Polarus 3 Solution Plates and Nails

Transcription

1 Surgical Technique Polarus 3 Solution Plates and Nails

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. Polarus 3 Solution Design Surgeon Mr Christopher Michael Robinson BM BS, B Med Sci, FRCS (Edin) 2 Acumed Polarus 3 Solution Plates and Nails The Acumed Polarus 3 Solution has been designed to offer plate and nail options to treat proximal humerus fractures. The system is comprised of instrumentation to perform both plate and nail surgeries. While they are provided together for convenience, a plate and nail should not be used on the same fracture. The system introduces a number of improvements to the implants as well as advancements in instrumentation compared to the first generation Polarus Nail, Polarus Plus Nail, and Polarus Proximal Humerus Plate (PHP). The information included in this surgical technique provides the recommended procedures for implantation and removal. Indications for use: The Acumed Polarus 3 Solution includes plates, nails, screws, and accessories designed to address fractures, fusions, and osteotomies of the humerus. Contents Introduction 2 Surgical Technique Overview 3 Standard and Posterior Plate Surgical Technique Proximal Nail Surgical Technique Distal Nail Surgical Technique Ordering Information 28 Notes 30

3 Standard and Posterior Plate Technique 1 PREOPERATIVE PLANNING Fluoroscopy should be used in all cases. Polarus 3 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-S), while less complex fracture patterns can utilize the Standard Plate ( XXX-S). The left plates are colored blue and the right plates are colored green. Images in this surgical technique indicate left plates only. Acumed Polarus 3 Solution Surgical Technique 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 delto-pectoral incision made obliquely, in line with the deltoid-pectoral 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. 3

4 Deltopectoral Approach Deltoid Split Approach 3 APPROACH Deltopectoral AND INCISION If posterior fixation is desired, the deltoid splitting approach is recommended. 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. 1. Surgical anatomy of the axillary nerve and its implication in the transdeltoid approaches to the shoulder J Shoulder Elbow Surg (2010) 19,

5 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. Note: Radiolucent Carbon Fiber Retractors ( and ) are available to assist in reduction without obscuring radiographic visibility. Plate Lengths 4-Hole 94 mm 6-Hole 115 mm 10-Hole 155 mm 14-Hole 195 mm 18-Hole 235 mm 22-Hole 275 mm 5 PLATE SELECTION The Polarus 3 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 Plates 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 Polarus 3 Implant Sizer ( ) can be used under fluoroscopy. The sizer can be used externally or inserted against the periosteum. Note: There are no plate trials. Plates are sterile packaged. X-ray templates are available. If plates longer than 10 holes (155 mm) are desired, Acumed provides optional plates which need to be requested prior to the surgery. Implant Sizer 5

6 6 PLATE PLACEMENT AND REDUCTION Select the appropriate Polarus 3 Targeting Guide, Plate (Left: or Right: ) and secure it to the plate with the Polarus 3 Plate Targeting Locking Bolt ( ), utilizing the thumb grip. If the Posterior Plate is used, Polarus 3 Plate Drill Guides, Locking ( ) can be used to adjust the angle of the two posterior tabs prior to screw placement. Caution: Do not bend past 20 ; do not bend more than once. To prevent screw interference, screws longer than 26 mm should not be used in these 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. When proper reduction and positioning are obtained, provisionally secure the plate to the bone with 2.0 mm Guide Wires (WS-2009ST), the Polarus 3 Reduction Device ( ), Ball Spike Reduction Tool ( ), or Polarus 3 Plate Tacks ( ). The reduction device should be used in the longest oblong slot to avoid blocking access to other screw holes. The Polarus 3 K-wire Guide ( ) is also available to assist with the placement of K-wires. Sutures may be utilized at this time to improve construct stability. The plate features suture holes to address greater tuberosity fragments in three and four-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 integrity. 6

