CT — Genunchi Restor3D Conformis (MCB)

Updated 05/05/24 CT Restor3D Conformis Knee Reviewed 05/15/25 Indications - pre surgical evaluation prior to knee joint replacement. Bill under CT LE w/o Contrast charge. Do not include separate hip, knee and ankle charges. GENERAL SCAN NOTES Remove any metal from the imaging field of view. Patient positioning: Patient in supine position feet first with knees extended and toes pointing straight up. Elevate contralateral leg if prosthesis present to minimize streak artifact. Do not allow patient movement between or during the scans. Topogram - iliac crests through feet. Craniocaudal scan coverage (see images below): Hip - acetabulum through bottom of femoral head. FOV 250-300 mm. Knee - distal third of femur through proximal half of tibia. FOV 200-250 mm. Ankle - 2 cm above to 2 cm below ankle joint. FOV 150-200 mm. IV Contrast: not given for this protocol. For GE scanners, it is essential for the 1st recon thickness on the scanner to match the 1st recon thickness in this protocol book for the prescribed Noise Index to be valid. The 1st recon should generally be the thickest recon in the protocol. Prepare an uncompressed DICOM disc containing all images. Hip CC Coverage Knee CC Coverage Ankle CC Coverage

CT Restor3D Conformis Knee SIEMENS PARAMETERS & RECONS For Hip scan: Scan
Care
Mode kV mAs Care
Dose kV & Lvl Pitch Acq Coll Rot Time Sensation 16 spiral 120 200 on NA 0.80 16 0.75 0.5 Go Up 32 spiral 130 109 on on 170 0.80 32 0.7 1.0 Sensation 64 spiral 120 200 on NA 0.90 64 0.6 0.5 Definition 64 spiral 120 190 on on 0.80 64 0.6 1.0 Go Top 64 spiral 120 131 on on 170 0.80 64 0.6 1.0 Drive 128 spiral 120 133 on on 0.80 128 0.6 1.0 Force 192 spiral 120 133 on on 0.80 192 0.6 1.0 For Knee and Ankle scans: Scan
Care
Mode kV mAs Care
Dose kV & Lvl Pitch Acq Coll Rot Time Sensation 16 spiral 120 140 on NA 0.55 16 0.75 1.0 Go Up 32 spiral on 75 0.40 32 0.7 1.0 Sn 110 366 on Sensation 64 spiral 120 140 on NA 0.90 64 0.6 1.0 0.80 64 0.6 1.0 Definition 64 spiral 120 100 on off Go Top 64 spiral Sn 110 898 on on 64 0.6 1.0 0.40 Drive 128 spiral 0.80 128 0.6 1.0 120 70 on off Force 192 0.80 192 0.6 1.0 spiral 120 70 on off HIP RECONS IR
Recon
Name of Series Thick Interval Kernel Window Lvl Direction AX HIP BONE 2.0 2.0 Br59 / B60 bone/osteo head/feet 3 KNEE RECONS AX KNEE BONE bone/osteo 1.0 0.5 Br59 / B60 3 head/feet COR KNEE BONE 1.0 1.0 Br59 / B60 bone/osteo front/back 3 SAG KNEE BONE 1.0 1.0 Br59 / B60 bone/osteo 3 left/right ANKLE RECONS AX ANKLE BONE 2.0 2.0 Br59 / B60 bone/osteo 3 head/feet

CT Restor3D Conformis Knee GE PARAMETERS & RECONS For Hip and Ankle scans: Smart
Slice
Beam
Dose
Pitch Speed Rot
Type SFOV kV mA
Red ASIR Scan
Range Noise
Index mA Thick Coll Time on 2.5 10 0.938 9.37 0.5 LS 16 helical large 120 100-440 12.50 NA NA Opt 540 helical large 120 100-440 12.50 on 2.5 10 0.938 9.37 0.5 NA NA LS VCT 64 helical large body 120 100-450 16.00 on 2.5 40 0.984 39.37 0.5 20 20 0.984 39.37 0.5 20 20 Disc VCT 64 helical large body 120 100-450 16.00 on 2.5 40 For Knee scan: Scan
Smart
Slice
Beam
Dose
Type SFOV kV mA
Range Noise
Index mA Thick Coll Pitch Speed Rot
Time Red ASIR LS 16 helical large 120 100-440 17.68 on 1.25 10 0.938 9.37 0.5 NA NA NA NA 10 0.938 9.37 0.5 1.25 Opt 540 helical large 120 100-440 17.68 on LS VCT 64 helical large body 120 100-450 22.63 on 1.25 40 0.984 39.37 0.5 20 20 Disc VCT 64 helical large body 120 100-450 22.63 on 1.25 40 0.984 39.37 0.5 20 20 HIP RECONS Window
Recon Recon
Name of Series Thickness Interval Algorithm/Mode Width/Level Direction AX HIP BONE 2.5 2.5 bone full 2500/480 head/feet Must be first recon. KNEE RECONS AX KNEE BONE 1.25 0.625 bone full 2500/480 head/feet Must be first recon. COR KNEE BONE 0.625 0.625 bone plus full 2500/480 front/back SAG KNEE BONE 0.625 0.625 bone plus full 2500/480 left/right ANKLE RECONS AX ANKLE BONE 2.5 2.5 bone full 2500/480 head/feet Must be first recon.

