RADIAL HEAD PROSTHESIS SYSTEM - …synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · Radial Head Prosthesis Surgical Technique DePuy Synthes 1 INTRODUCTION Radial

SURGICAL TECHNIQUE

For primary and revision joint replacement of the radial head

RADIAL HEAD PROSTHESIS SYSTEM

This publication is not intended for distribution in the USA.

WarningThis 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 MaintenanceFor 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-maintenanceFor 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

Radial Head Prosthesis Surgical Technique DePuy Synthes 1

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

TABLE OF CONTENTS

1 DePuy Synthes Radial Head Prosthesis Surgical Technique

RADIAL HEAD PROSTHESIS SYSTEMFor primary and revision joint replacement of the radial head

The DePuy Synthes Radial Head Prosthesis System is intended to restore joint func-tion.

System features• Modular: – Two-piece construct can accommo-

date a variety of patient anatomies• Side-loading head facilitates in-situ

insertion and assembly• Implant components are locked to-

gether by taper locking and a connec-tion 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

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

Taper locking mechanism secures head to stem

1 mm


* Data on fi le at Synthes.

Radial stems• Available in straight or curved option• Fluted design for rotational stability• Straight stem has beveled tip to facili-

tate insertion into the medullary cavity• Curved stem is designed to accommo-

date the biceps tuberosity to facilitate stem insertion

• Thin collar aids in adjusting height and guiding the head onto the stem

Uniform press fitThe stems are designed to be unce-mented and press-fi t into the radial canal.

The surface of the stems are roughened using a chemical etching process. The roughened surface helps promote bony ongrowth*. Chemical etching is a con-trolled manufacturing process, translating into a uniform 0.25 mm press-fi t.

Straight radial stem

Curved radial stem


SYSTEM COMPONENTS

24 Head Sizes (6 Diameters × 4 Heights)

Head Diameter: Extension: → Standard +2 mm +4 mm +6 mm

↓

18 mm

20 mm

22 mm

24 mm

26 mm

28 mm

Diameters: → 6 mm 7 mm 8 mm 9 mm 10 mm

Short,Straight

Long,Curved

10 Stem Sizes


INDICATIONS

The DePuy Synthes Radial Head Prosthesis System is indi-cated for primary replacement of the radial head after:1. Degenerative or posttraumatic disabilities presenting

pain, crepitation, and decreased motion at the radio-humeral 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 head3. Symptomatic sequelae after radial head resection

Revision following failed radial head arthroplasty.


PREOPERATIVE PLANNING

Position patient

Position the patient supine on the table. Prepare the ex-tremity 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.

1Approach

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 inci-sion in front of the anterior margin of the anco-neus 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.

SURGICAL TECHNIQUE


2Resect radial head

If the radial head is fractured and is not repairable, re-move the fragments to ensure no bone is left in the joint. Using a microsagittal saw, resect any remaining ra-dial 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 con-struct 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 2

Figure 1

Head height: 11.5 mm

18 mm diameter head,Standard height Collar thickness:

1.0 mm

Totalheight: 12.5 mm

Figure 3


3Determine radial head diameter and height

Instrument

03.402.701 Sizing Dish for Diameter 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 as-sembled to recreate the native radial head. If the re-sected head is between sizes, select the smaller diame-ter. Make note of the diameter determined for use in later steps.

Notes:• Compare the resected head with a trial head to as-

sess the head height.• When selecting a trial head size, take into account

that the collar on the stem adds 1 mm in height.

Surgical Technique

1 mm


4Open 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 proxi-mal 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 longitu-dinal axis of the radial neck.

Note: Avoid excessive planing as this may increase the height of the implant head required.


Surgical Technique

5Broach 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

1

2


It is important to identify the proper axial orientation. The forearm should be in midrotation with the radial tu-berosity directed medially. This position is favorable for broaching and implantation as the curved broaches/im-plant stems will point laterally, away from the radial tu-berosity. 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 ra-dial 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.

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.


6Insert 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 Stem diameter

White 6 mm

Purple 7 mm

Green 8 mm

Yellow 9 mm

Blue 10 mm

Surgical Technique


Secure the trial stem to the stem inserter/extractor by turning the knob and threading the stem onto the in-strument. 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 in-situ head assembly.

