SURGICAL TECHNIQUE GUIDE - freewheel

As described by:

Jorge L. Orbay, M.D.

Miami Hand Institute

Miami, Florida.

SURGICAL TECHNIQUE GUIDE

System Overview

The ALIGN™ Radial Head System is designed to restore the kinematics of the native radial head.

Through the use of a proprietary alignment instrumentation, the Head Alignment Tool is designed to position the prosthetic head perpendicular to the axis of forearm rotation.

When properly positioned, the revolutionary Radial Head locking mechanism allows you to securely affix the prosthetic head to the stem.

Optimized Titanium Alloy Stem Geometry • Long Stem designed for 3 point fixation

• Plasma coated to assist in biological fixation

• Distal flutes for rotational stability

Adjustable CoCr Head with Locking Screw• Versatility of a bipolar for optimal implant positioning

• Stability of a monoblock for solid fixation

• Self locking wedge ramp threads

DESIGN FEATURES

• Side Loading

• Hybrid Head Design

• Unique Alignment Instrumentation

The proximal and distal radioulnar joints are the two condyles of a single forearm joint that has one axis of rotation.

The axis of forearm rotation courses from the fovea of the ulna to the center of the radial head, which is oriented perpendicular to this axis.

The Head Alignment Tool defines the axis of forearm rotation to position the prosthetic radial head perpendicular to this axis. Italso provides the necessary counter-torque when tightening the Locking Screw.

This helps to restore the kinematics of the native radial head.

EXPOSURE

HEAD SIZING

1

2

Make an incision over the lateral aspect of the elbow; gain access to the radial head through your preferred muscle interval

Remove the radial head fragments; assemble and measure them using the Radial Head Sizing Tray

Note: If between radial head sizes, select the smaller.

FOREARM AXIS GUIDE

TRIAL HEAD SELECTION 3

4

Select the Trial Head that corresponds to the native head

Note: For elliptically shaped radial heads, select the trial head that matches the minimum diameter of the native head

Flex the wrist; then make a stab incision over the fovea of the ulna

Insert the Forearm Axis Guide through the stab incision until it seats flush onto the distal ulna

Drill a 1.5mm K-Wire into the fovea, in the direction of the radial head

Note: Fluoroscopic imaging should be used to verify proper K-Wire placement.

5

6

SECURING FOREARM AXIS JIG

ATTACH BONE FORCEPS

Bend the K-Wire where it exits the Forearm Axis Jig, which will secure it to the ulna

Note: Do not tighten the Forearm Axis Jig at this point to allow for adjustments

Secure the Bone Holding Forceps to the Rail, then clamp it just distal to the fracture line

7

8RESECTION

ADJUSTING GUIDE ASSEMBLY

Now tighten the knob on the Forearm Axis Jig to secure the assembly in place

Note: The Forearm Axis Guide assembly serves as a handle to control the radius during the radial neck resection.

Lift the radius with the Axis Guide assembly, then resect the radial neck fragment

Note: The minimum resection length is 16mm and the maximum resection length is 24mm

CAUTION: Protect the radial nerve when preparing the medullary canal.

9

10

CANAL PREPARATION

NECK PLANING

Broach the medullary canal starting with the smallest Rasp and progressing larger until cortical bone is encountered

Insert each of the Rasps up to the etched depth mark

Note: Make note of the final Rasp size used, then select the corresponding Planer and Trial Stem

Prepare the resected end of the radius using the Planer

11

12

TRIAL NECK SIZING

TRIAL STEM SELECTION

With the forearm pronated and elbow flexed, select the radial neck length using the Neck Sizing Gauges

Note: If between two lengths, always select the shortest sizing option.

Select the Trial Stem that corresponds to the final Rasp/Planer used and insert it into the prepared canal

13

14

TRIAL HEAD & NECK ASSEMBLY

TRIAL CONSTRUCT ASSEMBLY

Assemble the Trial Head and Neck by threading the two components together

Note: The Trial Neck corresponds to the Neck Sizing Gauge used

Thread the handle of the Neck Sizing Gauge into the Trial Head, then side load it onto the Trial Stem Note: The Trial Neck should snap into the Trial Stem when correctly assembled.

