The cannulated driver does not hold the screw, but is cannulated for a 1.25mm K-wire. Both may be used to seat all screws used in this technique. Screw Insertion without Compression If compression is unnecessary, ensure the compression slide is set to STATIC -Figure 21A. Prepare for the two 2.7mm Lateral screws (2.0mm inner diameter) by inserting the drill guide sleeve into the distal 2.7mm holes on the outrigger. To prepare for a screw, make a stab incision and advance the sleeve until it rests firmly against bone. Insert the 2.0mm drill guide into the sleeve until the guide rests on the cortex. Under fluoroscopic guidance, use the 2.0mm drill to bore through the implant down to the edge of the opposite cortex. The screws do not have to be bicortical because the A/P and proximal lateral screws lock into the shaft of the nail. The distal screw is locked by the end cap. 2.7mm screws are available in lengths from 12mm to 20mm in 2mm increments. To determine screw size, measure the screw length on the drill guide. When between sizes, use the smaller screw length to ensure the screw will not penetrate the opposite cortex. The measurement is taken from the small tick-mark next to the number to the larger line below -Figure MM A/P HOLE LEFT SIDE 2.7MM LATERAL HOLES LEFT OR RIGHT SIDE IF THE LINE ON THE DRILL FALLS WITHIN THIS REGION, THE DEPTH MEASUREMENT IS 18MM A

17 Once withdrawn from the screw caddy, the length of the screw should be confirmed by using the measurement gauge on the side of the caddy -Figure Insert the screw using the 2.5mm hex driver. Utilize the same sleeve, drill guide and drill for the A/P screw on the furthermost hole in the wing of the outrigger -Figure 24. NOTE: Make sure to use the appropriate L left or R right hole

18 For Compression NOTE: Compression must be performed before other Lateral or A/P screws can be inserted Slide the compression slide down until it clicks to COMP -Figure 25A. Insert the drill guide sleeve into the distal 2.7mm hole on the compression slide. Make a stab incision and advance the sleeve until it rests firmly against bone. Insert the 2.0mm drill guide into the sleeve until the guide rests on the cortex. Under fluoroscopic guidance, use the 2.0mm drill to bore through the implant down to the edge of the opposite cortex. The screw does not have to be bicortical because the locking cap will lock the screw in position. To determine screw size, measure the screw length on the drill guide. When between sizes, use the shorter screw length to ensure the screw will not penetrate the opposite cortex. Insert the screw using the 2.5mm hex driver. Verify the screw has passed through the implant by reinserting the activation driver and ensuring it cannot pass down the shaft. Compression is achieved by loading the compression driver into the threads in the attachment screw at the rear of the outrigger. Turn the driver until it bottoms out -Figure 26. A 25 This pushes the screw in the bone proximally and compresses the bone 2.5mm. Maintain the driver in the outrigger until a second screw is placed into the bone to maintain the compression

19 Syndesmotic Screw Insertion To prepare for the 3.5mm (2.5mm inner diameter) syndesmosis screws, utilize the drill guide sleeve and longer gold-colored 2.5mm drill guide and 2.5mm drill -Figure 27. Ensure the correct L or R syndesmotic screws are available in lengths from 40mm to 70mm in 5mm increments. Whatever number the drill line is closest to is the length of screw that should be used. (For example, if the line is between 50 and 55, but closer to 50, use a 50mm screw -Figure 28.) As the screw is lowered into the sheath, Use fingertips to steady the tip of the sheath at the point where it meets the bone surface. This will help guide the screw on the correct trajectory. Use flouroscopy to confirm the screw has been driven through the implant STEP 10. END CAP PLACEMENT To lock the distal Lateral screw, remove the outrigger and introduce the locking cap (Figure 29A) into the rear of the nail. The cap is cannulated so it may be directed with the cannulated 2.5mm hex drive along a 1.25 K-wire (Figure 29B) into position. A B 29 19

