Polarus 3 Solution Plates and Nails. Surgical Technique 4.3. Screws

Transcription

1 Polarus 3 Solution Plates and Nails Surgical Technique 4.3 mm Screws

2 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. Acumed Polarus 3 Solution Plates and Nails The Acumed Solution is a comprehensive system designed to treat proximal humerus fractures with an array of plate and nail options. The system introduces a number of improvements to both the implants and the instrumentation when compared to prior generations. Indications for Use The Acumed Solution includes plates, nails, screws, and accessories designed to address fractures, fusions, and osteotomies of the humerus. Note: While they are provided together for convenience, a plate and a nail should not be used on the same fracture. Definition Warning Caution Note Indicates critical information about a potential serious outcome to the patient or the user. Indicates instructions that must be followed in order to ensure the proper use of the device. Indicates information requiring special attention. This system utilizes 4.3 mm low-profile hexalobe screws only.

3 Table of Contents System Features...2 Instrumentation Overview...4 Surgical Technique Overview...6 Surgical Technique...8 Proximal Humerus: Standard and Posterior Plate Surgical Technique....8 Proximal Nail Surgical Technique Long Nail Surgical Technique Reference Ordering Information... 34

4 System Features Solution Proximal Humerus Plates Plate Lengths Standard 4-hole 6-hole 10-hole 14-hole* 18-hole* 22-hole* 94 mm 115 mm 155 mm 195 mm 235 mm 275 mm Posterior 4-hole 6-hole 94 mm 115 mm Standard Plate Proximal Screw Approximate Trajectories Hole # Superior Inclination (Degrees) Anterior/Posterior (Degrees) Superior Inclination Posterior Angulation Anterior Angulation Anterior Anterior Posterior Posterior Posterior Posterior Posterior Anterior 2

5 System Features [continued] Solution Nails Pre-assembled PEEK insert intended to create proximal locking screw friction Proximal Diameter 10 mm Proximal Diameter 10 mm Nail Lengths Proximal Nail 150 mm Long Nail 200 mm Long Nail Long Nail 220 mm 240 mm Distal Diameter 8 mm Long Nail Long Nail 260 mm 280 mm Distal Diameter 5.5 mm Versatile Screws and Instrumentation Low-Profile Screws 4.3 mm low-profile hexalobe screws, which function as locking screws, may be used in any hole of the plate and the proximal portion of the nail Low-profile screws are designed to reduce soft tissue irritation The hexalobe drive interface is designed to reduce the possibility of stripping the screw Instrumentation Innovative instrumentation is intended to streamlne the surgical experience. The system includes both a traditional sharp drill and an optional blunt drill. The blunt drill can be used to avoid perforation of the joint surface at the far cortex. Blunt Drill Low-profile Targeting Guide with Suture Cleat Radiolucent Carbon Fiber Retractors Ratcheting cannula to enhance targeting stability and assist with fracture reduction 3

6 Instrumentation Overview Polarus3 Washer Cannula ( ) 2.0 mm x 9" ST Guide Wire (WS-2009ST) Freehand Targeting Guide (MS-0210) Drill Guide, Nail ( ) Cannula, Ratcheting ( ) Cap Screw Driver ( ) Nail Targeting Locking Bolt ( ) Targeting Awl ( ) Plate Tack ( ) Plate Drill Guide, Locking ( ) Guide Wire Guide ( ) Guide Wire T Handle ( ) 10.0 mm Bud Drill (DRB1015) 8 mm Flexible Reamer ( ) 9 mm Flexible Reamer ( ) Implant Sizer ( ) Guide Wire, 20" Blunt ( ) Guide Wire, 20" Trocar Tip ( ) Locking Bolt Finger Wrench (MS-0611) Locking Knob ( ) Proximal Targeting Guide ( ) Proximal Targeting Guide, L ( ) Proximal Targeting Guide, R ( ) Nail Targeting Connector ( ) Browne-type Retractor, Carbon Fiber ( ) Blunt Hohmann Retractor, Carbon Fiber ( ) 4

7 Instrumentation Overview [continued] 8" Bone Reduction Forceps (MS-1280) 9" Bone Reduction Spanish Forceps (MS-47107) Rotator Cuff Retractor, 6 x 4 mm ( ) Blunt Gelpi Retractor 165 mm Long, Deep ( ) Periosteal Elevator (MS-46213) Medium Ratcheting Driver Handle ( ) Removal Instrument ( ) Depth Gauge ( ) Cannulated Awl ( ) Guide Wire Passer ( ) Cannulated Broach ( ) Multiple Contact Hammer ( ) 2.8 mm Long Drill ( ) 2.8 mm Blunt Long Drill ( ) 2.8 mm Blunt Short Drill ( ) Plate Drill Guide, Drop-In ( ) 2.8 mm Short Drill ( ) 4.3 mm Screw Tap ( ) Tap Sleeve ( ) Plate Targeting Locking Bolt ( ) Reduction Device ( ) Ball Spike Reduction Tool ( ) Long T15 Hexalobe Driver ( ) T15 Stick Fit Hexalobe Driver ( ) Targeting Guide, Plate, Left ( ) Targeting Guide, Plate, Right ( ) 5

8 Surgical Technique Overview Preparation Incision Reduction Proximal Humerus: Standard and Posterior Plate Surgical Technique Reduction Proximal Nail Surgical Technique Preparation Wire Insertion Canal Placement Long Nail Surgical Technique 6

9 Plate Placement Screw Preparation Closure Target Distal Screw Placement Targeting Guide Assembly Implant Insertion and Proximal Screw Placement Cap Screw Insertion Rotator Cuff Repair Freehand Distal Screw Placement 7