15

16

TRIAL VALIDATION

FLUOROSCOPIC CONFIRMATION

Reduce the joint and assess the sizing of the trial components. Manipulate the elbow through its full range of motion to ensure that the joint has not been over-stuffed

Note: Fluoroscopic imaging should be used to verify the proper fit of the trial components

Confirm a proper fit using fluoroscopy, then remove the trial components

17

18

PROSTHETIC STEM INSERTION

PROSTHETIC HEAD LOADING

Insert the Radial Stem implant using the Stem Impactor until the collar seats flush against the radius

Side load the Radial Head implant onto the Radial Stem, then rotate it until the threads for the Locking Screw are positioned laterally

Note: Each Radial Head implant is packaged with its respective Locking Screw.

19

20

Locking Screw INSERTION

HEAD ALIGNMENT TOOL

Loosen the knob on the Forearm Axis Jig and remove the Bone Holding Forceps, then slide the rail distally

Load the Locking Screw onto the Driver then threadit loosely into the Radial Head

Note: The Head Alignment Tool can be used to control the position of the Radial Head

With the Head Alignment Tool connected to the Radial Head, slide the rail into the handle until secured, then re-tighten the knob on the Forearm Axis Jig

Stabilize the Radial Head by holding the Head Alignment Tool, then tighten the Locking Screw using the Universal Driver Handle

Note: This will help to align the prosthetic head to the axis of forearm rotationwhile providing the necessary counter-torque when tightening the Locking Screw

21

22

IMPLANT LOCKING

IMPLANT VALIDATION

A B

Continue stabilizing the Radial Head using the Head Alignment Tool, then final tighten the Locking Screw using the Torque Indicating T-Handle Driver

Additional torque can be gained using the Universal Driver Handle

Note: The Torque Indicating T-Handle ensures that the minimum required torque has been achived.

Remove the Forearm Axis Guide assembly and K-wire

Manipulate the elbow through its full range of motion to confirm final implant alignment

A. Supination

B. Pronation

23

24

FLUOROSCOPIC CONFIRMATION

WOUND CLOSURE

A B

Confirm implant alignment one final time using fluoroscopic imaging

A. Supination

B. Pronation

Repair soft tissues as needed, then close the incision

ALIGN - Radial Head System - Cat.# ALN-RHA-SYS

(Locking Screw Included)

ALN-RHI-180 ∅ 18mm, CoCr





ALN-RHT-180 ALIGN Trial, Radial Head, 18mm





B

A

C

Catalog Number Radial Heads

Catalog Number Radial Stems

Catalog Number Trial Heads

A B C

ALN-RST-0700 7mm x 0mm, Ti 29mm

























ALIGN - Radial Head System - Cat.# ALN-RHA-SYS











ALN-RNT-000 ALIGN Trial, Radial Neck, 0.0mm





KWIR-STD-15127 K-Wire, Standard Tip, 1.5mm x 127mm, SS

DRVR-UQC-T20 Driver, Universal QC, T-20

HNDL-UQC-FXD Handle, Universal QC, Fixed

ALN-RHA-TRAY ALIGN Sterilization Tray System

ALN-STT-070 ALIGN Trial, Radial Stem, 7.0mm





ALN-RHG-PFA ALIGN, Percutaneous Forearm Axis Jig

ALN-RHG-CRL ALIGN, Captive Rail

ALN-RHG-BHF ALIGN, Bone Holding Foreceps

ALN-RHG-HAT ALIGN, Head Alignment Tool

ALN-RRA-070 ALIGN, Radial Rasp, Stem 7.0mm





ALN-RPL-070 ALIGN, Radial Planer, Stem 7.0mm





ALN-RHS-SZR ALIGN, Radial Head Sizer

ALN-NGI-000 ALIGN, Neck Gauge & Head Inserter, 0mm





ALN-RST-IMP ALIGN, Impactor, Radial Stem

ALN-RHA-TQH ALIGN, Torque Handle

Catalog Number Trial Necks

Catalog Number Trial Stems

Catalog Number System Instrumentation

Catalog Number General Instrumentation

Catalog Number Sterlization Tray

IndIcatIons General contraIndIcatIons

WarnInGs, PrecautIons and PotentIal adverse effects

The ALIGN™ Radial Head System and accessories are designed specifically for:• Replacement of the radial head for degenerative or post- traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: - Joint destruction and/or subluxation - Resistance to conservative treatment• Primary replacement after fracture of the radial head• Symptomatic sequelae after radial head resection• Revisions following failed radial head arthroplasty• The system is intended for press fit use

