ExploR Radial Head Plating System - Zimmer Biomet...several plating options while the instrumentation for both procedures are included in a single set. Provisional Fracture Reduction

ExploR® Radial Head Plating System

Surgical Technique

Table of Contents

Indications and Contraindications ........................................................................... 2

Patient Positioning and Incision ............................................................................... 3 Patient Positioning Surgical Incision/Exposure

Fracture Evaluation ................................................................................................... 5 Fracture Assessment Provisional Fracture Reduction Plate Selection

Radial Head Fracture Fixation ................................................................................ 10 Plate Placement and Final Reduction Initial Screw Insertion Additional Screw Insertion Closure

Post Operative Protocol .......................................................................................... 13

Ordering Information ............................................................................................. 15

This material represents the surgical technique utilized by Hill Hastings, M.D.; Glenn Gaston, M.D.; and Donald Lee, M.D. Biomet does not practice medicine. The treating surgeon is responsible for determining the appropriate treatment, technique(s), and product(s) for each individual patient.

2 | ExploR Radial Head Plating System Surgical Technique

INDICATIONSThe ExploR Radial Head Plating System is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal radius.

CONTRAINDICATIONS1. Infection

2. Patient conditions including blood supply limitations, obesity, and insufficient quantity or quality of bone.

3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

4. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device.


Figure 1

Patient PositioningWith the patient in a supine position, flex the elbow, pronate the forearm and rest the arm across the chest ensuring the arm is mobile and unencumbered by the drapes. This will allow you to approach the lateral elbow with the shoulder internally rotated.

Place a pneumatic tourniquet far enough proximally along the arm to allow adequate exposure to the lateral elbow (Figure 1).


EDC

ECRB

ECRL

Figure 2 Figure 3

Surgical Incision/ExposureUtilizing the Kaplan interval (lateral approach) begin the incision 2 cm proximal to the lateral epicondyle, parallel to the humerus, and extend the incision distally along the axis of the proximal radius (Figure 2). The deep dissection is performed by splitting the extensor through the interval between the Extensor Carpi Radialis Brevis (ECRB)/Extensor Carpi Radialis Longus (ECRL) and the Extensor Digitorum Communis (EDC) (Figure 3). Elevate the ECRB off of the humerus anteriorly. Care should be taken to avoid violating the periosteum of the radial neck as spot welding or scar down may occur. The lateral collateral/extensor origin posterior to the midline is left intact to protect against posterolateral instability. This is important to restoring the patient’s function post-operatively.

Note: Occasionally, the lateral collateral ligament may already be torn as part of a terrible triad injury. If this is the case, repair the lateral collateral ligament before closure using one or more of the JuggerKnot® Short Rigid Soft Anchors.

Note: For a complex elbow fracture dislocation, the Kocher interval (posterolateral approach) may be used to increase exposure of the lateral column and to better protect the Posterior Interosseus Nerve (PIN). The interval is located between the anconeus and extensor carpi ulnaris.


Fracture AssessmentForearm pronation and supination will allow visualization and assessment of the radial fracture. Based on the type of radial head fracture, associated complex elbow or longitudinal forearm injuries, select the appropriate treatment option.

Note: For treatment of a variety of radial head fractures, the ExploR Radial Head System includes both a modular radial head replacement and several plating options while the instrumentation for both procedures are included in a single set.

Provisional Fracture ReductionInitial fracture reduction should begin independent of plate selection in order to best determine the type and size of plate needed for fracture repair. Circumferentially collect head fragments using the radial head reduction clamp and reduce the fracture provisionally using .045 mm k-wires (Figure 4). These k-wires should be passed through the fracture site to avoid potential interference with the plate and screws construct.

Figure 4


Plate SelectionSelect the appropriate plate type and curvature required for permanent fixation. The ExploR Radial Head Plating System offers a Rim and Neck plate featuring either a standard or small curvature (Figure 5). The ExploR Radial Head Plates are designed to fit within the safe zone of the proximal radius, which is the area of the radial head that does not articulate with the ulna during pronation (Figure 6) and supination (Figure 7).

Note: If the fracture is too complex to verify the safe zone, it may also be identified as the area between lines drawn proximally from the radial styloid and Lister’s tubercle.1

Figure 5 Figure 6 Figure 7

Pronation Supination


The proximal screw holes provide a screw trajectory into the radial head capturing lateral head fragments within the safe zone of the radial head. The central screw holes angle proximally allowing the screws to cross through the neck into the head of the radius. The distal screw holes provide a screw trajectory directly into the radial shaft for plate stability (Figure 8).