7 7 SCREW INSERTION SHAFT Note: The same type of screw is used in every hole, there are no nonlocking screws. The locking behavior of a screw is determined by the hole it is inserted into. Round, threaded holes are locking, oblong slots are nonlocking. Take care to remove any burrs which may have formed during screw insertion. To prepare the bone, use the Polarus 3 Plate Drill Guide, Drop-In ( ) and the Polarus mm Surgibit Short Drill ( ), using the laser band to determine the appropriate length of screw. Screw depth can also be measured with the Polarus 3 Depth Gauge ( ). Using the T15 Stick-Fit Hexalobe Driver ( ) insert a 4.3 mm Low-profile Hexalobe Screw ( XX-S) of the appropriate length. The screw may be inserted through any oblong slot in the plate distal to the fracture. Ensure that the screw is fully seated into the plate. The second slot is the longest and will allow for the most adjustment. The provisional fixation hardware may now be removed. Note: Oblong slots do not provide the option to lock screws to the plate. Screws lengths of mm are commonly used in the shaft. If dense bone is encountered, the Polarus mm Screw Tap ( ) and Polarus 3 Tap Sleeve ( ) may be used to further prepare the bone for screw insertion. Locking Holes Nonlocking Slots 7

8 8 SCREW PREPARATION HUMERAL HEAD Please use the diagram for the suggested order of screw insertion. The first proximal screw placed should be the anterior screw second from the top (see image, #1) on the plate. Utilizing a Polarus mm Short Drill (Sharp: or Blunt: ), prepare the bone for screw insertion. Both a traditional sharp drill and a blunt-tipped drill are available. The blunt drill can be used to help avoid perforation of the joint surface at the far cortex. Care should be taken not to over-drill with either drill. Drill the hole and utilize the laser mark on the drill with the scale on the back of the drop-in plate drill guide to determine the appropriate screw length. Screw depth can also be measured with the depth gauge through the targeting guide. For accurate determination, be sure that the drill guide is fully seated into the targeting guide. The Locking Drill Guide is also available, but requires a second measurement step using the depth gauge, through the targeting guide. Using the T15 hexalobe driver, insert a low-profile hexalobe screw of the appropriate length. Note: Use of fluoroscopy will help confirm accurate screw placement in the humeral head. Prior to inserting locking screws, be sure to confirm that the fracture is reduced anatomically Standard Plate For the Standard Plate, the remaining proximal screws should be inserted in a clockwise order except for the hole occupied by the locking bolt. This hole (#8) can be drilled through the bolt but the targeting guide must be removed before using the depth gauge to determine the appropriate length of screw. Posterior Plate Suggested Standard Plate Screw Insertion Order For the Posterior Plate, the remaining proximal screws should be inserted in a clockwise order except for the tabs and the hole occupied by the locking bolt. This hole (#8) can be drilled through the bolt but the targeting guide must be removed before using the depth gauge to determine the appropriate length of screw. The tabs should be the last screws inserted, and screws longer than 26 mm should not be used to avoid screw interference. If the Posterior Plate is used, a locking drill guide can be used to adjust the angle of the two posterior tabs prior to screw placement. Caution: Do not bend past 20 ; do not bend more than once. 8 Suggested Posterior Plate Screw Insertion Order

9 After all proximal screws are inserted, remove the targeting guide and ensure that all screw heads are fully seated into the plate. If sutures are used with the targeting guide cleat, refer to Step 10 of the technique prior to removing the targeting guide. If any screws have trouble locking into the plate, remove them and use the Polarus 3 Targeting Awl ( ) to further prepare the entry site. 9 ADDITIONAL SHAFT SCREW INSERTION For the remaining shaft holes, insert a 4.3 mm screw to secure the plate to the shaft. For locking fixation use round holes. For nonlocking fixation, the screw may be inserted through any oblong slot in the plate. Use the Drop-In Plate Drill Guide and the 2.8 mm Surgibit Short Drill; using the Polarus 3 Depth Gauge ( ) to determine the appropriate length of screw to be used. Using the T15 hexalobe driver, insert a screw of the appropriate length. Note: If dense bone is encountered, a 4.3 mm screw tap and tap sleeve may be used to further prepare the hole. 9

