TORNIER BLUEPRINT. 3D Planning + PSI USER MANUAL V1.5.3

Transcription

1 TORNIER BLUEPRINT 3D Planning + PSI USER MANUAL V1.5.3

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3 Contents Chapter 1 4 Chapter Chapter Chapter Appendix A 25 Appendix B 26 Appendix C 27 Appendix D 31 Table of Figures Introduction Agreements Recommendations related to the application Warnings related to the application Troubleshooting Description of the Application Layout of the document Scope / Reference documents Precision of software calculations Nominal use case Software user license Patient unique ID User Interfaces Common toolbar Login screen Internet connection configuration Update BLUEPRINT 3D Planning screen Send pending cases screen Home screen Preview screen Processing screen Error Management and Assistance Measurement confirmation screen Planning screen Indications Compatible Implants Technical Notes Notes BLUEPRINT 3D Planning Software User Manual v

4 Table of Figures chapter 1 Pg Figure» Figure 1: Nominal use case» Figure 2: Message in case of offline mode» Figure 3: Login screen» Figure 4: Connection settings box» 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» Figure 9: Preview screen» Figure 10: Processing screen» Figure 11a: Processing Error screen» Figure 11b: Assistance request screen» Figure 11c: Assistance request confirmation screen» Figure 12: Measurement confirmation screen» Figure 13: 2D axial view» Figure 14: 2D frontal view» Figure 15: 3D view» Figure 16: Measurement bar» Figure 17: Advanced mode window» Figure 18: Glenoid orientation and direction angle» Figure 19: Humeral head subluxation (right) and direction (left)» Figure 20: Modification of parameters for AEQUALIS PERFORM (top) and AEQUALIS PERFORM + (bottom)» Figure 21a: Modification of the parameters for AEQUALIS PERFORM implant» Figure 21b: Modification of the parameters for AEQUALIS PERFORM+ implant» Figure 22: Seating parameter» Figure 23: Moving the implant» Figure 24: Front view of the polyamide guide on the scapula» Figure 25: Side view of the polyamide guide on the scapula» Figure 26: Front view of the titanium guide on the scapula» Figure 27: Information related to the planning report» Figure 28: Alert in case of operation date too close from current date» Figure 29: Summary of the order page for the polyamide guide» Figure 30: Summary of the order page for the titanium guide» Figure 31: Alert when the planning report can t be sent to the server» Figure 32: Planning report example» Figure 33: View of the web page cases list 4 BLUEPRINT 3D Planning Software User Manual v1.5.3

5 Introduction chapter 2 CAUTION: 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 Wright Medical. 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. 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 at: blueprint_us@wright.com. CAUTION: The life cycle of BLUEPRINT 3D Planning software is two years. CAUTION: Federal 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. BLUEPRINT 3D Planning Software User Manual v

6 Warning 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 requirements Any 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 requirements It is forbidden for unqualified or untrained persons to use this software. Risk-awareness related to losing/passing on credentials Pursuant 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 application This manual concerns BLUEPRINT 3D Planning software Troubleshooting In the event of a configuration problem involving the workstation, stop using the application and immediately contact Tornier s technical support. 6 BLUEPRINT 3D Planning Software User Manual v1.5.3

7 Description of the Application chapter 3 Layout of the document The 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 documents The environment, purpose, indications and contraindications of the application are detailed in the appendix entitled Indications. The ranges of implants 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 calculations Measurements ensured by the software have the following precision:» 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 BLUEPRINT 3D Planning Software User Manual v

8 Nominal use case Identify Update (optional) Send pending cases (optional) Select patient to planify Validate measures made by software Plan surgery Choose implant (position, type, size, radius) Create customized guide Figure 1: Nominal use case Save planning report 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. BLUEPRINT 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 (figure 2). Figure 2: Message in case of offline mode Each account is linked to an ID (2 alphanumerical digits) which allows identification of the surgeon. 8 BLUEPRINT 3D Planning Software User Manual v1.5.3

9 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: 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 Importance of the unique code patient identification To identify the patient, it is highly recommended to use the Patient UID (and not the Patient ID ) generated from patient s name and date of birth as the following pattern XYYZZZ with:» X: first letter of the first name» YY: year of birth on two digits» ZZZ: 3 first letters of the last name BLUEPRINT 3D Planning Software User Manual v