Note: The ExploR Radial Head plating system also offers a long rim plate for more complex radial head fractures.

Plate Selection (cont.)

The ExploR Rim Plate fits directly onto the rim portion of the radius (Figure 8) and is designed to be used in fractures where the annular ligament is torn as part of the initial elbow injury. The rim plate features proximal, central and distal screw holes.

Figure 8 Figure 9



The ExploR Neck Plate is designed to be positioned distal to the head on the shaft portion of the radius, in order to preserve the annular ligament and minimize the chance of scarring to the plate (Figure 10). The neck plate features proximal and distal screw holes. The proximal screws provide a trajectory directly into the radial head to capture medial radial head fragments. The distal screws provide a trajectory directly into the radial shaft for plate stability (Figure 11).

Note: The instrument tray offers a graphic display of the screw trajectories for each plate option.

Figure 10 Figure 11



Once provisional fixation has been performed and the appropriate neck or rim plate has been chosen, select the standard plate size and place it onto the radius to evaluate fit. The locking drill guide may be threaded into the plate and used as a handle during plate trialing. An ideal fit is achieved when the entire surface area of the plate fits against the bone. Visual confirmation of fit can be obtained by checking for gaps between the edge of the plate and bone or through the central portion of the plate. If an excessive gap is observed between the edge of the plate and bone, then the plate may be oversized (Figure 12). If the plate is undersized, there will be a gap observed through the central portion of the plate (Figure 13). Lastly, if the fit is observed to be too distal, select a plate that is one size smaller than the original plate size selected.

Note: If the head fracture is too complex to determine the necessary curvature in vivo, as an alternative choice, the plate curvature can be based upon the diameter of the radius. The standard plate has a curvature of 23 mm in diameter and the small plate a curvature of 21 mm in diameter.

Excessive Gap = Oversized Plate Central Gap = Undersized Plate

Figure 12 Figure 13


Plate Placement and Final Reduction Snap the positioning guide onto the selected plate and place it on the radius, ensuring that the plate is centered on the bone. When using a rim plate, verify that the proximal edge of the plate is parallel with the articulating surface. K-wires may be placed through the plate for additional fixation. Each plate allows for a combination of 3 or 4 k-wires placed through the plate and into the fractured segments (Figure 14). To prevent k-wires or screw trajectories from penetrating the articulating surface, ensure the top of the positioning guide sits flush against and positioned all the way to the edge of the radial head’s articulating surface. If k-wires are placed through the proximal k-wire holes for provisional fixation, they will pass through the bone more proximal than any screw trajectory. Therefore, no screw should pass further proximal than the most proximal k-wire, thus avoiding screw placement into the articulating surface (Figure 14b).

Ensure that the construct does not come in contact with the proximal ulna during pronation and supination. This will verify that the plate was accurately placed within the safe zone.

Tip: It may be difficult to determine the proximal to distal location of the plate if complete fracture reduction is not obtained. In this instance, use the positioning guide for plate placement assistance. In order to do so, align the top of the flanges of the guide with the edge of the articulating surface of the radial head.

The plate is now temporarily positioned and the fracture provisionally reduced. Initial screw insertion can begin.

Figure 14

Figure 14b


Screw Selection/Insertion Place the 1.5 mm end of the non-locking drill guide into the slotted hole located centrally on the plate. Using the 1.5 mm drill bit, drill through the guide perpendicular to the plate, and into the far cortex (Figure 15). Use the depth gauge to determine the length of the screw needed for the slotted hole (Figure 16). Select and loosely insert a 2.0 mm non-locking screw using the T6 hexalobular driver into the slotted hole.

Note: Take caution not to overtighten the 2.0 mm non-locking screw as minor proximal and distal adjustments may be needed to ensure proper plate placement.

Tip: It is important to confirm that the screw trajectory is perpendicular to the plate as you insert the screw to ensure that the central screws do not come in contact with the peripheral screws during insertion.

Once plate placement is confirmed, tighten the non-locking screw to compress the plate to the bone (Figure 17). It is critical that the non-locking screw is flush with the plate to ensure proper fixation. Verify screw depth under fluroscopy.