10 Proximal Humerus: Standard and Posterior Plate Surgical Technique Figure 1 1 Preoperative Planning Fluoroscopy should be used in all cases. Plate X-ray Templates ( ) are available and should be used preoperatively to aid in implant selection. Plate selection should be based on the fracture pattern. Fracture patterns which include posterior greater tuberosity fragments will likely require the Posterior Plate ( XXX), while less complex fracture patterns can utilize the Standard Plate ( XXX). The left plates are colored blue and the right plates are colored green. Images in this surgical technique indicate left plates only. Figure 2 Figure 3 2 Patient Positioning The patient is placed in a beach chair position and the arm is draped. Create an entry site for access to the proximal humerus through a 10 mm standard deltopectoral incision made obliquely, in line with the deltopectoral interval. As an alternative, a deltoid-splitting incision may be made in a more longitudinal direction, starting at the level of the acromioclavicular joint and extending distally. This approach may be more cosmetic for the patient. More detail for each approach is offered in the next section. Posterior Plate ( XXX) Standard Plate ( XXX) 8

11 Proximal Humerus: Standard and Posterior Plate Surgical Technique [continued] 3 Approach and Incision If posterior fixation is desired, the deltoid splitting approach is recommended. Deltopectoral Sharply dissect down to the level of the fascia and elevate the skin flaps. Identify the cephalic vein and develop the interval between the deltoid and the pectoralis. Retract the cephalic vein laterally and the pectoralis major medially. Release the fascia along the lateral border of the coracobrachialis and retract it medially to expose the proximal humerus with the subscapularis tendon attachment. To help facilitate reduction and improve fracture visualization, release the superior one-third of the pectoralis major from the shaft. It is important to place a finger underneath the pectoralis major as it is being released to protect the biceps tendon, which lies directly underneath. Deltoid Split Either a bra strap (with reflection of a distally-based skin flap) incision or a direct lateral skin incision can be used. The deltoid is split and reflected off the acromion proximally. The axillary nerve is identified and carefully protected. The nerve is often located approximately 5.6 cm from the apex of the humeral head and 6.9 cm from the acromion. 1 Two soft-tissue windows are created through the deltoid above and below the area where the axillary nerve passes. The upper window is used for fracture reduction, plate insertion and insertion of proximal screws into the plate. The lower window is used to ensure the plate is properly seated on the shaft of the humerus and to allow insertion of the distal screws. Figure 4 Deltopectoral Approach Figure 5 Deltoid Split Approach Figure 6 Deltoid Exposed 9

12 Proximal Humerus: Standard and Posterior Plate Surgical Technique [continued] Figure 7 Figure 8 Plate Lengths Standard 4-hole 94 mm 6-hole 115 mm 10-hole 155 mm 14-hole* 195 mm 18-hole* 235 mm 22-hole* 275 mm Posterior 4-hole 94 mm 6-hole 115 mm *Special-order, sterile-packed only 4 Bone Reduction The goals of bone reduction are: 1. Reduction of any subluxation or dislocation of the humeral head from the glenoid 2. Correction of any varus or valgus deformity of the humeral head 3. Restoration of the normal anatomic relationship between the head and tuberosities (if these are fractured) 4. Reduction of the humeral head to the shaft The definitive fixation should aim to fix the humeral head to one or both tuberosities and to secure the humeral head to the shaft without residual subluxation or varus/valgus deformity. This may require a combination of screws separate from the plate, non-absorbable interosseous sutures, and locking plate fixation. The Ball Spike Reduction Tool ( ) can aid in reducing a fracture in the proximal aspect of the humeral head. Note: Radiolucent Carbon Fiber Retractors ( and ) are available to assist in reduction without obscuring radiographic visibility. 5 Plate Selection The Proximal Humerus Plates are designed to fit an array of patient anatomies and are left and right specific. In most cases, the Standard Plate should be chosen. If the fracture involves the greater tuberosity, the Posterior Plate may be a better choice. If the fracture pattern includes a fracture line distal to the surgical neck, a variety of plate lengths are available. To assist with plate selection, the Implant Sizer ( ) can be used under fluoroscopy. The sizer can be used externally or inserted against the periosteum. Note: If plates longer than 10 holes (155 mm) are desired, optional plates of up to 22 holes (275 mm) may be requested from Acumed prior to surgery. Figure 9 Implant Sizer Ball Spike Reduction Tool ( ) Carbon Fiber Retractors ( or ) Implant Sizer ( ) 10

13 Proximal Humerus: Standard and Posterior Plate Surgical Technique [continued] 6 Plate Placement and Reduction Select the appropriate Targeting Guide, Plate (Left: or Right: ) and secure it to the plate with the Plate Targeting Locking Bolt ( ). Figure 10 If the Posterior Plate is selected, Plate Drill Guides, Locking ( ) can adjust the angle of the posterior tabs prior to screw placement. Caution: Do not bend tabs more than once or bend them past 20 degrees. To prevent screw interference, avoid using screws longer than 26 mm in the posterior holes. Place the plate approximately 5 mm posterior to the bicipital groove and approximately 8 10 mm inferior to the top of the greater tuberosity. Confirm fracture reduction and plate height fluoroscopically. Provisionally secure an oblong hole with a Plate Tack ( ), Ball Spike Reduction Tool ( ), or Reduction Device ( ). Do not fully seat the reduction device s threads under power. Rotate the reduction knob clockwise until the plate shaft is secured to the bone. This instrument should be used in the longest oblong slot to avoid blocking access to the surrounding screw holes. As the reduction device and the 4.3 mm hexalobe screws have the same outer diameter, the screw can replace the reduction instrument without additional drilling. Next, adjust the plate s position under fluoroscopy. A guide wire, placed through the Guide Wire Guide ( ), can be used to aid with positioning. Sutures may be used at this time to improve construct stability. The plate features suture holes to address greater tuberosity fragments in 3- and 4-part fractures. The targeting guide contains a suture cleat which can be used to temporarily maintain tension on the suture. This should be used with care to avoid damaging the suture s integrity. Figure 11 Figure 12 Reduction device insertion Targeting guide assembly and posterior tab adjustment Targeting Guide, Plate (80-15XX) Plate Targeting Locking Bolt ( ) Plate Drill Guides, Locking ( ) Plate Tacks ( ) Ball Spike Reduction Tool ( ) Reduction Device ( ) Guide Wire Guide ( ) 11

