CT Protocol Guide

8/17/2019 CT Protocol Guide

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CT Protocol Reference Guide

For the ConforMIS Family ofKnee Resurfacing Implants

nforMIS, Inc. (Phone: 781/345 ‐9170) 1 © Copyright 2013 ConforMIS, K‐02554 AC 0313

iUni iDuo iTotal® ® ®


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1.0 PATIENT POSITION PAGE 3

2.0 IMAGE AQUISITION PAGE 3

—Protocol Chart PAGE 4

3.0 CT ARTHROGRAM PAGE 7

4.0 IMAGE ARCHIVING PAGE 8

5.0 IMAGE DATA TRANSFER PAGE 8

nforMIS, Inc. (Phone: 781/345 ‐9170) 2 © Copyright 2013. ConforMIS, K‐02554 AC 0313

TABLE OF CONTENTS

All questions regarding this protocol reference guide should be addressed to:

ConforMIS Imaging Support28 Crosby Drive

Bedford, MA 01730-9998Tel: 781/345-9170

Email: [email protected]

ConforMIS Imaging Support is available:Monday-Friday

8.00 am – 6.00 pm (Eastern Time)


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1.0 Patient Position:

The patient should be at isocenter in the gantry and must be supine with extremity of interest fullyextended.To ensure our ability to correct for malalignment of the knee it is critical that the foot be

perpendicular to the table with toes pointing straight up andsecured to prevent motion. Do not place a sponge or pillow beneath the knee or ankle.

When an implant or other device is present in the opposite knee, please make everyeffort to position that knee flexed and out of the FOV to reduce the artifacts in the affected

knee joint. Please use a metal artifact reduction technique.

2.0 Image Acquisition:

The patient first and last name data in the DICOM headerMUST reflect the patient’s legal name

The scan protocol consists of 6 series. Each series should have a distinct series number.(Three short spiral series and coronal and sagittal reconstructions of the knee)

1. Full leg scout from the hip through the ankle2. Hip3. Knee4. Ankle5. Coronal MPR Knee6. Sagittal MPR Knee

Although the knee is of primary interest, limited images of the hip and ankle are required toensure appropriate alignment of the leg with the personalized implant. The axial reconstructionparameters are to be followed as closely as possible as permitted by your specific CT system’scapabilities.

Field Of View(FOV) on all series should be limited to only the affected side. Approximate FOVranges for the hip are 25-30cm, knee 20-25cm, and ankle 15-20cm.

Protocol Build, We recommend building a ConforMIS protocol in your CT scanner(s) with all ofthe appropriate ranges.

GE users tip, if you do not have a pre-defined protocol built: Between scan ranges select “Repeatseries” to scan the next range. Do Not select “Add a group”.

Toshiba users tip: Between scan ranges select “Quit series” and use original scout to scan thenext range.

KV/MaS Settings should be set at your standard setting for each of the anatomic ranges to bescanned.



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Series

1 Scout FULL LEG, Hip through Ankle

Kernel /Algorithm

Axial Reconstruction

Thickness X IncrementProjection

2 Hip – Femoral head only(acetabulum only) Bone2mm X 2mm

or2.5mm X 2.5mm

Axial

3

Knee – distal 1/3 of the femur throughproximal 1/3 of tibia

(should include the entire patella throughthe fibula head)

Bone1mm X .5mm

or1.25mm X .625mm

Axial

4Ankle – center at tibiotalar joint spacescan 2cm above the joint to 2cm below Bone

2mm X 2mmor

2.5mm X 2.5mmAxial

5 Multi Planar

Reformat–knee onlyBone 1mm X 1mm Coronal

6 Multi PlanarReformat–knee only Bone 1mm X 1mmSagittal


ConforMIS CT Scan Protocol


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Note: The imaging protocol described in this manual is only for the purpose of providing informationneeded by ConforMIS to generate the personalized implant design. It might differ from knee imagingprotocols routinely used by your institution for diagnostic purposes and might not provide the sameinformation. The responsible radiologist should decide whether additional scans from your routinediagnostic protocol should be added to the exam to provide any additional information.

Scout Hip Range

Knee Range

Ankle Range


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Knee MPR:

Sagittal and Coronal reformats should be limited to the side of interest andcover bone to bone only. It is preferred for Coronal MPR to be parallel tofemoral condyles, and Sagittal MPR to be perpendicular to femoral condyles.



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3.0 CT Arthrography Protocol:OPTIONALand is NOT required for a ConforMIS protocol scan

This CT imaging option is most often used to assist in the diagnostic evaluation of thepatellofemoral cartilage and the cartilage in the other tibiofemoral compartment. It can also beused for evaluating menisci and cruciate ligaments.

3.1 Routine Arthrography:A routine knee arthrogram should be performed using a contrast agent concentration ofapproximately 150 mg of iodine per milliliter. The dilution is important for the visualizationof the bone and soft tissue structures in the joint space.

Example 1: If Omnipaque 300 is used, dilute with 50 saline.

(DO NOT USE FULL STRENGTH 300)Example 2: If Omnipaque 180 is used, no dilution is necessary.

3.2 Post Arthrogram CT Imaging:As prescribed in sections 1.0 and 2.0 of the ConforMIS CT Protocol and preferably within 60minutes of contrast injection.



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4.0 Image Archive

Important: Your sitemustkeep a permanent archive (PACS) copy of the knee CT exams.

5.0 Image Data Transfer:

It is critical that ConforMIS protocol scans are sent immediately upon completion of theexam via electronic upload whenever possible to ensure the best possible care for the

patient.

There are several methods of image transfer available for ConforMIS protocol exams.

5.1 Image Transmission - Secure Web Upload:

ConforMIS exams can be uploaded from a CD, DVD, or a web enabled PACS to our securewebsite. Go to http://www.ConforMIS.com/Imaging-Professionals/Upload-a-Scan to upload ascan through our secure .ftp site.

5.2 Secure DICOM transfer:ConforMIS is able to retrieve images from cloud based image sharing sites. We are also able toestablish direct PACS to PACS connection in some instances. If you are currently using one ofthese types of applications or are intersted in direct DICOM push capabilities please contactConforMIS Image Support to discuss establishing a connection.

5.3 Priority Shipping:ConforMIS exams that have been saved in uncompressed or loss–less compression DICOM formaton a disk (CD or DVD) can be shipped to ConforMIS. We provide pre-paid envelopes. To obtaina supply please email [email protected] or visithttp://www.ConforMIS.com/Imaging-Professionals/Request-CD-Mailers

nforMIS, Inc. (Phone: 781/345 ‐9170) 8 © Copyright 2013. ConforMIS, K‐02554 AC0313

0086

Medical Device Safety Service, GMBH

Schiffgraben 41 30175 Hannover, Germany Tel: +49(511)6262 ‐8630 Fax: +49(511)6262 ‐8633
http://www.conformis.com/Imaging-Professionals/Upload-a-Scanmailto:[email protected]://www.conformis.com/Imaging-Professionals/Request-CD-Mailershttp://www.conformis.com/Imaging-Professionals/Request-CD-Mailershttp://www.conformis.com/Imaging-Professionals/Request-CD-Mailershttp://www.conformis.com/Imaging-Professionals/Request-CD-Mailershttp://www.conformis.com/Imaging-Professionals/Request-CD-Mailershttp://www.conformis.com/Imaging-Professionals/Request-CD-Mailersmailto:[email protected]://www.conformis.com/Imaging-Professionals/Upload-a-Scan

Documents

CT Protocol Guide