White Paper: Multitom Rax - True2scale Body Scan for Musculoskeletal Imaging - Imaging Technique and Clinical Application

White paper Multitom Rax – True2scale Body Scan for musculoskeletal imaging Imaging technique and clinical applications Karl-Philipp Kienle (MD, PhD, MBA), Magdalena Herbst, Marcel Beister (PhD), Andreas Fieselmann (PhD), Christoph Luckner (PhD), Ludwig Ritschl (PhD), Steffen Kappler (PhD), Axel Hebecker (PhD) SIEMENS Healthineers True2scale Body Scan · White paper Table of contents Introduction 3 The technique and its added value 4 Extended coverage & precision 4 Low dose 6 Fast acquisition and workflows 7 Clinical application and practice 9 Imaging of the whole spine in two planes 9 Imaging of the lower limbs 11 Imaging in natural weight-bearing and in lying patient position 12 Imaging of the whole body 14 True2scale Body Scan and beyond with Multitom Rax 14 Conclusion 15 Abbreviations 16 References 17 2 True2scale Body Scan · White paper Introduction True2scale Body Scan (T2S) is an option on the Twin- The first part of this white paper will provide a technical Robotic X-ray system Multitom Rax, developed for the overview of length-extended imaging, with a focus on requirements of a musculoskeletal department to obtain True2scale, a slot-scanning based image acquisition and length extended images of the skeletal system. Moreover, reconstruction technique, in comparison to conventional due to its modular design, Multitom Rax enables radiography and stitching. The second part will provide conventional radiography, fluoroscopic examinations an overview of typical clinical applications including first for functional assessment as well as 3D imaging – all on clinical images. one system. True2scale is engineered to capture geometrically accurate biplanar images of the entire body, whole spine, and long-leg. These images are intended to assess skeletal malposition, such as scoliosis1 or osteoarthritis secondary to malalignment of the limbs2. Since postural dysfunctions may be influenced by the scanning position of the patient, weight-bearing radiographs are preferred for length extended imaging procedures, if the patient is able to stand during the examination3. Long-leg images are also used for preoperative planning for total hip or knee prostheses4. 3 True2scale Body Scan · White paper True2scale Body Scan The technique and its added value In this section, the acquisition technique, and its special Especially for a small SID (source-image distance), this characteristics as well as the differentiation from other can result in relevant measurement deviations5. Thus, techniques is introduced. The operating options and the it is mandatory to perform calibration steps, such as processes are described, and necessary dose values placing a calibration ball in the relevant plane or according to the ALADA (As Low As Diagnostically measuring the table-object-distance (TOD)5,6. Acceptable) principle are discussed. Slot scanning technique Extended coverage & precision The slot-scanning technique allows geometrically accurate imaging of larger body areas or even the whole body. The active area of flat-panel detectors used in digital Here, images are either generated from highly collimated radiography is usually limited to approximately 43 x 43 cm X-ray beams captured by a linear detector entrance slit7 in size. Therefore, the full bone structure of the spine or (see Figure 1b), or reconstructed by a dedicated leg cannot be captured in a single image. To solve this reconstruction technique taking the small but existing problem, different technologies have been developed divergence of the beam into account, as recently to achieve length extended images that fully cover larger introduced with True2scale imaging (see Figure 1c)8. body parts. For True2scale X-ray source and detector move simultan- Source tilt & stiching technique eously and parallel along the body axis (head to toe or In conventional source tilt & stitching imaging, e.g., toe to head). During this process, highly collimated implemented in the SmartOrtho/ RaxOrtho function images are acquired with a divergence of approximately of Multitom Rax, the source is rotated at its stationary 2° in the scan direction. The True2scale reconstruction anchorage to create multiple, slightly overlapping technique takes this small divergence of the beam into images, which are then joined by software (Figure 1a). account, and effectively prohibits clinically relevant The rotation is aligned with the detector so that the distortion or magnification in this direction8. emitted beams always strike the entire detector