Warnings• The Head Alignment Tool must be used during the procedure to correctly align the prosthetic head and to provide the necessary counter-torque when tightening the Locking Screw.• The Locking Screw packaged with the Radial Head must be installed and fully tightened to fix the radial head to the Radial Stem. If the Locking Screw is not attached and/or fully secured, the Radial Head may loosen and/or disconnect from the Radial Stem, causing soft tissue irritation and/ or the device failure. • Improper selection, placement, positioning, alignment or fixation of the implanted components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.• Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the prosthesis or anatomical structures. • The information in this document should be shared with the patient. • The patient should be informed about the importance to follow the post operative rehabilitation to fully understand the possible limitations in normal activities of daily living. The patient must be warned that failure to follow postoperative care instructions may cause the prosthesis or treatment to fail.• Potential ALIGN Radial Head System construct failures such as stress fractures of the bones, loosening of the construct and/ or fixation, delayed fusion, non-fusion, or incomplete healing may occur as a result of non compliance to post operative rehabilitation, excessive wrist activities or construct overloading. • DO NOT reuse any of the ALIGN Radial Head System components. Reuse may compromise the structural integrity of the construct and/or lead to failure which may result in patient injury. • The Torque Handle included in the system requires calibration. DO NOT use if the calibration is overdue. Use of a Torque Handle out of calibration could result in device loosening or failure.

Precautions• The Radial Head with Locking Screw and Radial Stems are supplied sterile using gamma radiation sterilization. DO NOT use if sterile barrier is damaged or if the USE BY date has expired. Any implantable components used with an expired USE BY date will void the product warranty. • The implantable components are for single use only; DO NOT reuse, reprocess or re-sterilize. Reuse, reprocessing or resterilization of the implantable components may: - Compromise the structural integrity of the construct - Lead to failure resulting in patient injury - Create a risk of contamination of the device causing patient infection or cross contamination - Lead to the transmission of infectious disease(s) from one patient to another • Protect the implants against scratching or nicking as such stress concentration may lead to prosthesis failure.• Before using the ALIGN Radial Head System, inspect all prosthesis and instruments for wear, disfiguration and physical damage. If evidence of wear, disfiguration or physical damage is found, DO NOT use and contact your local Skeletal Dynamics representative or the Skeletal Dynamics Customer Care Department.• DO NOT permanently implant the Skeletal Dynamics K-Wires; they are intended to be used for provisional fixation of the ALIGN Radial Head System instrumentation.• The ALIGN Radial Head System has not been evaluated for safety and compatibility in the MR environment; nor has it been tested for heating or migration in the MR environment. • To maintain traceability of the system, record the Lot number for each of the implanted system components.

The ALIGN Radial Head System should not be used if any of the following are present: active or latent infection, sepsis, insufficient quantity or quality of bone and/or soft tissue, material sensitivity, or patients who are unwilling or incapable of following post operative care instructions.

Potential Adverse Events:The following potential risks or discomforts have been associated with radial head arthroplasty: Disassociation, loosening or migration of the prosthesis, infection, erosion of the capitellum, material sensitivity reaction, nerve injuries, undesirable shortening or lengthening of limb, stiffness of the elbow and/or forearm, dislocation and subluxation due to improper positioning, fretting and crevice corrosion can occur at interfaces between the components, wear and deformation of the articular surfaces, intraoperative and postoperative bone fracture and/or postoperative pain and infection.

NOTES:

8905 SW 87th Avenue, Miami, Florida 33176 Tele: 877 753 5396

© 2011 Skeletal Dynamics, LLC

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SURGICAL TECHNIQUE GUIDE - freewheel