Epoca Revision Set. Instrumentation for extraction and revision of Epoca shoulder implants.

Transcription

1 Epoca Revision Set. Instrumentation for extraction and revision of Epoca shoulder implants. Surgical Technique This publication is not intended for distribution in the USA. Instruments and implants approved by the AO Foundation.

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3 Table of Contents Introduction Introduction 2 Epoca Revision Set 4 Intended Use 6 Surgical Technique Removal / Extraction: Humeral Components 7 Removal: Glenoid Components 12 Implantation: Long or Extra-long Stem 20 Implantation: Head without Stem Change 22 Product Information Implants 24 Instruments 26 Optional Instruments 29 Sets 30 MRI Information 32 Image intensifier control Warning This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to: For general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: Epoca Revision Set Surgical Technique DePuy Synthes 1

4 Introduction Revision procedures differ from case to case. The operative strategies must be adapted to the specific case, therefore making preoperative planning one of the main determining factors for a successful outcome. The following key elements must be assessed preoperatively: Patient medical history Individual characteristics of the patient (e.g. bone quality, activity level) Implants to be extracted / revised (e.g. type of implant, type of fixation, stability) The assessment of these elements influences the operative strategy, i.e. whether a longitudinal corticotomy is needed for removal and what type of implant can be re-implanted. The following instrument sets are needed depending on what implant component is to be revised. It is important that the necessary selection of revision implants is available at the time of surgery. Extraction / Removal of implants Art. No. Required instruments sets Head and eccenter removal Humeral stem extraction Glenoid component removal Reco glenoid removal Epoca RH removal Instruments Epoca Revision Instruments Epoca Humerus Instruments Glenoids Epoca Instruments Epoca RH Instruments Epoca Reco Glenoid General Shoulder Instruments Set Extraction Module for Screws B 3.5, 4.0, 4.5 mm 2 DePuy Synthes Epoca Revision Set Surgical Technique

5 Implantation of a long humeral stem Art. No. Required instruments sets Implantation of long humeral stems Instruments Epoca Revision Epoca Humerus : Stem instruments Epoca Humerus : Press instruments Instruments Cable System Epoca General Shoulder Instruments Set SynReam Set in Vario Case Reaming Instrument Set for Humerus Epoca Revision Set Surgical Technique DePuy Synthes 3

6 Epoca Revision Set. Instrumentation for Extraction and Revision of Epoca Shoulder Implants. Removal/Extraction Removal / Extraction of humeral components Dedicated instruments for removal and extraction of humeral components are available. They are used with the same guide bar and the ram to gently remove the implant. Articulated head extractor For simple removal of the prosthesis head Self-centering independent of head size so that forces are applied axially Compatible with all Epoca heads (B mm) Articulated eccenter extractor For simple removal of eccenter Is always centered when attached to eccenter Stem extractor For atraumatic removal of the prosthesis stem Implantation Implantation of a long or extralong humeral stem In certain cases, long or extra-long stems must be implanted. The following instruments are available to facilitate implantation. Trial stems for long and extra-long stem implants Facilitate decision-making about correct stem implant size Short reaming rod 2.5 mm Length adapted for use in humerus Renders humerus reamers more rigid to facilitate reaming in revision cases 4 DePuy Synthes Epoca Revision Set Surgical Technique

7 Removal of glenoid components Bone-preserving removal of implants is essential in glenoid revision surgery. Used with general instruments, the following instruments can be used to remove Epoca glenoid components: Conical extraction screw Reverse thread functions like existing screw removal instruments Long shaft facilitates approach For use with chisel handle Bone-preserving removal of shell screws / metalback pegs Carbide drill bit Removal of metalback glenoid For use with drill suction device Drill sleeve for drill suction device Prevents metal debris in the joint Can be used with the drill suction device General instruments General instruments, such as a chisel, osteotomes/handle and an awl complete the set. Epoca Revision Set Surgical Technique DePuy Synthes 5