during the acquisition of up to four images as it moves along the region of interest being examined. Due to the different beam angles and distances between the emitter and the detector, distortion and magnification effects occur. a Source tilt & stitching b Slot-scanning c True2scale Body Scan Figure 1: Illustration of the techniques of conventional source tilt & stitching (a); slot-scanning (b); True2scale slot-scanning technique (c) 4 True2scale Body Scan · White paper In the orthogonal direction (patient left-right axis), the A True2scale acquisition in natural weight-bearing position image still bases on a divergent beam geometry; as the offers a scan length of up to 170 cm. In addition, True2scale patient position is defined by positioning markers, the can be used for examinations at the table, with the patient magnification factor is known and can be corrected during in a lying position, up to a scan length of 190 cm. The reconstruction by the software. The use of calibration maximal width at patient plane is 33 cm for anterior- objects (balls, rules, etc.) is not required. Due to the nature posterior (a.p.) images and 27 cm for lateral images. of the True2scale imaging technique, objects, that are positioned outside the focal volume, might cause artifacts A side-by-side overview of the techniques, True2scale and and will appear blurry. SmartOrtho/ RaxOrtho, as well as their functionalities, is shown in Table 1. True2scale Body Scan SmartOrtho/RaxOrtho Length extended images 170 cm standing, 190 cm supine 154 cm standing, 143 cm supine Coverage Width 33 cm for a.p., Width approx. 40 cm at 3 m SID 27 cm for lateral images Acquisition Slot scanning reconstruction technique Source tilt & stitching technique allowing with geometrical accuracy manual pixel-based optimization Workflow Biplanar length extended acquisition Monoplanar length extended acquisition without repositioning Patient positioning Flexible positioning: standing (weight-bearing), seated or supine Spatial resolution Continuous acquisition in binned mode High resolution radiographic images Dose Dedicated low dose imaging protocols for e.g., scoliosis Table 1: Comparison of the length extended imaging techniques, True2scale Body Scan and SmartOrtho/ RaxOrtho. The True2scale reconstruction method applied on the acquired images yields geometrically accurate images in scanning direction. The user does not need H. to perform additional calibration steps. 5 True2scale Body Scan · White paper Low dose Another benefit of the high beam collimation, as described Therefore, the method of high beam collimation creates as the basis for the slot-scanning technique, is a native a higher SNR, thus an image of comparable quality can scatter reduction9. Scattered radiation impairs image be obtained with a lower radiation dose10. Figure 3 quality, as it reduces the image contrast and the signal- shows an example of the same Dose Area Product (DAP) to-noise ratio (SNR). Figure 2 illustrates how the beam (2.3 µGy*m²) and the respective image quality. collimation reduces scattered radiation in slot scan images two patterns are mainly relevant. First, less scatter Luckner et al. investigated the dose saving potential – events take place, which would cause scattered photons in on a prototype of the slot-scanning technique with a the relevant area. Second, an amount of the scattered slot size of 5 x 43 cm compared to a full-field acquisition photons reaches the detector outside the collimated area, (43 x 43 cm)9. Two distinct acquisition settings (80 kVp and thus do not affect the acquired image. without copper filtration and 120kVp with 0.3 mm copper filtration) were evaluated on two different regions of a body phantom: thoracic spine and lumbar spine. ----- ......... .................... Figure 2: Beam collimation as native scatter reduction method. Figure 3: Phantom images acquired with conventional full-field (top) Due to the collimation, less scatter events take place. Furthermore, and the slot-scanning technique (bottom). DAP of both images is less scattered photons reach the detector in the relevant area. 2.3 µGy*m². 6 True2scale Body Scan · White paper 100% -65% -72% -54% -61% -69% -65% -52% -47% Dose of full-field acquisition with grid T2S without grid 0% T2S with grid 80 kVp; 120 kVp; 80 kVp; 120 kVp; 0.0 mm CU 0.3 mm CU 0.0 mm CU 0.3 mm CU Lumbar spine Thoracic spine Figure 4: Dose saving potentials, comparing full-field to slot-scanning acquisition, without compromising on image quality in terms of SNR [Luckner et al. [9] ]. 