BLUEPRINT 3D Planning Software - v1.4 user · PDF fileSeveral buttons are common to all screens (with the exception of the "Processing" screen, which is merely a standby screen

3 D P L A N N I N G S O F T W A R E

BLUEPRINT TM 3D Planning Software - v1.4 user manual

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S H O U L D E R Solutions by Tornier

BLUEPRINT TM 3D Planning Software - v1.4USER

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StandardsThis product complies with the following regulatory requirements: EN 62304Copyright©2015 Imascap. All rights reserved. Reproduction or transmission of this document, in whole or in part, in any format or by any means whatsoever is prohibited without IMASCAP’s prior written consent.ModificationWe have done everything we can to ensure that the information contained in this document is accurate. However, this information may be modified without prior notice.CautionFederal law restricts this device to sale by or on the order of a physician

CE (EC) MarkingThis product was CE approved in 2013. CE-0029.

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table of contentsB L U E P R I N T T M 3 D P L A N N I N G S O F T W A R E - v 1 . 4 - U S E R M A N U A L

TABLE OF FIGURES p. 4

INTRODUCTION p. 4-6• Agreements 4• Recommendations related to the application 5• Warnings related to the application 5• Troubleshooting 6

DESCRIPTION OF THE APPLICATION p. 6-8• Layout of the document 6• Scope / Reference documents 6• Precision of software calculations 6• Nominal use case 7• Software user license 7• Patient unique ID 8

USER INTERFACES p. 8-21• Common toolbar 8• "Login" screen 9• "Update BLUEPRINTTM 3D Software Planning - v1.4" screen 9• "Send pending cases" screen 10 • "Home" screen 10• "Preview" screen 10• "Processing" screen 10• "Measurement confirmation" screen 11 - General description 11 - Display menu 12 - Action menu 13 - Patient information 13 - 2D (front and axial) / 3D views 13 - Measurement bar 14 - Advanced mode button 14• "Planning" screen 17 - Display menu 16 - Patient information 16 - 2D (front and axial) / 3D views 16 - Positioning bar 18 - Implant modification bar 19 - Action menu 20 - Saving the planning report 22

ANNEXE 1 : INDICATIONS p. 24

ANNEXE 2 : COMPATIBLE IMPLANTS p. 25

ANNEXE 3 : TECHNICAL NOTES p. 25

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TABLE OF FIGURES• Figure 1: Nominal use case

• Figure 2: Alert in case of invalid license

• Figure 3: "Login" screen

• Figure 4: Connection settings box

• Figure 5: Alert in case of new update available

• Figure 6: View while downloading an update

• Figure 7: "Send pending cases" screen

• Figure 8: "Home" screen

• Figure 9: "Preview" screen

• Figure 10: "Processing" screen

• Figure 11: Measurement confirmation" screen

• Figure 12: 2D axial view

• Figure 13: 2D view

• Figure 14: 3D view

• Figure 15: Measurement bar

• Figure 16: Advanced mode window

• Figure 17: Glenoid orientation and direction angle

• Figure 18: Humeral head subluxation(right) and direction (left)

• Figure 19: "Planning" screen

• Figure 20 : Modification of type, size and radius of curvature for "Aequalis PerForm" implant

• Figure 21: Reaming max and seating

• Figure 22: Front view of the guide on the scapula

• Figure 23: Side view of the guide on the scapula

• Figure 24: Information related to the planning report

• Figure 25: Alert in case of operation date too close from curent date

• Figure 26: Summary of the Order Page

•Figure 27: Alert when the planning report can't be sent to the server

• Figure 28: Planning report example

• Figure 29: View of the web page ''cases list''

INTRODUCTIONCAUTION: all the information contained in this document is confidential, and its duplication in paper or electronic form for the benefit of a third party is prohibited without IMASCAP's prior written consent.

This document describes the detailed features of the planning application. It is intended for use by surgeons previously trained by Tornier.

AGREEMENTS

Caution: This symbol is used to warn users of a potential risk related to using this product, which may have repercussions on the patient or user.

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Recommendation: This symbol is used to attract the user's attention about the recommended use of the product, when no risk to the patient or user is involved

Read the user instructions.A paper version can be requested for free by email at: [email protected].

Caution:The life cycle of BLUEPRINTTM 3D Planning Software is two years.

CautionFederal law restricts this device to sale by or on the order of a physician

RECOMMENDATIONS RELATED TO THE APPLICATION

Please read the description of the application very carefully before using.

Please read the recommended CT scan protocol very carefully.

WARNINGS RELATED TO THE APPLICATION

Please read the following warnings very carefully in order to ensure you use the application in the best conditions and in optimum safety conditions.

Confidentiality requirementsAny patient-related information used by the software is strictly confidential. Duplicating any information for any purpose other than that provided by the application is prohibited.

Staff qualification requirementsIt is forbidden for unqualified or untrained persons to use this software.

