Health technology assessment in musculoskeletal radiology: the case study of EOSedge™.

OBJECTIVES: Health technology assessment (HTA) is a systematic process used to evaluate the properties and effects of healthcare technologies within their intended use context. This paper describes the adoption of HTA process to assess the adoption of the EOSedge™ system in clinical practice. METHODS: The EOSedge™ system is a digital radiography system that delivers whole-body, high-quality 2D/3D biplanar images covering the complete set of musculoskeletal and orthopedic exams. Full HTA model was chosen using the EUnetHTA Core Model® version 3.0. The HTA Core Model organizes the information into nine domains. Information was researched and obtained by consulting the manufacturers' user manuals, scientific literature, and institutional sites for regulatory aspects. RESULTS: All nine domains of the EUnetHTA Core Model® helped conduct the HTA of the EOSedge, including (1) description and technical characteristics of the technology; (2) health problem and current clinical practice; (3) safety; (4) clinical effectiveness; (5) organizational aspects; (6) economic evaluation; (7) impact on the patient; (8) ethical aspects; and (9) legal aspects. CONCLUSIONS: EOS technologies may be a viable alternative to conventional radiographs. EOSedge has the same intended use and similar indications for use, technological characteristics, and operation principles as the EOS System and provides significant dose reduction factors for whole spine imaging compared to the EOS System without compromising image quality. Regarding the impact of EOS imaging on patient outcomes, most studies aim to establish technical ability without evaluating their ability to improve patient outcomes; thus, more studies on this aspect are warranted.

Does Laminectomy Affect Spino-Pelvic Balance in Lumbar Spinal Stenosis? A Study Based on the EOS X-Ray Imaging System.

PURPOSE: Lumbar spinal stenosis (LSS) is a degenerative disorder causing the forward bending of the trunk and pelvic retroversion with the consequent loss of lumbar lordosis; surgical treatment is intended to enlarge the canal and foramina and decompress the nerve roots. The purpose of our study is to determine whether and to what extent facet-sparing laminectomy affects the spino-pelvic balance. METHODS: The spino-pelvic balance of 26 patients was analysed before and after surgery through the EOS X-ray Imaging System. The following parameters were considered: thoracic kyphosis (TK), lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT) and sacral slope (SS). Clinical data were expressed in numeric values according to the Oswestry Disability Index (ODI), the visual analogue scale (VAS) and the modified Japanese Orthopaedic Association (mJOA) scoring system. RESULTS: Significant SS decreases and PT increases were noticed after surgery, without modification in LL, axial vertebral rotation (AVR) and the general alignment. Pain and disability had a significant improvement, as represented by a decrease in scores on the VAS and ODI scales and an increase in scores on the mJOA functional scale. CONCLUSION: The most important parameter seems to be a congruence between pelvic and spinal parameters, which achieves an economic posture with the physiologic position of the axis of gravity. According to the literature, a standard sagittal balance (SB) has not been defined.

Gravity center estimation for evaluation of standing whole body compensation using virtual barycentremetry based on biplanar slot-scanning stereoradiography - validation by simultaneous force plate measurement.

BACKGROUND: Whole body standing alignment (WBSA) in terms of biomechanics can be evaluated accurately only by referring the gravity line (GL) which lies on the gravity center (GC). Here, we introduce a method for estimating GL and simultaneous WBSA measurement using the EOS® imaging system and report on the reproducibility and reliability of the method. METHODS: A 3-dimensional (3D) avatar to estimate GC was created following three steps: 3D reconstruction of the bone based on EOS images; deformation into a generic morphotype (MakeHuman statistical model) before density integration with 3D rasterization of the full body into 1-mm3 voxels (the content of each voxel is considered homogeneous); computation of the density of all the voxels provides the center of mass, which can be projected onto the floor as the GC of the full body, providing the GL in relation to the WBSA. The repeatability, reproducibility, and accuracy of the estimated GC and body weight of the avatar were compared with clinical estimation using a force plate in healthy volunteers and patients with degenerative and deformative diseases. RESULTS: Statistical analyses of the data revealed that the repeatability and reproducibility of the estimation was high with intra-rater and inter-rater intraclass correlation coefficient. ≥0.999. The coordinate values of the GC and body weight estimation did not differ significantly between the avatar and force plate measurements, demonstrating the high accuracy of the method. CONCLUSION: This new method of estimating GC and WBSA is reliable and accurate. Application of this method could allow clinicians to quickly and qualitatively evaluate WBSA with GL with various spinal malalignment pathologies.

