Monitoring of Curve Progression in Patients with Adolescent Idiopathic Scoliosis Using 3-D Ultrasound.

OBJECTIVE: The aim of the work described here was to determine whether 3-D ultrasound can provide results comparable to those of conventional X-ray examination in assessing curve progression in patients with adolescent idiopathic scoliosis (AIS). METHODS: One hundred thirty-six participants with AIS (42 males and 94 females; age range: 10-18 y, mean age: 14.1 ± 1.9 y) with scoliosis of different severity (Cobb angle range: 10º- 85º, mean: of 24.3 ± 14.4º) were included. Each participant underwent biplanar low-dose X-ray EOS and 3-D ultrasound system scanning with the same posture on the same date. Participants underwent the second assessment at routine clinical follow-up. Manual measurements of scoliotic curvature on ultrasound coronal projection images and posterior-anterior radiographs were expressed as the ultrasound curve angle (UCA) and radiographic Cobb angle (RCA), respectively. RCA and UCA increments ≥5º represented a scoliosis progression detected by X-ray assessment and 3-D ultrasound assessment, respectively. RESULTS: The sensitivity and specificity of UCA measurement in detecting scoliosis progression were 0.93 and 0.90, respectively. The negative likelihood ratio of the diagnostic test for scoliosis progression by the 3-D ultrasound imaging system was 0.08. CONCLUSION: The 3-D ultrasound imaging method is a valid technique for detecting coronal curve progression as compared with conventional radiography in follow-up of AIS. Substituting conventional radiography with 3-D ultrasound is effective in reducing the radiation dose to which AIS patients are exposed during their follow-up examinations.

Three-dimensional ultrasonography could be a potential non-ionizing tool to evaluate vertebral rotation of subjects with adolescent idiopathic scoliosis.

Background: Three-dimensional (3D) ultrasonography is nonionizing and has been demonstrated to be a reliable tool for scoliosis assessment, including coronal and sagittal curvatures. It shows a great potential for axial vertebral rotation (AVR) evaluation, yet its validity and reliability need to be further demonstrated. Materials and Methods: Twenty patients with adolescent idiopathic scoliosis (AIS) (coronal Cobb: 26.6 ± 9.1°) received 3D ultrasound scan for twice, 10 were scanned by the same operator, and the other 10 by different operators. EOS Bi-planar x-rays and 3D scan were conducted on another 29 patients on the same day. Two experienced 3D ultrasonographic researchers, with different experiences on AVR measurement, evaluated the 3D ultrasonographic AVR of the 29 patients (55 curves; coronal Cobb angle: 26.9 ± 11.3°). The gold standard AVR was determined from the 3D reconstruction of coronal and sagittal EOS radiographs. Intra-class correlation coefficients (ICCs), mean absolute difference (MAD), standard error measurements (SEM), and Bland-Altman's bias were reported to evaluate the intra-operator and inter-operator/rater reliabilities of 3D ultrasonography. The reliability of 3D ultrasonographic AVR measurements was further validated using inter-method with that of EOS. Results: ICCs for intra-operator and inter-operator/rater reliability assessment were all greater than 0.95. MAD, SEM, and bias for the 3D ultrasonographic AVRs were no more than 2.2°, 2.0°, and 0.5°, respectively. AVRs between both modalities were strongly correlated (R 2 = 0.901) and not significantly different (p = 0.205). Bland-Altman plot also shows that the bias was less than 1°, with no proportional bias between the difference and mean of expected and radiographic Cobb angles. Conclusion: This study demonstrates that 3D ultrasonography is valid and reliable to evaluate AVR in AIS patients. 3D ultrasonography can be a potential tool for screening and following up subjects with AIS and evaluating the effectiveness of nonsurgical treatments.

Sagittal Spinal Alignment in People with Chronic Spinal Cord Injury and Normal Individual: A Comparison Study Using 3D Ultrasound Imaging.

