Clinical trial NCT02269657: Adolescent Idiopathic Scoliosis (AIS) Patient Positioning in EOS System®
Official title: Patients' Arm Positioning in the EOS® Stereoradiography System: Study the Sagittal Spinal Parameters and Postural Balance in EOS® Full Spine X-rays in Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Postural balance
Lordosis
Kyphosis
X-rays
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: EOS imaging Inc.
First posted: 2014-10-21
Enrollment: 37
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters
timeFrame: Up to 30 minutes
measure: Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters
timeFrame: Up to 30 minutes
measure: Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters
timeFrame: Up to 30 minutes
measure: Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters
timeFrame: Up to 30 minutes
measure: Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters
timeFrame: Up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Surgical Associates
name: Saba Pasha, PhD
role: PRINCIPAL_INVESTIGATOR
References: