Intervertebral Disc DegenerationNCT03076658
Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers
A study testing EOS imaging in people with Intervertebral Disc Degeneration and Osteoarthritis, Spine, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervertebral Disc Degeneration, Osteoarthritis, Spine
- What is being tested?
- EOS imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females age 21-85 without a history of spine surgery.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Coloardo Denver
Aurora, Colorado, 80045
David Calabrese, 303-724-9265, David.Calabrese@ucdenver.edu
Christopher Kleck, MD
About this study
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.
Read the 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.
- Being tested
- EOS imaging
- Medical subject headings
- Intervertebral Disc Degeneration, Osteoarthritis, Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS imagingRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic EOS Imaging | Other | patients that qualify for study and EOS imaging to analyze spino-pelvic parameters Receives: Radiation: EOS imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronal plumb-line
Measured: Through 1 EOS scan, 20 minutes
Sagittal vertebral axis (SVA)
Measured: Through 1 EOS scan, 20 minutes
External auditory meatus plumb-line
Measured: Through 1 EOS scan, 20 minutes
Cervical lordosis
Measured: Through 1 EOS scan, 20 minutes
Thoracic kyphosis
Measured: Through 1 EOS scan, 20 minutes
Lumbar lordosis
Measured: Through 1 EOS scan, 20 minutes
Hip flexion/extension
Measured: Through 1 EOS scan, 20 minutes
Knee flexion/extension
Measured: Through 1 EOS scan, 20 minutes
Ankle flexion/extension
Measured: Through 1 EOS scan, 20 minutes
T1 tilt
Measured: Through 1 EOS scan, 20 minutes
T1 spino-pelvic instance
Measured: Through 1 EOS scan, 20 minutes
Acetabular index
Measured: Through 1 EOS scan, 20 minutes
Pelvic tilt (PT)
Measured: Through 1 EOS scan, 20 minutes
Pelvic incidence (PI)
Measured: Through 1 EOS scan, 20 minutes
Sacral slope (SS)
Measured: Through 1 EOS scan, 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startSep 2016
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Kleck, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076658
- Sponsor's protocol ID
- 15-2433
- Status last verified
- Sep 2023
- First submitted
- 11 Jan 2017
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Researchers, at the end of the study, can make data request to Principle Investigator and then requested data can be obtained via RedCap.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers
- ClinicalTrials.gov ID
- NCT03076658
- Acronym / sponsor ID
- 15-2433
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asymptomatic EOS Imaging | Other | Radiation: EOS imagingpatients that qualify for study and EOS imaging to analyze spino-pelvic parameters |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males and females age 21-85 without a history of spine surgery.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOS imagingThe 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). | Radiation | asymptomatic EOS Imaging |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Yes. Researchers, at the end of the study, can make data request to Principle Investigator and then requested data can be obtained via RedCap.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Kleck, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS imaging in people with Intervertebral Disc Degeneration and Osteoarthritis, Spine, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Calabrese (303-524-2550, david.calabrese@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronal plumb-line (time frame: Through 1 EOS scan, 20 minutes). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.