80kVp as a typical setting for a.p. images and 120kVp for lateral images. (CU = copper filter) Depending on the compared acquisition settings, in The scatter-rejecting property of the the study from Luckner et al., dose savings between True2scale acquisition technique allows 47% and 72% were feasible compared to a full-field to reduce dose compared to a full-field H. acquisition, keeping the SNR constant9. All results are acquisition while maintaining a good SNR shown in Figure 4. with a gridless acquisition, independent of the patient size. Fast acquisition and workflows True2scale images can be acquired in supine or upright To adapt to patient-specific conditions, e.g. pediatric (weight-bearing) patient position. Supine images are imaging, obese patients, etc., True2scale can be operated in acquired at the table; for weight-bearing images, the three different speeds. In the fastest acquisition mode, the patient stand of Multitom Rax is used and helps to reduce system moves with 27 cm/s (0.972 km/h) along the patient. motion artifacts during image acquisition, by giving the To avoid blurring of the images, as known for example patient a good balance with attachable handles and from long time exposed night shots in photography, the positioning aids for secure patient positioning. exposure time must be adapted (shortened) accordingly. For the fastest acquisition mode, the exposure time is True2scale offers acquisitions in a.p. and/or lateral limited to 2 ms. During this time, the system moves appro- orientation for three positions supine, seated or standing. ximately 0.54 mm, yielding sufficient spatial resolution. As the system moves around the patient, the patient does With an exposure time of 2 ms, the dose output of the tube not need to be repositioned. There is the choice between is limited. Especially for larger patients, longer exposure a.p., lateral, or combined a.p. and lateral scans,* where times are required for adequate image quality, thus, the system acquires first the a.p. and then the lateral view. two modes with slower acquisition speeds are offered (14 cm/s and 8 cm/s), which allow longer exposure times For a fast readout at 30 frames per second, the detector (4 ms and 7 ms) without affecting the spatial resolution. is operated in a 2x2 binning mode, resulting in 0.296 mm x 0.296 mm detector pixel spacing. This combi- Despite the 2x2 binning and the fast system movement nation enables unilateral full-body acquisitions (170 cm) in during the scan, all True2scale scanning modes yield a as little as 8 seconds, and biplanar full-body acquisitions spatial resolution that is sufficient for typical orthopedic in as little as 22 seconds,depending on the patient's examinations in terms of musculoskeletal measurements Body-Mass-Index (BMI). (14 lp/cm @ 10 % MTF)11. *The combined acquisition is available up to a patient BMI of 30 kg/m2 7 True2scale Body Scan · White paper i The following table summarizes typical acquisition parameters: Overview of typical acquisition parameters and image characteristics of True2scale Body Scan Scan time single plane 8 – 18 s biplane 22 – 34 s Tube voltage 40 – 150kV (lower for pediatric examinations) Source-detector distance 132 – 150 cm Image type frontal and lateral 2D reconstructed image Pixel size (detector) 0.296 mm (2x2 binning, native 0.148 mm) Pixel size (recon) 0.25 mm Spatial resolution up to 1.4 lp/mm ± 10% @ 10% MTF Max. image length 170 cm standing 190 cm lying Max. image width 34 cm for a.p. view 28 cm for lateral view 8 True2scale Body Scan · White paper True2scale Body Scan Clinical application and practice The first section focused on the technical conditions and During follow-up examinations, imaging of the coronal capabilities. In the following, clinical application areas plane only is often considered sufficient in order to of True2scale (whole spine, long-leg, and whole body) minimize radiation dose. Thus, it is not only important are specifically addressed. To make this as practical as to have the possibility to acquire bi-planar orthogonal possible, the areas of application are discussed using real images without repositioning, but to decide to only case examples. operate one plane. Imaging of the whole spine In the context of the above, it is important to mention scoliosis, an abnormal lateral curvature of the spine in two planes (skolios = curved/crooked)18. Often young patients are affected, who require regular radiographic follow-up The German Back Pain Study and Health Survey evaluated (therefore ALADA plays an even more important role to the lifetime prevalence of low back pain which was 85%12. keep the live time exposure as low as possible), in which This was increasing