RADIAL HEAD PROSTHESIS SYSTEM For primary and revision joint replacement of the radial head This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE
Warning This description alone does not provide sufficient background for direct use of the instrument set. Instruction by a surgeon experienced in handling these instruments 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: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance 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: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
TABLE OF CONTENTS INTRODUCTION Radial Head Prosthesis System 2 System Components 4 Indications 5 SURGICAL TECHNIQUE Preoperative Planning 6 Surgical Technique 6 Revision / Implant Removal 22 PRODUCT INFORMATION Implants 24 Instruments 26 Optional Instruments 30 Sets 31 MRI INFORMATION 33 Radial Head Prosthesis Surgical Technique DePuy Synthes 1
RADIAL HEAD PROSTHESIS SYSTEM For primary and revision joint replacement of the radial head The DePuy Synthes Radial Head Prosthesis System is intended to restore joint function. System features Modular: Two-piece construct can accommodate a variety of patient anatomies Side-loading head facilitates in-situ insertion and assembly Implant components are locked together by taper locking and a connection screw Radial head Round and symmetrical, allowing for adaptability and ease of sizing and implantation Slight trapezoidal shape features a smooth head-neck transition in order to accommodate the annular ligament Facilitates in-situ placement through side loading application and intuitive instrumentation Integrated connection screw: Aids in the construct assembly Engages the taper locking connection Indicates when the head is positively locked to the stem Taper locking mechanism secures head to stem Integrated connection screw captivated in head Articulating Dish Dish depth grows 0.1 mm with head diameter from 1.9 mm 2.4 mm Centered in implant head 1 DePuy Synthes Radial Head Prosthesis Surgical Technique
Radial stems Available in straight or curved option Fluted design for rotational stability Straight stem has beveled tip to facilitate insertion into the medullary cavity Curved stem is designed to accommodate the biceps tuberosity to facilitate stem insertion Thin collar aids in adjusting height and guiding the head onto the stem Uniform press fit The stems are designed to be uncemented and press-fit into the radial canal. Straight radial stem The surface of the stems are roughened using a chemical etching process. The roughened surface helps promote bony ongrowth*. Chemical etching is a controlled manufacturing process, translating into a uniform 0.25 mm press-fit. Curved radial stem 1 mm * Data on file at Synthes. Radial Head Prosthesis Surgical Technique DePuy Synthes 1
SYSTEM COMPONENTS 24 Head Sizes (6 s 4 Heights) Head : Extension: Standard +2 mm +4 mm +6 mm 18 mm 20 mm 22 mm 24 mm 26 mm 28 mm 10 Stem Sizes s: 6 mm 7 mm 8 mm 9 mm 10 mm Short, Straight Long, Curved 1 DePuy Synthes Radial Head Prosthesis Surgical Technique
INDICATIONS The DePuy Synthes Radial Head Prosthesis System is indicated for primary replacement of the radial head after: 1. Degenerative or posttraumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: a) Joint destruction and/or subluxation visible on x-ray b) Resistance to conservative treatment 2. Fracture of the radial head 3. Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty. Radial Head Prosthesis Surgical Technique DePuy Synthes 5
