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

NCT02269657 | Completed Results

• 1 other identifier: 14-011016
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis; Postural balance; Lordosis; Kyphosis; X-rays

Outcome Measures

Primary Outcomes (5)

• 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).

  Up to 30 minutes

Study Arms (1)

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).

Device: EOS® imaging system

Interventions

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.

Subject Cohort

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• EOS imaging Inc.: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Scoliosis; Lordosis; Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Saba Pasha, PhD
• Organization: Children's Hospital of Philadelphia

pashas@email.chop.edu

215-590-1815

Study Officials

• Saba Pasha, PhD

  Children's Surgical Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 13, 2017
• Results First Posted: February 13, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)