10 10 SUTURES Remove sutures from targeting guide and remove the targeting guide from the plate. Secure sutures to the plate by passing them through the suture holes on the edges of the plate. Optional: Plate tabs may also be used as suture holes. 11 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. 12 POSTOPERATIVE PROTOCOL Passive range of motion exercises are initiated for the first four weeks, then active assisted for two weeks. Active range of motion and strengthening are started at approximately six 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 removal. 10

11 Proximal Nail Surgical Technique 1 PREOPERATIVE PLANNING Fluoroscopy should be used in all cases. Polarus 3 Nail X-ray Templates ( ) are available and should be used preoperatively to aid in implant selection. The proximal nails are left and right specific. Acumed Polarus 3 Solution Surgical Technique 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. 3 FRACTURE REDUCTION The goals of fracture 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 nail, non-absorbable interosseous sutures, and locking nail fixation. 11

12 4 GUIDE WIRE INSERTION The implant insertion point is located approximately 10 mm posterior to the bicipital groove, medial to the greater tuberosity. For three-part fractures, care should be taken to make the starting point at the junction of the articular surface and the greater tuberosity. Assemble the Polarus 3 Guide Wire T Handle ( ) and the Polarus 3 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. The tip of the Polarus 3 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 Polarus 3 Guide Wire, 20" Blunt ( ) down into the canal. The guide wire position should be verified with images in both the 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 or K-wire 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. 12

13 5 CANAL PREPARATION The entry site is then prepared using the 10 mm bud drill 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. An alternate technique for preparing the canal is to use the Polarus 3 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 Polarus 3 Guide Wire Passer ( ) is available to assist in passing the guide wire past the fracture site. 6 ASSEMBLE THE TARGETING GUIDE 1) Attach the Polarus 3 Nail Targeting Connector ( ) to the appropriate Proximal Targeting Guide (Left: or Right: ), securing with a Locking Knob ( ). 2) Insert the Locking Bolt ( ) through the barrel of the targeting connector. Note: When removing implant from sterile packaging, take care not to disengage PEEK insert from head of nail. The insert should be visible through the slot in the nail prior to insertion. 3) 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 marks on the implant and targeting connector. Note: The slot on the implant is offset to prevent misalignment. 4) Tighten the bolt into position with the provided Locking Bolt Finger Wrench (MS-0611). When assembled properly, the nail should curve toward the targeting guide

14 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. Once proper depth is achieved, the nail and targeting guide may be rotated up to 20 to both align the screws with the bone fragments and to avoid the biceps tendon. To avoid injury to the axillary nerve, do not insert the nail more than 10 mm deep relative to the cortex. If a good A/P image of the humeral head is viewed, the forearm can be locked at approximately 30 of external rotation. Using a K-wire in the hole marked 30 retroversion in the targeting guide will indicate this angle. 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 is exactly parallel to the arm to obtain an accurate image of implant depth. Note: Remove the guide wire prior to drilling PROXIMAL SCREW PLACEMENT Note: The same type of screw is used in every hole, there are no nonlocking screws. The locking behavior of a screw is determined by the hole it is inserted into. 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. 4.3 mm Low-profile Hexalobe Screws ( XX-S) are inserted proximally utilizing the Polarus 3 Cannula, Ratcheting ( ), Polarus 3 Targeting Awl ( ), and Polarus 3 Drill Guide, Nail ( ). Note: The cannula will lock into the targeting guide when the arrow and flat 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. Important: Remove the guide wire prior to drilling. The diagram on the following page shows the suggested order of screw insertion. Starting with the most anterior screw position, 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.

15 Remove the awl and insert the drill guide through the cannula and up to the bone surface. The drill guide should be flush to the surface. Before drilling, be sure the guide wire is removed. Utilizing a Polarus mm Long Drill (Sharp: or Blunt: ), prepare the bone for screw insertion. Both a traditional sharp drill and a blunt-tipped drill are available. The blunt drill can be used to help avoid perforation of the joint surface at the far cortex. Care should be taken not to over-drill with either drill. Use the laser mark on the drill with the scale on the back of the drill guide to determine the appropriate screw length. 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 Polarus 3 Long T15 Hexalobe Driver ( ) insert a 4.3 mm 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 approaching the bone. Care should be taken not to advance screws into the articular surface. Repeat these steps to install additional locking proximal screws. At the surgeon s discretion, Polarus 3 8 mm Washer, Locking ( S) is available for use. The Polarus 3 Washer Cannula ( ) is required to insert a washer and this cannula will not lock like the ratcheting cannula Suggested Screw Insertion Order (Left Nail Shown) Suggested Screw Insertion Order (Right Nail Shown) 15