Risk-awareness related to losing/passing on credentialsPursuant to the previous point made, but also to avoid any malicious acts, the user of this application must prevent anyone from gaining access to his credentials. Credentials may not be passed on to a third party. In the event of credentials being lost, the user can contact the technical department.

Valid version of the applicationThis manual concerns BLUEPRINTTM 3D Planning Software

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TROUBLESHOOTINGIn the event of a configuration problem involving the workstation, stop using the application and immediately contact Tornier's technical support.

DESCRIPTION OF THE APPLICATION

LAYOUT OF THE DOCUMENTThe rest of the document describes the different stages of the planning application from the surgeon's point of view. These steps are described firstly in a section that describes the individual use of the application, and secondly in sections that describe all the application screens and their main functions.

SCOPE / REFERENCE DOCUMENTSThe environment, purpose, indications and contraindications of the application are detailed in the appendix entitled "Indications".

The ranges of implant for which the application can be used are detailed in the appendix entitled "Compatible implants".

The description of data used and measured by the software is detailed in the section entitled "Planning screen".

The minimum/optimum configuration of the user's workstation (OS, graphics card, random access memory, etc) is detailed in the appendix entitled "Configuration of the user's workstation".

The surgeon's role at all stages of the planning process is critical and it is essential for him to be fully acquainted with it.

PRECISION OF SOFTWARE CALCULATIONSMeasurements ensured by the software have the following precision:• 1 mm for maximum reaming.• 6.3% ± 5.7% when measuring the percentage of seating surface

between the implant and the glenoid fossa.• HH Subluxation percentage: 0.6%±0.65% and direction precision

3.9°± 4°• The accuracy of the use of patient specific guide generated by the

software (clinical validation test on 17 patients): - 0.9 ± 2.1 mm for the entry point- 3.4° ± 5.1° for the version angle- 1.8° ± 5.3° for the inclination angles

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NOMINAL USE CASE

SOFTWARE USER LICENSE

In order to be able to use the software, the user must log in to the application using credentials (mail address and password obtained after registration process). At this time, the license is checked. Whenever the license is not, or is no longer valid, the user will be informed by a warning message.

BLUEPRINTTM 3D Planning Software offers two modes: online mode and offline mode. The first login is always online. Then, in case of unavailability of network connection, user can log in using offline mode. The license is then valid for 7 days and for 10 cases. In order to update the license, the surgeon has to log in using online mode. Then he can send the pending cases to the server. The management of online and offline modes is transparent for surgeon. He is simply notified in case of offline mode.

Each account is linked to an ID (2 alphanumerical digits) which allows identification of the surgeon.

Figure 1 : Nominal use case

Update (optional)

Send pending cases(optional)

Select patient to planify

Validate measures made by software

Plan surgery

Choice of implant (position, type, size, radius)

Create customized guide

Save planning report

Identify

Figure 2: Message in case of offline mode

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* ( GAUCHE ou DROITE)

PATIENT UNIQUE ID

In order to ensure the traceability of software-coordinated planning, each recording is identified by a unique identifier. This identifier is made up of 7 characters:

USER INTERFACESThe application is made up of several screens:• The “Login” screen to log in to the application,• The “Update BLUEPRINTTM 3D Planning Software - v 1.4” screen to download software updates,• The “Send pending cases” screen to send the pending cases to the server,• The "Home" screen, to load patient or to load planning report,• The "Preview" screen, to choose the DICOM series to be processed in the event of several valid DICOM series having been detected,• The "Processing" screen displayed during the processing of patient-related data,• The "Measurement confirmation" screen, to enable the surgeon to modify and validate measurements computed by the software,• The "Planning" screen, to simulate the positioning and the choice of the implant, create the customized guide, save and send

the planning report.Each screen is described in more details in the following paragraphs.

COMMON TOOLBAR

Several buttons are common to all screens (with the exception of the "Processing" screen, which is merely a standby screen and the "Screenshot" button that only appears on the "Measurement confirmation" and "Planning" screens). These buttons are activated by clicking on the left-hand button on the mouse.

ELEMENT AVAILABLE ON ACTION

Planning Page The "Reset" button is used to reset all the planning parameters with those obtained immediately after confirming the measurements.

Planning Page

This button enables the user to take a screenshot of the software as animage. The image will be saved with the planning report. This button is

only available after processing step. NOTE : A default filename is proposed, however it can be changed during screenshot step.

Planning Page "Open" button allows to open a new case by opening the "HOME" screen.

All Pages Settings button opens a dialog window where a connection using a proxy can be configured.

All Pages The "About" button displays software-related information(version, copyright, regulatory information).

All Pages The "Help" button gives access to the support information. Italso gives access to the software's user manual.

XX F or M or O L or R YYY

2 alphanumerical digits to identify the surgeon

1 character to identify the gender

1 character to identify the side (LEFT or RIGHT)

3 alphanumerical digits corresponding to the number of records made with the surgeon

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Figure 3: "Login" screen

• Screenshots taken by the user cannot under any circumstances be used as a planning report.

