Trial Outcomes & Findings for Adolescent Idiopathic Scoliosis (AIS) Patient Positioning in EOS System® (NCT NCT02269657)
NCT ID: NCT02269657
Last Updated: 2017-02-13
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
37 participants
Primary outcome timeframe
Up to 30 minutes
Results posted on
2017-02-13
Participant Flow
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.
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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37
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Protocol Violation
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3
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Baseline Characteristics
Adolescent Idiopathic Scoliosis (AIS) Patient Positioning in EOS System®
Baseline characteristics by cohort
| Measure |
Subject Cohort
n=37 Participants
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.
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|---|---|
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Age, Continuous
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14.7 years
STANDARD_DEVIATION 1.7 • n=5 Participants
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Gender
Female
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30 Participants
n=5 Participants
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Gender
Male
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7 Participants
n=5 Participants
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|
Region of Enrollment
United States
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37 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.
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.
Outcome measures
| Measure |
Wall Position
n=37 Participants
Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. 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.
|
Clavicle Position
n=37 Participants
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.
|
Natural Standing Position
Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
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|---|---|---|---|
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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
|
7.6 degrees
Standard Deviation 24.9
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—
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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
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29.5 degrees
Standard Deviation 10.3
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33.55 degrees
Standard Deviation 12.5
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—
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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
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19.8 degrees
Standard Deviation 10.4
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22.6 degrees
Standard Deviation 10.6
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—
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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
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45.5 degrees
Standard Deviation 13.1
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—
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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
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56.3 degrees
Standard Deviation 13.7
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57.7 degrees
Standard Deviation 13.1
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—
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PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.
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.
Outcome measures
| Measure |
Wall Position
n=37 Participants
Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. 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.
|
Clavicle Position
n=37 Participants
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.
|
Natural Standing Position
Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
|
|---|---|---|---|
|
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
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-4.1 degrees
Standard Deviation 8.8
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-8.6 degrees
Standard Deviation 11.3
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—
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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
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-8.2 degrees
Standard Deviation 12.5
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-5.3 degrees
Standard Deviation 9.3
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—
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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
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23.5 degrees
Standard Deviation 12.6
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27.7 degrees
Standard Deviation 7.8
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—
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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
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50.3 degrees
Standard Deviation 17.5
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51.3 degrees
Standard Deviation 17.2
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—
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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
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-3.4 degrees
Standard Deviation 2.4
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-2.3 degrees
Standard Deviation 3.2
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—
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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
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1.9 degrees
Standard Deviation 2.3
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1.0 degrees
Standard Deviation 2.4
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—
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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
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43.9 degrees
Standard Deviation 16.4
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41.3 degrees
Standard Deviation 17.7
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—
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PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.
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.
Outcome measures
| Measure |
Wall Position
n=37 Participants
Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. 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.
|
Clavicle Position
n=37 Participants
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.
|
Natural Standing Position
Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
|
|---|---|---|---|
|
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
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-12.0 degrees
Standard Deviation 9.8
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—
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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
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14.6 degrees
Standard Deviation 9.9
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13.7 degrees
Standard Deviation 8.8
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—
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.
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.
Outcome measures
| Measure |
Wall Position
n=37 Participants
Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. 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.
|
Clavicle Position
n=37 Participants
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.
|
Natural Standing Position
Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
|
|---|---|---|---|
|
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
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51.0 degrees
Standard Deviation 14.8
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50.6 degrees
Standard Deviation 14.3
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—
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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
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44.1 degrees
Standard Deviation 12.4
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49.9 degrees
Standard Deviation 15.6
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—
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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
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6.8 degrees
Standard Deviation 8.8
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9.5 degrees
Standard Deviation 11.2
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—
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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
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5.4 degrees
Standard Deviation 8.1
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4.1 degrees
Standard Deviation 6.9
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—
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: 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.
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).
Outcome measures
| Measure |
Wall Position
n=37 Participants
Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. 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.
|
Clavicle Position
n=37 Participants
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.
|
Natural Standing Position
n=37 Participants
Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
|
|---|---|---|---|
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Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters
Right foot
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44.9 percentage of pressure under
Standard Deviation 4.5
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44.0 percentage of pressure under
Standard Deviation 5.6
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44.2 percentage of pressure under
Standard Deviation 6.2
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Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters
Left foot
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55.0 percentage of pressure under
Standard Deviation 4.5
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55.9 percentage of pressure under
Standard Deviation 5.6
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55.7 percentage of pressure under
Standard Deviation 6.1
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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
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34.2 percentage of pressure under
Standard Deviation 7.1
|
40.1 percentage of pressure under
Standard Deviation 10.4
|
41.6 percentage of pressure under
Standard Deviation 8.6
|
|
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
|
59.8 percentage of pressure under
Standard Deviation 10.4
|
58.4 percentage of pressure under
Standard Deviation 8.7
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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
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39.3 percentage of pressure under
Standard Deviation 9.5
|
41.6 percentage of pressure under
Standard Deviation 9.8
|
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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
|
60.6 percentage of pressure under
Standard Deviation 9.5
|
58.3 percentage of pressure under
Standard Deviation 9.8
|
Adverse Events
Subject Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place