Implant Orientation Measurement After THA Using the EOS X-Ray Image Acquisition System.

We investigated the accuracy of measuring implant orientation after THA in standing position using EOS system (EOS Imaging Inc., Paris, France). Ninety patients who underwent THA were subjected to this study by comparing angles measured by EOS system and those measured from CT scans using 3D image analyzing software, ZedHip (LEXI, Tokyo, Japan). The radiographic cup inclination and anatomical cup anteversion were measured with respect to the anterior pelvic plane (APP) coordinate. The femoral stem antetorsion was analyzed by measuring the angles between the stem neck axis and the post-condylar axis in the femoral functional axis coordinate.The differences (mean ± SD) (range of 95%CI) between angles measured by EOS system and those from CT scans in the cup inclination, cup anteversion, and stem antetorsion were - 2.3° ± 2.7° (-2.8°âˆ¼ - 1.7°), -0.1° ± 5.0° (-1.2°âˆ¼0.9°), and - 1.3° ± 6.5° (-2.7°âˆ¼0.1°), respectively. Cup inclination measured on 14 hips, cup anteversion measured on 28 hips, and stem antetorsion measured on 27 hips were classified as outliers whose differences were over 5°. Difficulties in defining the reference points for APP correlated with the incidences of the outliers in cup orientation measurements.We could not set new reference points on the 3D bone surface models reconstructed by EOS system, so we have to use reference points defined on 2D images. In addition, the APP coordinate in EOS system was not the same as the standard definition. EOS system may not be used to measure the implant positions after THA until these problems will be improved.

Organ doses and lifetime attributable risk evaluations for scoliosis examinations of adolescent patients with the EOS imaging system.

PURPOSE: The goal of this work is to evaluate organ doses and lifetime attributable risk of cancer incidence and mortality in scoliosis examinations of adolescent patients performed with EOS imaging system, in order to optimize patient dose and protocols. METHODS: An anthropomorphic phantom of a normal patient, with thermoluminescent dosimeters in correspondence with the main organs at risk, was imaged with both EOS and computed radiography (CR). For each modality, effective dose was calculated from the measured organ doses. Lifetime attributable risk was computed accordingly to the Committee on the Biological Effects of Ionizing Radiation (BEIR VII) and Public Health England (HPA) publications. RESULTS: Except for testes and eyes, which were excluded from the scan in CR protocol, for all the other organs the doses delivered with CR examination were higher than these delivered by EOS system. The effective dose in EOS examination (0.43 ± 0.04 mSv) is about two times less than the dose in computed radiography with anti-scatter grid examination (0.87 ± 0.09 mSv), and, consequently, also the cancer probability is lower (5.4 vs 9.7 number of any cancers induction cases per 100,000 person examined, for a 20-year-old male patient). CONCLUSIONS: The EOS system is efficient in limiting patient dose. The shielding of testes and the exclusion of eyes from the scan could allow to further reduce the dose.

Intra and inter-observer reliability of determining degree of pelvic obliquity in neuromuscular scoliosis using the EOS-CHAIR® protocol.

PURPOSE: Scoliosis with pelvic obliquity (PO) could be investigated with the EOS-CHAIR protocol as the most common deformity especially in patients with trunk hypotonia and quadriplegia. However, the intra-observer and inter-observer reliability of various angles assessing PO was not investigated with this new imaging protocol. METHODS: A retrospective cohort of 36 EOS frontal full-spine acquisitions made in sitting position was used. The sacroiliac pelvic obliquity angle, iliac crest pelvic obliquity angle, and ischiatic pelvic obliquity angle were assessed in an intra-observer and inter-observer study. RESULTS: The use of the EOS-CHAIR protocol was implemented satisfactory with a high acceptance rate by all caregivers and patients and their families. Intra-observer and inter-observer reliability was excellent for the three tested angular measurements. DISCUSSION: As for idiopathic scoliosis, we postulate the EOS system as being superior to standard radiographs to assess 3D spinal deformities in neuromuscular conditions. The EOS-CHAIR protocol improves preoperative comprehension of the lumbosacral junction anatomy in patients with poor standing or sitting postures. Our results show a very high reliability of three different angular measurements of the frontal pelvic obliquity in sitting position. Then it is possible to use one of these three angles as well as the others to assess frontal pelvic obliquity in neuromuscular patients. This frontal pelvic obliquity protocol in sitting position with the EOS-CHAIR is a validated measurement technique that needs to be used now to measure PO as a critical parameter of the global trunk balance in neuromuscular patients.

Good vs Poor Results After Total Hip Arthroplasty: An Analysis Method Using Implant and Anatomic Parameters With the EOS Imaging System.