• The user is responsible for deciding when to take screenshots. It is possible that parameters that are visible on the screenshot will not coincide with those recorded by the user when the planning report is generated.

"LOGIN" SCREEN

This screen allows the surgeon to log in to the application for online and offline modes. The credentials and the license are checked. Errors are displayed if credentials or license are not valid.

INTERNET CONNECTION CONFIGURATION

default uses the direct connection to the Internet to connect to BLUEPRINTTM Server. The Direct connection to the Internet is checked in the connection settings box.You can configure BLUEPRINTTM 3D Planning Software to use a proxy server to connect to the Internet.

1. Click on to access to the connection settings widget.

2. Check Manual proxy configuration3. In the Proxy Type box, select the proxy type such as HTTP, FTP or SOCKS4. In the Server box, type the IP address of the proxy server5. In the Port box, type the port number that is used by the proxy server for client connections6. Only if your proxy server requires an authentication, type the username and password in according boxes, otherwise leave these fields blank7. Click Test Connection to check the settings (Recommended)8. Click OK to close the configuration box

Figure 4: Connection settings box

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"UPDATE BLUEPRINTTM 3D PLANNING SOFTWARE" SCREENIn case an update is available for the software, the update is proposed to the surgeon.If user accepts the update, the file is automatically downloaded, BLUEPRINTTM 3D Planning Software launches the installation and closes itself.

"SEND PENDING CASES" SCREENWhen the surgeon saves a plan with no network connection, the planning report is queued. After the login, the software will inform the surgeon that he has pending cases through the “Send pending cases” screen. From this page, the surgeon can see all the details of his planned cases then he can send them to the server by clicking on Send All.If guides have to be ordered, this will be done automatically.The surgeon can also Skip this step if he does not want to send all his cases immediately.It is possible to have 10 pending planning reports. When 10 planningreports are pending, the surgeon has to send them to the server.

"HOME" SCREENThis screen allows user to:• Select the patient to plan by selecting a DICOM series. The "Plan New Case"

button enables the user to choose the folder that contains the DICOM series. Images can be stored on the computer's hard disk, on an external disk (USB key or external hard disk) or on a DVD/CD. Only the DICOM series that are compliant with the parameters defined in the CT scan protocol (cf. BLUEPRINTTM CT Scan Protocol) are considered to be valid.

• Select a planning report to load it. The “Load Prior Case from Computer ” button enables user to select a planning report stored on the computer's hard disk, on an external disk (USB key or external hard disk) or on a DVD/CD.

"PREVIEW" SCREENThis screen is displayed when several valid DICOM series are detected by the application and is divided into two parts:• On the left, a table lists the different DICOM series and the

information relating to each one: - the patient's name, - dimensions of images, - spacing of images.

• On the right, a sample of the selected DICOM set is displayed with a scroll bar

Simply clicking on one of the lines of the table displays the corresponding sample on the right side of the screen. To confirm his choice, the user must press the "Valid selection" button.

Figure 9: "Preview" screen

Figure 5: Alert if a new update is available

Figure 6: View while downloading an update

Figure 7: "Send pending cases" screen

Figure 8: "Home" screen

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"PROCESSING" SCREEN

This screen is a standby screen displayed while the application processes the selected DICOM series. When this screen is displayed, the user is unable to do anything else. A progress bar informs of processing progress.

"MEASUREMENT CONFIRMATION" SCREEN

For more information about the measures, Please refer to the Annexe 3.

General description

This screen enables the user to visualize the measurements made by the software, the position and orientation of scapula plane, the angle values (version and inclination).

Several interface elements are shared by the "planning" screen, and only the availability of several buttons changes according to the screen:• Display menu (top left),• Action menu (top right),• Patient information and Advanced mode button (top center),• 2D (front and axial) / 3D views,• Measurement bar (in the center, below the views).

At this stage, the user must confirm or reject the measures made by the software. In case of confirmation ("Confirm CT-Scan Measures" button) the software goes to the "Planning" screen. In case of rejection (the "Deny CT-Scan Measures" button), the software requests confirmation then shuts down.

• The surgeon validates measurements, and is responsible for his own choices.

• Once measurements have been validated, Planning will be only applied according to the validated measurements.

Figure 11 : "Measurement confirmation" screen

Figure 10 : "Processing" screen

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Display menu

The display menu enables the user to display any elements of his choice on 2D (front and axial) and 3D views. It is made up of buttons that can be activated by clicking on the left-hand button on the mouse.