Notes:• The size of the trial stem is the same as the corres-

ponding 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.


Surgical Technique

7Attach 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


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 aqua-

colored 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 screw-driver 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.


8Trial 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 capitel-lum is normal with forearm rotation.

The head should articulate up to the most proximal mar-gin 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 ulno-humeral joint space relative to the lateral ulno-humeral joint space. Overstuffing may have a detri-mental effect on motion.

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.


Surgical Technique

9Insert implant stem

Instruments



Optional Instrument


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.


10Assemble 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 assemblyAssemble the implant head to the implant stem by hand.

Assembly using reduction forcepsWith 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 in-terfere with assembly.

Using the 1.2 Nm torque limiter with the T15 Stardrive screwdriver shaft, guide the implant head onto the im-plant stem by threading the captivated screw into the recess of the implant stem, engaging the taper connec-tion. Maintain constant compression of the head to the stem during assembly.


Surgical Technique

Tighten the screw until an audible click of the screw-driver handle indicates the implant head is secure and locked onto the implant stem.


Optional insertion technique

Instruments




03.402.744 Impactor, convex, for Radial Head Prosthesis


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.


REVISION / IMPLANT REMOVAL

1Remove implant head

Instruments



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.


2Remove implant stem

Instruments

03.010.059 Hammer Guide for Combined Hammer 400 g



Optional Instrument


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.


IMPLANTS

Radial Stems, straight, Titanium Alloy (TAN), sterile Diameter Length (mm) (mm)

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

Radial Stems, curved, Titanium Alloy (TAN), sterile Diameter Length (mm) (mm)

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

Length

1 mm collar

1 mm collar

Diameter

Diameter


Radial Heads, Standard height, CoCr, sterile Diameter Height (mm) (mm)

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

Radial Heads, with Extension 4.0 mm, CoCr, sterile Diameter Height (mm) (mm)

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


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


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

Diameter

Height

Diameter

Diameter

Height

Height

Diameter


INSTRUMENTS



398.410 Reduction Forceps, with Points, wide, ratchet lock, length 132 mm

Trial Radial Stems, straight Diameter Length (mm) (mm)

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

Trial Radial Stems, curved Diameter Length (mm) (mm)

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

Length

Diameter

Diameter


Trial Radial Heads, Standard height Diameter Height (mm) (mm)

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

Trial Radial Heads, with Extension 4.0 mm Diameter Height (mm) (mm)

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


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


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

Diameter

Height

Diameter

Height

Diameter

Height

Diameter


Instruments


03.010.059 Hammer Guide for Combined Hammer 400 g



03.402.701 Sizing Dish for Diameter of Radial Head Implant

03.402.710 Awl for Opening of Intramedullary Canal for Radial Head Prosthesis



03.402.711 Planer for Radial Head Prosthesis

Broach for Radial Head Prosthesis, straight

03.402.716 6 mm white03.402.717 7 mm purple 03.402.718 8 mm green 03.402.719 9 mm yellow03.402.720 10 mm blue

Broach for Radial Head Prosthesis, curved

03.402.721 6 mm white03.402.722 7 mm purple03.402.723 8 mm green03.402.724 9 mm yellow03.402.725 10 mm blue

03.402.744 Impactor, convex, for Radial Head Prosthesis


Broach for Radial Head Prosthesis, curved, with Offset Handle


Broach for Radial Head Prosthesis, straight, with Offset Handle


03.402.712 Planer for Radial Head Prosthesis, with Offset Handle


OPTIONAL INSTRUMENTS


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


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.

Sets


MRI INFORMATION

Torque, Displacement and Image Artifacts according to ASTM F2213-06, ASTM F2052-06e1 and ASTM F2119-07Non-clinical testing of a worst case scenario in a 3 T MRI system did not reveal any relevant torque or displace-ment 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 F2182-11aNon-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 tempera-ture and/or pain sensations.

• Patients with impaired thermo regulation or tem-perature 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 conduc-tive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

• Using the ventilation system may further contrib-ute to reduce temperature increase in the body.

0123

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.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 ©

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Documents

RADIAL HEAD PROSTHESIS SYSTEM - …synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · Radial Head Prosthesis Surgical Technique DePuy Synthes 1 INTRODUCTION Radial