The aim of this study was to compare the sagittal spinal alignment of people with chronic spinal cord injury (SCI) with normal individuals and to determine whether transcutaneous electrical spinal cord stimulation (TSCS) could cause a change in the thoracic kyphosis (TK) and lumbar lordosis (LL) to re-establish normal sagittal spinal alignment. A case series study was conducted, wherein twelve individuals with SCI and ten neurologically intact subjects were scanned using 3D ultrasonography. In addition, three people with SCI having complete tetraplegia participated further to receive a 12-week treatment (TSCS with task-specific rehabilitation) after evaluation of sagittal spinal profile. Pre- and post-assessments were conducted to evaluate the differences in sagittal spinal alignment. The results showed that the TK and LL values for a person with SCI in a dependent seated posture were greater than those of normal subjects for: standing (by TK: 6.8° ± 1.6°; LL: 21.2° ± 1.9°), sitting straight (by TK: 10.0° ± 4.0°; LL: 1.7° ± 2.6°), and relaxed sitting (by TK: 3.9° ± 0.3°; LL: 7.7° ± 1.4°), respectively, indicating an increased risk for spinal deformity. In addition, TK decreased by 10.3° ± 2.3° after the TSCS treatment, showing a reversible change. These results suggest that the TSCS treatment could be used to restore normal sagittal spinal alignment for individuals with chronic SCI.

Semi-automatic ultrasound curve angle measurement for adolescent idiopathic scoliosis.

PURPOSE: Using X-ray to evaluate adolescent idiopathic scoliosis (AIS) conditions is the clinical gold standard, with potential radiation hazards. 3D ultrasound has demonstrated its validity and reliability of estimating X-ray Cobb angle (XCA) using spinous process angle (SPA), which can be automatically measured. While angle measurement with ultrasound using spine transverse process-related landmarks (UCA) shows better agreed with XCA, its automatic measurement is challenging and not available yet. This research aimed to analyze and measure scoliotic angles through a novel semi-automatic UCA method. METHODS: 100 AIS subjects (age: 15.0 ± 1.9 years, gender: 19 M and 81 F, Cobb: 25.5 ± 9.6°) underwent both 3D ultrasound and X-ray scanning on the same day. Scoliotic angles with XCA and UCA methods were measured manually; and transverse process-related features were identified/drawn for the semi-automatic UCA method. The semi-automatic method measured the spinal curvature with pairs of thoracic transverse processes and lumbar lumps in respective regions. RESULTS: The new semi-automatic UCA method showed excellent correlations with manual XCA (R2 = 0.815: thoracic angles R2 = 0.857, lumbar angles R2 = 0.787); and excellent correlations with manual UCA (R2 = 0.866: thoracic angles R2 = 0.921, lumbar angles R2 = 0.780). The Bland-Altman plot also showed a good agreement against manual UCA/XCA. The MADs of semi-automatic UCA against XCA were less than 5°, which is clinically insignificant. CONCLUSION: The semi-automatic UCA method had demonstrated the possibilities of estimating manual XCA and UCA. Further advancement in image processing to detect the vertebral landmarks in ultrasound images could help building a fully automated measurement method. LEVEL OF EVIDENCE: Level III.

Using Ultrasound to Screen for Scoliosis to Reduce Unnecessary Radiographic Radiation: A Prospective Diagnostic Accuracy Study on 442 Schoolchildren.

Scoliosis screening is important for timely initiation of brace treatment to mitigate curve progression in skeletally immature children and adolescents. School scoliosis screening programs in Hong Kong follow the protocol of referring children screened positive with a scoliometer and Moiré topography for confirmatory standard radiography. Despite being highly sensitive (88%) in detecting those who require specialist referral, the screening program was found to have a false-positive rate >50%, which could lead to unnecessary X-ray radiation. Radiation-free ultrasound has been reported to be valid and reliable for quantitative assessment of curve severity in scoliosis patients. The aim of this prospective diagnostic accuracy study was to determine the accuracy of ultrasound in determining the threshold of referral that requires X-ray for children screened positive with the scoliometer and Moiré topography. Our study recruited 442 schoolchildren with a mean Cobb angle of 14.0 ± 6.6°. The sensitivity and specificity of ultrasound in predicting the correct referral status, confirmed by X-ray, were 92.3% and 51.6%, with positive and negative predictive values of 29.0% and 96.9%, respectively. Receiver operating characteristic curve analysis revealed area under the curve values of 0.735 for ultrasound alone and 0.832 for ultrasound in combination with measurement of angle of trunk rotation. The finding supports the accuracy of using ultrasound to determine referral status, which could result in a >50% reduction of unnecessary radiation for children undergoing scoliosis screening.