16 9 TARGET 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 the fragments 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 of external rotation. Using a K-wire in the hole marked 30 retroversion in the targeting guide will indicate this angle. Insert the cannula and targeting awl into the most distal hole in the targeting guide. Lightly tap the awl against the bone to create a dimple. The drill guide is then inserted through the cannula. Using the long drill, drill through both cortices. Leaving this placeholder drill engaged will help to preserve the positioning of the distal fragment. Place another cannula into the other distal hole and dimple the bone with the awl. Use a second drill to drill through both cortices. Note: The distal holes are angled relative to the bone by 15 to provide multiplanar fixation. 10 INSERT DISTAL SCREWS Remove the more proximal drill, then, following the above technique, insert a screw into the most proximal of the distal holes. The Polarus mm Screw Tap ( ) is available if dense bone is encountered. Verify the screw position under fluoroscopy. The screw should not extend past the medial cortex by more than 1 mm. Remove the placeholder drill from the distal hole and insert the second screw. 16

17 11 INSERT CAP SCREW Select an appropriate length Cap Screw ( X-S). Place the Cap Screw onto the Polarus 3 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 flush 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 flush to the bone surface if desired. Never leave the construct proud of the proximal bone. 12 REPAIR ROTATOR CUFF It is important to close the rotator cuff after insertion of the nail. A permanent suture such as Number 2 Ethibond may be utilized to close the rotator cuff. Generally, two figure-8 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. 17

18 13 POSTOPERATIVE PROTOCOL 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 one to two weeks, a passive motion program for two to six weeks, and active strengthening at six 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 T15 hexalobe driver. If Acumed drivers are unavailable, the hexalobe screws may be removed with a T15 hexalobe connection. Use the tip of the Polarus 3 Removal Instrument ( ) to remove any ingrown tissue in the head of the nail. Remove the cap screw using the Polarus 3 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. 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 instrument and break the nail loose with short, sharp blows. The hammer has two sides, one of which has a 20 offset. 18

19 Distal Nail Surgical Technique 1 PREOPERATIVE PLANNING Fluoroscopy should be used in all cases. Polarus 3 Nail X-ray Template ( ) 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 Polarus 3 Distal Nails ( mm) are not left or right specific. 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. 19

20 3 GUIDE WIRE INSERTION The implant insertion point is located approximately 10 mm posterior to the bicipital groove, just medial to the greater tuberosity. For three-part fractures, care should be taken to make the starting point at the junction of the articular surface and the greater tuberosity. Assemble the Polarus 3 Guide Wire T Handle ( ) and the Polarus 3 Locking Knob ( ) onto the Polarus 3 Guide Wire, 20" Trocar Tip ( ) as shown to the left (see image), 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 Polarus 3 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 Polarus 3 Guide Wire, 20" Blunt ( ) down into the canal. The guide wire position should be verified with images in both the 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. 20

21 4 CANAL PREPARATION The entry site is then prepared using the 10 mm bud drill 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. An alternate technique for preparing the canal is to use the Polarus 3 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 Polarus 3 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 Polarus 3 Nails is 8 mm. 5 ASSEMBLE THE TARGETING GUIDE Attach the Polarus 3 Nail Targeting Connector ( ) to the Polarus 3 Proximal Targeting Guide ( ), securing with a Polarus 3 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 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. Note: The slot on the implant is offset to prevent misalignment. When assembled properly, the nail will curve toward the targeting guide. Tighten the bolt into position with the provided Locking Bolt Finger Wrench (MS-0611). 21