8 Intended Use The Epoca Revision Set is intended for the extraction and revision of Epoca Shoulder System implants. Application of Epoca revision instruments Art. No. Description Head extraction Eccenter extraction Stem extraction PE Glenoid extraction Hybrid Glenoid extraction Metalback extraction Reco Glenoid extraction Revision humeral stem Guide Bar for Removal of Implants Ram Articulated Head Extractor, for Guide Bar No Stem Extractor, for Guide Bar No Wrench, hexagonal B 5.0 mm, long, angled Articulated Eccenter Extractor, for Guide Bar No S Carbide Drill Bit B 9.5 mm, for Instrument Steel and Titanium, sterile Extraction Screw, conical, for inner diameter 7.0 mm Extension for Carbide Drill Bit B 6.0 mm Drill Suction Device Drill Sleeve 9.5, clip-on, for No Handle, long, with Quick Coupling Chisel, for Foot, straight, wide, width 15 mm, length 124 mm Osteotome, width 10 mm, length 150 mm Vice Grip, length 180 mm Drill Bit B 6.0 mm, length 195 /170 mm, 2-flute, for Quick Coupling Awl for TEN E5113-6L 14XL Trial Stems Epoca, long or extra-long, size Reaming Rod B 2.5 mm, short, length 400 mm = optional 6 DePuy Synthes Epoca Revision Set Surgical Technique

9 Removal / Extraction: Humeral Components 1 Preoperative planning Preoperative planning includes deciding whether a short or long stem shall be re-implanted. It should be decided whether the extraction requires a longitudinal corticotomy or not. Note: Please ensure that long and / or extra-long stem implants and instruments are available in all revision cases of the humeral component. 2 Patient positioning and approach Patient positioning is generally beach chair. The approach is generally deltopectoral. Expose the joint after subscapularis detachment with or without osteotomy of the lesser tuberosity. Consider soft-tissue releases to expose the head. Epoca Revision Set Surgical Technique DePuy Synthes 7

10 Removal / Extraction: Humeral Components 3 Head/eccenter removal and humeral stem extraction Instruments Guide bar for removed of implants Ram Articulated head extractor Articulated eccenter extractor Stem extractor Wrench, hexagonal B 5.0 mm, long, angled Optional instruments Handle, long, with Quick Coupling Chisel, straight, wide, width 15 mm, length 124 mm Vice grip, length 180 mm Awl Osteotome, width 10 mm, length 150 mm Mount the articulated head extractor on the prosthetic head. Pass the guide bar through the ram, screw the guide bar into the articulated head extractor. Make sure the thread fully catches. Apply gentle blows with the ram. Note: The head typically comes off without the eccenter. 8 DePuy Synthes Epoca Revision Set Surgical Technique

11 Mount the articulated eccenter extractor (if necessary, use the vice grip to rotate the eccenter into a more favorable position). Mount the ram/guide bar and apply gentle blows. Note: If the articulated extractor instruments cannot be mounted correctly, carefully tap in two thin osteotomes between the stem and eccenter/head. Precaution: Do not damage the surrounding soft tissues when using the chisel. Pay attention that the articulated head extractor or the articulated eccenter extractor do not slip off as this could damage the surrounding soft tissues. Epoca Revision Set Surgical Technique DePuy Synthes 9

12 Removal / Extraction: Humeral Components To remove the stem, mount and fully tighten the stem extractor using the hexagonal wrench. Mount the ram/guide bar and apply gentle blows. To ease stem extraction, the proximal bone/implant interface can be gently released using thin osteotomes. Retighten the guide bar/extraction tool connection after a couple of blows to make sure that it is not loose. Note: If the stem does not readily loosen, consider performing a longitudinal corticotomy before irreparable damage to the humerus occurs. Remove any residual bone cement as necessary using standard techniques and tools. 11 DePuy Synthes Epoca Revision Set Surgical Technique

