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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
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
A study of the skeletal structure and how the structure changes over time. The aim of the study is to evaluate the skeleton in 10 year increments to determine an understanding of the normal skeleton as a person ages. By using x-ray analysis, a new low dose x-ray system (EOS) can be used to evaluate the whole body to see changes in the bone structure over time. Subjects will be asked to undertake one x-ray analysis of their whole body skeletal structure. There will be 25 male and 25 female subjects per decade. The averaging of the measured skeletal parameters will provide information on changes over time generating a standardized expectation of general changes in skeletal structure as participants age.

Condition or disease Intervention/treatment Phase
Intervertebral Disc Degeneration Osteoarthritis, Spine Radiation: EOS imaging Not Applicable

Detailed Description:

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.

Specific Aims

  1. 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.
  2. To document age related changes that occur in radiographic parameters in the spine and pelvis by including subjects across a wide range of ages.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Coronal plumb-line [ Time Frame: Through 1 EOS scan, 20 minutes ]
  2. Sagittal vertebral axis (SVA) [ Time Frame: Through 1 EOS scan, 20 minutes ]
  3. External auditory meatus plumb-line [ Time Frame: Through 1 EOS scan, 20 minutes ]
  4. Cervical lordosis [ Time Frame: Through 1 EOS scan, 20 minutes ]
  5. Thoracic kyphosis [ Time Frame: Through 1 EOS scan, 20 minutes ]
  6. Lumbar lordosis [ Time Frame: Through 1 EOS scan, 20 minutes ]
  7. Hip flexion/extension [ Time Frame: Through 1 EOS scan, 20 minutes ]
  8. Knee flexion/extension [ Time Frame: Through 1 EOS scan, 20 minutes ]
  9. Ankle flexion/extension [ Time Frame: Through 1 EOS scan, 20 minutes ]
  10. T1 tilt [ Time Frame: Through 1 EOS scan, 20 minutes ]
  11. T1 spino-pelvic instance [ Time Frame: Through 1 EOS scan, 20 minutes ]
  12. Acetabular index [ Time Frame: Through 1 EOS scan, 20 minutes ]
  13. Pelvic tilt (PT) [ Time Frame: Through 1 EOS scan, 20 minutes ]
  14. Pelvic incidence (PI) [ Time Frame: Through 1 EOS scan, 20 minutes ]
  15. Sacral slope (SS) [ Time Frame: Through 1 EOS scan, 20 minutes ]


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females age 21-85 without a history of spine surgery.

Exclusion Criteria:

  • History of spine or neural axis surgery
  • History of cancer with or without metastatic disease
  • Connective tissue, rheumatologic (or other inflammatory arthropathies), or neurologic disorders
  • History of knee replacement surgery, as these may have contractures causing unexpected changes in alignment
  • Severe osteoarthritis of the hips/knees/ankles
  • Spondylitis
  • Compression fractures or other trauma of the spinal column
  • Previous trauma/fractures of the pelvis whether or not surgery was required
  • Previous trauma or fractures of the lower extremities requiring surgery
  • Pregnant women
  • BMI >37
  • Oswestry Disability Index score >25

Information from the National Library of Medicine

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


Contacts
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Contact: David Calabrese 303-524-2550 david.calabrese@ucdenver.edu

Locations
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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         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Christopher Kleck, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03076658     History of Changes
Other Study ID Numbers: 15-2433
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Researchers, at the end of the study, can make data request to Principle Investigator and then requested data can be obtained via RedCap.
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Osteoarthritis, Spine
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Bone Diseases
Spondylarthritis
Spondylitis