14 Proximal Humerus: Standard and Posterior Plate Surgical Technique [continued] Figure 13 Blunt Drill Sharp Drill Figure 14 Depth gauge Figure Suggested standard plate screw insertion order Screw Preparation Humeral Head Standard or Posterior Plate Referencing the suggested screw order in figures 15 and 16, insert 4.3 mm Low-profile s ( XX) by preparing the humeral head with the 2.8 mm Short Drill (Sharp: or Blunt: ). The blunt drill can help avoid perforation of the joint surface. The Plate Drill Guide, Drop In ( ) or Plate Drill Guide, Locking ( ) is used with the selected drill. The drop-in drill guide allows for measuring without a traditional depth gauge. Ensure this instrument is fully seated in the targeting guide for accurate measurement. The Depth Gauge ( ) is used in conjunction with the locking drill guide. Remove the locking drill guide from the Targeting Guide, Plate ( or ) to properly measure screw length. The 4.3 mm Low-profile functions as a locking screw. Insert the appropriate 4.3 mm Low-profile ( XX) using the T15 Stick Fit Hexalobe Driver ( ). Use fluoroscopy to help confirm accurate screw placement throughout the procedure. Implant the remaining proximal screws with the exception of hole #8. Hole #8 can be drilled through the Plate Targeting Locking Bolt ( ). Next, remove sutures from the targeting guide before disconnecting from the plate. Followed by removing the locking bolt and targeting guide to measure and insert the respective screw. Then secure the sutures by passing through the respective holes on the plate s edges. Optional: Plate tabs can be used as suture holes. Caution: If using the Posterior Plate, screws longer than 26 mm should not be used in the posterior tabs to avoid screw interference. 6 Figure 16 Suggested posterior plate screw insertion order Figure 17 Axial screw view with posterior plate 4.3 mm Low-profile ( XX) 2.8 mm Short Drill (Sharp: or Blunt: ) Plate Drill Guide, Drop In ( ) Plate Drill Guide, Locking ( ) Depth Gauge ( ) Plate Targeting Locking Bolt ( ) 15 Stick Fit Hexalobe Driver ( ) 12

15 Proximal Humerus: Standard and Posterior Plate Surgical Technique [continued] 8 Additional Shaft Screw Insertion For the remaining shaft holes, insert 4.3 mm Low-profile ( XX). Take care to remove any burrs that may have formed during screw insertion. The Plate Drill Guide, Locking ( ) must be used when drilling in the round locking holes. Note: If dense bone is encountered when implanting 4.3 mm low-profile hexalobe screws, a 4.3 mm Screw Tap ( ) and Tap Sleeve ( ) are available. Figure mm Low-profile ( XX) Plate Drill Guide, Locking ( ) 4.3 mm Screw Tap ( ) Tap Sleeve ( ) 13

16 Proximal Humerus: Standard and Posterior Plate Surgical Technique [continued] Figure 19 9 Soft-Tissue Closure Layered closure is performed using heavy absorbable sutures. In the deltoid-splitting approach, meticulous repair of the deltoid split is important to avoid deltoid dehiscence. Direct transosseous suturing of the deltoid to the acromion is recommended. Close the wound in layers with a subcuticular stitch. 14

17 Proximal Humerus: Standard and Posterior Plate Surgical Technique [continued] 10 Postoperative Protocol replaced with an alternative protocol at performing surgeon s discretion. Note: The following protocol may be Passive range of motion exercises are initiated for the first 4 weeks, then active assisted for 2 weeks. Active range of motion and strengthening are started at approximately 6 weeks postoperatively. Clinical and radiological monitoring should continue until a satisfactory functional outcome and fracture union have been achieved. Implant Removal If removal of the implant is desired, prepare the exposure as in Step 3. Locate the screws and remove them with the T15 hexalobe driver, then remove the plate. If Acumed drivers are unavailable, the hexalobe screws may be removed with a T15 hexalobe connection. The Acumed Screw Removal System can also assist with removal. 15

18 Proximal Nail Surgical Technique 1 Preoperative Planning Fluoroscopy should be used in all cases. Nail X-ray Templates ( ) are available and should be used preoperatively to aid in implant selection. The proximal nails are left and right specific. Figure 20 2 Patient Positioning and Surgical Exposure The patient may be placed either supine or in a beach chair position so that fluoroscopy can be used to allow intraoperative assessments of fracture reduction, implant insertion, and a thorough evaluation of the final implant position. A radiolucent table is recommended to facilitate fluoroscopy. Position the shoulder off the edge of the table or, alternatively, a bolster can be placed beneath the scapula to elevate the shoulder. Ensure there is enough clearance to externally rotate the humerus without the screw targeting guide contacting the table during later steps. For an anterolateral approach, a 3 5 cm incision is made at the anterolateral aspect of the acromion extending parallel to the fibers of the deltoid. The supraspinatus tendon is then split in the direction of the fibers to expose the proximal humerus posterior to the biceps tendon. It is important not to detach the insertion of the tendon. A Rotator Cuff Retractor ( ) is available to assist with exposure. Figure 21 Rotator Cuff Retractor, 6 x 4 mm ( ) 16

