3.5 mm LCP Clavicle Hook Plates

Transcription

1 Part of the Synthes Locking Compression Plate (LCP ) System 3.5 mm LCP Clavicle Hook Plates Surgical Technique

2 Table of Contents Introduction 3.5 mm LCP Clavicle Hook Plates 2 AO Principles 4 Indications 5 Surgical Technique Lateral Clavicle Fractures 6 Dislocation of the Acromioclavicular Joint 13 Implant Removal 20 Product Information Implants 21 Set List 22 MR Information The 3.5 mm LCP Clavicle Hook Plates have not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the 3.5 mm LCP Clavicle Hook Plates in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Image intensifier control 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 1

3 3.5 mm LCP Clavicle Hook Plates The 3.5 mm LCP Clavicle Hook Plate provides fixation for lateral clavicle fractures and for acromioclavicular joint injuries. Lateral clavicle fracture Acromioclavicular joint dislocation Anatomically precontoured The plate facilitates optimal implant placement and surgery to provide an improved outcome. Rounded shaft profile helps minimize the risk of soft tissue irritation between the plate and surrounding soft tissue, the acromioclavicular joint and the rotator cuff Undercuts in shaft reduce impairment of blood supply 12º bend in shaft eases implant placement 2 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

4 3.5 mm LCP Clavicle Hook Plates Intraoperative choice of hook size 6 sizing templates help in selection of the proper hook size Optimized implant selection Left and right plates 4, 5, 6 and 7 hole plates 3 hook depths: 12 mm, 15 mm and 18 mm Stainless steel and titanium Locking compression plate (LCP Plates) Locking screws provide ability to create a fixed-angle construct while utilizing familiar AO plating techniques Reduced impairment of periosteal blood supply due to the limited plate contact Fixed-angle construct provides advantages in osteopenic bone or multifragmentary fractures where traditional screw purchase is compromised Smooth hook design and posterior hook offset 3 different hook depths 12 mm, 15 mm and 18 mm Combi hole Intraoperative choice between compression and angular stable locking With standard screws: interfragment or dynamic-axial compression With locking screws: stable plate-screw connection without loss of reduction, regardless of plate modeling 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 3

5 AO Principles AO PRINCIPLES In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation. 1, 2 In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation 1, 2. 4_Priciples_03.pdf :08 Anatomic Anatomic reduction reduction Fracture Fracture reduction reduction and and fixation fixation to to restore restore anatomical anatomical relationships. relationships. 1 2 Stable Stable fixation fixation Fracture Fracture fixation fixation providing providing absolute absolute or relative or relative stability, stability, as required as by the required patient, by the the injury, patient, and the the injury, personality and the personality of the fracture. of the fracture. Early, active mobilization Early Early and and safe safe mobilization and rehabilitation of of the injured part and and the the patient as as a whole. 4 3 Preservation Preservation of of blood blood supply supply Preservation Preservation of of the the blood blood supply supply to to soft soft tissues tissues and and bone bone by by gentle reduction gentle reduction techniques techniques and and careful careful handling. handling. 1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer-Verlag; Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal 2nd ed. Stuttgart New York: Thieme; Fixation. 3rd ed. Berlin Heidelberg New York: Springer Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

6 Indications Fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 5

7 Lateral Clavicle Fractures 1 Position the patient Required set Small Fragment LCP Instrument and Implant or Set, with self-tapping screws Small Fragment LCP Instrument and Titanium Implant Set, with self-tapping screws Place the patient in the beach-chair position and tilt the head away from the affected side. Use a sandbag under the thoracic spine to allow the scapula to fall backward. This aids in realignment and reduction of the fracture and assists regaining length. Excessive extension of the neck should be avoided. Note: For information on fixation principles using conventional and locked plating techniques, please refer to the Small Fragment Locking Compression Plate (LCP) Technique Guide. 6 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

8 Lateral Clavicle Fractures 2 Approach If image intensification is to be used, determine that access for the C-arm is sufficient for the anteroposterior and cephalic tilt views. Through either a superior or transacromial incision, expose the deltotrapezial fascia. Take care to avoid injury to the lateral supraclavicular nerves. 3 Reduce the fracture and provide temporary fixation Perform temporary fixation of the fracture with Kirschner wires or pointed reduction forceps. Identify the posterior aspect of the acromioclavicular joint capsule. Perform a 5 mm detachment of the extracapsular fibers of the trapezius from the medial border of the acromion, to allow passage of the hook of the plate under the acromion. 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 7