ELEMENT INTERACTION ACTION

Left click on mouse Show / hide the humerus on the 3D view

Left click on mouse Show / hide the scapula on the 3D view

Left click on mouse Show / hide the scapula plane on the 2D view (front and axial)

Left click on mouseShow / hide the glenoid plane on the 2D view

(front and axial)

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Action menuThe action menu enables the user to carry out specific operations. Several actions are controlled using the shared buttons described earlier (See the chapter "Common toolbar").At this stage, several menu buttons are disabled. They are hidden and they will be enabled on the "Planning" screen.

Patient information

Patient information is visible on the "Measurement confirmation" screen and on the "Planning" screen. It gives the patient's name and the shoulder side.

2D (front and axial) / 3D views

The central part of the "Measurement confirmation" screen is made up of 3 views. They enable the user to visualize the elements calculated by the software by superimposing them on the patient's anatomy.• 2D axial view

- Standard axial slice of the patient's CT scan exam, - A scroll bar is used to navigate between slices, - The mouse wheel is used to navigate between slices, - The "Zoom in" and "Zoom out" buttons above the view are used

to control the zoom function around the center of the glenoid.• 2D front view

- Front slice through the scapula plane, - A scroll bar is used to navigate between slices, - The mouse wheel is used to navigate between slices,

The "Zoom in" and "Zoom out" buttons above the view are used to control the zoom function around the center of the glenoid fossa.

• 3D view- Enables the user to visualize 3D models of the humerus and scapula,- The left-hand button on the mouse + moving the mouse are

used to rotate around center of the glenoid fossa,- The mouse wheel is used to control the zoom function around

the center of the glenoid fossa,- The left-hand button on the mouse + the "shift" button are used

to move 3D models,- The "Zoom in" / "Zoom out" buttons above the view are used to

control the zoom function around the center of the glenoid fossa.

Figure 12: 2D axial view

Figure 13: 2D view

Figure 14: 3D view

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Measurement barThe Measurement bar is used to display the inclination, version and depth of the glenoid plane.

Description of the version is displayed in text form directly below the version angle value, according to the value of that angle:

The depth value is displayed as "Depth (mm)".

Description of the inclination is displayed in text form directly below the inclination angle value, according to the value of that angle:

Advanced mode button

An additional button is available for use, located to the left of the positioning bar.

VERSION ANGLE (°) DISPLAYED TEXT

< 0 Retroversion

= 0 Version

> 0 Anteversion

INCLINATION ANGLE (°) DISPLAYED TEXT

< 0 Inclination Inf

= 0 Inclination

> 0 Inclination Sup


Left click on mouse"Advanced mode" button allows to display additional measures.

Figure 15: Measurement bar

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When the advanced mode is triggered, a new window appears to display four additional measures : - The glenoid orientation and direction - The HH subluxation and direction.

This Glenoid coordinate system is used to measure the Orientationand the Direction of the glenoid version.The glenoid center and the best-fit-sphere center define the glenoidcenterline.The Orientation angle is the angle (degrees) between the glenoidcenterline and the LAT-axis (Fig. 17 left).The Direction is the angle (degrees) between the projection ofthe glenoid centerline on the SUP-ANT-plane and the POST-axis(Fig. 17 right).The Humeral Head subluxation and direction measures are defined asfollowed:

Figure 17 : Glenoid orientation and direction angle

Figure 16: Advanced mode window

DIRECTION ANGLE (°) DISPLAYED TEXT

-180<x<-160 ANT

-160<x<-110 ANT-INF

-110<x<-70 INF

-70<x<-20 POST-INF

-20<x<20 POST

20<x<70 POST-SUP

70<x<110 SUP

110<x<160 ANT-SUP

160<x<180 ANT

If ORIENTATION ANGLE <10° CENTERED

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Figure 18 : Humeral head subluxation(right) and direction (left)

Those measurements have been defined by Terrier and al. in the article "Measurements of three-dimensional glenoid erosion when planning the prosthetic replacement of osteoarthritic shoulders." (Bone Joint J. 2014 Apr;96-B(4):513-8.)".

- Although Total Shoulder Arthroplasty is a successful technique to treat primary gleno-humeral osteoarthritis, complications have been specifically associated to shoulders with high preoperative humeral head subluxation. It is usually assumed that posterior subluxation of the humeral head can lead to posterior erosion of the glenoid. Furthermore, there is a risk of recurrence of the subluxation after TSA and which may be responsible for wear and early loosening of the glenoid component. Although a causality link between humeral head subluxation and glenoid version of osteoarthritic shoulders is intuitively expected, no statistical correlation have been reported yet.

- The most accepted measurement of the humeral head subluxation was derived from that described by Papilion and Larry. It was then adapted by Badet and Walch, and used by Walch to propose its classification. They defined the gleno-humeral subluxation as the percentage of humeral head offset from the glenoid axis, relative to the humeral head diameter. This measure is done in 2D, in a CT slice approximately in the middle of the glenoid surface. Since then, other techniques to measure the subluxation were developed.