22 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. Once proper depth is achieved, the nail and targeting guide may be rotated up to 20 to both align the screws with the bone fragments and to avoid the biceps tendon. 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 arm to obtain an accurate image of implant depth. Note: Remove the guide wire prior to drilling. 4.3 mm Low-profile Hexalobe Screws ( XX-S) are inserted proximally utilizing the Polarus 3 Cannula, Ratcheting ( ), Polarus 3 Targeting Awl ( ) and Polarus 3 Drill Guide, Nail ( ). Note: The cannula will lock into the targeting guide when the arrow and flat 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. The diagram on the following page shows the recommended order of screw insertion. Starting with the most anterior screw position, 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. Remove the awl and insert the drill guide through the cannula and up to the bone surface. The drill guide should be flush to the surface. Before drilling, be sure the guide wire is removed. Utilizing the Polarus mm Long Drill (Sharp: or Blunt: ), prepare the bone for screw insertion. Both a traditional sharp drill and a blunt-tipped drill are available. The blunt drill can be used to help avoid perforation of the joint surface at the far cortex. Care should be taken not to over-drill with either drill. Use the laser mark on the drill with the scale on the back of the drill guide to determine the appropriate screw length. If the screw size reading is between sizes, round down to the shorter size. 22

23 Prior to inserting the screw, remove the drill guide. Using the Polarus 3 Long T15 Hexalobe Driver ( ) insert a 4.3 mm 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 approaching the bone. Repeat these steps to install additional locking proximal screws, following the recommended order shown At the surgeon s discretion, Polarus 3 8 mm Washer, Locking ( S) is available for use. The Polarus 3 Washer Cannula ( ) is required to insert a washer and this cannula will not lock like the ratcheting cannula. Screw Insertion Order (Left Shoulder Shown) FREEHAND TARGETING OF THE DISTAL SCREWS In order to target either the M/L or 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 Guide and tap it to create a starting dimple. Place the Polarus 3 2.8mm Surgibit Short Drill ( ), and Polarus 3 Plate Drill Guide, Drop-In ( ) 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. Screw Insertion Order (Right Shoulder Shown) 23

24 8 INSERT DISTAL SCREWS 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 7. Remove the more proximal drill, then, following the above technique, insert a screw into the most proximal of the distal holes. The Polarus mm Screw Tap ( ) is available if dense bone is encountered. Verify the screw position under fluoroscopy. The screw should not extend past the medial cortex by more than 1 mm. Remove the placeholder drill from the distal slot and use the drill guide to determine screw length. Install the appropriate screw length as before. A/P Plane M/L Plane 9 INSERT CAP SCREW Select an appropriate length Cap Screw ( X-S). Place the Cap Screw onto the Polarus 3 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 flush with the top of the nail. The 0 mm cap screw will be fully threaded into the nail when properly inserted. 10 REPAIR ROTATOR CUFF It is important to close the rotator cuff after insertion of the nail. A permanent suture such as Number 2 Ethibond may be utilized to close the rotator cuff. Generally, two figure-8 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. 24

25 11 POSTOPERATIVE PROTOCOL 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 one to two weeks, a passive motion program for two to six weeks, and active strengthening at six 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 T15 hexalobe driver. If Acumed drivers are unavailable, the hexalobe screws may be removed with a T15 hexalobe connection. Use the tip of the Polarus 3 Removal Instrument ( ) to remove any ingrown tissue in the head of the nail. Remove the cap screw using the Polarus 3 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. 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 two sides, one of which has a 20 offset. 25