9 Lateral Clavicle Fractures 4 Determine hook size and plate length Instruments Sizing Template for LCP Clavicle Hook Plate, 12 mm hook depth, left Sizing Template for LCP Clavicle Hook Plate, 12 mm hook depth, right Sizing Template for LCP Clavicle Hook Plate, 15 mm hook depth, left Sizing Template for LCP Clavicle Hook Plate, 15 mm hook depth, right Sizing Template for LCP Clavicle Hook Plate, 18 mm hook depth, left Sizing Template for LCP Clavicle Hook Plate, 18 mm hook depth, right Sizing templates aid in determining the appropriate hook size. To determine hook size, start by passing the 12 mm hook sizing template under the acromion. Place the shaft of the sizing template onto the superior aspect of the clavicle. If it is difficult to lower the shaft onto the reduced clavicle, try the 15 mm hook template or the 18 mm hook template. After determining the correct size, choose the appropriate implant. Once the plate shaft is placed on the clavicle, the end of the hook should be in contact with the underside of the acromion. Confirm that the correct anatomic alignment of the clavicle and acromion has been restored without impinging on the rotator cuff. Use the C-arm to verify that full shoulder motion, particularly in abduction and external rotation, can be achieved without the hook impinging on the humeral head. The plate length must be appropriate for fixation on the medial side of the fracture. Check plate positioning with AP and axial C-arm views. Note: Do not bend or implant the sizing templates. 8 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

10 Lateral Clavicle Fractures 5 Adapt plate to the patient s anatomy (optional) Optional instruments Bending Iron, for 2.7 mm and 3.5 mm plates and Bending Pliers, for 2.7 mm and 3.5 mm plates Note: Since the plate shaft is anatomically precontoured (12 ), bending or twisting of the plate is not generally necessary, but may be needed in some cases. Contour the plate using the appropriate bending instruments. The Combi holes should not be deformed excessively during bending, as this may interfere with the insertion of locking screws. If possible, bend the plate between the Combi holes. Precautions: The Combi holes should not be deformed excessively during bending, as this may hinder the subsequent insertion of locking screws. If possible, bend the plate between the Combi holes. Do not bend the shaft between the holes more than 20 to 25. Do not bend the hook more than 10 to 15. Do not bend the plate and hook back and forth. Take care that the plate surface does not get scratched. Sharp edges can irritate soft tissue. 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 9

11 Lateral Clavicle Fractures 6 Fix the plate temporarily Instruments mm Kirschner Wire with Thread mm Drill Sleeve mm Wire Sleeve Position the implant and confirm the correct plate position under the image intensifier, using a K-wire for temporary fixation. Drill the K-wire through the drill sleeve in the distal hole to fix the distal part of the plate. By aligning the medial and lateral fracture fragments with the plate using reduction forceps, indirect reduction and definitive fixation can be performed. 11 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

12 Lateral Clavicle Fractures 7 Screw insertion Instruments mm Drill Bit, quick coupling, gold, 110 mm mm Drill Bit, quick coupling, 110 mm Handle, with quick coupling, small Small Hexagonal Screwdriver with Holding Sleeve or Small Hexagonal Screwdriver Shaft Depth Gauge, for 2.7 mm and smaller screws mm Universal Drill Guide Determine whether cortex screws, locking screws, or a combination of both will be used. Note: When treating lateral clavicle fractures, it is recommended to begin fixation in the most lateral hole with a 3.5 mm locking screw or 3.5 mm cortex screw. Fixation with 3.5 mm cortex screws Use the 2.5 mm drill bit through the 3.5 mm drill guide to drill for the threaded hole and the 3.5 mm drill bit to drill for the gliding hole. Determine the required length of the cortex screw with the depth gauge. Insert the self-tapping 3.5 mm cortex screw using the small hexagonal screwdriver shaft connected to a power tool, or use the small hexagonal screwdriver with holding sleeve. Note: The screw length should be carefully observed in order to avoid neurovascular injuries. 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 11

13 Lateral Clavicle Fractures 7 Screw insertion continued Instruments mm Drill Bit, quick coupling, 165 mm Handle, with quick coupling, small mm Threaded Drill Guide StarDrive Screwdriver Shaft, quick coupling, T Depth Gauge, for 2.7 mm and small screws Torque Limiting Attachment, 1.5 Nm Fixation with 3.5 mm locking screws Carefully screw the 2.8 mm threaded drill guide into a threaded hole of the plate. Use a 2.8 mm drill bit to predrill the screw hole through both cortices. Use the depth gauge to check the length of screw. Insert the locking screw using the StarDrive Screwdriver Shaft manually, or under power with the torque limiting attachment (TLA). When using power, reduce speed when tightening the head of the screw into the plate, and insert until a click is heard. Repeat the procedure until all predetermined holes are used. Perform a final check to confirm all screws are locked. It is recommended that final tightening is done manually. Precaution: Always use a TLA when using power to fully insert screws. Notes: Do not mix titanium and stainless steel implants. To ensure a stable fixation of the implant, use at least two screws in the medial part of the plate. One or two screws can be used to fix the lateral fragments. The screw length should be carefully observed in order to avoid neurovascular injuries. 11 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