19 Proximal Nail Surgical Technique [continued] 3 The goals of fracture reduction are: Fracture Reduction 1. Reduction of any subluxation or dislocation of the humeral head from the glenoid 2. Correction of any varus or valgus deformity of the humeral head 3. Restoration of the normal anatomic relationship between the head and tuberosities (if these are fractured) 4. Reduction of the humeral head to the shaft The definitive fixation should aim to fix the humeral head to one or both tuberosities and to secure the humeral head to the shaft without residual subluxation or varus/valgus deformity. This may require a combination of screws separate from the nail, non-absorbable interosseous sutures, and locking nail fixation. Figure 22 17

20 Proximal Nail Surgical Technique [continued] Figure 23 Figure mm Lesser Tuberosity Bicipital Groove Rotator Cuff Insertion Greater Tuberosity 4 Guide Wire Insertion The implant insertion point is located approximately 10 mm posterior to the bicipital groove, medial to the greater tuberosity. For 3-part fractures, care should be taken to make the starting point at the junction of the articular surface and the greater tuberosity. Assemble the Guide Wire T Handle ( ) and the Locking Knob ( ) onto the Polarus 3 Guide Wire, 20" Trocar Tip ( ) as shown to the left, paying particular attention to the orientation of the depth markings along the length of the wire. The trocar tip guide wire can be advanced into the canal as a guide for subsequent steps. Optional: An optional technique is to perforate the cortex with a 2.8 mm drill and then pass the Guide Wire, 20" Blunt ( ) down into the canal. The guide wire position should be verified with images in both the anterior/posterior (A/P) and oblique planes to ensure that the guide wire is inside the humerus and in the canal. Fluoroscopy can be utilized to ensure the guide wire has not exited through the fracture site. Note: A drill bit or guide wire may also be used in the proximal fragment as a joystick to aid in fracture reduction and realignment. The drill should be positioned to avoid interference with both the nail and targeting guide during insertion. Figure 25 Guide Wire T Handle ( ) Locking Knob ( ) Guide Wire, 20" Trocar Tip ( ) Guide Wire, 20" Blunt ( ) 18

21 Proximal Nail Surgical Technique [continued] 5 Canal Preparation The tip of the Cannulated Awl ( ) should be carefully buried over the guide wire no deeper than 30 mm below the bone surface to create an entry hole 10 mm in diameter. The groove on the awl is approximately 50 mm from the tip. If the fracture runs through the insertion site, it may be necessary to create a starting hole with a burr or rongeur. Another option for preparing the entry site is using the 10 mm Bud Drill (DRB1015) over the guide wire. Drill with the 10 mm Bud Drill to a depth of approximately mm to allow the nail to pass into the canal. A third technique for preparing the canal is to use the Cannulated Broach ( ). Insert the broach to the level of the last cutting tooth. The lateral side of the broach is designated by the direction of the broach handle. After the bud drill is used, the Guide Wire Passer ( ) is available to assist in passing the guide wire past the fracture site. Figure 26 Figure 27 Figure 28 6 Targeting Guide Assembly 1. Attach the Nail Targeting Connector ( ) to the appropriate Proximal Targeting Guide (Left: or Right: ), securing with a Locking Knob ( ). 2. Insert the Nail Targeting Locking Bolt ( ) through the barrel of the targeting connector. Note: When removing implant from sterile packaging, take care not to disengage the polyether ether ketone (PEEK) insert from the head of the nail. The insert should be visible through the slot in the nail prior to insertion. 3. Assemble implant onto the targeting connector, aligning the reference marks on the implant and targeting connector. Note: The slot on the implant is offset to prevent misalignment. 4. Tighten the locking bolt into position with the provided Locking Bolt Finger Wrench (MS-0611). When assembled properly, the nail should curve toward the targeting guide Cannulated Awl ( ) 10 mm Bud Drill (DRB1015) Cannulated Broach ( ) Guide Wire Passer ( ) Nail Targeting Connector ( ) Proximal Targeting Guide (80-162X) Locking Knob ( ) Nail Targeting Locking Bolt ( ) Locking Bolt Finger Wrench (MS-0611) 19

22 Proximal Nail Surgical Technique [continued] Figure 29 7 Implant Insertion Insert the nail over the guide wire. Verify that the proximal end of the nail is at least 5 mm below the cortex to avoid impingement. The nail should be inserted with hand pressure. To avoid injury to the axillary nerve, do not insert the nail more than 10 mm deep relative to the cortex. Note: Marks on the barrel of the targeting connector are a reference for the surgeon that the nail is either 5 mm or 10 mm below the cortex. The depth of the nail may also be verified by inserting a 2.0 mm Guide Wire (WS-2009ST) through the small hole located below the knob on the targeting guide. Under fluoroscopy, the wire will point to the top of the nail. It is important that the C-arm be exactly parallel to the patient s arm to obtain an accurate image of the implant depth. Important: Remove the guide wire prior to drilling. Figure 30 Figure 31 Figure 33 Figure 32 8 Proximal Screw Placement 4.3 mm Low-profile s ( XX) are inserted proximally utilizing the Cannula, Ratcheting ( ), Targeting Awl ( ), and Drill Guide, Nail ( ). The proximal PEEK insert will create locking friction as the screw threads into it. Small burrs may form during screw insertion into PEEK, but these should remain contained inside the nail. Note: The cannula will lock into the targeting guide when both the arrow and the flat edge are facing up. This locking action can be used to assist with reduction of the fracture and to hold fragments reduced. To unlock the cannula, turn it a quarter-turn to the left or right. Figure 34 Guide Wire (WS-2009ST) 4.3 mm Low-profile s ( XX) Cannula, Ratcheting ( ) Targeting Awl ( ) 20