3D ultrasound imaging provides reliable angle measurement with validity comparable to X-ray in patients with adolescent idiopathic scoliosis.

BACKGROUND & OBJECTIVE: The application of ultrasound imaging for spine evaluation could minimize radiation exposure for patients with adolescence idiopathic scoliosis (AIS). A customized three-dimensional (3D) ultrasound imaging system has been demonstrated to provide reliable and valid coronal curvature measurements. However, these measurements were using the spinous processes as anatomical reference, leading to a predictable underestimation of the traditionally used Cobb angles. An alternative 3D ultrasound image reconstruction method was applied to create coronal images with more lateral features for angle measurement. The objective of this study was to test the reliability and the validity of this angle, the ultrasound curve angle (UCA), and compare the UCA with the Cobb angles on X-ray images of patients with AIS. MATERIALS AND METHODS: This study was divided into: 1) Investigation of intra- and inter-reliability between two raters for measuring the UCA and two operators for acquiring ultrasound images; 2) Investigation of the validity between the radiographic Cobb angle and the UCA. Fifty patients and 164 patients with AIS, were included in the two stages, respectively. Patients underwent bi-planar X-ray and 3D ultrasound scanning on the same day. The proposed UCA was used to measure the coronal curvature from the ultrasound coronal images, which were formed using a newly customized volume projection imaging (VPI) method. The intra-rater/operator and inter-rater and operator reliability of the UCA were tested by intra-class correlation coefficient (ICC) (3,1) and (2,1), respectively. The validity of UCA measurements as compared to radiographic Cobb angles was tested by inter-method ICC (2,1), mean absolute difference (MAD), standard error of measurement (SEM), Pearson correlation coefficient and Bland-Altman statistics. The level of significance was set as 0.05. RESULTS: Excellent intra-rater and intra-operator (ICC (3,1)≥0.973) and excellent inter-rater and inter-operator reliability (ICC (2,1)≥0.925) for UCA measurement, with overall MAD and SEM no more than 3.5° and 1.7° were demonstrated for both main thoracic and (thoraco)lumbar curvatures. Very good correlations were observed between UCA and Cobb angle for main thoracic ( R 2 =0.893) and (thoraco)lumbar ( R 2 =0.884) curves. The mean (SD) measurements in terms of radiographic Cobb and UCA were 27.2 â€‹± â€‹11.6° and 26.3 â€‹± â€‹11.4° for main thoracic curves; and 26.2 â€‹± â€‹11.4° and 24.8 â€‹± â€‹9.7° for (thoraco)lumbar curve respectively. One hundred sixty-four subjects (33 male and 131 female subjects; 11-18 years of age, mean of 15.1 â€‹± â€‹1.9 years) were included for the validity session. Excellent inter-method variations (ICC (2,K) ≥0.933) with overall MAD and SEM no more than 3.0° and 1.5° were demonstrated for both main thoracic and (thoraco)lumbar curvatures. In addition, Bland-Altman plots demonstrated an acceptable agreement between ultrasound and radiographic Cobb measurements. CONCLUSION: In this study, very good correlations and agreement were demonstrated between the ultrasound and X-ray measurements of the scoliotic curvature. Judging from the promising results of this study, patients with AIS with different severity of curves can be evaluated and monitored by ultrasound imaging, reducing the usage of radiation during follow-ups. This method could also be used for scoliosis screening.The Translational potential of this article: Ultrasound curve angle (UCA) obtained from 3D ultrasound imaging system can provide reliable and valid evaluation on coronal curvature for patients with AIS, without the need of radiation.

Investigation of the Phenomenon of Coronal-Sagittal Curvature Coupling on Curve Progression: An Exploratory Study using 3-D Ultrasound.