14 Dislocation of the Acromioclavicular Joint Required set Small Fragment LCP Instrument and Implant Set, with self-tapping screws or Small Fragment LCP Instrument and Titanium Implant Set, with self-tapping screws 1 Position the patient Place the patient in the beach-chair position and tilt the head away from the affected side. Use a sandbag under the thoracic spine to allow the scapula to fall backward. This aids in realignment and reduction of the fracture and assists regaining length. Excessive extension of the neck should be avoided. Note: For information on fixation principles using conventional and locked plating techniques, please refer to the Small Fragment Locking Compression Plate (LCP) Technique Guide. 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 11

15 Dislocation of the Acromioclavicular Joint 2 Approach If image intensification is to be used, determine that access for the C-arm is sufficient for the anteroposterior and cephalic tilt views. Through either a superior or transacromial incision, expose the deltotrapezial fascia. Take care to avoid injury to the lateral supraclavicular nerves. 3 Reduce the dislocation and provide temporary fixation Elevate the arm and scapula toward the clavicle. Reduce the acromion to the clavicle in the horizontal and vertical planes. Temporary fixation may be achieved by a transacromial K-wire passed into the distal clavicle. Identify the posterior aspect of the acromioclavicular joint capsule. Perform a 5 mm detachment of the extracapsular fibers of the trapezius from the medial border of the acromion, to allow passage of the hook of the plate under the acromion. 11 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

16 Dislocation of the Acromioclavicular Joint 4 Determine hook size and plate length Instruments Sizing Template for LCP Clavicle Hook Plate, 12 mm hook depth, left Sizing Template for LCP Clavicle Hook Plate, 12 mm hook depth, right Sizing Template for LCP Clavicle Hook Plate, 15 mm hook depth, left Sizing Template for LCP Clavicle Hook Plate, 15 mm hook depth, right Sizing Template for LCP Clavicle Hook Plate, 18 mm hook depth, left Sizing Template for LCP Clavicle Hook Plate, 18 mm hook depth, right Sizing templates aid in determining the appropriate hook size. To determine hook size, start by passing the 12 mm hook sizing template under the acromion. Place the shaft of the sizing template onto the superior aspect of the clavicle. If it is difficult to lower the shaft onto the reduced clavicle, try the 15 mm hook template or the 18 mm hook template. After determining the correct size, choose the appropriate implant. Once the plate shaft is placed on the clavicle, the end of the hook should be in contact with the underside of the acromion. Confirm that the correct anatomic alignment of the clavicle and acromion has been restored without impinging on the rotator cuff. Use the C-arm to verify that full shoulder motion, particularly in abduction and external rotation, can be achieved without the hook impinging on the humeral head. The plate length must be appropriate for fixation on the medial side of the fracture. Check plate positioning with AP and axial C-arm views. Note: Do not bend or implant the sizing templates. 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 11

17 Dislocation of the Acromioclavicular Joint 5 Adapt plate to the patient s anatomy (optional) Optional instruments Bending Iron, for 2.7 mm and 3.5 mm plates and Bending Pliers, for 2.7 mm and 3.5 mm plates Note: Since the plate shaft is anatomically precontoured (12 ), bending or twisting of the plate is not generally necessary, but may be needed in some cases. Contour the plate using the appropriate bending instruments. The Combi holes should not be deformed excessively during bending, as this may interfere with the insertion of locking screws. If possible, bend the plate between the Combi holes. Precautions: The Combi-holes should not be deformed excessively during bending, as this may hinder the subsequent insertion of locking screws. If possible, bend the plate between the Combi holes. Do not bend the shaft between the holes more than 20 to 25. Do not bend the hook more than 10 to 15. Do not bend the plate and hook back and forth. Take care that the plate surface does not get scratched. Sharp edges can irritate soft tissue. 11 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

18 Dislocation of the Acromioclavicular Joint 6 Fix the plate temporarily Instruments mm Kirschner Wire with Thread mm Drill Sleeve mm Wire Sleeve Position the implant and confirm the correct plate position under the image intensifier, using a K-wire for temporary fixation. Drill the K-wire through the wire sleeve in the distal hole to fix the distal part of the plate. 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 11

