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Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers

Primary Purpose

Intervertebral Disc Degeneration, Osteoarthritis, Spine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EOS imaging
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intervertebral Disc Degeneration

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Coloardo DenverRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

asymptomatic EOS Imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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)
Sacral slope (SS)

Secondary Outcome Measures

Full Information

First Posted
January 11, 2017
Last Updated
September 26, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03076658
Brief Title
Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers
Official Title
Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2031 (Anticipated)
Study Completion Date
January 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Degeneration, Osteoarthritis, Spine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
asymptomatic EOS Imaging
Arm Type
Other
Arm Description
patients that qualify for study and EOS imaging to analyze spino-pelvic parameters
Intervention Type
Radiation
Intervention Name(s)
EOS imaging
Intervention Description
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 Information:
Title
Coronal plumb-line
Time Frame
Through 1 EOS scan, 20 minutes
Title
Sagittal vertebral axis (SVA)
Time Frame
Through 1 EOS scan, 20 minutes
Title
External auditory meatus plumb-line
Time Frame
Through 1 EOS scan, 20 minutes
Title
Cervical lordosis
Time Frame
Through 1 EOS scan, 20 minutes
Title
Thoracic kyphosis
Time Frame
Through 1 EOS scan, 20 minutes
Title
Lumbar lordosis
Time Frame
Through 1 EOS scan, 20 minutes
Title
Hip flexion/extension
Time Frame
Through 1 EOS scan, 20 minutes
Title
Knee flexion/extension
Time Frame
Through 1 EOS scan, 20 minutes
Title
Ankle flexion/extension
Time Frame
Through 1 EOS scan, 20 minutes
Title
T1 tilt
Time Frame
Through 1 EOS scan, 20 minutes
Title
T1 spino-pelvic instance
Time Frame
Through 1 EOS scan, 20 minutes
Title
Acetabular index
Time Frame
Through 1 EOS scan, 20 minutes
Title
Pelvic tilt (PT)
Time Frame
Through 1 EOS scan, 20 minutes
Title
Pelvic incidence (PI)
Time Frame
Through 1 EOS scan, 20 minutes
Title
Sacral slope (SS)
Time Frame
Through 1 EOS scan, 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Calabrese
Phone
303-524-2550
Email
david.calabrese@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Kleck, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Coloardo Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Calabrese
Phone
303-724-9265
Email
David.Calabrese@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Christopher Kleck, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers

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