- We extended the above 2D gleno-humeral and scapulo-humeral subluxation to 3D, to evaluate not only the amplitude but also the orientation of the subluxation. We defined the 3D humeral head subluxation as the percentage of the posterior portion of the HH volume to the total volume of the HH according to the scapula plane.

The direction of the 3D HH subluxation was the polar angle of the humeral head center relative to the glenoid center and the medio-lateral axis.

For more information about the measures, Please refer to the Annexe 3.

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"PLANNING" SCREEN

This screen enables the user to plan the surgery:• Position the implant,• Select the type, size and radius of curvature of the implant,• Create the customized guide,• Save and send the planning report.

Several interface elements are shared with the "Measurement confirmation" screen, and only the availability of several buttons changes according to the screen:• The display menu (top left),• The action menu (top right),• Patient information (top center),• 2D (front and axial) / 3D views,• The positioning bar (in the center, below the views),• Generate patient specific guide button (at the right of the

positioning bar).

The main difference with the "Measurement confirmation" screen is located at the bottom of the screen with the glenoid implant modification bar, which replaces the buttons used to confirm or reject the measurements. The generate Patient Specific Guide button is available while the advanced mode button isn't anymore.

Figure 19: "Planning" screen

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Display menuThe display menu enables the user to display the elements of his choice on 2D (front and axial) and 3D views. It uses the same menu as the "Measurement confirmation" screen (cf p.11) with has a few extra buttons.

Patient information

This part is identical on the "Measurement confirmation" page (cf p.12).

2D (front and axial) / 3D views

This part is identical on the "Measurement confirmation" page (cf p.12). However it is also possible to display additional elements, such as the implant, the template and the axis of the implant.

Positioning bar

This part is identical on the "Measurement confirmation" page (cf p.12) except the buttons control the position of the implant.


Left click on mouseShow / hide the implant on 2D / 3D views and the

implant modification bar (shown by default)

Left click on mouseShow / hide the axis of the implant on the 3D view

(hidden by default)

Left click on mouseShow / hide the customized guide on the 3D view (available once the

template has been created)


Left click on mouseModification of the posterior/anterior orientation (1° per click ) and updating of version value

Left click on mouseModification of the inferior/superior orientation (1° per click) and updating of inclination value

Left click on mouseModification of the medial/lateral position

(0.5 mm per click) and updating of depth value

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Implant modification bar

This bar is used to modify the implant's parameters. It also enables the user to position the implant. And finally, two measurements ("reaming max" and "seating") enable the user to position the prosthesis as accurately as possible.

• Modification of implant's parametersIn order to adapt to each patient's morphology as accurately aspossible, “AequalisTM PerForm” implants come in several sizes andradius of curvature. These parameters can be determinedsimply by comparing the characteristics of the implants and thearticular surface in 2D and 3D.Modifications are made by clicking on the left-hand button of themouse. Two selectors enable the user to modify the size and radiusof curvature of implant.

• "Reaming max" and "Seating"These measurements enable the user to evaluate the position of the implant on the glenoid fossa.Indeed, the "Reaming max" measurement tells the surgeon the maximum reaming depth according to the implant position.The "Seating" measurement tells the surgeon how well the backside of the implant fits on the glenoid fossa. The blue parts show the areas where the backside of the implant meets the glenoid fossa and the red parts show where the backside of the implant does not ream the glenoid fossa.For an optimal position, user has to try to maximize seating while minimizing reaming max.

To know more these measures, please consult the annexe 3.

Moving the implant

To move the implant in all directions, the user can use the arrows present on the bottom right-hand side of the implant modification bar by clicking on the left-hand button of the mouse.

• Rotation of the implant around its axis• Anterior / posterior translation• Inferior / superior translation

Each time the implant is moved, its inclination, version, reaming and seating values are recomputed. 2D and 3D views are also updated.

Figure 21: Reaming max and seating

Figure 20: Modification of type, size and radius of curvature for "Aequalis PerForm" implant

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Action menu

The action menu enables the user to perform specific operations. Several actions use the previously described common buttons (See the chapter "Common toolbar").

At this stage, the user can perform new actions:• Generation of the Patient Specific GuideAn additional button is available for use, located to the right of the positioning bar.

The patient specific guide is computed to represent the alignment of the central pin according to the surgeon's planning process.

To compute it, the user must first complete the following steps:• Select the seating markers on the surface of the glenoid fossa by

clicking on the 3D view with the right-hand button on the mouse,- It is necessary to have 4 valid markers. Valid markers are shown

in green and invalid markers are shown in red. To delete an invalid point, simply click on it once more using the right-hand button on the mouse,

- To ensure stability and facilitate the implanting process, it is necessary to select 1 marker on the posterior part of the glenoid fossa and 3 markers on the anterior part of the glenoid fossa,

- The inferior-posterior quarter of the glenoid fossa is an invalid area,- Markers that are located too far from the edge of the glenoid fossa

will be considered invalid.