BACKGROUND: Existing imaging techniques and single-parameter analyses, in nonfunctional positions, fail to detect the differences between patients with good vs poor results after total hip arthroplasty. METHODS: The present study developed an analysis method using the EOS full-body, low-dose, biplanar, weightbearing imaging system to compare good vs poor patients after total hip arthroplasty and to report on our preliminary experiences (17 good, 18 poor). RESULTS: All revision cases were found to have at least 4 high or low implant or anatomic parameters relative to the good group. These included acetabular cup orientation, sagittal pelvic tilt, sacral slope, femoral offset, and neck-shaft angle. Acetabular cup orientation differed significantly between groups. CONCLUSION: With the EOS system, a large cohort can be studied relatively quickly and at low dose, which could lead to patient-specific guidelines.

Comparison of slot-scanning standing, supine, and fulcrum radiographs for assessment of curve flexibility in adolescent idiopathic scoliosis: a pilot study.

PURPOSE: With the goal of reducing radiation dosing for patients, we sought to compare the results of slot-scanning (EOS) standing flexibility radiographs to supine bending and fulcrum radiographs for surgical planning in adolescent idiopathic scoliosis (AIS). We hypothesized that slot-scanning standing bending radiographs provide similar mean curve flexibility as supine bending and fulcrum radiographs. METHODS: This is a retrospective review of 224 AIS patients with concomitant upright standing and flexibility images. Curve flexibility, defined the percent change in Cobb angle from standing upright to flexibility images, was used to compare the results of slot-scanning standing, supine and fulcrum radiographs. Statistical analysis utilized ANOVA one-way tests and two-sample t tests to detail differences as indicated. RESULTS: A total of 256 imaging studies were included, 75 slot-scanning standing, 112 supine, and 69 fulcrum radiographs. Fulcrum images only investigated thoracic curves and were, therefore, excluded from proximal thoracic and lumbar flexibility comparisons. Relevant mean standing curve magnitudes were similar between the groups with some variance in thoracic curves between fulcrum and supine image series (p = 0.003). There was no statistical difference in curve flexibility for proximal thoracic curves (p = 0.389) and lumbar curves (p = 0.798). However, for thoracic curves, slot-scanning standing images result in less measured curve flexibility compared to supine (p = 1.00E-7) and fulcrum images (p = 2.84E-18). Furthermore, supine bending images resulted in less measured curve flexibility in comparison to fulcrum images (p = 2.85E-7). CONCLUSION: Slot-scanning standing bending films show comparable results in curve flexibility as supine bending films for proximal thoracic and lumbar curves but may show reduced flexibility for thoracic curves when compared to supine or fulcrum bending films. Given lower radiation dosing, slot-scanning films could be substituted for traditional supine films for assessment of proximal thoracic and lumbar curve flexibility.

Pitfalls in assessing limb alignment affected by rotation and flexion of the knee after total knee arthroplasty: Analysis using sagittal and coronal whole-body EOS radiography.

BACKGROUND: Inappropriate posture during radiographic assessment may lead to misunderstanding of postoperative alignment after total knee arthroplasty (TKA). The EOS system assesses coronal and sagittal alignment simultaneously. This study aimed to evaluate the effect of flexion and/or rotation on alignment, and identify the patterns of knee posture with serial follow-up using the EOS system. METHODS: One-hundred and fifteen patients of TKA and serial whole-body EOS were included. The hip-knee-ankle (HKA) angle in the coronal and sagittal planes, femoral component rotation ratio (FCR), tibial component rotation ratio (TCR), and fibular overlap ratio (FO) were measured immediately and at six months and one year postoperatively. Total and partial correlation, using flexion and rotation as a control variable was performed. RESULTS: The mean HKA values and flexion immediately post-operation were different compared with the values noted at six months and one year postoperatively (for all, P < 0.05). The FCR and FO were correlated with the HKA angle during all periods (for both, P < 0.05). The Pearson correlation coefficients of the HKA angle with rotation parameters decreased when flexion was controlled. CONCLUSIONS: Combined rotation and flexion of the knee joint has a greater effect on coronal alignment compared with isolated flexion or rotation and was more frequently observed during the early postoperative period. Therefore, surgeons should be made aware of the potential knee rotation and flexion errors after TKA.

Combination of whole-spine lateral radiograph and lateral scanogram in the assessment of global sagittal balance.