23 Proximal Nail Surgical Technique [continued] Remove the awl and insert the drill guide through the cannula and up to the bone surface. The drill guide should be fully seated. Utilizing a 2.8 mm Long Drill (Sharp: or Blunt: ), prepare the bone for screw insertion. The blunt-tipped drill can be used to help avoid perforation of the joint surface at the far cortex. If the screw size reading is between sizes, round down to the shorter size. Prior to inserting the screw, remove the drill guide. Using the Long T15 Hexalobe Driver ( ), insert a 4.3 mm low-profile hexalobe screw of the appropriate length. The insertion torque of the screw into the nail may increase as the screw engages the internal locking sleeve of the nail. This resistance will lock the screw into position. When the groove on the driver shaft aligns with the end of the cannula, the screw head is flush with the bone. Care should be taken not to advance screws into the articular surface. Figure 35 Figure 36 Repeat these steps to install additional proximal screws. At the surgeon s discretion, the 8 mm Washer, Locking ( S) is available for use. The Washer Cannula ( ) is required to insert a washer. This cannula will not lock like the ratcheting cannula. Caution: To ensure proper screw length and placement, judicious use of intraoperative radiographic evaluation to verify screw length and placement is recommended. Figures 38 and 39 show a suggested order of screw insertion. Insert the cannula and targeting awl through the targeting guide and through a stab incision over the target site. Lightly tap the awl with the Multiple Contact Hammer ( ) to create a small indentation in the bone to assist with targeting accuracy. Only light tapping should be used on the awl to avoid splitting the cortex. Ensure the cannula is fully seated to the bone. 1 5 Figure 38 Figure Figure mm low-profile hexalobe screw insertion order (left shoulder shown) mm low-profile hexalobe screw insertion order (right shoulder shown) 2.8 mm Long Drill (Sharp: or Blunt: ) Long T15 Hexalobe Driver ( ) 8 mm Washer, Locking ( S) Washer Cannula ( ) Multiple Contact Hammer ( ) 21

24 Proximal Nail Surgical Technique [continued] Figure 40 9 Targeting Distal Screws Note: It is important to lock the distal humerus in the correct amount of retroversion relative to the humeral head. The fragments can be rotated under fluoroscopy until they are restored to their anatomical positioning. If a good A/P image of the humeral head is viewed, the forearm can be locked at approximately 30 degrees of external rotation. Using a guide wire in the hole marked 30 degrees retroversion in the targeting guide will indicate this angle. Insert the cannula and targeting awl into the most proximal of the 2 distal holes in the targeting guide. Tap and twist the awl against the bone to score the near cortex. Importance is placed on using the awl because it prevents walking of the drill. The drill guide is then inserted through the cannula. Using the 2.8 mm Long Drill (Sharp: ), drill through both cortices. Note: The distal holes are angled relative to each other by 15 degrees to provide multiplanar fixation. Figure mm Long Drill ( ) 22

25 Proximal Nail Surgical Technique [continued] 10 ( X-S). Cap Screw Insertion Select an appropriate length Cap Screw Place the cap screw onto the Cap Screw Driver ( ) and insert into the top of the nail. The nose of the cap screw driver will align the screw with the head of the nail. Advance the cap until it is fully seated, level with the top of the nail. The 0 mm cap screw will be fully threaded into the nail when properly inserted; do not over-torque this screw. Additional length cap screws are available to place the proximal part of the construct level with the bone surface if desired. Never leave the construct proud of the proximal bone. Figure Rotator Cuff Repair insertion of the nail. A permanent suture such as Number 2 Ethibond may be utilized to close the rotator cuff. Generally, two figure-eight sutures are used to close the small longitudinal incision of the rotator cuff. After this the deltoid is closed. The wound is then closed in layers with the deltoid closed with Number One Vicryl or similar absorbable suture and the skin is closed in standard fashion. It is important to close the rotator cuff after Figure 43 Cap Screw ( X-S) Cap Screw Driver ( ) 23

26 Proximal Nail Surgical Technique [continued] Figure Postoperative Protocol with an alternative protocol at performing surgeon s discretion. Note: The following protocol may be replaced Postoperatively, the patient is placed in an arm sling and a pain pump may be placed in the subacromial space to help with postoperative pain relief. The patient is started on pendulum motion exercises at 1 to 2 weeks, a passive motion program for 2 to 6 weeks, and active strengthening at 6 weeks when evident signs of healing are seen. Implant Removal If removal of the implant is desired, prepare the exposure as in Step 2. Locate the screws under fluoroscopy and remove only the proximal screws with the Long T15 Hexalobe Driver. If Acumed drivers are unavailable, the hexalobe screws may be removed with a T15 hexalobe connection. Use the tip of the Removal Instrument ( ) to remove any ingrown tissue in the head of the nail. Remove the cap screw using the Cap Screw Driver ( ). Thread the removal instrument into the nail. The threaded portion of the removal tool has cutting flutes that will remove tissue as it is inserted. The tip will fit into the cannulation to prevent cross threading. The removal instrument will not point straight down the humeral shaft, but will angle laterally about 4 degrees. Caution: Locate and remove the distal screws before using the Multiple Contact Hammer. Failure to do so could result in breaking the screws, nail, or removal instrument. Figure 45 After verifying that the distal screws have been removed, slip the forked end of the hammer over the shaft of the removal instrument and break the nail loose with short, sharp blows. The hammer has two sides, one of which has a 20 offset. Removal Instrument ( ) Cap Screw Driver ( ) 24