10 User Interfaces chapter 4 The application is made up of several screens:» The Login screen to log in to the application,» The Update BLUEPRINT 3D Planning software 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.» The Guide Design screen to create the patient-specific guide.» The Recording screen to allow the surgeon to: - Fill in the patient and planning information, - Save and send the planning report to the server (if online), - Order the guide (if online). 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 Planning Page Planning Page All Pages All Pages All Pages The Reset button is used to reset all the planning parameters with those obtained immediately after confirming the measurements. This button enables the user to take a screenshot of the software as an image. 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. Open button allows to open a new case by opening the HOME screen. Settings button opens a dialog window where a connection using a proxy can be configured. The About button displays software-related information (version, copyright, regulatory information). The Help button gives access to the support information. It also gives access to the software s user manual.» 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. 10 BLUEPRINT 3D Planning Software User Manual v1.5.3

11 Figure 3: Login screen Figure 4: Connection settings box Figure 5: Alert if a new update is available Figure 6: View while downloading an update Login screen This screen allows the surgeon to log in to the application for online and offline modes (figure 3). The credentials and the license are checked. Errors are displayed if credentials or license are not valid. Internet connection configuration BLUEPRINT 3D Planning software by default the direct connection to the internet to connect to BLUEPRINT Server. The Direct connection to the Internet is checked in the connection settings box (figure 4). You can configure BLUEPRINT 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 configuration. 3. In the Proxy Type box, select the proxy type such as HTTP, FTP or SOCKS. 4. In the Server box, type the IP address of the proxy server. 5. In the Port box, type the port number that is used by the proxy server for client connections. 6. Only if your proxy server requires an authentication, type the username and password in according boxes, otherwise leave these fields blank. 7. Click Test Connection to check the settings (Recommended). 8. Click OK to close the configuration box. Update BLUEPRINT 3D Planning screen In case an update is available for the software, the update is proposed to the surgeon (figure 5). If user accepts the update, the file is automatically downloaded, BLUEPRINT 3D Planning software launches the installation and closes itself (figure 6). Send pending cases screen When 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 (figure 7). 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 planning reports are pending, the surgeon has to send them to the server. Figure 7: Send pending cases screen BLUEPRINT 3D Planning Software User Manual v

12 Figure 8: Home screen Figure 9: Preview screen Home screen (figure 8) This 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. BLUEPRINT CT Scan Protocol) are considered to be valid.» Select a planning report to load it. The Load Prior Case 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.» Load a Demo case: The surgeon can directly load a demo case embedded in BLUEPRINT to allow them to trial the software planning functions. Preview screen (figure 9) This 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. Processing screen (figure 10) 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. Figure 10: Processing screen 12 BLUEPRINT 3D Planning Software User Manual v1.5.3

13 Figure 11a: Processing Error screen Figure 11b: Assistance request screen Error Management and Assistance An error can occur during the processing with different possible causes:» A non-compatible CT scan protocol» Images from a cadaver» Revision surgery case (with / without implant)» A challenging or very pathologic case» See also Contraindications A specific dialog box (figure 11a) will appear to help the surgeon to understand the cause and send information directly to the BLUEPRINT coordinator in order to fix any issues due to the images in the future. Assistance can be requested (figure 11b) and the surgeon will be contacted by or phone within one business day (figure 11c). Figure 11c: Assistance request confirmation screen Measurement confirmation screen For more information about the measures (figure 12), please refer to the Appendix C. Figure 12: Measurement confirmation screen 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). BLUEPRINT 3D Planning Software User Manual v

14 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. 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 views (front and axial) Left click on mouse Show / hide the glenoid plane on the 2D views (front and axial) Action menu The 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. 14 BLUEPRINT 3D Planning Software User Manual v1.5.3

15 Figure 13: 2D axial view Figure 14: 2D frontal view 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 (figure 13) - 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 (figure 14) - 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 (figure 15) - 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 15: 3D view Measurement bar The Measurement bar is used to display the inclination, version and depth of the glenoid plane (figure 16). Figure 16: Measurement bar Description of the version is displayed in text form directly below the version angle value, according to the value of that angle: Version angle ( ) Displayed text < 0 Retroversion = 0 Version > 0 Anteversion BLUEPRINT 3D Planning Software User Manual v

16 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: Inclination angle ( ) Displayed text < 0 Inclination Inf = 0 Inclination > 0 Inclination Sup Advanced mode button An additional button is available for use, located to the left of the positioning bar. Element Interaction Action Left click on mouse Advanced mode button allows to display additional measures. Figure 17: Advanced mode window When the advanced mode is triggered, a new window appears to display five additional measures (figure 17):» The radius of the best-fit sphere.» The glenoid orientation and direction.» The Humeral Head subluxation and direction. This Glenoid coordinate system is used to measure the Orientation and the Direction of the glenoid version. The glenoid center and the best-fit-sphere center define the glenoid centerline. The Orientation angle is the angle (degrees) between the glenoid centerline and the LAT-axis (figure 18 left). The Direction is the angle (degrees) between the projection of the glenoid centerline on the SUP-ANT-plane and the POST-axis (figure 18 right). Figure 18: Glenoid orientation and direction angle 16 BLUEPRINT 3D Planning Software User Manual v1.5.3