13 4 Removal of an Epoca resurfacing head To remove a resurfacing head, resect the humeral head following the anatomical neck using an oscillating saw. Note: Pay attention not to damage the insertion line of the rotator cuff. If necessary, correct the resection plane. Continue with the implantation of a hemi- or total prosthesis as described in the Epoca Surgical Technique Epoca Revision Set Surgical Technique DePuy Synthes 11

14 Removal: Glenoid Components 1 Patient positioning and approach Patient positioning is generally beach chair. The approach is generally deltopectoral. 11 DePuy Synthes Epoca Revision Set Surgical Technique

15 2 Remove glenoid components 2a Cemented all-poly glenoid removal Instruments Handle, long, with Quick Coupling Chisel, straight, wide, width 15 mm, length 124 mm Optional instruments Drill Bit B 6.0 mm, length 195/170 mm, 2-flute, for Quick Coupling Awl Slide a chisel between the face plate of the polyethylene glenoid and the glenoid. Mobilize the PE using slight tilting movements. Extract the implant with a forceps. Note: If it is not possible to extract the PE en-bloc you may cut the PE pegs with the chisel and then overream the PE pegs with a 6 mm drill bit. Precaution: Pay attention not to damage the surrounding soft tissues when using the chisel. Remove any residual bone cement using standard tools and techniques. Epoca Revision Set Surgical Technique DePuy Synthes 11

16 Removal: Glenoid Components 2b Hybrid glenoid / shell screws removal Instruments Handle, long, with Quick Coupling Chisel, straight, wide, width 15 mm, length 124 mm Extraction Screw, conical, for inner diameter 7.0 mm Optional instruments Drill Bit B 6.0 mm, length 195/170 mm, 2-flute, for Quick Coupling Awl F Screwdriver Epoca, hexagonal, width across 4.5 mm Combined Hammer Remove the PE glenoid as described in step 2a. Note: If the PE pegs remain within the shell screws, overdrill the PE with a 6 mm drill bit. Remove PE residuals. Attach the conical extraction screw to the handle and lightly hammer it into the shell screw. Turn in a counterclockwise direction. The conus will gain purchase inside the shell screw and the shell screw will begin to back out. Precaution: Do not apply too much force when hammering the conical extraction screw into the shell screws as this could damage the threads of the extraction screw and /or cause an iatrogenic glenoid fracture. Alternatively, the shell screws can be removed after extraction of the bone cement using the standard hexagonal screwdriver. 11 DePuy Synthes Epoca Revision Set Surgical Technique

17 2c Metalback glenoid removal Instruments S Carbide Drill Bit B 9.5 mm, for Instrument Steel and Titanium, sterile Extension for Carbide Drill Bit Drill Suction Device Drill Sleeve 9.5, clip-on, for No Chisel, for Foot, straight, wide, width 15 mm, length 124 mm Handle, long, with Quick Coupling Conical extraction screw, for inner diameter 7.0 mm Optional instruments Drill Bit B 6.0 mm, length 195/170 mm, 2-flute, for Quick Coupling Awl F Screwdriver, hexagonal Epoca, width across 2.5 mm Combined Hammer Remove the PE glenoid implant as described in step 2a. Note: If the PE pegs remain within the metalback, use a 6.0 mm drill bit to overream them. In case of additional cortical screw fixation, extract the screws with a 3.5 mm screwdriver. First, try removing the metalback glenoid using a chisel. If the metalback glenoid cannot be removed using the chisel, continue with the following steps. Epoca Revision Set Surgical Technique DePuy Synthes 11