PREOPERATIVE PLANNING Position patient Position the patient supine on the table. Prepare the extremity from the axilla to the hand. This allows rotation of the forearm and flexion and extension of the elbow during the operative replacement of the radial head. SURGICAL TECHNIQUE 1 Approach A lateral approach is most commonly used. Precautions: Take care to avoid the deep branch of the radial nerve, which runs anterior to the capsule and the radial head. To minimize the risk of operative disruption of the lateral collateral ligament, keep the capsular incision in front of the anterior margin of the anconeus muscle and parallel to the fascial limit of the extensor carpi ulnaris. Open the annular ligament, laterally or slightly anteriorly to allow full inspection of the damaged radial head. In selected cases, an osteotomy of the lateral epicondyle will allow an extensile approach. 6 DePuy Synthes Radial Head Prosthesis Surgical Technique
2 Resect radial head If the radial head is fractured and is not repairable, remove the fragments to ensure no bone is left in the joint. Using a microsagittal saw, resect any remaining radial head at the level of the radial neck, perpendicular to the axis of the neck (Figures 1 and 2). In order to determine the cut level, the shortest construct to consider yields a total height of 12.5 mm. The tallest possible construct is 21.0 mm. Be careful to avoid excessive neck resection. Notes: The collar on the stem adds 1.0 mm of height to the selected head. Head heights are shown on pages 25 and 27. The shortest construct is obtained with the 18 mm diameter head, Standard height (Figure 3). Figure 1 Figure 2 18 mm diameter head, Standard height Head height: 11.5 mm Collar thickness: 1.0 mm Total height: 12.5 mm Figure 3 Radial Head Prosthesis Surgical Technique DePuy Synthes 1
Surgical Technique 3 Determine radial head diameter and height Instrument 03.402.701 Sizing Dish for of Radial Head Implant Determine the head diameter by placing the resected head into the circular cutouts in the sizing dish. When there are multiple articular fragments, these can be assembled to recreate the native radial head. If the resected head is between sizes, select the smaller diameter. Make note of the diameter determined for use in later steps. 1 mm Notes: Compare the resected head with a trial head to assess the head height. When selecting a trial head size, take into account that the collar on the stem adds 1 mm in height. 1 DePuy Synthes Radial Head Prosthesis Surgical Technique
4 Open radial canal Instrument 03.402.710 Awl for Opening of Intramedullary Canal for Radial Head Prosthesis If the elbow is unstable, varus stress and rotation of the forearm into supination allows improved access to the medullary canal. Retraction and elevation of the proximal radial shaft/neck can allow medullary access. Use the awl to initially enter the canal. Optional technique: Planing Instrument 03.402.711 Planer for Radial Head Prosthesis Optional Instrument 03.402.712 Planer for Radial Head Prosthesis, with Offset Handle By gently rotating the planer, create a smooth contact surface on the radial neck, perpendicular to the longitudinal axis of the radial neck. Note: Avoid excessive planing as this may increase the height of the implant head required. Radial Head Prosthesis Surgical Technique DePuy Synthes 9
Surgical Technique 5 Broach radial canal Instruments 03.402.716 Broach for Radial Head Prosthesis, 03.402.720 straight, size 6 10 mm 03.402.721 Broach for Radial Head Prosthesis, 03.402.725 curved, size 6 10 mm 359.221 Combined Hammer for TEN Optional Instruments 03.402.726 Broach for Radial Head Prosthesis, 03.402.730 straight, size 6 10 mm, with Offset Handle 03.402.731 Broach for Radial Head Prosthesis, 03.402.735 curved, size 6 10 mm, with Offset Handle 11 DePuy Synthes Radial Head Prosthesis Surgical Technique