with age, with 11% of those under comparability, but also weight-bearing imaging, plays 30 years of age reporting low back pain (defined as a significant role19. persisting for at least three months) in the past year, compared with 30% of those aged 65 years and older13. To illustrate the clinical value-add of True2scale, a scoliosis Approximately one-third of sufferers are not pain-free after case will be discussed in more detail. one year, and the relapse rate is equally high14. Since back pain is very nonspecific, the goal of diagnostics is to find out the causalities and to recognize emergencies. It is not generally recommended to perform imaging for episodes of low back pain, but if the pain persists for more than four to six weeks, the indication for imaging is suggested to be considered15,16. For imaging spinal deformities and diseases, True2scale can be a well-suited tool for the radiologist and orthopedist. In this context, the factors of high precision, described above, due to the comparability of even small progression changes, as well as the low dose play a significant factor. Furthermore, the limited mobility and the possible pain during positioning for imaging play a significant role. Therefore, it is also advantageous from the perspective of patient comfort and workflow to be able to acquire the coronary and sagittal image planes without repositioning17. 9 True2scale Body Scan · White paper a Study ID: 5aad375 b c d Study ID: 5aad373 Study ID: 5aad373 Figure 5: Images of a patient one year after internal spinal fusion with the radiological indication of loosening or dislocation. Comparable images in the source tilt & stitching (image (a)), and in the True2scale technique (image (b – d)), a.p. (image (c)) and lateral (image (d)) are shown. (Courtesy of Pediatric Radiology, Children’s and Youth Hospital “Auf der Bult“ Hannover, Germany) Case 1: Figure 5 shows the a.p. and lateral images of an adolescent processed by the technician, which was not done in this patient (age 15-20 years), who had received an internal particular case. This takes additional time and is error spinal fusion one year earlier due to progredient scoliosis, prone. The same area, taken with True2scale (image (b)), based on a progressive neurological disease (neuronal reveals good diagnostic quality. Moreover, both, the a.p. ceroid lipofuscinosis CLN 6 mutation) with advancing (image (c)) and lateral (image (d)) view of the True2scale cognitive and motor impairment. The objective in this Body Scan are shown in Figure 5. case was a routine check to exclude implant loosening or dislocation. On image (a) a typical “stitching artifact” can In this case, True2scale plays out its advantage of be seen as it might occur with the source-tilting technique, bi-planar imaging without repositioning and distortion- making it difficult to reveal loosening of the implanted free imaging. material. These artifacts must be identified and manually 10 True2scale Body Scan · White paper Imaging of the lower limbs In long-leg images of the lower extremity, an anatomical entire limb20. For this purpose, the long-leg scan has proven and a mechanical axis can be described (Figure 6). to be an effective and high quality instrument with a low The mechanical axis in particular plays an important role dose.21 The determination of the anatomical and mecha- in planning a successful knee arthroplasty treatment. nical axis as well as joint orientation angles can be seen A clinically and functionally good outcome is found to be in Figure 7. Case 2 illustrates such a long-leg allocation. based on a good mechanical alignment of the knee and the a b c d Femur Tibia Femur Tibia (a) Anatomical axes Anatomical axes (b) Mechanical axes Mechanical axes (c) Joint orientation lines Joint orientation lines Figure 6: Differentiation between anatomical and mechanical axis of the lower extremity as well as joint orientation angle. a) hip joint orientation line; b) distal femoral knee joint orientation line; c) proximal tibial knee joint orientation line; d) ankle joint orientation line LPFA = 90° MPFA = 84° (80° – 89°) (85° – 95°) aLDFA = 81° mLDFA = 88° (79° – 83°) (85° – 90°) MPTA = 87° MPTA = 87° (85° – 90°) (85° – 90°) LDTA = 89° LDTA = 89° (86° – 92°) (86° – 92°) a Anatomical axes (a) Anatomical axis b Mechanical axis (b) Mechanical axis c Joint orientation angles (c) Joint orientation d Joint orientation angles (d) Joint orientation of the lower limb. of the lower limb. of the lower limb. of the lower limb. relative to the anatomical angles relative to the relative to the mechanical angles relative to the axes of the