Adolescent Idiopathic Scoliosis
Conditions
Keywords
Scoliosis, Postural balance, Lordosis, Kyphosis, X-rays
Brief summary
The EOS® imaging system, a new imaging modality which offers low dose, weight bearing and full body X-ray imaging, requires a new standing position where patients put their hands and forearms on the wall vertically for stability. Although this method provides enough support for the patients during the extended X-ray acquisition time, its impact on the postural balance and sagittal profile of the spine and sacro-pelvic parameters has not been evaluated. The goal of this study is to identify the impact of patients' arm positioning on the sagittal profile and postural balance of the patient and subsequently propose a standardized method for full spine X-ray acquisition in the EOS® imaging system.
Detailed description
Spino-pelvic sagittal analysis and postural assessment are important parameters in adolescent idiopathic scoliosis (AIS) treatment and surgical planning.The three-dimensional (3D) shape of the spine is impacted by the patients' posture particularly in adolescents with flexible spinal curves. The latter highlights the importance of the patients' positioning during X-ray acquisition in order to avoid any misleading measurements that may adversely impact monitoring and surgical curve correction in AIS. Participating subjects will undergo two bi-planar X-rays in different positions. The positions will be instructed by the means of graphical presentation and verbal explanation by the radiology technician. The first standing position in the EOS® imaging system for full spinal X-ray acquisition will consist of putting both hands and forearms in front of the subject on the wall vertically. In the second position, knuckles are loosely placed on ipsi-lateral clavicles. Bi-planar X-rays will be taken in the EOS® imaging system for both positions. Moreover to compare the postural balance of the patient in the two described positions, a pressure mat will be placed in the EOS® system. The pressure mat will be calibrated with the EOS® system and permits to identify the position of the center of pressure (COP) with respect to the anatomical landmarks. The magnitude of pressure under the patients' feet will be measured during each X-ray and compared.
Interventions
DEVICEEOS® imaging system
The EOS® imaging system is a low dose, 3-dimensional imaging system that provides weight bearing images which provide visual information with respect to the interaction between the joints and the rest of the musculoskeletal system, particularly the spine, hips and legs. The imaging system is used for clinical purposes with additional images captured as part of this study to collect data from subjects in two different arm positions during imaging.
Sponsors
EOS imaging Inc.
Children's Hospital of Philadelphia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Subjects age 10-18 * Diagnosis of adolescent idiopathic scoliosis * Prescribed bi-planar full spine X-ray images * Must be able to stand still for 10 seconds without any support * Must be able to follow verbal and visual instruction
Exclusion criteria
* Previous surgical treatment * Diagnosis of a neuro-muscular disorder * Have supernumerary vertebrae, congenital deformities, spondylolisthesis, or spina bifida * Have any other musculoskeletal disorder that impacts standing balance such as hip, knee, ankle pain and instability or lower back pain * BMI higher than 30 * Pregnant or lactating females * Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | Up to 30 minutes | Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. |
| Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Up to 30 minutes | Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. |
| Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters | Up to 30 minutes | Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. |
| Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Up to 30 minutes | Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. |
| Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Up to 30 minutes | Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. Images were only recorded during the wall and clavicle position, not during the natural standing position. Pressure mat parameters were recorded for both arm positions and compared to the natural standing position (arms hanging on either side). |
Countries
United States
Participant flow
Recruitment details
Outpatient adolescent idiopathic scoliosis (AIS) patients were prospectively recruited from the orthopedic clinic at Children's Hospital of Philadelphia. Males and females ages 10-18 years with a diagnosis of AIS with no previous spinal surgery were included.
Participants by arm
| Arm | Count |
|---|---|
| Subject Cohort Two bi-planar full spinal X-rays were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 3 |
Baseline characteristics
| Characteristic | Subject Cohort |
|---|---|
| Age, Continuous | 14.7 years STANDARD_DEVIATION 1.7 |
| Gender Female | 30 Participants |
| Gender Male | 7 Participants |
| Region of Enrollment United States | 37 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters
Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.
Time frame: Up to 30 minutes
Population: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Main thoracic Cobb | 50.3 degrees | Standard Deviation 17.5 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | T1 tilt | -4.1 degrees | Standard Deviation 8.8 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Proximal thoracic Cobb | 23.5 degrees | Standard Deviation 12.6 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | L4 tilt | -8.2 degrees | Standard Deviation 12.5 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Lumbar Cobb | 43.9 degrees | Standard Deviation 16.4 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Lumbar apical vertebral translation | 1.9 degrees | Standard Deviation 2.3 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Main thoracic apical vertibral translation | -3.4 degrees | Standard Deviation 2.4 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Lumbar apical vertebral translation | 1.0 degrees | Standard Deviation 2.4 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Main thoracic apical vertibral translation | -2.3 degrees | Standard Deviation 3.2 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Proximal thoracic Cobb | 27.7 degrees | Standard Deviation 7.8 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Main thoracic Cobb | 51.3 degrees | Standard Deviation 17.2 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | Lumbar Cobb | 41.3 degrees | Standard Deviation 17.7 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | T1 tilt | -8.6 degrees | Standard Deviation 11.3 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters | L4 tilt | -5.3 degrees | Standard Deviation 9.3 |
Primary
Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters
Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.