17 The Humeral Head subluxation and direction measures are defined as followed (figure 19): Figure 19: Humeral head subluxation (right) and direction (left) 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 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 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 mediolateral axis. For more information about the measures, please refer to the Appendix C. BLUEPRINT 3D Planning Software User Manual v

18 Planning screen Figure 20: Modification of parameters for AEQUALIS PERFORM (top) and AEQUALIS PERFORM+ (bottom) This screen enables the user to plan the surgery (figure 20):» 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 also available. Display menu The 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.13) with has a few extra buttons. Element Interaction Action Left click on mouse Show / hide the implant on 2D / 3D views Left click on mouse Show / hide the axis of the implant on the 3D view (hidden by default) Left click on mouse Show / hide the customized guide on the 3D view (available once the template has been created) 18 BLUEPRINT 3D Planning Software User Manual v1.5.3

19 Patient information This part is identical on the Measurement confirmation page (cf p.13). 2D (front and axial) / 3D views This part is identical on the Measurement confirmation page (cf p.13). 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.13) except the buttons control the position of the implant. Element Interaction Action Left click on mouse Modification of the posterior/anterior orientation (1 per click ) and updating of version value Left click on mouse Modification of the inferior/superior orientation (1 per click) and updating of inclination value Left click on mouse Modification of the medial/lateral position (0.5 mm per click) and updating of depth value Implant modification bar This bar is used to modify the implant s parameters. It also enables the user to position the implant. And finally, the seating measurement enables the user to position the prosthesis as accurately as possible. BLUEPRINT 3D Planning Software User Manual v

20 Figure 21a: Modification of the parameters for AEQUALIS PERFORM implant» Modification of implant s parameters (figure 21a and 21b) In order to adapt to each patient s morphology as accurately as possible several parameters can be determined simply by comparing the characteristics of the implants and the articular surface in 2D and 3D. Modifications are made by clicking on the left-hand button of the mouse. Figure 21b: Modification of the parameters for AEQUALIS PERFORM+ implant Figure 22: Seating parameter» Seating (figure 22) 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. To know more these measures, please consult the annexe 3. Figure 23: Moving the implant Moving the implant (figure 23) 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 lefthand 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. 20 BLUEPRINT 3D Planning Software User Manual v1.5.3

21 Element Interaction Action 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 ). The guide computation button is used to create the patient-specific guide Left click on mouse Figure 24: Front view of the polyamide guide on the scapula Figure 25: Side view of the polyamide guide on the scapula At this stage, the user can perform new actions:» Generation of the Patient-Specific Guide An 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 (figures 24, 25 and 26). 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. Figure 26: Front view of the titanium guide on the scapula BLUEPRINT 3D Planning Software User Manual v

22 » Request guide computation by pressing the Guide computation button 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 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 Saving the planning report By pressing the «Save» button the user activates the report saving process. Element Interaction Action Left click on mouse This button is used to save the planning report. This operation will be detailed below. 22 BLUEPRINT 3D Planning Software User Manual v1.5.3

23 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) (figure 27). If surgeon chooses a planned operation date less than three weeks compared to the current date, a message is displayed to warn that the deadline for making the guide may be too short (figure 28). Figure 27: Information related to the planning report Figure 28: Alert if operation date too close from current date The software displays the Summary of the Order page that shows the guide with the Scapula surrogate in 3D (figures 29 and 30). 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 (figure 31). Figure 29: Summary of the order page for the polyamide guide Figure 30: Summary of the order page for the titanium guide Figure 31: Alert when the planning report can t be sent to the server BLUEPRINT 3D Planning Software User Manual v

24 The planning report contains several elements (figure 32):» 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. Planning reports are available in the tab Cases of the exchange platform (figure 33). Click here: Figure 32: Planning report example The surgeon is responsible for saving the planning report once the planning stage has been completed. Figure 33: View of the web page cases list 24 BLUEPRINT 3D Planning Software User Manual v1.5.3

25 Indications APPENDIX A Purpose BLUEPRINT 3D Planning software is an application that helps surgeon 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 BLUEPRINT 3D Planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT 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 BLUEPRINT 3D Planning software. BLUEPRINT 3D Planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon 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. BLUEPRINT 3D Planning software does not include any system to manufacture the guide. BLUEPRINT 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 AEQUALIS PERFORM or AEQUALIS 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. BLUEPRINT 3D Planning Software User Manual v