lower limb. anatomical axes of axes of the lower limb. mechanical axes of the lower limb. the lower limb. Figure 7: Planning of total knee replacement based on the mechanical axis and alignment 11 True2scale Body Scan · White paper Imaging in natural weight-bearing and in lying patient position Case 2: This case is a 70 - 80-year-old patient with a condition Since True2scale of both body regions can be acquired after hip replacement and a known gonarthrosis on the with the patient in supine or standing position, the latter right side with increasing pain especially under weight- case allows imaging under natural weight-bearing bearing. In preparation for knee arthroplasty, a long-leg conditions. Advantages in clinical decision-making and True2scale Body Scan was taken under weight bearing treatment planning have been described in the literature conditions. for weight-bearing imaging of the spine and lower extremity. In Figure 8, the native image of the scan and the measure- ments, using mediCAD® planning software22 for long-leg Several studies investigated spinal curvature (main application measurements, can be seen. KPI Cobb angle) and the rotational component of scoliosis 23,24,25,26 . Significant differences could be found between weight-bearing and supine positions. These discrepancies were found for 2D (radiography), 3D imaging (computed tomography (CT), and magnetic resonance imaging (MRI)). The variations in the studies ranged from 1° to 21° for scoliosis measurements. This shows the importance of this type of examination. The findings for the lower extremity are similar. A.p. natural weight-bearing hip imaging is described as standard, since better assessability of joint space narrowing (JSN) in osteo- arthrosis or the extent of hip dysplasia are described27,28,29. Advantages of weight-bearing have also been described in the initial assessment of the knee (a.p., lateral, and skyline views) for assessing the JSN and measuring the knee axes30. For example, Adelani et al. described that in patients > 40 years of age with a JSN greater than 50% on weight-bearing radiographs, MRI is not useful, as it has no impact on treatment decisions in 95% of cases31. Finally, weight-bearing is also a decisive factor in imaging the foot. Both in the evaluation of foot geometry and osteo- arthritis, weight-bearing images should be preferred32,33. Study ID: 5aad373 Figure 8: True2scale long-leg imaging of a 70- 80-year-old patient with gonarthrosis of the right knee for pre-operative planning; left – native image; right – measurements on the True2scale examination using mediCAD® planning software (green = anatomical axis lower limb; blue = mechanical axis lower limb; yellow = mechanical axis femur/ tibia) (Courtesy of Department of diagnostic and interventional radiology, Krankenhaus der Augustinerinnen, Cologne, Germany) 12 True2scale Body Scan · White paper CO im Liegen a b Study ID: 5aad145 Study ID: 5aad144 Figure 9: Patient (12 – 15-year-old) with idiopathic lumbar scoliosis. Routine control after fitting with a day and night orthosis. Image a (left) taken under weight-bearing conditions, image b (right) in supine. (Courtesy of Institute and Polyclinic for Diagnostic and Interventional Radiology, University Hospital Carl Gustav Carus, Technical University Dresden, Germany) Case 3: In this case, a young patient (12 – 15 years) with idiopathic lumbar scoliosis was fitted with a day and a night orthosis due to progressive scoliosis. The indication for the present X-ray imaging was a routine check, performed in the supine and standing position (Figure 9). The above- described findings of a more prominent cobb angle under weight-bearing can be validated with measurements – weight-bearing 35.2° vs. supine position 19.9°. However, therapy was evaluated as sufficient and kept until progression of clinical symptoms or radiographic findings. 13 True2scale Body Scan · White paper Imaging of the whole body Another use case is full-body radiography, which allows the system’s range of motion of 190 cm supine and 170 cm standing. From a clinical perspective, the need for such images is not an everyday routine, yet it can add value for specific issues. Advanced Trauma Life Support, foreign body detection, pediatric imaging and control of ventri- culoperitoneal shunts have been reported as fields for full body X-ray34,35,36,37,38. However, True2scale is only intended to be used for positional diagnostics of the body axes. True2scale Body Scan and beyond with Multitom Rax Multitom Rax is designed not only for length extended images, but has a variety of applications, that add value