27 Long Nail Surgical Technique 1 Preoperative Planning Nail X-ray Templates ( ) are available and should Fluoroscopy should be used in all cases. Nail X-ray Templates ( ) are available and should be used preoperatively to aid in implant selection. The nail length should be chosen so that the distal holes are distal to the fracture line and do not obstruct the radial nerve. The Long Nails ( mm) are not left or right specific. Figure 46 2 Patient Positioning and Surgical Exposure The patient may be placed either supine or in a beach The patient may be placed either supine or in a beach chair position so that fluoroscopy can be used to allow intraoperative assessments of fracture reduction, implant insertion, and a thorough evaluation of the final implant position. A radiolucent table is recommended to facilitate fluoroscopy. Position the shoulder off the edge of the table or, alternatively, a bolster can be placed beneath the scapula to elevate the shoulder. Ensure there is enough clearance to externally rotate the humerus without the screw targeting guide contacting the table during later steps. For an anterolateral approach, a 3 5 cm incision is made at the anterolateral aspect of the acromion extending parallel to the fibers of the deltoid. The supraspinatus tendon is then split in the direction of the fibers to expose the proximal humerus posterior to the biceps tendon. It is important not to detach the insertion of the tendon. A Rotator Cuff Retractor ( ) is available to assist with exposure. Figure 47 Nail X-ray Templates ( ) Long Nails ( x)) Rotator Cuff Retractor ( ) 25

28 Long Nail Surgical Technique [continued] Figure 48 Figure mm Lesser Tuberosity Bicipital Groove Rotator Cuff Insertion Greater Tuberosity 3 Guide Wire Insertion 10 mm posterior to the bicipital groove, just medial to the The implant insertion point is located approximately 10 mm posterior to the bicipital groove, just medial to the greater tuberosity. For 3-part fractures, care should be taken to make the starting point at the junction of the articular surface and the greater tuberosity. Assemble the Guide Wire T Handle ( ) and the Locking Knob ( ) onto the Guide Wire, 20" Trocar Tip ( ) as shown in image at left, paying particular attention to the orientation of the depth markings along the length of the wire. The trocar tip guide wire can be advanced into the canal as a guide for subsequent steps. The tip of the Cannulated Awl ( ) should be carefully buried over the guide wire no deeper than 30 mm below the bone surface to create an entry hole 10 mm in diameter. The groove on the awl is approximately 50 mm from the tip. If the fracture runs through the insertion site, it may be necessary to create a starting hole with a burr or rongeur. Optional: An optional technique is to perforate the cortex with a 2.8 mm drill and then pass the Guide Wire, 20" Blunt ( ) down into the canal. The guide wire position should be verified with images in both the anterior/posterior (A/P) and oblique planes to ensure that the guide wire is inside the humerus and in the canal. Fluoroscopy can be utilized to ensure that the guide wire has not exited through the fracture site. Note: A drill bit may also be used in the proximal fragment as a joystick to aid fracture reduction and realignment. The drill should be positioned to avoid interference with both the nail and targeting guide during insertion. Figure 50 Guide Wire T Handle ( ) Locking Knob ( ) Guide Wire, 20" Trocar Tip ( ) Cannulated Awl ( ) Guide Wire, 20" Blunt ( ) 26

29 Long Nail Surgical Technique [continued] 4 Canal Preparation should be carefully buried over the guide wire no deeper The tip of the Cannulated Awl ( ) should be carefully buried over the guide wire no deeper than 30 mm below the bone surface to create an entry hole 10 mm in diameter. The groove on the awl is approximately 50 mm from the tip. If the fracture run through the insertion site, it may be necessary to create a starting hole with a burr or rongeur. Another option for preparing the entry site is using the 10 mm Bud Drill (DRB1015) over the guide wire. Drill with the 10 mm Bud Drill to a depth of approximately mm to allow the nail to pass into the canal. A third technique for preparing the canal is to use the Cannulated Broach ( ). Insert the broach to the level of the last cutting tooth. The lateral side of the broach is designated by the direction of the broach handle. After the bud drill is used, the Guide Wire Passer ( ) is available to assist in passing the guide wire past the fracture site. Flexible reamers are available for distal canal preparation. These should be used sequentially over the guide wire starting with the 8 mm size. The distal diameter of the mm Nails is 8 mm. Figure 51 Figure 52 Figure 53 5 Targeting Guide Assembly ( ) to the Proximal Targeting Guide ( ), Attach the Nail Targeting Connector ( ) to the Proximal Targeting Guide ( ), securing with a Locking Knob ( ). Insert the Locking Bolt ( ) through the barrel of the Targeting Connector ( ). Note: When removing implant from sterile packaging, take care not to disengage the polyether ether ketone (PEEK) insert from the head of the nail. Make sure the internal PEEK sleeve is still fully seated in the head of the nail prior to attaching the targeting guide. Assemble implant onto the targeting connector, aligning the reference mark on the implant and targeting connector. Tighten the locking bolt into position with the provided Locking Bolt Finger Wrench (MS-0611). Note: The slot on the implant is offset to prevent misalignment. When assembled properly, the nail will curve toward the targeting guide. 10 mm Bud Drill (DRB1015) Cannulated Broach ( ) Guide Wire Passer ( ) Nail Targeting Connector ( ) Proximal Targeting Guide ( ) Locking Knob ( ) Nail Targeting Locking Bolt ( ) Locking Bolt Finger Wrench (MS-0611) 27

