Creating a database of full body radiographs in healthy volunteers
Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers
This study is trying to create a database of full body x-rays from healthy people to help doctors understand normal bone structure and improve treatment for spine issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03076658 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the skeletal structure of healthy individuals by analyzing full body radiographs taken at 10-year intervals. Using a low dose x-ray system called EOS, the researchers will collect images from 25 male and 25 female volunteers per decade, ranging from ages 21 to 85. The goal is to establish a baseline of 'normal' skeletal parameters that can inform clinical decision-making and surgical planning for spine-related conditions. The resulting open access database will serve as a valuable resource for both spine surgeons and researchers.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 21 to 85 without a history of spine surgery or significant skeletal disorders.
Not a fit: Patients with a history of spine surgery, severe osteoarthritis, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical normative data that enhances the understanding of skeletal changes with age, improving patient outcomes in spine surgery.
How similar studies have performed: While the approach of creating a normative database is established, the use of the EOS imaging system for this specific purpose is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Coloardo Denver — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Kleck, MD — University of Colorado, Denver
- Study coordinator: David Calabrese
- Email: david.calabrese@ucdenver.edu
- Phone: 303-524-2550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.