Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers

NCT03076658 | Recruiting

• 1 other identifier: 15-2433
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervertebral Disc Degeneration; Osteoarthritis, Spine

Outcome Measures

Primary Outcomes (15)

• Coronal plumb-line

  Through 1 EOS scan, 20 minutes

• Sagittal vertebral axis (SVA)

  Through 1 EOS scan, 20 minutes

• External auditory meatus plumb-line

  Through 1 EOS scan, 20 minutes

• Cervical lordosis

  Through 1 EOS scan, 20 minutes

• Thoracic kyphosis

  Through 1 EOS scan, 20 minutes

• Lumbar lordosis

  Through 1 EOS scan, 20 minutes

• Hip flexion/extension

  Through 1 EOS scan, 20 minutes

• Knee flexion/extension

  Through 1 EOS scan, 20 minutes

• Ankle flexion/extension

  Through 1 EOS scan, 20 minutes

• T1 tilt

  Through 1 EOS scan, 20 minutes

• T1 spino-pelvic instance

  Through 1 EOS scan, 20 minutes

• Acetabular index

  Through 1 EOS scan, 20 minutes

• Pelvic tilt (PT)

  Through 1 EOS scan, 20 minutes

• Pelvic incidence (PI)

  Through 1 EOS scan, 20 minutes

• Sacral slope (SS)

  Through 1 EOS scan, 20 minutes

Study Arms (1)

asymptomatic EOS Imaging

OTHER

patients that qualify for study and EOS imaging to analyze spino-pelvic parameters

Radiation: EOS imaging

Interventions

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).

asymptomatic EOS Imaging

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Coloardo Denver

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Osteoarthritis, Spine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylarthritis; Spondylitis; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• Christopher Kleck, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Calabrese

CONTACT

303-524-2550; david.calabrese@ucdenver.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: March 10, 2017
• Study Start: September 1, 2016
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)