A 3-D ultrasound system was determined to provide reliable and valid results for scoliosis assessment in the coronal and sagittal planes. The objective of this study was to investigate whether 3-D ultrasound can detect coronal-sagittal coupling and to study its potential effect on curve progression in patients with adolescence idiopathic scoliosis (AIS) as per the traditional Cobb angle classification. Radiographic and ultrasonic coronal and sagittal curvatures of 126 patients with AIS were evaluated. Thoracic kyphosis (TK) and lumbar lordosis (LL) with different coronal deformity were compared correspondingly based on either main thoracic or (thoraco)lumbar curve groups. The TK and LL of patients with single curves were also compared with study the curve effect on sagittal curvatures. A prospective cohort of 51 patients were followed for an average of 23 months for preliminary progression investigation. TKs in patients with larger main thoracic Cobb angles was significantly smaller than those with smaller main thoracic Cobb angles, judging by the results obtained from ultrasound and X-ray. The TKs of patients with only single right main thoracic curves were significantly smaller than those of patients with only single left (thoraco)lumbar curves. In addition, patients with progressive curves were observed to be relative hypokyphotic during early visits.

Validation of Scolioscan Air-Portable Radiation-Free Three-Dimensional Ultrasound Imaging Assessment System for Scoliosis.

To diagnose scoliosis, the standing radiograph with Cobb's method is the gold standard for clinical practice. Recently, three-dimensional (3D) ultrasound imaging, which is radiation-free and inexpensive, has been demonstrated to be reliable for the assessment of scoliosis and validated by several groups. A portable 3D ultrasound system for scoliosis assessment is very much demanded, as it can further extend its potential applications for scoliosis screening, diagnosis, monitoring, treatment outcome measurement, and progress prediction. The aim of this study was to investigate the reliability of a newly developed portable 3D ultrasound imaging system, Scolioscan Air, for scoliosis assessment using coronal images it generated. The system was comprised of a handheld probe and tablet PC linking with a USB cable, and the probe further included a palm-sized ultrasound module together with a low-profile optical spatial sensor. A plastic phantom with three different angle structures built-in was used to evaluate the accuracy of measurement by positioning in 10 different orientations. Then, 19 volunteers with scoliosis (13F and 6M; Age: 13.6 ± 3.2 years) with different severity of scoliosis were assessed. Each subject underwent scanning by a commercially available 3D ultrasound imaging system, Scolioscan, and the portable 3D ultrasound imaging system, with the same posture on the same date. The spinal process angles (SPA) were measured in the coronal images formed by both systems and compared with each other. The angle phantom measurement showed the measured angles well agreed with the designed values, 59.7 ± 2.9 vs. 60 degrees, 40.8 ± 1.9 vs. 40 degrees, and 20.9 ± 2.1 vs. 20 degrees. For the subject tests, results demonstrated that there was a very good agreement between the angles obtained by the two systems, with a strong correlation (R2 = 0.78) for the 29 curves measured. The absolute difference between the two data sets was 2.9 ± 1.8 degrees. In addition, there was a small mean difference of 1.2 degrees, and the differences were symmetrically distributed around the mean difference according to the Bland-Altman test. Scolioscan Air was sufficiently comparable to Scolioscan in scoliosis assessment, overcoming the space limitation of Scolioscan and thus providing wider applications. Further studies involving a larger number of subjects are worthwhile to demonstrate its potential clinical values for the management of scoliosis.

Is Radiation-Free Ultrasound Accurate for Quantitative Assessment of Spinal Deformity in Idiopathic Scoliosis (IS): A Detailed Analysis With EOS Radiography on 952 Patients.

Radiation exposure with repeated radiography required at follow-up poses serious health concerns for scoliosis patients. Although spinous process angle (SPA) measurement of spinal curvatures with ultrasound has been reported with promising results, an evidence-based account on its accuracy for translational application remains undefined. This prospective study involved 952 idiopathic scoliosis patients (75.7% female, mean age 16.7 ± 3.0 y, Cobb 28.7 ± 11.6°). Among 1432 curves (88.1%) detected by ultrasound, there was good correlation between radiologic Cobb angles measured manually on EOS (E_Cobb) whole-spine radiographs and automatic ultrasound SPA measurement for upper spinal curves (USCs) (r = 0.873, apices T7-T12/L1 intervertebral disc) and lower spinal curves (LSCs) (r = 0.740, apices L1 or below) (p < 0.001). Taller stature was associated with stronger correlation. For E_Cobb <30°, 66.6% USCs and 62.4% LSCs had absolute differences between E_Cobb and predicted Cobb angle calculated from SPA ≤5°. Ultrasound could be a viable option in lieu of radiography for measuring coronal curves with apices at T7 or lower and Cobb angle <30°.