BACKGROUND CONTEXT: Global balance of human standing is analyzed as the geometric sum of the individual alignments extending from the spinal column to the pelvis, and to the lower limbs. The innovative EOS system has opened new perspectives for the global analysis of whole-body alignment, but its use is very limited because of its high cost. An alternative may be to combine the whole-spine lateral radiograph and the lateral scanogram in the global sagittal analysis of whole-body alignment. PURPOSE: We examined to determine the validity and reliability of a lateral scanogram in the measurement of sacropelvic parameters. STUDY DESIGN/SETTING: A retrospective radiological study was carried out. PATIENT SAMPLE: We randomly selected 100 sets of digital radiographs, both whole-spine radiographs and lower-limb scanograms, from our database. OUTCOME MEASURES: Sacropelvic parameters, including pelvic incidence, sacral slope, and pelvic tilt, were measured on both whole-spine radiographs and lower-limb scanograms by three independent examiners on three separate occasions. METHODS: Agreement regarding the measurements on both image types was calculated to assess the validity of the lateral scanogram for use in whole-body alignment determinations. Intraobserver and interobserver reliabilities among the types of measurements were calculated. RESULTS: The sacropelvic area on the lateral scanogram was not visible in 19 patients (19%). In the remaining 81 patients, the sacropelvic parameters on the lateral scanogram were similar to those on the whole-spine lateral radiograph (Pearson correlation coefficient, 0.764-0.805). Intraobserver and interobserver reproducibilities for both modalities were good to excellent (intraclass correlation coefficient, 0.657-0.984). CONCLUSIONS: Sacropelvic parameter measurements on lateral scanogram were reliable and were similar to those measured on whole-spine lateral radiograph. Thus, global alignment can be evaluated using the lateral scanogram in combination with the whole-spine lateral radiograph.

Measuring femoral and rotational alignment: EOS system versus computed tomography.

INTRODUCTION: Computed tomography (CT) is currently the reference standard for measuring femoral and tibial rotational alignment. The EOS System is a new biplanar low-dose radiographic device that allows 3-dimensional lower-limb modelling with automated measurements of femoral and tibial rotational alignment (torsion). HYPOTHESIS: Femoral and tibial torsion measurements provided by the EOS System are equivalent to those obtained using CT. MATERIALS AND METHODS: In a retrospective analysis of 43 lower limbs in 30 patients, three senior radiologists measured femoral and tibial torsion on both CT and EOS images. Agreement between CT and EOS values was assessed by computing Pearson's correlation coefficient and interobserver reproducibility by computing the intraclass correlation coefficient (ICC). RESULTS: Femoral torsion was 13.4° by EOS vs. 13.7° by CT (P=0.5) and tibial torsion was 30.8° by EOS vs. 30.3° by CT (P=0.4). Strong associations were found between EOS and CT values for both femoral torsion (P=0.93) and tibial torsion (P=0.89). With EOS, the ICC was 0.93 for femoral torsion and 0.86 for tibial torsion; corresponding values with CT were 0.90 and 0.92. DISCUSSION: The EOS system is a valid alternative to CT for lower-limb torsion measurement. EOS imaging allows a comprehensive evaluation in all three planes while substantially decreasing patient radiation exposure. LEVEL OF EVIDENCE: Level III, case-control.

Three-dimensional assessment of the intervertebral kinematics after Mobi-C total disc replacement at the cervical spine in vivo using the EOS stereoradiography system.

BACKGROUND: Because 3-dimensional computed tomography and magnetic resonance imaging analysis of the spinal architecture is done with the patient in the supine position, stereoradiography may be more clinically relevant for the measurement of the relative displacements of the cervical vertebrae in vivo in the upright position. The innovative EOS stereoradiography system was used for measuring the relative angular displacements of the cervical vertebrae in a limited population to determine its feasibility. The precision and accuracy of the method were investigated. METHODS: In 9 patients with 16 Mobi-C prostheses (LDR Medical, Troyes, France) and 12 healthy subjects, EOS stereoradiography of the lower cervical spine (C3-7) was performed in the neutral upright position of the neck, flexion, extension, left and right lateral bending, and left and right axial rotation. The angular displacements were measured from the neutral position to every other posture. The random error was studied in terms of reproducibility. In addition, an in vitro protocol was performed in 6 specimens to investigate accuracy. RESULTS: The reproducibility and the accuracy variables varied similarly between 1.2° and 3.2° depending on the axis and direction of rotation under consideration. The Mobi-C group showed less mobility than the control group, whereas the pattern of coupling was similar. CONCLUSIONS: Overall, the feasibility of dynamic EOS stereoradiography was shown. The prosthesis replicates the pattern of motion of the normal cervical spine.