Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers
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|ClinicalTrials.gov Identifier: NCT03076658|
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intervertebral Disc Degeneration Osteoarthritis, Spine||Radiation: EOS imaging||Not Applicable|
Current techniques of advanced spinal surgery allow physicians to correct complex spinal deformity to nearly any alignment desired. The investigators ability to analyze spino-pelvic alignment has evolved concurrently; however, the investigators goals in deformity correction are still not completely understood. With increasing ability to assess whole body alignment, the investigators must establish a baseline for the "normal" population inclusive of age related changes. the investigators hypothesis is that global body alignment will vary based on sex and progressively vary with age.
The goal of this study is to create an open access database of "normal" volunteer full body radiographic images obtained using the new EOS biplanar x-ray imaging system. The system provides a radiographic view of the weight-bearing skeleton equivalent to plain radiography. The development of an open access database of full body images and global spine parameters will provide spine surgeons with normative data that can be used to guide clinical decision making and surgical planning. Furthermore, the database can be used by researchers to obtain control measurements for comparison in studies of various spine, and potentially non-spine, pathologies.
- To create an open access database of radiographic full body images in the sagittal and coronal planes of subjectswithout spine deformities or acute or severe chronic disease, across a range of age groups from 20 to 80 year old males and females.
- To document age related changes that occur in radiographic parameters in the spine and pelvis by including subjects across a wide range of ages.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
asymptomatic EOS Imaging
patients that qualify for study and EOS imaging to analyze spino-pelvic parameters
Radiation: EOS imaging
The EOS imaging system will be utilized to obtain full-body radiographs in frontal and sagittal projections obtained in the upright standing position. Measurements will include a coronal plumb-line, sagittal vertebral axis (SVA), external auditory meatus plumb-line, cervical lordosis, thoracic kyphosis, lumbar lordosis, hip flexion/extension, knee flexion/extension, ankle flexion/extension, T1 tilt, T1 spino-pelvic instance, acetabular index, pelvic tilt (PT), pelvic incidence (PI), and sacral slope (SS).
- Coronal plumb-line [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Sagittal vertebral axis (SVA) [ Time Frame: Through 1 EOS scan, 20 minutes ]
- External auditory meatus plumb-line [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Cervical lordosis [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Thoracic kyphosis [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Lumbar lordosis [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Hip flexion/extension [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Knee flexion/extension [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Ankle flexion/extension [ Time Frame: Through 1 EOS scan, 20 minutes ]
- T1 tilt [ Time Frame: Through 1 EOS scan, 20 minutes ]
- T1 spino-pelvic instance [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Acetabular index [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Pelvic tilt (PT) [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Pelvic incidence (PI) [ Time Frame: Through 1 EOS scan, 20 minutes ]
- Sacral slope (SS) [ Time Frame: Through 1 EOS scan, 20 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076658
|Contact: David Calabreseemail@example.com|
|United States, Colorado|
|University of Coloardo Denver||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: David Calabrese 303-724-9265 David.Calabrese@ucdenver.edu|
|Principal Investigator: Christopher Kleck, MD|
|Principal Investigator:||Christopher Kleck, MD||University of Colorado, Denver|