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.

Study Overview

• Status: Recruiting
• Conditions: Intervertebral Disc Degeneration; Osteoarthritis, Spine
• Intervention / Treatment: Radiation: EOS imaging

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Calabrese; Phone Number: 303-524-2550; Email: david.calabrese@ucdenver.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Coloardo Denver
      • Contact: David Calabrese; Phone Number: 303-724-9265; Email: David.Calabrese@ucdenver.edu
      • Principal Investigator: Christopher Kleck, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Christopher Kleck, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthritis; Spondylitis; Osteoarthritis; Intervertebral Disc Degeneration; Osteoarthritis, Spine
• Other Study ID Numbers: 15-2433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.