30 Long Nail Surgical Technique [continued] Figure 54 6 Implant Insertion Insert the nail over the guide wire. Verify that the proximal end of the nail is at least 5 mm below the cortex to avoid impingement. The nail should be inserted with hand pressure. To avoid injury to the axillary nerve, do not insert the nail more than 10 mm deep relative to the cortex. Note: Marks on the barrel of the targeting connector are a reference for the surgeon that the nail is either 5 mm or 10 mm below the cortex. The depth of the nail may also be verified by inserting a 2.0 mm Guide Wire (WS-2009ST) through the small hole located just above the center hole on the targeting guide. Under fluoroscopy, the wire will point to the top of the nail. It is important that the C-arm is exactly parallel to the patient s arm to obtain an accurate image of implant depth. Note: Remove the guide wire prior to drilling. Figure 55 7 Proximal Screw Placement 4.3 mm Low-profile s ( XX) are inserted proximally utilizing the Cannula, Ratcheting ( ), Targeting Awl ( ), and Drill Guide, Nail ( ). The proximal PEEK insert will create locking friction as the screw threads into it. Small burrs may form during screw insertion into PEEK, but these should remain contained inside the nail. Note: The cannula will lock into the targeting guide when both the arrow and the flat edge are facing up. This locking action can be used to assist with reduction of the fracture and to hold fragments reduced. To unlock the cannula, turn it a quarter-turn to the left or right. Figure 57 Figure mm Guide Wire (WS-2009ST) 4.3 mm Low-profile s ( XX) Cannula, Ratcheting ( ) Targeting Awl ( ) Drill Guide, Nail ( ) 28

31 Long Nail Surgical Technique [continued] Remove the awl and insert the drill guide through the cannula and up to the bone surface. The drill guide and cannula should be against the bone surface. Utilizing the 2.8 mm Long Drill (Sharp: or Blunt: ), prepare the bone for screw insertion. The blunt-tipped drill can be used to help avoid perforation of the joint surface at the far cortex. If the screw size reading is between sizes, round down to the shorter size. Prior to inserting the screw, remove the drill guide. Using the Long T15 Hexalobe Driver ( ), insert a 4.3 mm low-profile hexalobe screw of the appropriate length. The insertion torque of the screw into the nail may increase as the screw engages the internal locking sleeve of the nail. This resistance will lock the screw into position. When the groove on the driver shaft aligns with the end of the cannula, the screw head is flush with the bone. Repeat these steps to install additional 4.3 mm low-profile hexalobe screws. At the surgeon s discretion, the 8 mm Washer, Locking ( S) is available for use. The Washer Cannula ( ) is required to insert a washer and this cannula will not lock like the ratcheting cannula. Caution: To ensure proper screw length and placement, judicious use of intraoperative radiographic evaluation to verify screw length and placement is recommended. Figures 58 and 59 show the suggested orders of screw insertion. Insert the cannula and targeting awl through the targeting guide and through a stab incision over the target site. Lightly tap the awl with the Multiple Contact Hammer ( ) to create a small indentation in the bone to assist with targeting accuracy. Only light tapping should be used on the awl to avoid splitting the cortex. 1 5 Figure mm low-profile hexalobe screw insertion order (left shoulder shown) Figure mm low-profile hexalobe screw insertion order (right shoulder shown) mm Long Drill (Sharp: or Blunt: Long T15 Hexalobe Driver ( ) 8 mm Washer, Locking ( S) Washer Cannula ( ) Multiple Contact Hammer ( ) 29

32 Long Nail Surgical Technique [continued] Figure 60 8 Freehand Targeting of the Distal Screws In order to target either the medial/lateral (M/L) or anterior/ In order to target either the medial/lateral (M/L) or anterior/ posterior (A/P) distal screws, locate the distal screw hole, utilizing fluoroscopy. Care should be taken to avoid damaging the radial nerve when making the incision for the distal interlocking screws when the M/L approach is used. Careful spreading of tissue and retraction down to the bone will minimize injury to the nerve and improve visibility of the screw insertion site. Using a C-arm and the Freehand Targeting Guide (MS-0210), find the bottom of the most distal slot. Stand up the Freehand Targeting Guide and tap it to create a starting dimple. Place the 2.8 mm Short Drill ( ) and Drill Guide, Nail ( ) into the dimple and drill parallel with the C-arm beam. Leaving this placeholder drill engaged will help to preserve the positioning of the distal fragment during compression. Leaving the drill in the bottom of the distal slot, apply manual compression if necessary. Figure 61 Figure 62 9 Distal Screws Insertion the Freehand Targeting Guide to find the second distal hole. While maintaining compression, use the C-arm and the Freehand Targeting Guide to find the second distal hole. Use the drill guide and drill through both cortices as in Step 8. Remove the more proximal drill, then, following the above technique, insert a 4.3 mm low-profile hexalobe screw into the most proximal of the distal holes. Remove the placeholder drill from the distal slot and use the drill guide to determine screw length. A/P plane M/L plane Targeting Guide (MS-0210) 2.8 mm Short Drill ( ) Drill Guide, Nail ( ) 30

33 Long Nail Surgical Technique [continued] 10 ( X-S). Cap Screw Insertion Select an appropriate length Cap Screw Place the cap screw onto the Cap Screw Driver ( ) and insert into the top of the nail. The nose of the cap screw driver will align the screw with the head of the nail. Advance the cap until it is fully seated, level with the top of the nail. The 0 mm cap screw will be fully threaded into the nail when properly inserted. Figure Rotator Cuff Repair insertion of the nail. A permanent suture such as Number 2 Ethibond may be utilized to close the rotator cuff. Generally, two figure-eight sutures are used to close the small longitudinal incision of the rotator cuff. After this the deltoid is closed. The wound is then closed in layers with the deltoid closed with Number One Vicryl or similar absorbable suture and the skin is closed in standard fashion. It is important to close the rotator cuff after Figure 64 Cap Screw ( X-S) Cap Screw Driver ( ) 31