19 Dislocation of the Acromioclavicular Joint 7 Screw insertion Instruments mm Drill Bit, quick coupling, gold, 110 mm mm Drill Bit, quick coupling, 110 mm Handle, with quick coupling, small Small Hexagonal Screwdriver with Holding Sleeve or Small Hexagonal Screwdriver Shaft Depth Gauge, for 2.7 mm and smaller screws mm Universal Drill Guide Determine whether cortex screws, locking screws, or a combination of both will be used. Fixation with 3.5 mm cortex screws Use the 2.5 mm drill bit through the 3.5 mm drill guide to drill for the threaded hole and the 3.5 mm drill bit to drill for the gliding hole. Determine the required length of the cortex screw with the depth gauge. Insert the self-tapping 3.5 mm cortex screw using the small hexagonal screwdriver shaft connected to a power tool, or use the small hexagonal screwdriver with holding sleeve. Note: The screw length should be carefully observed in order to avoid neurovascular injuries. 11 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

20 Dislocation of the Acromioclavicular Joint Instruments mm Drill Bit, quick coupling, 165 mm Handle, with quick coupling, small mm Threaded Drill Guide StarDrive Screwdriver Shaft, quick coupling, T Depth Gauge, for 2.7 mm and small screws Torque Limiting Attachment, 1.5 Nm Fixation with 3.5 mm locking screws Carefully screw the 2.8 mm threaded drill guide into a threaded hole of the plate. Use a 2.8 mm drill bit to predrill the screw hole through both cortices. Use the depth gauge to check the length of screw. Insert the locking screw using the StarDrive Screwdriver Shaft manually, or under power with the torque limiting attachment (TLA). When using power, reduce speed when tightening the head of the screw into the plate, and insert until a click is heard. Repeat the procedure until all predetermined shaft holes are used. Perform a final check to confirm all screws are locked. It is recommended that final tightening is done manually. Precaution: Always use a TLA when using power to fully insert screws. Notes: Do not mix titanium and stainless steel implants. To ensure a stable fixation of the implant, use at least two screws in the medial part of the plate. One or two screws can be used to fix the lateral fragments. The screw length should be carefully observed in order to avoid neurovascular injuries. 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 11

21 Implant Removal Required instruments Handle, with quick coupling, small Small Hexagonal Screwdriver Shaft StarDrive Screwdriver Shaft, T15, quick coupling Warning: It is recommended that the 3.5 mm LCP Clavicle Hook Plate is removed after healing to prevent potential irritation of the acromion or impinging on the rotator cuff. Implant removal is usually done three months after implantation. To remove the implants, unlock all locking screws before removing them completely. The plate may otherwise rotate while the last screw is being removed, causing soft tissue damage. 22 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

22 Implants 3.5 mm LCP Clavicle Hook Plates Available in: 4 lengths 3 hook sizes Left and right versions Stainless steel and titanium Sterile packed Stainless Length* Hook depth Steel Titanium (mm) (mm) S S 4 holes, right S S 4 holes, left S S 4 holes, right S S 4 holes, left S S 4 holes, right S S 4 holes, left S S 5 holes, right S S 5 holes, left S S 5 holes, right S S 5 holes, left S S 5 holes, right S S 5 holes, left S S 6 holes, right S S 6 holes, left S S 6 holes, right S S 6 holes, left S S 7 holes, right S S 7 holes, left S S 7 holes, right S S 7 holes, left mm Locking Screws, self tapping, with StarDrive Recess mm 60 mm mm Cortex Screws, self-tapping mm 50 mm *Hook length of 26 mm is included in full length measurement Note: 3.5 mm locking screws are available in 316L stainless steel and titanium alloy (Ti-6Al-7Nb) 3.5 mm LCP Clavicle Hook Plates Surgical Technique DePuy Synthes 22

23 3.5 mm LCP Clavicle Hook Templates and Graphic Case Set ( ) Graphic Case mm LCP Clavicle Hook Plate Graphic Case Instruments Sizing Templates for LCP Clavicle Hook Plate mm, left mm, right mm, left mm, right mm, left mm, right Required Set Small Fragment LCP Instrument and Implant Set, with self-tapping screws or Small Fragment LCP Instrument and Titanium Implant Set, with self-tapping screws Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or sterilization instructions, if provided. 22 DePuy Synthes 3.5 mm LCP Clavicle Hook Plates Surgical Technique

24 Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets. Manufactured or distributed by: Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA Synthes USA, LLC 1101 Synthes Avenue Monument, CO To order (USA): To order (Canada): Note: For recognized manufacturer, refer to the product label. DePuy Synthes All rights reserved. DSUS/TRM/1016/1127 5/17 DV