It is important to identify the proper axial orientation. The forearm should be in midrotation with the radial tuberosity directed medially. This position is favorable for broaching and implantation as the curved broaches/implant stems will point laterally, away from the radial tuberosity. Starting with the smallest broach, prepare the canal for the stem. Use sequentially larger broaches until a tight fit is achieved. Precaution: Continuing to increase broach size after a tight fit is achieved, or using excessive force while broaching the canal, may produce a longitudinal radial neck fracture. Utilize special care during this step. Note that the implant stems are slightly larger than the broaches to ensure an adequate press fit. 1 Notes: Straight broaching: When broaching with a straight broach, use an in-line (on-axis) forward and backward technique with a twist motion (1 and 2). Curved broaching: When broaching with a curved broach, use only an in-line (on-axis) forward and backward technique (2). If necessary, gently hammer to fully seat the straight or curved broach. 2 Radial Head Prosthesis Surgical Technique DePuy Synthes 11
Surgical Technique 6 Insert trial stem Instruments 03.402.006 Trial Radial Stems, straight, 03.402.010 size 6 10 mm, length 24 32 mm 03.402.106 Trial Radial Stems, curved, 03.402.110 size 6 10 mm, length 40 48 mm 03.402.740 Stem Inserter/Extractor for Radial Head Prosthesis Optional Instrument 03.402.741 Stem Inserter/Extractor for Radial Head Prosthesis, with Offset Handle Choose the trial stem that corresponds to the last broach size used. Broaches and trial stems are color coded to facilitate the selection process. Color White Purple Green Yellow Blue Stem diameter 6 mm 7 mm 8 mm 9 mm 10 mm 11 DePuy Synthes Radial Head Prosthesis Surgical Technique
Secure the trial stem to the stem inserter/extractor by turning the knob and threading the stem onto the instrument. Introduce the trial stem into the canal, making sure it is fully seated. The knob of the stem inserter/ extractor should face lateral and opposite the radial tuberosity. This will orient the trial stem properly for insitu head assembly. Notes: The size of the trial stem is the same as the corresponding broach. Trial stems are smooth to facilitate insertion. Trial stems are slightly smaller than the implant stems. Trial stems will not have a press fit. Radial Head Prosthesis Surgical Technique DePuy Synthes 11
Surgical Technique 7 Attach trial head Instruments Trial Radial Heads 03.402.018 B 18 28 mm, 03.402.028 Standard height 11.5 14 mm 03.402.218 B 18 28 mm, height 13.5 16 mm, 03.402.228 with Extension 2.0 mm 03.402.418 B 18 28 mm, height 15.5 18 mm, 03.402.428 with Extension 4.0 mm 03.402.618 B 18 28 mm, height 17.5 20 mm, 03.402.628 with Extension 6.0 mm 398.410 Reduction Forceps, with Points, wide, ratchet lock, length 132 mm 03.113.019 Screwdriver Shaft 3.5 Stardrive, T15, long, self-holding, for AO/ASIF Quick Coupling 311.430 Handle with Quick Coupling, length 110 mm Implant Trial 11 DePuy Synthes Radial Head Prosthesis Surgical Technique
Trial heads can be attached to the trial or definitive stem for determination of the implant height. Select a trial head that appears to correctly fill the gap. Guide the trial head onto the trial stem by hand or using the reduction forceps. Check the head height, positioning the implant flush with the upper edge of the sigmoid notch. Continue using different trial heads until satisfied with the height. Notes: Trial heads have a matte finish and an aquacolored connecting screw. Implant heads have a shiny finish and a gray connecting screw. When using the reduction forceps to hold the trial head, invert the reduction forceps (jaws pointed upward) and insert tips of the forceps into the two adjacent holes. Firmly squeeze the forceps to secure the trial head. Secure the trial head to the stem using the screwdriver and handle with quick coupling. Precautions: Do not overtighten the screw on the trial head. Do not use the torque limiting attachment to tighten the screw on the trial head. Radial Head Prosthesis Surgical Technique DePuy Synthes 11