CT Restor3D Conformis Knee PHILIPS PARAMETERS & RECONS For Hip, Knee and Ankle scans: Scan
Dose
3D
Rot Mode kV Avg
mAs Index Dose Pitch Detect Colli Time Incisive 128 helical 120 103 20 on 0.80 64 0.625 0.75 HIP RECONS Recon
Name of Series Thick Interval Filter Window iDose Direction AX HIP BONE 2.0 2.0 YC bone 3 head/feet KNEE RECONS AX KNEE BONE 1.0 0.5 YC bone 3 head/feet COR KNEE BONE 1.0 1.0 YC bone 3 front/back SAG KNEE BONE 1.0 1.0 YC bone 3 left/right ANKLE RECONS AX ANKLE BONE 2.0 2.0 YC bone 3 head/feet

CT Lower Extremity Protocol Reference Guide For the restor3d Family of Knee Replacement Implants restor3d® 2024 MK-02554 AJ 07.24 1 Phone: (781) 345-9170

Introduction: Patients who present with an order for a CT Scan of the lower extremity following restor3d protocol are being considered as a candidate for one of the restor3d knee implants. These are customized implants designed from CT scans. TABLE OF CONTENTS 1.0 PATIENT POSITION PAGE 3 2.0 IMAGE ACQUISITION PAGE 4 -Protocol Chart PAGE 5 3.0 IMAGE ARCHIVING PAGE 8 4.0 IMAGE DATA TRANSFER PAGE 8 All questions regarding this protocol reference guide should be addressed to: restor3d Imaging Support 600 Research Dr. Wilmington, MA 01887 Tel: 781-345-9170 Email: [email protected] Imaging Support is available: Monday-Friday 8:00am - 4:00pm (Eastern Time) restor3d® 2024 MK-02554 AJ 07.24 2 Phone: (781) 345-9170

1.0 Patient Position: To ensure our ability to correct malaignment position the extremity of interest with the foot perpendicular to the table and with the toes pointing straight up. While some patients may not be able to be placed exactly as described orientation. Immobilize the legs and toes to prevent motion. The use of positioning aids is encouraged. It is the best not to place a sponge or pillow beneath the knee or ankle of interest. Instruct the patient to hold very still during the scan acquisition. Ensure that no foreign objects are in the scan field. IMMOBILIZATION IS ESSENTIAL The use of a solid, firm positioning aid (as depicted by the black board in the images on this page) is recommended to help immobilize the feet and legs to prevent motion during the scan. There are many common objects that can be used for this purpose. *** When an implant or other device is present in the opposite knee, please make every effort to position that knee flexed and out of the FOV to reduce the artifacts in the affected knee joint. Please do so before acquir­ ing any of the study images. If you available please use a metal artifact reduction technique. *** restor3d® 2024 MK-02554 AJ 07.24 3 Phone: (781) 345-9170

2.0 Image Acquisition: The patient’s first and last name data in the DICOM header MUST reflect the patient’s legal name associated with supporting documentation (ex: license or insurance card) From the full leg scout scan the hip, knee and ankle images in a single acquisition following the protocol outlined in the graph on page 4. Series 1: Full leg scout from the hip through the ankle Series 2: Hip, Knee, Ankle Series 3: Coronal MPR Knee
Series 4: Sagittal MPR Knee Please note: It is acceptable to scan the Hip, Knee and Ankle in separate series. But restor3d strongly suggests scanning them as a single series to help reduce the chance of patient motion. For GE scanners use add group feature to build protocol with 3 ranges. For Siemens scanners used fixed axial option only. Although the knee is of primary interest, limited images of the hip and ankle are required to ensure appropriate alignment of the personalized implant. The axial reconstruction parameters are to be followed as closely as possible as permitted by your specific CT system’s capabilities Displayed Field Of View (DFOV) on all series should be limited to only the affected side. Approximate FOV ranges for the hip are 25-30cm, knee 20-25cm, and ankle 15-20cm. Check the images to make sure that all the anatomy is included. If necessary please reconstruct any series with appropriate centering to recover missing anatomy.