26 Ordering Information Polarus 3 Standard Plates Polarus 3 Proximal Nails Polarus 3 Standard Plate 4-hole L L-S Polarus 3 Proximal Locking Nail 150 mm L L-S Polarus 3 Standard Plate 4-hole R R-S Polarus 3 Proximal Locking Nail 150 mm R R-S Polarus 3 Standard Plate 6-hole L L-S Polarus 3 Standard Plate 6-hole R R-S Polarus 3 Distal Nails Polarus 3 Standard Plate 10-hole L L-S Polarus 3 Locking Nail 200 mm S Polarus 3 Standard Plate 10-hole R R-S Polarus 3 Locking Nail 220 mm S Polarus 3 Standard Plate 14-hole L L-S Polarus 3 Locking Nail 240 mm S Polarus 3 Standard Plate 14-hole R R-S Polarus 3 Locking Nail 260 mm S Polarus 3 Standard Plate 18-hole L L-S Polarus 3 Locking Nail 280 mm S Polarus 3 Standard Plate 18-hole R R-S Polarus 3 Standard Plate 22-hole L L-S Polarus 3 Cap Screws and Washers Polarus 3 Standard Plate 22-hole R R-S Polarus 3 Cap Screw 0 mm S Polarus 3 Cap Screw 2 mm S Polarus 3 Posterior Plates Polarus 3 Cap Screw 4 mm S Polarus 3 Posterior Plate 4-hole L L-S Polarus 3 Cap Screw 6 mm S Polarus 3 Posterior Plate 4-hole R R-S Polarus 3 8 mm Washer, Locking S Polarus 3 Posterior Plate 6-hole L L-S Polarus 3 Posterior Plate 6-hole R R-S Polarus 3 Instruments Polarus 3 Guide Wire, 20" Blunt Polarus 3 Guide Wire, 20" Trocar Tip Polarus mm Surgibit Short Drill Polarus 3 Plate Tack Polarus mm Blunt Short Drill Polarus mm Surgibit Long Drill Polarus mm Blunt Long Drill mm X 9" ST Guide Wire WS-2009ST 26

27 4.3 mm Low-Profile Hexalobe Screws 4.3 mm x 18 mm Low-Profile Hexalobe Screw S 4.3 mm x 20 mm Low-Profile Hexalobe Screw S 4.3 mm x 22 mm Low-Profile Hexalobe Screw S 4.3 mm x 24 mm Low-Profile Hexalobe Screw S 4.3 mm x 26 mm Low-Profile Hexalobe Screw S 4.3 mm x 28 mm Low-Profile Hexalobe Screw S 4.3 mm x 30 mm Low-Profile Hexalobe Screw S 4.3 mm x 32 mm Low-Profile Hexalobe Screw S 4.3 mm x 34 mm Low-Profile Hexalobe Screw S 4.3 mm x 36 mm Low-Profile Hexalobe Screw S 4.3 mm x 38 mm Low-Profile Hexalobe Screw S 4.3 mm x 40 mm Low-Profile Hexalobe Screw S 4.3 mm x 42 mm Low-Profile Hexalobe Screw S 4.3 mm x 44 mm Low-Profile Hexalobe Screw S 4.3 mm x 46 mm Low-Profile Hexalobe Screw S 4.3 mm x 48 mm Low-Profile Hexalobe Screw S 4.3 mm x 50 mm Low-Profile Hexalobe Screw S 4.3 mm x 52 mm Low-Profile Hexalobe Screw S 4.3 mm x 54 mm Low-Profile Hexalobe Screw S 4.3 mm x 56 mm Low-Profile Hexalobe Screw S 4.3 mm x 58 mm Low-Profile Hexalobe Screw S 4.3 mm x 60 mm Low-Profile Hexalobe Screw S 4.3 mm x 62 mm Low-Profile Hexalobe Screw S 4.3 mm x 64 mm Low-Profile Hexalobe Screw S To learn more about the full line of Acumed innovative surgical solutions, please contact your local Acumed Sales Representative, call , or visit acumed.net. 27

28 SHD10-06-B Effective: 04/ Acumed LLC Acumed Headquarters 5885 NW Cornelius Pass Road Hillsboro, OR Office: Fax: acumed.net These materials contain information about products that may or may not be available in any particular country or may be available under different trademarks in different countries. The products may be approved or cleared by governmental regulatory organizations for sale or use with different indications or restrictions in different countries. Products may not be approved for use in all countries. Nothing contained on these materials should be construed as a promotion or solicitation for any product or for the use of any product in a particular way which is not authorized under the laws and regulations of the country where the reader is located. Specific questions physicians may have about the availability and use of the products described on these materials should be directed to their particular local sales representative. Specific questions patients may have about the use of the products described in these materials or the appropriateness for their own conditions should be directed to their own physician. Polarus, and Acumed are registered trademarks of Acumed, LLC. Surgibit is a registered trademark of Surgibit IP Holding PTY Limited.