34 Long Nail Surgical Technique [continued] Figure 65 Figure Postoperative Protocol replaced with an alternative protocol at performing surgeon s discretion. Note: The following protocol may be Postoperatively, the patient is placed in an arm sling and a pain pump may be placed in the subacromial space to help with postoperative pain relief. The patient is started on pendulum motion exercises at 1 to 2 weeks, a passive motion program for 2 to 6 weeks, and active strengthening at 6 weeks when evident signs of healing are seen. Implant Removal If removal of the implant is desired, prepare the exposure as in Step 2. Locate the screws under fluoroscopy and remove only the proximal screws with the Long T15 Hexalobe Driver. If Acumed drivers are unavailable, the hexalobe screws may be removed with a T15 hexalobe connection. Use the tip of the Removal Instrument ( ) to remove any ingrown tissue in the head of the nail. Remove the cap screw using the Cap Screw Driver ( ). Thread the removal instrument into the nail. The threaded portion of the removal instrument has cutting flutes that will remove tissue as it is inserted. The tip will fit into the cannulation to prevent cross threading. The removal instrument will not point straight down the humeral shaft, but will angle laterally about 4 degrees. Caution: Locate and remove the distal screws before using the Multiple Contact Hammer. Failure to do so could result in breaking the screws, nail, or removal instrument. After verifying that the distal screws have been removed, slip the forked end of the hammer over the shaft of the removal tool and break the nail loose with short, sharp blows. The hammer has 2 sides, one of which has a 20 offset. Removal Instrument ( ) Cap Screw Driver ( ) 32

35 Reference 1. Stecco C, Gagliano G, Lancerotto L, et al. Surgical anatomy of the axillary nerve and its implication in the transdeltoid approaches to the shoulder. J Shoulder Elbow Surg. 2010;19(8):

36 Ordering Information Tray Components Instruments 1 Browne-type Retractor, Carbon Fiber T15 Stick Fit Hexalobe Driver Blunt Hohmann Retractor, Carbon Fiber Plate Tack Periosteal Elevator MS Cap Screw Driver Blunt Gelpi Retractor 165 mm Long, Deep mm Screw Tap Rotator Cuff Retractor, 6 x 4 mm Reduction Device " Bone Reduction Forceps MS Long T15 Hexalobe Driver " Bone Reduction Forceps MS mm Long Drill Tap Sleeve mm Blunt Long Drill Plate Drill Guide, Drop-In mm Blunt Short Drill Targeting Guide, Plate, Left mm Short Drill Targeting Guide, Plate, Right mm x 9" ST Guide Wire WS-2009ST 12 Guide Wire Guide Targeting Awl Plate Drill Guide, Locking Depth Gauge Ball Spike Reduction Tool Plate Targeting Locking Bolt Medium Ratcheting Driver Handle

37

38 Ordering Information [continued] Tray Components Posterior Plates Instruments Posterior Plate 4-Hole, Left Posterior Plate 4-Hole, Right Posterior Plate 6-Hole, Left Posterior Plate 6-Hole, Right L 11 8 mm Flexible Reamer R 12 9 mm Flexible Reamer L 13 Guide Wire, 20" Blunt R 14 Guide Wire, 20" Trocar Tip Standard Plates mm Bud Drill DRB Standard Plate 4-Hole, Left Standard Plate 4-Hole, Right Standard Plate 6-Hole, Left Standard Plate 6-Hole, Right Standard Plate 10-Hole, Left Standard Plate 10-Hole, Right L 16 Cannulated Broach R 17 Cannulated Awl L 18 Guide Wire T Handle R 19 Implant Sizer L R 36

39

40 Ordering Information [continued] Tray Components Instruments 1 Cannula, Ratcheting Drill Guide, Nail Washer Cannula Nail Targeting Connector Proximal Targeting Guide, Right Proximal Targeting Guide, Left Nail Targeting Locking Bolt Multiple Contact Hammer Locking Bolt Finger Wrench MS Removal Instrument Locking Knob Freehand Targeting Guide MS Proximal Targeting Guide Sterile-Packed* Polaru 3 Standard Plates Standard Plate 14-Hole, Left Standard Plate 14-Hole, Right Standard Plate 18-Hole, Left Standard Plate 18-Hole, Right Standard Plate 22-Hole, Left Standard Plate 22-Hole, Right Long Nails L-S Locking Nail 200 mm S R-S Locking Nail 220 mm S L-S Locking Nail 240 mm S R-S Locking Nail 260 mm S L-S Locking Nail 280 mm S R-S Cap Screws and Washers Proximal Nails Cap Screw 0 mm S Proximal Locking Nail 150 mm, Left Proximal Locking Nail 150 mm, Right L-S Cap Screw 2 mm S R-S Cap Screw 4 mm S Cap Screw 6 mm 8 mm Washer, Locking S S Note: *Sterile-packed and available upon request. Contact Acumed prior to surgery for these special-order plates. 38

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42 Ordering Information [continued] Polarus Screws 4.3 mm Screws 4.3 mm x 18 mm Low-profile mm x 42 mm Low-profile mm x 20 mm Low-profile mm x 44 mm Low-profile mm x 22 mm Low-profile mm x 46 mm Low-profile mm x 24 mm Low-profile mm x 48 mm Low-profile mm x 26 mm Low-profile mm x 50 mm Low-profile mm x 28 mm Low-profile mm x 52 mm Low-profile mm x 30 mm Low-profile mm x 54 mm Low-profile mm x 32 mm Low-profile mm x 56 mm Low-profile mm x 34 mm Low-profile mm x 58 mm Low-profile mm x 36 mm Low-profile mm x 60 mm Low-profile mm x 38 mm Low-profile mm x 62 mm Low-profile mm x 40 mm Low-profile mm x 64 mm Low-profile Note: All screws and plates are also available sterile-packed. To learn more about the full line of Acumed innovative surgical solutions, please contact your local Acumed independent sales contractor, call , or visit 40