Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03076658

Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intervertebral Disc Degeneration Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Spine Rheumatic Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Coloardo Denver

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Christopher Kleck, MD

PRINCIPAL_INVESTIGATOR

David Calabrese

CONTACT

[email protected]

303-724-9265

About this study

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

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOS imaging

Radiation

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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

David Calabrese

CONTACT

[email protected]

303-524-2550

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2031
Study completion
2031
First posted
Mar 10, 2017
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.