Surgical Technique 8 Trial reduction Secure the trial head to the stem using the screwdriver and handle with quick coupling. Manipulate the elbow through a full range of elbow flexion-extension and forearm pronation-supination positions. The head should articulate with the capitellum and the sigmoid notch smoothly through a full arc of motion. Some translation of the trial head relative to the capitellum is normal with forearm rotation. The head should articulate up to the most proximal margin of the proximal radioulnar joint. Taking an image intensification view may be helpful to visualize the ulnohumeral joint. Precaution: Avoid unnecessary exposure to image intensification. Confirm that the medial and lateral joints are close to symmetric and not overstuffed. Warning: A prosthesis that is too large will result in varus alignment with opening of the medial ulnohumeral joint space relative to the lateral ulnohumeral joint space. Overstuffing may have a detrimental effect on motion. 11 DePuy Synthes Radial Head Prosthesis Surgical Technique
Continue to place different trial heads until satisfied with the size and motion. Loosen the screw on the trial head using the screwdriver shaft and handle with quick coupling to remove the trial head. Use the inserter/extractor to remove the trial stem. Note: Do not use the torque limiting attachment to remove the trial head. Precaution: Once desired size is determined, remove the trial head and the trial stem. Radial Head Prosthesis Surgical Technique DePuy Synthes 11
Surgical Technique 9 Insert implant stem Instruments 03.402.740 Stem Inserter/Extractor for Radial Head Prosthesis 359.221 Combined Hammer for TEN Optional Instrument 03.402.741 Stem Inserter/Extractor for Radial Head Prosthesis, with Offset Handle Choose the implant stem for insertion that corresponds to the last broach size used. Secure the implant stem to the stem inserter/extractor by turning the knob and threading the stem onto the instrument. Using the stem inserter/extractor, place the stem into the canal, making sure it is fully seated. The knob of the stem inserter/ extractor should face lateral and opposite the radial tuberosity during insertion, which will orient the implant stem properly for in-situ head assembly. The stem inserter/extractor can also be used as an impactor. Gently hammer to fully seat the stem. 11 DePuy Synthes Radial Head Prosthesis Surgical Technique
10 Assemble implant head Instruments 03.110.002 Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling 03.110.005 Handle for Torque Limiters 0.4/0.8/1.2 Nm 03.113.019 Screwdriver Shaft 3.5 Stardrive, T15, long, self-holding, for AO/ASIF Quick Coupling Choose the implant head that corresponds to the appropriate trial head found during trial reduction. Assemble the implant head to the implant stem by hand or using the reduction forceps. Manual assembly Assemble the implant head to the implant stem by hand. Assembly using reduction forceps With the implant head inverted, tighten the jaws around the neck portion of the head. Precaution: When applying the reduction forceps to the implant head, make certain the jaws do not interfere with assembly. Using the 1.2 Nm torque limiter with the T15 Stardrive screwdriver shaft, guide the implant head onto the implant stem by threading the captivated screw into the recess of the implant stem, engaging the taper connection. Maintain constant compression of the head to the stem during assembly. Radial Head Prosthesis Surgical Technique DePuy Synthes 11
Surgical Technique Tighten the screw until an audible click of the screwdriver handle indicates the implant head is secure and locked onto the implant stem. 22 DePuy Synthes Radial Head Prosthesis Surgical Technique