Figure 15

Figure 16

Figure 17


Peripheral Screw Selection/InsertionUtilizing the positioning guide, thread the locking drill guide into the desired hole on the plate (Figure 18). The positioning guide is designed for easier placement of the locking drill guides. Pass the calibrated drill through the drill guide and into the bone. Note the depth of the drill using the 10–30 mm depth markings on the drill guide (Figure 18 inset).

Verify drill trajectory and depth under fluoroscopy. Take special care to avoid the articulating surface of the radial head. If there is any k-wire or drill perforations into the articulating junction, loosen the non-locking screw, reposition the plate and re-tighten (Figure 19).

Tip: All locking screws come in 2 mm increments.

Select and tighten a 2.0 mm locking screw through the drill guide and into the plate using the T6 hexalobular hand driver (Figure 19). It is critical that the peripheral screws are flush with the plate to ensure proper fixation. Take special care to not over torque the screws as the T6 hexalobular drive may be easily deformed. Verify screw trajectory and fracture reduction under fluoroscopy.

Repeat these steps for the remaining peripheral screws, doing so using a method that allows for continued fracture reduction (Figure 20).

Once all screws have been inserted, check all flexion and extension as well as pronation and supination to ensure that the soft tissue is free from irritation. Remove the positioning guide and all k-wires used for provisional fixation.

Figure 18 Figure 20

Figure 19


ClosureRepair the ECRB/EDC interval which includes the annular ligament with figure 8 braided nylon sutures. Close wound (Figure 21).

Note: When the lateral collateral annular ligament has been torn from its humeral origin, repair it back with a #2 Maxbraid® suture through a bone anchor or through divergent bone tunnels that exit posteriorly. One limb of the suture should pass down the anconeal/ECU interval, then to the midline and back to the lateral epicondyle origin.

Figure 21

Post-Operative ProtocolSplint with forearm in supination or neutral position. After 7–10 days, evaluate incision and remove stitches. Begin early active range of motion as soon as possible. Consider a long arm thermoplast or hinged elbow brace for high energy injuries/instability.


Post-Operative Protocol (cont.)

Physical therapy may begin with pronation and supination exercises which are best done with the elbow in 90 degrees of flexion. When the ulnar collateral ligament is intact or stable, extension exercises are best done in pronation, avoiding supination, which protects the lateral collateral annular ligament repair. If posterolateral elbow instability is noted, the forearm is held in pronation. Patients with Essex-Loprestic injuries are held in full supination for 3–4 weeks. At 6 weeks, if a flexion contracture is present, consider static nighttime extension splinting.

At 3 months, progress with ROM and begin sport specific therapy.

At 6 months the patient may return to full activities.

It may take 6–12 months to regain ROM.

Note: Contractures are not uncommon at 10 degrees to 15 degrees of flexion.


Product Label Part Number Description Size

Not Pictured A IFI-491459 Drive Handle w/AO Connection Mini –

B IFI-491478 X-Lock Driver with AO Connection –

C 418070418071418072418073418074418075

Rasp 5 x 22 mm6 x 24 mm7 x 26 mm8 x 28 mm9 x 30 mm10 x 32 mm

D 408034 Radial Hook –

E 408030 Cutting Jig –

F 408033 Cutting Jig Pin –

593653 - ExploR Radial Head Replacement Tray

A

B

C

D

EF

G

H

I

J

K

L

M



G 418078 Offset Handle –

H 418092 Stem Inserter/Extractor –

I 418098 Provisional Locking Screws –

J 418082 Head Inserter/Extractor –

K 418022418023418024418025418026418031418032418033418034418035418041418042418043418044418045

Trial Head 10 x 20 mm12 x 20 mm14 x 20 mm16 x 20 mm18 x 20 mm10 x 22 mm12 x 22 mm14 x 22 mm16 x 22 mm18 x 22 mm10 x 24 mm12 x 24 mm14 x 24 mm16 x 24 mm18 x 24 mm

L 418060418061418062418063418064

Trial Stem 5 x 22 mm6 x 24 mm7 x 26 mm8 x 28 mm9 x 30 mm

M MQC Mini Quick Connect (used with T6 Hexalobular Driver w/MQC Connection found in other tray)

–



A IFI-491407 Sharp Hook 6”

B IFI-491422 Hohmann Retractor 20 mm

C IFI-491410IFI-491458

Drill-Calibrated w/AO Connection 1.5 x 85 mm2.0 x 85 mm

D IFI-491435 Double End Drill Guide 1.6/2.0 mm

E IFI-491412 Locking Drill Guide for 2.0 mm LockingScrew

1.5 mm

F 110018125 T6 Hexalobular Driver w/MQC Connection (Fits in MQC Driver found in other tray)