like True2scale in musculoskeletal (MSK) imaging. Thanks to its modular design, Multitom Rax can be quickly configured to suit patients’ needs. Starting with precision radiography, it also allows Real3D imaging for the extremities and lumbar spine, as well as fluoroscopic imaging for functional assessment. This way, Multitom Rax enables comprehensive diagnosis and can provide the basis for treatment planning – all in a single room on a single system. Study ID: 5aac694 Figure 10: True2scale Body Scan whole body image for positional diagnostics. (Courtesy of Institute and Polyclinic for Diagnostic and Interventional Radiology, University Hospital Carl Gustav Carus, Technical University Dresden, Germany) 14 True2scale Body Scan · White paper True2scale Body Scan Conclusion Siemens Healthineers True2scale Body Scan employs a slot-scanning based acquisition and reconstruction technique as an option of the Twin-Robotic X-ray system Multitom Rax. In addition to the diagnostic use in standard radiography, fluoroscopy and 3D imaging, the True2scale functionality of Multitom Rax offers uni- or biplanar, fast and geometrically accurate information. It allows low-dose imaging of the whole spine for assessment of spinal deformities and associated malposition, as well as long-leg or whole-body imaging for the diagnosis of malalignment. Having the option of performing the image acquisition with the patient in natural weight-bearing or lying position, this acquisition can be done without the need for calibration or stitching of images, or the need of repositioning the patient. 15 True2scale Body Scan · White paper Abbreviations µ Micro a.p. Anterior – posterior ALADA As low as diagnostically acceptable BMI Body-Mass-Index cm Centimeter CT Computed tomography Cu Copper DAP Dose area product e.g. Exempli gratia Gy Gray JSN Joint space narrowing k Kilo kVp Kilo volt peak lp Line pairs m² Square meter MRI Magnetic resonance imaging ms Milliseconds MSK Musculoskeletal MTF Modulation transfer function s Seconds SID Source-image distance SNR Signal to noise ratio T2S True2scale Body Scan TOD Table-object-distance V Volt 16 True2scale Body Scan · White paper References 1 Diebo BG, Shah NV, Boachie-Adjei O, Zhu F, 9 Luckner C, Weber T, Herbst M, Ritschl L, Kappler S, Rothenfluh DA, Paulino CB, Schwab FJ, Lafage V. Maier A. A phantom study on dose efficiency for Adult spinal deformity.Lancet 2019; 394:160-72. orthopedic applications: Comparing slot-scanning 2 Gheno R, Nectoux E, Herbaux B, Baldisserotto M, radiography using ultra-small-angle tomosynthesis Glock L, Cotten A, Boutry N. Three-dimensional to conventional radiography. 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Scoliosis 2014; 9 (01) 16 low-dosage, digital X-ray scanning (LODOX-Statscan) 24 Torell G, Nachemson A, Haderspeck-Grib K, Schultz A. in trauma. Scand J Trauma Resusc Emerg Med. 2009 Standing and supine Cobb measures in girls with Sep 12;17:41. doi: 10.1186/1757-7241-17-41. PMID: idiopathic scoliosis. Spine 1985; 10 (05) 425-427 19747397; PMCID: PMC2753336. 18 True2scale Body Scan · White paper 35 Deyle S, Wagner A, Benneker LM, Jeger V, Eggli S, Bonel HM, Zimmermann H, Exadaktylos AK. Could full- body digital X-ray (LODOX-Statscan) screening in trauma challenge conventional radiography? J Trauma. 2009 Feb;66(2):418-22. doi: 10.1097/ TA.0b013e31818a5d1a. PMID: 19204516. 36 Mantokoudis G, Hegner S, Dubach P, Bonel HM, Senn P, Caversaccio MD, Exadaktylos AK. How reliable and safe is full-body low-dose radiography (LODOX Statscan) in detecting foreign bodies ingested by adults? Emerg Med J. 2013 Jul;30(7):559-64. doi: 10.1136/emermed-2011-200911. Epub 2012 Jul 25. PMID: 22833594. 37 Pitcher RD, Wilde JCH, Douglas TS, van As AB. The use of the Statscan digital X-ray unit in paediatric polytrauma. Pediatric Radiology. 2009;39(5):433–437. 38 Fathi AR, Mariani L, Farkas ZS, Exadaktylos AK, Bonel HM. Evaluation of the new statscan radiography device for ventriculoperitoneal shunt assessment. American Journal of Roentgenology. 2011;196(3):W285–W289. 19 The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed. True2scale Body Scan can be run without restrictions up to a BMI of 30 kg/m². From software version VF11H (expected to be available from December 2022) up to a BMI of 40 kg/m². Exceeding the BMI limit requires manual and separate anterior-posterior and lateral scans. For patients with a BMI >40 kg/m², a lateral long axis image is limited to max. 130 cm. Results from case studies are not predictive of results in other cases. Results in other cases may vary. 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