18 Removal: Glenoid Components Prepare drill suction device Before drilling attach the 9.5 mm drill sleeve to the drill suction device. Then connect the drill suction device to the irrigation system and the vacuum pump. To release the drill sleeve, press the side flange. Warning: Drilling metal causes drill chips, which need to be suctioned away. It is also important to cool the drill bit during the drilling process. The use of the drill suction device allows an efficient aspiration of the drill chips while at the same time cooling the drill bit. Mount drill bit onto extension for carbide drill bit 1. Attach the extension to the universal chuck of the power tool. 2. Tighten. 3. Open the sleeve of the extension by turning the nut (lefthand thread). 4. Attach the drill bit to the extension. Ensure that the drill bit fit is mounted accurately on the sleeve of the extension. 5. Manually close the sleeve. Note: It is not advisable to tighten the nut with a pin wrench. When releasing the nut the pin wrench may, however, be useful, as the drilling process itself can tighten the left-hand thread of the extension. 11 DePuy Synthes Epoca Revision Set Surgical Technique

19 Start drilling process Switch on the rinsing equipment and the vacuum pump. Position the drill suction device on the metalback plate/peg junction. Insert the 9.5 mm carbide drill bit into the drill sleeve and start drilling at the plate/peg junction to separate the plate from the peg. Repeat this step for the second peg. Carefully remove all metal debris. Precautions: Do not interrupt the water supply. Ensure that the supply and waste hoses are not bent. Make sure that there is no more metal debris in the joint as this could harm the revised joint replacement. Note that the carbide drill bit may not be reprocessed or resterilized. Since it is used to drill metal which may cause damage during use, the drill bit is designed for single use only. Metal drill bits are hard and brittle. To prevent breakage, start drilling with the drill bit already revolving while maintaining the chosen drill axis throughout the drilling process. While drilling, do not exert excessive forces on the drill by pushing. Instead, gently oscillate the drill back and forth. Carefully slide a chisel under the titanium plate to remove it. Precaution: Pay attention not to damage the surrounding soft tissues when using the chisel. Epoca Revision Set Surgical Technique DePuy Synthes 11

20 Removal: Glenoid Components Attach the conical extraction screw to the handle and lightly hammer it into the first peg as described for the shell screws in step 3. Turn in a counterclockwise direction to engage the extraction screw. Continue turning in a counterclockwise direction. Then extract the pegs applying axial force. Precaution: Do not apply too much force when hammering the conical extraction screw into the pegs as this could damage the peg / threads of the extraction screw and / or cause an iatrogenic glenoid fracture. 11 DePuy Synthes Epoca Revision Set Surgical Technique

21 2d Remove reconstruction glenoid Instruments F Screwdriver, hexagonal, Epoca, width across 2.5 mm Handle, long, with Quick Coupling Chisel, for Foot, straight, wide, width 15 mm, length 124 mm Awl Optional instrument Drill Bit B 6.0 mm, length 195/170 mm, 2-flute, for Quick Coupling Use a chisel to remove the PE inlay. Use the awl to expose the screw heads by removing residual cement. Untighten and remove the screws. In case the screws cannot be removed, use the screw extraction module. Carefully slide the chisel between the glenoid and the metalback support to remove it. Note: It could occur that the central PE peg remains in the glenoid. In this case use a 6.0 mm drill to remove it. Precaution: Pay attention that the awl does not slip off as this could damage the surrounding soft tissues. Epoca Revision Set Surgical Technique DePuy Synthes 11

22 Implantation: Long or Extra-long Stem 1 Patient positioning and approach Patient positioning is generally beach chair. The approach is generally deltopectoral. 22 DePuy Synthes Epoca Revision Set Surgical Technique

23 2 Preparation of medullary canal Sets Reaming Instrument set for Humerus (reamer diameters mm) and/or SynReam Set (reamer diameters mm) Epoca Humerus: Stem instruments Instruments Reaming Rod B 2.5 mm, short, length 400 mm E5113-6L Trial Stems Epoca, long, sizes 6 14 E L or E5113-6XL Trial Stems Epoca, extra-long, sizes 6 14 E XL Introduce the 2.5 mm reaming rod, slide the reamer head and the reamer shaft over the reaming rod and gently ream until the desired diameter is reached. Consider that the humeral diaphysis might be relatively thin. Precaution: Do not penetrate the humeral cortex with either the reaming rod or the reamer. Note: Check the reaming rod for damages before using it. Otherwise the reamer heads and the reamer shaft cannot advance smoothly. Prepare the proximal part with standard rasps. Probe the correct implant size with the long stem trial implants. Continue with the implantation of a hemi- or total prosthesis as described in the Epoca Surgical Technique Epoca Revision Set Surgical Technique DePuy Synthes 22