–

G IFI-491433 Depth Gauge 50 mm

H IFI-491414 K-Wire .045” x 4.72”

I IFI-491408 Radial Head Reduction Clamp 2.0/2.7 mm

593652 - ExploR Radial Head Plating Tray

AB

C

D

E

F

G

H

I

J

K

L

M

N

O


Product Part Number Description Size

593650 Instrument Case –

593650 - Instrument Case


J IFI-491438 Screw Forceps –

K IFI-491443 K-Wire Snippers –

L IFI-491430 Small Point Reduction Forceps –

M 14-400786 Jacobs to AO Adapter –

N IFI-491452IFI-491453IFI-491450IFI-491451

Custom PLT Position Rim Standard LeftSmall LeftStandard RightSmall Right

O IFI-491456IFI-481457IFI-491454IFI-491455

Custom PLT Position Neck Standard LeftSmall LeftStandard RightSmall Right


Product Part Number Description Size

IFE-111000IFE-121000IFE-211000IFE-221000

Radial Head Rim Plate Left SmallLeft StandardRight SmallRight Standard

IFE-113000IFE-123000IFE-213000IFE-223000

Radial Head Rim Plate Long Left SmallLeft StandardRight SmallRight Standard

IFE-112000IFE-122000IFE-212000IFE-222000

Radial Head Neck Plate Left SmallLeft StandardRight SmallRight Standard

IFS-203010IFS-203012IFS-203014IFS-203016IFS-203018IFS-203020IFS-203022IFS-203024IFS-203026IFS-203028IFS-203030

Non-Locking Screw 2.0 x 10 mm2.0 x 12 mm2.0 x 14 mm2.0 x 16 mm2.0 x 18 mm2.0 x 20 mm2.0 x 22 mm2.0 x 24 mm2.0 x 26 mm2.0 x 28 mm2.0 x 30 mm

IFS-204010IFS-204012IFS-204014IFS-204016IFS-204018IFS-204020IFS-204022IFS-204024IFS-204026IFS-204028IFS-204030

Locking Screw 2.0 x 10 mm2.0 x 12 mm2.0 x 14 mm2.0 x 16 mm2.0 x 18 mm2.0 x 20 mm2.0 x 22 mm2.0 x 24 mm2.0 x 26 mm2.0 x 28 mm2.0 x 30 mm

Implants and Accessories

Notes

References

1. Hotchkiss, R. et al. Radial head and neck fractures: Anatomic guidelines for proper placement of internal fixation. Journal of Shoulder and Elbow Surgery. 5(2): 113-6 1996.

All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet.

This material is intended for health care professionals. Distribution to any other recipient is prohibited. For indications, contraindications, warnings, precautions, potential adverse effects and patient counselling information, see the package insert or contact your local representative; visit www.zimmerbiomet.com for additional product information.

Zimmer Biomet does not practice medicine. This technique was developed in conjunction with health care professionals. This document is intended for surgeons and is not intended for laypersons. Animations and virtual reality are provided as a visual guide based on surgical techniques; a written copy of the surgical technique is available at www.zimmerbiomet.com or from your local representative. Each surgeon should exercise his or her own independent judgment in the diagnosis and treatment of an individual patient, and this information does not purport to replace the comprehensive training surgeons have received.

As with all surgical procedures, the technique used in each case will depend on the surgeon’s medical judgment as the best treatment for each patient. Results will vary based on health, weight, activity and other variables. Not all patients are candidates for this product and/or procedure. Caution: Federal (USA) law restricts this device to sale by or on the order of a surgeon. Rx only.

© 2019 Zimmer Biomet

0620.1-GLBL-en-REV0619

2797

CE mark on a surgical technique is not valid unless there is a CE mark on the product label.

Authorized RepresentativeBiomet UK Ltd.Waterton Industrial Estate Bridgend, South Wales, CF31 3XA, United Kingdom

Maxbraid Legal ManufacturerTeleflex Medical2917 Weck DriveResearch Triangle Park, North Carolina27709USA

ExploR Legal ManufacturerBiomet Orthopedics56 E. Bell Drive P.O. Box 587Warsaw, Indiana 46581-0587 USA

www.zimmerbiomet.com

Documents

ExploR Radial Head Plating System - Zimmer Biomet...several plating options while the instrumentation for both procedures are included in a single set. Provisional Fracture Reduction