26 Compatible Implants APPENDIX B The implants accepted by this version are as follows:» AEQUALIS PERFORM Shoulder System, keeled glenoid» AEQUALIS PERFORM Shoulder System, pegged glenoid» AEQUALIS PERFORM Shoulder System, pegged-cortiloc glenoid» AEQUALIS PERFORM+ Shoulder System, pegged-cortiloc glenoid For each AEQUALIS PERFORM implant several sizes and radii of curvature are available. The following table shows the correspondence between size and radius of curvature: SIZE (mm)/radius (mm) Small X X X Medium X X X Large X X X Extra Large X X X Implant not available The AEQUALIS PERFORM+ Shoulder System is an extension of the AEQUALIS PERFORM Shoulder System and was developed to address posterior glenoid deficiencies. The AEQUALIS PERFORM+ Shoulder System features four sizes (Small, Medium, Large, and Extra Large) with a 40 mm backside radius of curvature. Three augmented angles are available to choose from (15, 25, and 35 ) in both lefts and rights. SIZE (mm)/radius (mm) 40 Small Medium Large Extra Large X X X X 26 BLUEPRINT 3D Planning Software User Manual v1.5.3

27 Technical Notes APPENDIX C Figure 1 Figure 1a: Scapula plane landmarks and example of truncated scapulae Figure 1b: Planes and axis calculated by the software Fully automatic method to assess 3D-Glenoid orientation Preoperative 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. BLUEPRINT 3D Planning software introduces a new fully automatic method to compute 3D glenoid version. This method, validated and published 1, 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 (figure 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) (figure 1a). 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/figure 1b) 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/figure 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/figure 1b) is calculated as the best fit line of the cross points between the superior border, the scapular spine and the scapular body. BLUEPRINT 3D Planning Software User Manual v

28 APPENDIX C LAT Figure 2: Glenoid Coordinate Reference System Orientation angle INF SUP SUP ANT Fig. 3a Fig. 3b Glenoid reference coordinate system Once the scapular plane is computed, a glenoid coordinate system ANT-LAT-SUP is defined as following (figure 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 (figure 3a). The Direction angle is the angle (degrees) between the projection of the glenoid centerline on the SUP-ANT-plane and the POST-axis (figure 3b). It is characterized depending of the angle value as following: Direction angle ( ) -180< x <-160 ANT Displayed text -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 POST Direction angle Glenoid Center line INF ANT Figure 3: Glenoid Orientation and Direction Angle 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 Apr;96-B(4):513-8.). 28 BLUEPRINT 3D Planning Software User Manual v1.5.3

29 APPENDIX C Scapular transversal plane Glenoid best-fitsphere center Scapula plane Version angle Inclination angle Figure 4: Glenoid Version and Inclination Angle Figure 5a: HH Volume Fig. 4a Fig. 4b Glenoid version and inclination angle (2D angles) The version angle is defined as the projected orientation angle on the transverse scapular plane (figure 4a). The inclination angle is defined as the projected orientation angle on the scapular plane (figure 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 tests 1. 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 (figure 5a). The direction of the 3D HH subluxation was the polar angle of the humeral head center relative to the glenoid center and the mediolateral axis (figure 5b). Figure 5b: HH Direction BLUEPRINT 3D Planning Software User Manual v

30 APPENDIX C Figure 6: The seating measure Seating The seating measure is used by surgeons to help to position the implant on the glenoid. The measurement is computed when the CT-scans are confirmed by the user and when a new implant is selected. It also updates 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 (figure 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). References 1 Gilles 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 (2015), Terrier A, Ston J, Larrea X, Farron A. Measurements of three-dimensional glenoid erosion when planning the prosthetic replacement of osteoarthritic shoulders. Bone Joint J Apr;96-B(4): doi: / x.96b PubMed PMID: BLUEPRINT 3D Planning Software User Manual v1.5.3

31 Notes APPENDIX D BLUEPRINT 3D Planning Software User Manual v

32 BLUEPRINT 3D PLANNING SOFTWARE HELPLINE Phone: Nesbitt Avenue South Bloomington, MN Rue Lavoisier Montbonnot Saint Martin France +33 (0) Proper surgical procedures and techniques are the responsibility of the medical professional. This material is furnished for information purposes only. Each surgeon must evaluate the appropriateness of the material based on his or her personal medical training and experience. Prior to use of any Tornier implant system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications, and adverse effects. Package inserts are also available by contacting Wright. Contact information can be found in this document and the package insert. The AEQUALIS Glenoid Guides are patient specific instruments specifically designed to facilitate the implementation of the AEQUALIS PERFORM or AEQUALIS PERFORM + shoulder prostheses and are exclusively reserved for this use. and denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved CAW-8338 Rev B DCR Jan-2017