Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT03076658

Conditions

Intervertebral Disc Degeneration

Osteoarthritis, Spine

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

EOS imaging

Study Details

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

Study ID

NCT03076658

Start date

Sep, 2016

Status verified date

Sep, 2023

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: asymptomatic EOS Imaging

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

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

David Calabrese

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

Locations

University of Coloardo Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

David Calabrese

303-724-9265David.Calabrese@ucdenver.edu

Principal Investigator:

Christopher Kleck, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2023-09-28.