A Novel Method to Measure the Sagittal Curvature in Spinal Deformities: The Reliability and Feasibility of 3-D Ultrasound Imaging.

The objective of this study was to test the reliability of sagittal spinal curvature measurements using 3-D ultrasound in patients with adolescent idiopathic scoliosis (AIS). Ultrasound spinous process angle (USSPA) and ultrasound laminae angle (USLA) were measured on sagittal ultrasound images, while the Cobb angle (XCA) was measured on sagittal X-ray images. Intra-class correlation coefficients (ICC) for the intra- and inter-observer variability, linear regression analysis and Bland-Altman method, including mean absolute difference (MAD), were investigated to evaluate the reliability and validity of the two ultrasound angles compared with XCA. Excellent measurement reliabilities were demonstrated for both ultrasound angles (ICC ≥ 0.91). Moderate to good and significant linear correlations and good agreement were demonstrated between the ultrasound methods and XCA (Thoracic [R2 ≥ 0.574] / Lumbar [R2 ≥ 0.635]). No significant differences were found for the MADs between both corrected ultrasound angles and XCA. Sagittal ultrasound angles were demonstrated to be reliable for assessing sagittal curvature using spinous processes and laminae and to have good and significant correlations with XCAs. Since it is non-ionizing and relatively low cost, this method opens the possibility of providing frequent curve monitoring and evaluation, and screening for AIS patients, particularly based on sagittal profiles.

Patterns of coronal curve changes in forward bending posture: a 3D ultrasound study of adolescent idiopathic scoliosis patients.

PURPOSE: The Adam's forward bending test is the most commonly used approach to assess the spine deformity in adolescent idiopathic scoliosis (AIS) patients. However, there are noticeable differences in the hump appearance from standing to forward bending. This phenomenon has yet to be understood due to limitations of conventional radiographs. This study aimed to investigate effects of postural change in the spine deformity in the coronal plane of AIS patients using a 3D ultrasound imaging system. METHODS: This was a prospective study that recruited 72 AIS patients at a single institute. All patients were scanned twice in the sitting and sitting forward bending postures. A coronal ultrasound image showing the spinal curvature was generated after each scan and the spinous process angle (SPA) representing the deformity was manually measured from it. Correlation of SPAs under sitting and sitting forward bending postures was analyzed. RESULTS: In the comparison test, it was noted that there were three types of spine profile alternation after the postural change. In types I and II, the SPA angle numbers were the same before and after forward bending and only SPA values changed. In type III, the two curvatures were changed to one curvature in the forward bending posture. Moderate correlation was observed between the angles obtained in the two postures (r = 0.55, p < 0.001). CONCLUSIONS: Spine deformities of AIS patients vary with different postures. The patterns of changes in sitting and sitting forward bending postures are highly subject dependent. These slides can be retrieved under Electronic Supplementary Material.

An effective assessment method of spinal flexibility to predict the initial in-orthosis correction on the patients with adolescent idiopathic scoliosis (AIS).

BACKGROUND: Spinal flexibility is an essential parameter for clinical decision making on the patients with adolescent idiopathic scoliosis (AIS). Various methods are proposed to assess spinal flexibility, but which assessment method is more effective to predict the effect of orthotic treatment is unclear. OBJECTIVE: To investigate an effective assessment method of spinal flexibility to predict the initial in-orthosis correction, among the supine, prone, sitting with lateral bending and prone with lateral bending positions. METHODS: Thirty-five patients with AIS (mean Cobb angle: 28° ± 7°; mean age: 12 ± 2 years; Risser sign: 0-2) were recruited. Before orthosis fitting, spinal flexibility was assessed by an ultrasound system in 4 positions (apart from standing) including supine, prone, sitting with lateral bending and prone with lateral bending. After orthosis fitting, the initial in-orthosis correction was routinely assessed by whole spine standing radiograph. Comparisons and correlation analyses were performed between the spinal flexibility in the 4 positions and the initial in-orthosis correction. RESULTS: The mean in-orthosis correction was 41% while the mean curve correction (spinal flexibility) in the 4 studied positions were 40% (supine), 42% (prone), 127% (prone with lateral bending) and 143% (sitting with lateral bending). The correlation coefficients between initial in-orthosis correction and curve correction (spinal flexibility) in the 4 studied positions were r = 0.66 (supine), r = 0.75 (prone), r = 0.03 (prone with lateral bending) and r = 0.04 (sitting with lateral bending). CONCLUSIONS: The spinal flexibility in the prone position is the closest to and most correlated with the initial in-orthosis correction among the 4 studied positions. Thus, the prone position could be an effective method to predict the initial effect of orthotic treatment on the patients with AIS.

A reliability and validity study for Scolioscan: a radiation-free scoliosis assessment system using 3D ultrasound imaging.

BACKGROUND: Radiographic evaluation for patients with scoliosis using Cobb method is the current gold standard, but radiography has radiation hazards. Several groups have recently demonstrated the feasibility of using 3D ultrasound for the evaluation of scoliosis. Ultrasound imaging is radiation-free, comparatively more accessible, and inexpensive. However, a reliable and valid 3D ultrasound system ready for clinical scoliosis assessment has not yet been reported. Scolioscan is a newly developed system targeted for scoliosis assessment in clinics by using coronal images of spine generated by a 3D ultrasound volume projection imaging method. The aim of this study is to test the reliability of spine deformity measurement of Scolioscan and its validity compared to the gold standard Cobb angle measurements from radiography in adolescent idiopathic scoliosis (AIS) patients. METHODS: Prospective study divided into two stages: 1) Investigation of intra- and inter- reliability between two operators for acquiring images using Scolioscan and among three raters for measuring spinal curves from those images; 2) Correlation between the Cobb angle obtained from radiography by a medical doctor and the spine curve angle obtained using Scolioscan (Scolioscan angle). The raters for ultrasound images and the doctors for evaluating radiographic images were mutually blinded. The two stages of tests involved 20 (80 % females, total of 26 angles, age of 16.4 ± 2.7 years, and Cobb angle of 27.6 ± 11.8°) and 49 (69 % female, 73 angles, 15.8 ± 2.7 years and 24.8 ± 9.7°) AIS patients, respectively. Intra-class correlation coefficients (ICC) and Bland-Altman plots and root-mean-square differences (RMS) were employed to determine correlations, which interpreted based on defined criteria. RESULTS: We demonstrated a very good intra-rater and intra-operator reliability for Scolioscan angle measurement with ICC larger than 0.94 and 0.88, respectively. Very good inter-rater and inter-operator reliability was also demonstrated, with both ICC larger than 0.87. For the thoracic deformity measurement, the RMS were 2.5 and 3.3° in the intra- and inter-operator tests, and 1.5 and 3.6° in the intra- and inter-rater tests, respectively. The RMS differences were 3.1, 3.1, 1.6, 3.7° in the intra- and inter-operator and intra- and inter-rater tests, respectively, for the lumbar angle measurement. Moderate to strong correlations (R(2) > 0.72) were observed between the Scolioscan angles and Cobb angles for both the thoracic and lumbar regions. It was noted that the Scolioscan angle slightly underestimated the spinal deformity in comparison with Cobb angle, and an overall regression equation y = 1.1797x (R(2) = 0.76) could be used to translate the Scolioscan angle (x) to Cobb angle (y) for this group of patients. The RMS difference between Scolioscan angle and Cobb angle was 4.7 and 6.2°, with and without the correlation using the overall regression equation. CONCLUSIONS: We showed that Scolioscan is reliable for measuring coronal deformity for patients with AIS and appears promising in screening large numbers of patients, for progress monitoring, and evaluation of treatment outcomes. Due to it being radiation-free and relatively low-cost, Scolioscan has potential to be widely implemented and may contribute to reducing radiation dose during serial monitoring.