Left click on mouse

The "guide computation" button is usedto create the patient specific guide

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• Request guide computation by pressing the "Guide computation" button

A warning is generated whenever the user attempts to create the guide without having previously selected 4 valid markers, or whenever he attempts to create the template when the implant collides with the scapula.

• The surgeon selects the 4 markers required to create the template.

• The template must be created once the user has finished to choose the position, type, size and radius of curvature of the implant.

• The surgeon should avoid picking points on non-stable osteophytes

SELECTED POINTS STATUS SELECTED POINTS STATUS

Invalid marker as located too far from the edge of the glenoid fossa

1 invalid marker as located in the inferior-posterior quarter of

the glenoid fossa

2 invalid markers as 2 markers located on the posterior side of

the glenoid fossa

4 invalid markers as all are located on the anterior side of

the glenoid fossa

4 valid markers

Figure 22: Front view of the guide on the scapula

Figure 23: Side view of the guide on the scapula

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Saving the planning report

By pressing the "Save" button the user activates the report saving process.

The software will then ask for the operation date, the patient's gender (if not specified in DICOM fields) and the surgeon's notes (optional).

If surgeon chooses a planned operation date less than one month compared to the current date, a message is displayed to warn that the deadline for making the guide may be too short.

The software displays the "Summary of the Order" page that shows the guide with the Scapula surrogate in 3D.

It is possible to increase the volume of the Scapula surrogate if the surgeon feels that the current surrogate is not sufficient to let him check the nesting of the guide on the Scapula.

When he is satisfied with the order, he can:

- Save: to save the planning only (including the guide if appropriate) but without ordering anything

- Save and Order the guide: to save the planning and order the guide

If a network connection is available, the planning report is automatically sent to the server after saving. Otherwise, the planning report is queued. It will be visible on the “Send pending cases” screen.

The report can be saved without the guide if the user does not need a guide. A warning message will be displayed to inform him that the guide is missing.

The planning report contains several elements:• The planning report in HTML format containing HTML files and images,• A TXT file containing the measurements provided by the software,• A STL file representing the 3D model of the scapula truncated at

glenoid fossa level,• A STL file representing the generated guide (if guide computed)• A SEG file representing the scan segmentation,• Screenshots.

Figure 28 : Planning report example

Figure 27 : Alert when the planning report can't be sent to the server

Figure 26 : Summary of the Order Page

Figure 25: Alert if operation date too close from curent date

Figure 24 Information related to the planning report

ÉLÉMENT INTERACTION ACTION

Left click on mouse

This button is used to save the planning report. This operation will be

detailed below.

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Planning reports are available in the tab "Cases" of the exchange platform. Click here: https://oms.tornierblueprint.com/auth/login

• The surgeon is responsible for saving the planning report once the planning stage has been completed.

Figure 29: View of the web page ''cases list''

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ANNEXE 1 : INDICATIONS

PURPOSE

BLUEPRINTTM 3D Planning Software is an application that helps surgeons to plan their patients' shoulder prosthesis surgery. It generates the information required to produce a guide that is specific to each patient and enables the insertion of a pin following the reaming axis aimed at preparing the glenoid fossa surface.

INDICATIONS

BLUEPRINTTM 3D Planning Software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.BLUEPRINTTM 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINTTM 3D Planning Software .BLUEPRINTTM 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeons to design patient specific guides based on the pre-surgical plan.This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINTTM 3D Planning Software does not include any system to manufacture the guide.BLUEPRINTTM 3D Planning Software is to be used for adult patients only and should not be used for Diagnostic purpose.

CONTRAINDICATIONS

Using this medical device is contraindicated in the following cases:• When used for a joint other than the shoulder joint,• When used for a range of implants other than AequalisTM PerFORM• Any medical examination other than a CT scan,• A medical arthroscan examination,• A medical examination on a shoulder containing a metal object

(which would degrade (artifact) the quality of the x-ray examination),• When used with non-adult patients,• When used on images showing both shoulders,• When used on images showing elbow.

BLUEPRINTTM 3D Planning Software is only cleared for use with the AequalisTM

PerFORM Glenoid System.

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ANNEXE 2 : COMPATIBLE IMPLANTSThe implants accepted by this version are as follows:• Tornier AequalisTM PerForm – Glenoid System Keeled• Tornier AequalisTM PerForm – Glenoid System Pegged• Tornier AequalisTM PerForm – Glenoid System Pegged-Cortiloc

For each AequalisTM PerForm implant several sizes and radii of curvature are available. The following table shows the correspondence between size and radius of curvature:

