Adolescent Idiopathic Scoliosis (AIS) Patient Positioning in EOS System®

Adolescent Idiopathic Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269657
• Other study ID #: 14-011016
• Status: Completed
• Phase: N/A
• First received: October 13, 2014
• Last updated: December 14, 2016
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2016
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• EOS® 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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	EOS imaging Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of the patients' arm positioning on clinical evaluation of bi-planar spinal X-rays using the EOS system	Spinal (coronal and sagittal) and sacro-pelvic parameters will be used to evaluate the equivalence between the two arm positions for bi-planar full spinal x-rays in the EOS imaging system. Patients' arm positioning in the standing posture during the full spine X-ray acquisition using EOS® imaging system will be studied. The primary efficacy endpoint will be the change in spinal and sacro-pelvic parameters between the two X-rays (one for each arm position).	Up to 30 minutes	No