Time frame: Up to 30 minutes
Population: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Pelvic incidence | 51.0 degrees | Standard Deviation 14.8 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Sacral slope | 44.1 degrees | Standard Deviation 12.4 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Pelvic tilt | 6.8 degrees | Standard Deviation 8.8 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Anterior pelvic plane inclination | 5.4 degrees | Standard Deviation 8.1 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Anterior pelvic plane inclination | 4.1 degrees | Standard Deviation 6.9 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Pelvic incidence | 50.6 degrees | Standard Deviation 14.3 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Pelvic tilt | 9.5 degrees | Standard Deviation 11.2 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters | Sacral slope | 49.9 degrees | Standard Deviation 15.6 |
Primary
Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters
Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. Images were only recorded during the wall and clavicle position, not during the natural standing position. Pressure mat parameters were recorded for both arm positions and compared to the natural standing position (arms hanging on either side).
Time frame: Up to 30 minutes
Population: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions and pressure mat recording in the two positions and the natural standing position.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Right foot | 44.9 percentage of pressure under | Standard Deviation 4.5 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Left foot | 55.0 percentage of pressure under | Standard Deviation 4.5 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Front of right foot | 34.2 percentage of pressure under | Standard Deviation 7.1 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Back of right foot | 65.7 percentage of pressure under | Standard Deviation 7.1 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Front of left foot | 35.7 percentage of pressure under | Standard Deviation 9.2 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Back of left foot | 64.2 percentage of pressure under | Standard Deviation 9.2 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Back of left foot | 60.6 percentage of pressure under | Standard Deviation 9.5 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Right foot | 44.0 percentage of pressure under | Standard Deviation 5.6 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Back of right foot | 59.8 percentage of pressure under | Standard Deviation 10.4 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Front of left foot | 39.3 percentage of pressure under | Standard Deviation 9.5 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Left foot | 55.9 percentage of pressure under | Standard Deviation 5.6 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Front of right foot | 40.1 percentage of pressure under | Standard Deviation 10.4 |
| Natural Standing Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Left foot | 55.7 percentage of pressure under | Standard Deviation 6.1 |
| Natural Standing Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Front of right foot | 41.6 percentage of pressure under | Standard Deviation 8.6 |
| Natural Standing Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Back of left foot | 58.3 percentage of pressure under | Standard Deviation 9.8 |
| Natural Standing Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Back of right foot | 58.4 percentage of pressure under | Standard Deviation 8.7 |
| Natural Standing Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Right foot | 44.2 percentage of pressure under | Standard Deviation 6.2 |
| Natural Standing Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters | Front of left foot | 41.6 percentage of pressure under | Standard Deviation 9.8 |
Primary
Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters
Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.
Time frame: Up to 30 minutes
Population: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | T1-T12 Thoracic kyphosis | 29.5 degrees | Standard Deviation 10.3 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | L1-L5 Lumbar lordosis | 46.1 degrees | Standard Deviation 13.9 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | Cervical lordosis | 5.9 degrees | Standard Deviation 25.4 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | L1-S1 Lumbar lordosis | 56.3 degrees | Standard Deviation 13.7 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | T4-T12 Thoracic kyphosis | 19.8 degrees | Standard Deviation 10.4 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | L1-S1 Lumbar lordosis | 57.7 degrees | Standard Deviation 13.1 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | T1-T12 Thoracic kyphosis | 33.55 degrees | Standard Deviation 12.5 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | T4-T12 Thoracic kyphosis | 22.6 degrees | Standard Deviation 10.6 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | L1-L5 Lumbar lordosis | 45.5 degrees | Standard Deviation 13.1 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters | Cervical lordosis | 7.6 degrees | Standard Deviation 24.9 |
Primary
Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters
Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.
Time frame: Up to 30 minutes
Population: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters | Main thoracic apical vertebral rotation | -10.8 degrees | Standard Deviation 16.5 |
| Wall Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters | Lumbar apical vertebral rotation | 14.6 degrees | Standard Deviation 9.9 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters | Main thoracic apical vertebral rotation | -12.0 degrees | Standard Deviation 9.8 |
| Clavicle Position | Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters | Lumbar apical vertebral rotation | 13.7 degrees | Standard Deviation 8.8 |