Available Glenoid Components

Glenoid components list

RADIUS / SIZE 30 35 40 50 60

SmallMediumLargeXLarge

KEELED GLENOID

REFERENCE DESCRIPTION

DWE501 S30 Keeled Glenoid



DWE511 M30 Keeled Glenoid



DWE521 L40 Keeled Glenoid



DWE531 XL40 Keeled Glenoid



PEGGED GLENOID


DWE301 S30 Pegged Glenoid



DWE311 M30 Pegged Glenoid



DWE321 L40 Pegged Glenoid



DWE331 XL40 Pegged Glenoid



CORTILOCTM PEGGED GLENOID


DWE401 S30 Cortiloc Glenoid



DWE411 M30 Cortiloc Glenoid



DWE421 L40 Cortiloc Glenoid



DWE431 XL40 Cortiloc Glenoid



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Figure 1a: Scapula plane landmarks andexample of truncated scapulae

Figure 1b: Planes and axis calculated by the software

ANNEXE 3 : TECHNICAL NOTES

FULLY AUTOMATIC METHOD TO ASSESS 3D-GLENOID ORIENTATIONPreoperative assessment of glenoid retroversion, using 3D-CT scan images, is crucial to optimize glenoid implant positioning during total shoulder arthroplasty. New 3D manual methods have been recently proposed, however they are time-consuming and accuracy depends on the surgeon’s experience. BLUEPRINTTM 3D Planning Software introduces a new fully automatic method to compute 3D glenoid version. This method, validated and published1, works on truncated scapula scans.

SCAPULA REFERENCE PLANE

New methods to compute 3D version angle of the glenoid have been proposed. These methods proposed different definitions of the glenoid plane and use only 3 points to define each plane on the 3D model of the scapula (Fig. 1). In practice, patients often come to consultation with their CT-scans. In order to reduce the x-ray dose or the scanning time, the scapula are often truncated inferiorly, medially, or both. In these cases, the referential scapula plane defined in the cited methods cannot be calculated because it is based on specific points on the scapula. Therefore, the patient will need another CT-scan which is not acceptable. We hypothesized that a new plane definition, of the scapula and the glenoid, that takes into account all the 3D points, would be less vulnerable to changes and provide more reliable measures whatever the scapula is truncated or not.)

Instead of using classical bone landmarks defined manually by the user, we propose a new automatic method to assess the 3D orientation of the glenoid 1,2.

The automatic method for 3D reconstruction of the scapula defines a new reference scapular plane (Yellow/fig.1a) based on all 3D points of the scapula body (as a median plane). It is computed by fitting a plane using the mathematical principle of least-squares-minimization.

The same process is applied to define a best-fit-sphere of the glenoid surface which is detected automatically.

The glenoid plane (blue/fig.1b) represents the best fit plane of the glenoid fossa. This plane is adjusted according to all the points of the glenoid surface. It helps to provide a visual assessment of the glenoid orientation in the axial 2D view.

The Transverse axis (Orange/fig.1b) is calculated as the best fit line of the cross points between the superior border, the scapular spine and the scapular body.

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GLENOID REFERENCE COORDINATE SYSTEM

Once the scapular plane is computed, a glenoid coordinate system ANT-LAT-SUP is defined as following (Fig. 2):• The origin of the coordinate system is set at the glenoid points

centroid projected on the glenoid surface.• The medio-lateral (LAT) axis is fitted on the supraspinatus fossa as

the intersection line between the scapular spine and the scapula body. This line is projected on the scapular plane.

• The posterior-anterior (ANT) axis is perpendicular to the scapular plane, and thus to the medio-lateral (LAT) axis and placed on the origin.

• The infero-superior (SUP) axis is perpendicular to the ANT-axis and LAT-axis and passed by the origin.

GLENOID ORIENTATION AND DIRECTION ANGLE (3D ANGLES)

This Glenoid coordinate system is used to measure the Orientation and the Direction of the glenoid version2. The glenoid center and the best-fit-sphere center define the glenoid centerline.The Orientation is the angle (degrees) between the glenoid centerline and the LAT-axis (Fig. 3a).The Direction angle is the angle (degrees) between the projection of the glenoid centerline on the SUP-ANT-plane and the POST-axis (Fig 3b). It is characterized depending of the angle value as following:

Those measurements have been defined by Terrier and al. in the article "Measurements of three-dimensional glenoid erosion when planning the prosthetic replacement of osteoarthritic shoulders." (Bone Joint J. 2014 Apr;96-B(4):513-8.)".

Figure 2: Glenoid Coordinate Reference System

Figure 3: Glenoid Orientation and Direction Angle

Orientation angle

INF

INF

SUP

SUP

ANT

ANTPOST

LAT

Direction angle

Glenoid Center line

ANT axis

ANT axis

ANT axis

LAT axis

LAT axis

SUP axis

SUP axis

Fig. 3a

Fig. 3b

DIRECTION ANGLE (°) DISPLAYED TEXT

-180<x<-160 ANT

-160<x<-110 ANT-INF

-110<x<-70 INF

-70<x<-20 POST-INF

-20<x<20 POST

20<x<70 POST-SUP

70<x<110 SUP

110<x<160 ANT-SUP

160<x<180 ANT

If ORIENTATION ANGLE <10° CENTERED

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GLENOID VERSION AND INCLINATION ANGLE (2D ANGLES)

The version angle is defined as the projected orientation angle on the transverse scapular plane (Fig. 4a).The inclination angle is defined as the projected orientation angle on the scapular plane (Fig. 4b).

