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| Name | Class |
|---|---|
| EOS imaging Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject Cohort | Two bi-planar full spinal X-rays will be taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray will be taken while the subject's hands and forearms in front of them on the wall vertically. A second image will be taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat will record the magnitude of pressure under the subjects' feet during each set of images. A third set of pressure mat recordings will be obtained while the subject is in a natural standing position with both arms hanging on either side (no x-ray images will be taking in this position). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOS® imaging system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 minutes |
| 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. | Up to 30 minutes |
| 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. | Up to 30 minutes |
| 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. | Up to 30 minutes |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatient adolescent idiopathic scoliosis patients visiting the orthopedic clinic at Children's Hospital of Philadelphia who require bi-plannar full spine x-ray imaging for clinical purposes.
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| Name | Affiliation | Role |
|---|---|---|
| Saba Pasha, PhD | Children's Surgical Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Identifiable pressure mat data from select subjects that is recorded during this study will be shared with investigators at this institution working on another approved study which requires pre-surgical pressure mat data. Many subjects in the companion study will have already undergone surgery, yet none in the current study will have at the time pressure mat data is recorded. Thus this data will be shared. Data will be stored in a password protected file on a secure shared drive and is only accessible by IRB-approved members of the current and companion study teams.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subject Cohort | Two bi-planar full spinal X-ray 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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40 subjects consented to participate; however 3 were subsequently deemed ineligible. The analysis population only includes the 37 eligible subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions. | Posted | Mean | Standard Deviation | degrees | Up to 30 minutes |
|
30 Minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subject Cohort | Two bi-planar full spinal X-ray 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saba Pasha, PhD | Children's Hospital of Philadelphia | 215-590-1815 | pashas@email.chop.edu |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D008141 | Lordosis |
| D007738 | Kyphosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Up to 30 minutes |
| years |
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| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Clavicle Position | Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured. |
|
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| 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. | Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions. | Posted | Mean | Standard Deviation | degrees | Up to 30 minutes |
|
|
|
| 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. | Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions. | Posted | Mean | Standard Deviation | degrees | Up to 30 minutes |
|
|
|
| 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. | Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions. | Posted | Mean | Standard Deviation | degrees | Up to 30 minutes |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | percentage of pressure under | Up to 30 minutes |
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| 0 |
| 37 |
| 0 |
| 37 |
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| Lumbar Cobb |
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| T1 tilt |
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| L4 tilt |
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| Main thoracic apical vertibral translation |
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| Lumbar apical vertebral translation |
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| Pelvic tilt |
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| Anterior pelvic plane inclination |
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| Front of right foot |
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| Back of right foot |
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| Front of left foot |
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| Back of left foot |
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