Optional insertion technique Instruments 03.110.002 Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling 03.110.005 Handle for Torque Limiters 0.4/0.8/1.2 Nm 03.113.019 Screwdriver Shaft 3.5 Stardrive, T15, long, self-holding, for AO/ASIF Quick Coupling 03.402.744 Impactor, convex, for Radial Head Prosthesis 359.221 Combined Hammer for TEN Assemble the head to the stem on the table. Guide the implant head onto the implant stem. Thread the integrated connecting screw into the recess of the implant stem using the 1.2 Nm torque limiter and the T15 screwdriver shaft. Tighten the screw on the head with the torque limiter until an audible click is heard, which indicates the head is secured to the stem. Insert the assembled implant using the convex impactor and the combined hammer. Gently hammer to fully seat the stem. Radial Head Prosthesis Surgical Technique DePuy Synthes 22
REVISION / IMPLANT REMOVAL 1 Remove implant head Instruments 03.113.019 Screwdriver Shaft 3.5 Stardrive, T15, long, self-holding, for AO/ASIF Quick Coupling 311.430 Handle with Quick Coupling, length 110 mm Using the handle with quick coupling and the T15 Stardrive screwdriver shaft, begin backing the head off the stem by applying torque in a counterclockwise direction. Once the screw in the head is disengaged from the stem, remove the head. Precautions: Do not reuse implant heads. Do not use torque limiting attachment to remove the implant head. 22 DePuy Synthes Radial Head Prosthesis Surgical Technique
2 Remove implant stem Instruments 03.010.059 Hammer Guide for Combined Hammer 400 g 03.402.740 Stem Inserter/Extractor for Radial Head Prosthesis 359.221 Combined Hammer for TEN Optional Instrument 03.402.741 Stem Inserter/Extractor for Radial Head Prosthesis, with Offset Handle Thread the hammer guide into the top of the stem inserter/extractor. Attach the stem inserter/extractor to the implant stem, as described in Step 9. The tuning fork section of the hammer slides onto the hammer guide. Extract the implant stem by applying gentle taps away from the proximal radius. Precaution: Do not reuse implant stems. Radial Head Prosthesis Surgical Technique DePuy Synthes 22
IMPLANTS Radial Stems, straight, Titanium Alloy (TAN), sterile Length 04.402.006S 6 24 04.402.007S 7 26 04.402.008S 8 28 04.402.009S 9 30 04.402.010S 10 32 Length 1 mm collar Radial Stems, curved, Titanium Alloy (TAN), sterile Length 04.402.026S 6 40 04.402.027S 7 42 04.402.028S 8 44 04.402.029S 9 46 04.402.030S 10 48 Length 1 mm collar 11 DePuy Synthes Radial Head Prosthesis Surgical Technique
Radial Heads, Standard height, CoCr, sterile Height 09.402.018S 18 11.5 09.402.020S 20 12.0 09.402.022S 22 12.5 09.402.024S 24 13.0 09.402.026S 26 13.5 09.402.028S 28 14.0 Height Radial Heads, with Extension 2.0 mm, CoCr, sterile Height 09.402.218S 18 13.5 09.402.220S 20 14.0 09.402.222S 22 14.5 09.402.224S 24 15.0 09.402.226S 26 15.5 09.402.228S 28 16.0 Height Radial Heads, with Extension 4.0 mm, CoCr, sterile Height 09.402.418S 18 15.5 09.402.420S 20 16.0 09.402.422S 22 16.5 09.402.424S 24 17.0 09.402.426S 26 17.5 09.402.428S 28 18.0 Height Radial Heads, with Extension 6.0 mm, CoCr, sterile Height 09.402.618S 18 17.5 09.402.620S 20 18.0 09.402.622S 22 18.5 09.402.624S 24 19.0 09.402.626S 26 19.5 09.402.628S 28 20.0 Height Radial Head Prosthesis Surgical Technique DePuy Synthes 15
INSTRUMENTS 311.430 Handle with Quick Coupling, length 110 mm 359.221 Combined Hammer for TEN 398.410 Reduction Forceps, with Points, wide, ratchet lock, length 132 mm Trial Radial Stems, straight Length 03.402.006 6 24 03.402.007 7 26 03.402.008 8 28 03.402.009 9 30 03.402.010 10 32 Length Trial Radial Stems, curved Length 03.402.106 6 40 03.402.107 7 42 03.402.108 8 44 03.402.109 9 46 03.402.110 10 48 Length 16 DePuy Synthes Radial Head Prosthesis Surgical Technique
