N/A N=40

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

Adolescent Idiopathic Scoliosis

Bottom Line

View on ClinicalTrials.gov: NCT02269657 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters — 5.9; 7.6; 29.5; 33.55 degrees

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: EOS® imaging system (Device)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters	5.9; 7.6; 29.5; 33.55; 19.8; 22.6	—
PRIMARY Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters	23.5; 27.7; 50.3; 51.3; 43.9; 41.3	—
PRIMARY Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters	-10.8; -12.0; 14.6; 13.7	—
PRIMARY Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters	51.0; 50.6; 44.1; 49.9; 6.8; 9.5	—
PRIMARY Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters	44.9; 44.0; 44.2; 55.0; 55.9; 55.7	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02269657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.