24 Implantation: Head without Stem Change 1 Extract head Extract the head as described in chapter one, Removal / Extraction of Humeral Components. 2 Attach trial eccenter disc Sets Epoca Humerus: Stem instruments Epoca Humerus: Press instruments Use a surgical marker pen to extend the midline marking on the stem onto the adjacent soft tissues (supraspinatus and calcar). 22 DePuy Synthes Epoca Revision Set Surgical Technique

25 Insert the trial eccenter into the trial head in position A. Mount the construct onto the stem and check for optimal offset. Should the offset be inadequate, extract the construct, adjust the offset (e.g. to position B) and recheck the position. After determination of the required offset, record the combination. Mount the revision eccenter on the head in the correct position. Place the eccenter/head construction onto the eccenter/impactor Epoca. Place the eccenter/impactor Epoca upside down into the press. Using the torque wrench, turn the handle of the press clockwise until a click is heard, signifying the positive engagement of the eccenter and the head. Introduce the assembly onto the prosthetic shaft. Rotate it to the correct position in respect to the soft-tissue marking. Use the head impactor and apply gentle blows with a hammer. Note: Be sure that the basis of the head sits flush onto the neck of the stem. Epoca Revision Set Surgical Technique DePuy Synthes 22

26 Implants All implants are sterile packed. Humeral Stem, long, cemented Stainless Steel Art. No. Size (mm) Length (mm) /15L /16L /16L /17L /17L Humeral Stem, extra-long, cemented Stainless Steel Art. No. Size (mm) Length (mm) /19XL /20XL /20XL /21XL /21XL DePuy Synthes Epoca Revision Set Surgical Technique

27 Revision eccenter Titanium alloy (TAV) Art. No /6REV Usage Revision The revision eccenter is slightly thicker in diameter than the standard eccenter. The increased thickness allows for a pressfit connection between the original stem and the head implant. For standard Epoca implants, please refer to the following Surgical Techniques: Epoca Shoulder Arthroplasty System Stem and Glenoid. Components for degenerative and posttraumatic conditions Epoca Shoulder Arthroplasty System Fracture. Hemi and total joint replacement for fractures Epoca Shoulder Arthroplasty System. Reconstruction glenoid for rotator cuff deficiencies Epoca Shoulder Arthroplasty System Resurfacing Head RH. Resurfacing head for degenerative conditions. Epoca Revision Set Surgical Technique DePuy Synthes 22

28 Instruments Handle, long, with Quick Coupling Chisel, for Foot, straight, wide, width 15 mm, length 124 mm Guide Bar for Removal of Implants Used with Articulated Head Extractor, for Guide Bar No Used with Stem Extractor, for Guide Bar No Used with DePuy Synthes Epoca Revision Set Surgical Technique

29 Articulated Eccenter Extractor, for Guide Bar No Used with Reaming Rod B 2.5 mm, short, length 400 mm S Carbide Drill Bit B 9.5 mm, for Instrument Steel and Titanium, sterile. Used with Note: The carbide drill bit may not be reprocessed or resterilized. Since it is used to drill metal which may cause damage during use, the drill bit is designed for single use only Extraction Screw, conical, for inner diameter 7.0 mm Drill Sleeve 9.5, clip-on, for No Epoca Revision Set Surgical Technique DePuy Synthes 27

30 Instruments Extension for Carbide Drill Bit B 6.0 mm Drill Suction Device Ram. Used with Guide Bar No E5113-6L Trial Stems Epoca, long, sizes 6 14 E L E5113-6XL Trial Stems Epoca, extra-long, E XL sizes DePuy Synthes Epoca Revision Set Surgical Technique

31 Optional Instruments Drill Bit B 6.0 mm, length 195/170 mm, 2-flute, for Quick Coupling Awl for TEN Vice Grip, length 180 mm Spare Parts Screw M6 x 18 for No Nut M8 for Nos and Epoca Revision Set Surgical Technique DePuy Synthes 29

32 Sets Epoca Revision Instruments Naming clip for Epoca Revision Instruments Vario Case, Framing, size 1/1, height 126 mm Lid (Stainless Steel), size 1/1, for Vario Case Instruments Modular tray 1 Qty Modular tray for removal 1 instruments, Epoca Revision, size 1/1, without content Guide Bar for Removal of Implants Articulated Head Extractor, 1 for Guide Bar No Stem Extractor, for Guide Bar 1 No Articulated Eccenter Extractor, 1 for Guide Bar No Wrench, hexagonal B 5.0 mm, 1 long, angled Osteotome, width 10 mm, 2 optional length 150 mm Vice Grip, length 180 mm 1 optional Drill Bit B 6.0 mm, 1 optional length 195/170 mm, 2-flute, for Quick Coupling Awl for TEN 1 optional S Carbide Drill Bit B 9.5 mm, 1 for instrument Steel and Titanium Extraction Screw, conical, 1 for inner diameter 7.0 mm Ram Extension for Carbide Drill Bit B 6.0 mm Handle, long, with Quick Coupling Chisel, for Foot, straight, wide, 1 width 15 mm, length 124 mm Drill Suction Device Drill Sleeve 9.5, clip-on, 1 for No Please note that the carbide drill bit is only available sterile packed. 33 DePuy Synthes Epoca Revision Set Surgical Technique

33 Instruments Modular tray 2 Qty Modular tray for trial stems, 1 Epoca Revision, size 1/1, without content E5113-6L Trial Stem Epoca, long, size 6 1 E5113-8L Trial Stem Epoca, long, size 8 1 E L Trial Stem Epoca, long, size 10 1 E L Trial Stem Epoca, long, size 12 1 E L Trial Stem Epoca, long, size 14 1 E5113-6XL Trial Stem Epoca, extra-long, size 6 1 E5113-8XL Trial Stem Epoca, extra-long, size 8 1 E XL Trial Stem Epoca, extra-long, size 10 1 E XL Trial Stem Epoca, extra-long, size 12 1 E XL Trial Stem Epoca, extra-long, size Reaming Rod B 2.5 mm, short, 2 length 400 mm Epoca Revision Set Surgical Technique DePuy Synthes 33

34 MRI Information Torque, Displacement and Image Artifacts according to ASTM F , ASTM F e1 and ASTM F Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system. Radio-Frequency-(RF-)induced heating according to ASTM F a Non-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 C with an average temperature rise of 6.6 C (1.5 T) and a peak temperature rise of 5.9 C (3 T) under MRI Conditions using RF Coils [whole body averaged specific absorption rate (SAR) of 2 W/kg for 6 minutes (1.5 T) and for 15 minutes (3 T)]. Precautions: The above mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: It is recommended to thoroughly monitor patients undergoing MR scanning for perceived temperature and/or pain sensations. Patients with impaired thermo regulation or temperature sensation should be excluded from MR scanning procedures. Generally it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible. Using the ventilation system may further contribute to reduce temperature increase in the body. 33 DePuy Synthes Epoca Revision Set Surgical Technique

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36 DSEM/TRM/0714/0131(1) 10/15 Synthes GmbH Eimattstrasse Oberdorf Switzerland Tel: Fax: This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at DePuy Synthes Trauma, a division of Synthes GmbH All rights reserved