Trial Radial Heads, Standard height Height 03.402.018 18 11.5 03.402.020 20 12.0 03.402.022 22 12.5 03.402.024 24 13.0 03.402.026 26 13.5 03.402.028 28 14.0 Height Trial Radial Heads, with Extension 2.0 mm Height 03.402.218 18 13.5 03.402.220 20 14.0 03.402.222 22 14.5 03.402.224 24 15.0 03.402.226 26 15.5 03.402.228 28 16.0 Height Trial Radial Heads, with Extension 4.0 mm Height 03.402.418 18 15.5 03.402.420 20 16.0 03.402.422 22 16.5 03.402.424 24 17.0 03.402.426 26 17.5 03.402.428 28 18.0 Height Trial Radial Heads, with Extension 6.0 mm Height 03.402.618 18 17.5 03.402.620 20 18.0 03.402.622 22 18.5 03.402.624 24 19.0 03.402.626 26 19.5 03.402.628 28 20.0 Height Radial Head Prosthesis Surgical Technique DePuy Synthes 11
Instruments 03.010.059 Hammer Guide for Combined Hammer 400 g 03.110.002 Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling 03.402.701 Sizing Dish for of Radial Head Implant 03.110.005 Handle for Torque Limiters 0.4/0.8/1.2 Nm 03.113.019 Screwdriver Shaft 3.5 Stardrive, T15, long, self-holding, for AO/ASIF Quick Coupling 03.402.710 Awl for Opening of Intramedullary Canal for Radial Head Prosthesis 11 DePuy Synthes Radial Head Prosthesis Surgical Technique
03.402.711 Planer for Radial Head Prosthesis Broach for Radial Head Prosthesis, straight 03.402.716 6 mm white 03.402.717 7 mm purple 03.402.718 8 mm green 03.402.719 9 mm yellow 03.402.720 10 mm blue Broach for Radial Head Prosthesis, curved 03.402.721 6 mm white 03.402.722 7 mm purple 03.402.723 8 mm green 03.402.724 9 mm yellow 03.402.725 10 mm blue 03.402.740 Stem Inserter/Extractor for Radial Head Prosthesis 03.402.744 Impactor, convex, for Radial Head Prosthesis Radial Head Prosthesis Surgical Technique DePuy Synthes 19
OPTIONAL INSTRUMENTS 03.402.712 Planer for Radial Head Prosthesis, with Offset Handle Broach for Radial Head Prosthesis, straight, with Offset Handle 03.402.726 6 mm white 03.402.727 7 mm purple 03.402.728 8 mm green 03.402.729 9 mm yellow 03.402.730 10 mm blue Broach for Radial Head Prosthesis, curved, with Offset Handle 03.402.731 6 mm white 03.402.732 7 mm purple 03.402.733 8 mm green 03.402.734 9 mm yellow 03.402.735 10 mm blue 03.402.741 Stem Inserter/Extractor for Radial Head Prosthesis, with Offset Handle 11 DePuy Synthes Radial Head Prosthesis Surgical Technique
SETS Implants 01.402.011 Basic Implants for Radial Head Prosthesis Instruments 01.402.010 Basic Instruments for Radial Head Prosthesis, in Modular Tray, Vario Case System 68.402.001 Modular Tray 1, for Instruments, for Radial Head Prosthesis, size 1/1, without Contents, Vario Case System 68.402.002 Modular Tray 2, for Instruments, for Radial Head Prosthesis, size 1/2, without Contents, Vario Case System Radial Head Prosthesis Surgical Technique DePuy Synthes 33
Sets 68.402.003 Modular Tray 3, for Broaches, for Radial Head Prosthesis, size 1/1, without Contents, Vario Case System 68.402.004 Modular Tray 4, for Trial Implants, for Radial Head Prosthesis, size 1/2, without Contents, Vario Case System Note: Delivered with lid. 33 DePuy Synthes Radial Head Prosthesis Surgical Technique
MRI INFORMATION Torque, Displacement and Image Artifacts according to ASTM F2213-06, ASTM F2052-06e1 and ASTM F2119-07 Non-clinical testing of a 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 91 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 F2182-11a Non-clinical electromagnetic and thermal simulations of a worst case scenario lead to temperature rises of 7.5 C (1.5 T) and 6.1 C (3 T) under MRI Conditions using RF Coils (whole body averaged specific absorption rate [SAR] of 2 W/kg for 15 minutes). 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 an MRI 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. Radial Head Prosthesis Surgical Technique DePuy Synthes 33
DSEM/TRM/1014/0210(2) 06/15 Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 Fax: +41 61 965 66 00 www.depuysynthes.com This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at www.depuysynthes.com/ifu 0123 DePuy Synthes Trauma, a division of Synthes GmbH. 2015. All rights reserved. 036.001.450