This 3D measure of the version is compared to the classical 2D method and other 3D methods. Intra-observer and inter-observer variability of our measures was evaluated with the interclass correlation coefficient (ICC). Three observers repeated randomly 3 times the same measure on three CT. The significance level was set at 5% for all statistical tests1.

HUMERAL HEAD SUBLUXATION AND DIRECTION MEASURE

Although Total Shoulder Arthroplasty is a successful technique to treat primary gleno-humeral osteoarthritis, complications have been specifically associated to shoulders with high preoperative humeral head subluxation. It is usually assumed that posterior subluxation of the humeral head can lead to posterior erosion of the glenoid. Furthermore, there is a risk of recurrence of the subluxation after TSA and which may be responsible for wear and early loosening of the glenoid component. Although a causality link between humeral head subluxation and glenoid version of osteoarthritic shoulders is intuitively expected, no statistical correlation have been reported yet.

The most accepted measurement of the humeral head subluxation was derived from that described by Papilion and Larry. It was then adapted by Badet and Walch, and used by Walch to propose its classification. They defined the glenohumeral subluxation as the percentage of humeral head offset from the glenoid axis, relative to the humeral head diameter. This measure is done in 2D, in a CT slice approximately in the middle of the glenoid surface. Since then, other techniques to measure the subluxation were developed.

We extended the above 2D gleno-humeral and scapulo-humeral subluxation to 3D, to evaluate not only the amplitude but also the orientation of the subluxation. We defined the 3D humeral head subluxation as the percentage of the posterior portion of the HH volume to the total volume of the HH according to the scapula plane.

The direction of the 3D HH subluxation was the polar angle of the humeral head center relative to the glenoid center and the medio-lateral axis.

Figure 4: Glenoid Version and Inclination Angle

Scapula plane

Scapular transversal plane

Version angle

Inclination angle

Glenoid best-fit- sphere center

Fig. 4a

Fig. 4b

Figure 5a: HH Subluxation

Figure 5b: HH Direction

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REAMING MAX AND SEATING The reaming and seating measures are used by surgeons to help to position the implant on the glenoid.

These measurements are computed when the CT-scans are confirmed by the user-and, when a new implant is selected. They also update each time the surgeon moves the implant.

SEATING MEASUREMENT

The software allows surgeons to assess seating of the glenoid prosthesis. The seating quality is presented by the percentage of well covered backside points. A distance map of the glenoid prosthesis backside is displayed in addition to the percentage (Fig. 6). The red area represents points that are not covered by the bone. The blue area represents points that are well seated on the bone (distance equal to or less than zero with a tolerance of 0.5mm).

REAMING MAX MEASUREMENT

This measure gives the surgeon information about the maximum of reaming related to each implant position. The maximum of reaming is measured in mm as the maximum distance between the reamer surface and the glenoid surface (Fig. 6).

REFERENCES1Gilles Walch MD, Peter S. Vezeridis MD, Pascal Boileau MD, Pierric Deransart, M. Eng, Jean Chaoui, PhDe. Three-dimensional planning and use of patient specific guides improve glenoid component position: an in vitro study. J Shoulder Elbow Surg (2014) -, 1-8.

2Terrier A, Ston J, Larrea X, Farron A. Measurements of three-dimensional glenoid erosion when planning the prosthetic replacement of osteoarthritic shoulders. Bone Joint J. 2014 Apr;96-B(4):513-8. doi:10.1302/0301-620X.96B4.32641. PubMed PMID: 24692620.

Figure 6a: The seating measure

Figure 6b: The maximum of reaming measure

REAMING MAX (mm)

SEATING (%)

Maximum of reaming

user manual

BLUEPRINTTM 3D Planning Software - v1.4 - User Manual - CAW7865 - rev A - ECN 150638 - 2015/04/30

www.tornier.com

US HEADQUARTERS

Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 USA + 1 952 426 7600

MANUFACTURER INTERNATIONAL HEADQUARTERS

Tornier SAS161 rue Lavoisier38330 Montbonnot Saint MartinFrance+ 33 (0)4 76 61 35 00

ENGINEERED WITHIMASCAP™ TECHNOLOGY

3 D P L A N N I N G S O F T W A R E

Prior to using any Tornier device, please review the instructions for use and surgical technique for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.

BLUEPRINTTM 3D PLANNING SOFTWARE HELPLINE

UNITED STATES SUPPORT

Email: [email protected] number: +1 855 378 1459

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Documents

BLUEPRINT 3D Planning Software - v1.4 user · PDF fileSeveral buttons are common to all screens (with the exception of the "Processing" screen, which is merely a standby screen