Protocol Build, We recommend building a restor3d protocol in your CT scanner(s) with all of the appropriate ranges. KV/MaS Settings should be set at your standard setting for each of the anatomic ranges to be scanned. restor3d suggests employing dose reduction techniques whenever possible. Bilateral Imaging—To reduce radiation exposure bilateral imaging should be accomplished in a single acquisition with separate reconstructions of each leg. See example on last page. Before the patient leaves the scan table, please review all images to ensure that there is no motion and that the patient did not change position during the scan.
If motion and/or positional changes are detected, all series (hip, knee and ankle) should be reacquired. restor3d® 2024 MK-02554 AJ 07.24 4 Phone: (781) 345-9170

restor3d Protocol for CT of the Lower Extremity All scans should be acquired in the helical/spiral mode, pitch as close to 1:1 as possible, using the body filter (50 cm SFOV). From the full leg scout the hip, knee and ankle images can be acquired in Series a single scan acquisition. Then provide reconstructed series in the coronal and sagittal planes of the knee. Send all images that are acquired including the scout and dose page. FULL LEG, Hip through Ankle 1 Scout Reconstruction Thickness X Increment Kernal / (table increment should Projection Algorithm not exceed slice thickness) 2mm X 2mm Hip - Femoral head only or Bone Axial 2 (acetabulum only) 2.5mm X 2.5mm Knee – distal 1/3 of the femur 1mm X .5mm
through proximal 1/2 of tibia
(should include the entire or 2 Bone Axial patella through midpoint of the 1.25mm X .625mm lower leg) Ankle – center at tibiotalar joint 2mm X 2mm space scan 2cm above the Bone Axial or 2 joint to 2cm below 2.5mm X 2.5mm Multi Planar 1mm X 1mm Bone Coronal 3 Reformat– knee only Multi Planar Reformat– 1mm X 1mm Sagital 4 knee only Bone restor3d® 2024 MK-02554 AJ 07.24 5 Phone: (781) 345-9170

Note: The imaging protocol described in this manual is only for the purpose of providing information needed by restor3d to generate the personalized implant design. It might differ from knee imaging protocols routinely used by your institution for diagnostic purposes and might not provide the same information. The responsible radiologist should decide whether additional scans from your routine diagnostic protocol should be added to the exam to provide any additional information. Scout Hip Range Knee Range Ankle Range restor3d® 2024 MK-02554 AJ 07.24 6 Phone: (781) 345-9170

Knee MPR: Sagital and Coronal Can use DMPR to make reformats Sagital MPR Coronal MPR restor3d® 2024 MK-02554 AJ 07.24 7 Phone: (781) 345-9170

3.0 Image Archive Important: Your site must keep a permanent archive (PACS) copy of the CT exams. We also encourage you to protect the the raw data for as long as possible. 4.0 Image Data Transfer It is critical that restor3d protocol scans are sent immediately upon completion of the exam via electronic upload whenever possible to ensure the best possible care for the patient. There are several methods of image transfer available for restor3d protocol scans. Prior to transmitting, ensure that your DICOM data file is complete, containing the scout, the dose page and all images and series aquired for the patient. 4.1 Secure Web Upload: restor3d scans can be uploaded from a CD, DVD, or a web enabled PACS to our
secure website. Go to https://widgets.nuancepowershare.com/easyupload/Con­ formis to upload a scan through our secure .ftp site. 4.2 Secure DICOM transfer via Cloud Sharing Networks: restor3d is able to retrieve images from cloud based image sharing sites. If you are currently using one of these types of applications or are interested in establishing a secure cloud connection please contact restor3d Image Support at 781-345-9170 to discuss establishing a connection. We are a Nuance PowerShare Hub and can be found under Conformis Inc. Just send an invite. 4.3 Priority Shipping: To ensure that the patient’s images are received and reviewed as quickly as possible we strongly recommend the use of an electronic method of DICOM data transfer for restor3d protocol scans. However if you are unable to send studies electronically restor3d scans that have been saved in uncompressed or loss–less compression DICOM format on a disk (CD or DVD) can be shipped to restor3d.
We provide pre-paid envelopes labels. To obtain a supply please email imaging- [email protected] restor3d® 2024 MK-02554 AJ 07.24 8 Phone: (781) 345-9170

Example of biilateral scan below. If scanner will not allow you to manipulate the raw data to produce a right and left leg with the smaller FOV’s you will need to scan each leg seperately. restor3d® 2024 MK-02554 AJ 07.24 9 Phone: (781) 345-9170