20 APPENDIX A REMOVAL TECHNIQUE 1. Utilize a K-wire to find the drive of the end cap. Remove the end cap using a 2.5mm hex driver. Remove all interlocking screws using a 2.5mm hex driver Thread the hub attachment screw and deactivator into the distal end of the FibuLock Nail. Rotate the deactivator counterclockwise to deactivate the talons until slight resistance is felt. Verify using fluoroscopy. Place the strike plate over the shaft of the removal screw. Extract the FibuLock Nail by striking the strike 4. plate with a mallet. 20

21 FIBULOCK NAIL DIMENSIONS 130mm OR 180mm NEED HI-RES ENDCAP_1 40mm 30mm 19mm 14mm 13mm 3mm OR 3.8mm 10mm 6º 6mm FIBULOCK NAIL IMPLANTS EXPANDS UP TO 5mm EXPANDS UP TO 6mm 3.0mm NAIL TALON EXPANSION 3.8mm NAIL TALON EXPANSION CATALOG NUMBER FIB30130L FIB30130R FIB30180L FIB30180R FIB38130L FIB38130R FIB38180L FIB38180R LABEL DESCRIPTION 3.0x130mm Sonoma FibuLock Nail, Standard Left 3.0x130mm Sonoma FibuLock Nail, Standard Right 3.0x180mm Sonoma FibuLock Nail, Long Left 3.0x180mm Sonoma FibuLock Nail, Long Right 3.8x130mm Sonoma FibuLock Nail, Standard Left 3.8x130mm Sonoma FibuLock Nail, Standard Right 3.8x180mm Sonoma FibuLock Nail, Long Left 3.8x180mm Sonoma FibuLock Nail, Long Right 21

22 distal screws are introduced SYNDESMOSIS SCREWS 40, 45, 50, 55, 60, 65, 70mm 3.5mm 6mm 3.5mm 2.5mm CATALOG NUMBER CO3540-D CO3545-D CO3550-D CO3555-D CO3560-D CO3565-D CO3570-D LABEL DESCRIPTION 3.5mm x 40mm Quick Thread Cortical Screw 3.5mm x 45mm Quick Thread Cortical Screw 3.5mm x 50mm Quick Thread Cortical Screw 3.5mm x 55mm Quick Thread Cortical Screw 3.5mm x 60mm Quick Thread Cortical Screw 3.5mm x 65mm Quick Thread Cortical Screw 3.5mm x 70mm Quick Thread Cortical Screw 22

23 END CAP 7.6mm CATALOG NUMBER FIB6000 LABEL DESCRIPTION Sonoma FibuLock Nail End Cap DISTAL SCREWS 12, 14, 16, 18, 20mm 2.7mm 5mm 2mm CATALOG NUMBER SC2712 SC2714 SC2716 SC2718 SC2720 LABEL DESCRIPTION 2.7mm x 12mm Self Tapping Cortical Screw 2.7mm x 14mm Self Tapping Cortical Screw 2.7mm x 16mm Self Tapping Cortical Screw 2.7mm x 18mm Self Tapping Cortical Screw 2.7mm x 20mm Self Tapping Cortical Screw 23

24 Sonoma Orthopedic Products, Inc Busch Parkway Buffalo Grove, IL P: F: Sonoma Orthopedic Products, Inc. has made these technique guidelines available for informational purposes only and to illustrate the physician authors suggested treatment for an uncomplicated procedure. Proper surgical procedures and techniques are the responsibility of the surgeon, who must evaluate the appropriateness of the procedures described, based upon his/her own personal medical training, experience and the needs of the individual patient. Prior to the use of the Sonoma Orthopedic Products system, the surgeon should refer to the product instruction for use (IFU) for complete indications, warnings, precautions and contra indications. Package inserts are also available by contacting Sonoma Orthopedic Products, Inc Sonoma Orthopedic Products, Inc. All Rights Reserved USA Patents 7,846,162; 7,909,825; 7,914,533 and 7,942,875, 8,287,539 8,439,917 USA and International Patents Pending LB-1324 Rev A TM Trademarks and Registered Marks of Sonoma Orthopedic Products, Inc.