KyphosisNCT02165514
Cobb Angle Measurement of Kyphosis and Scoliosis
A study testing Lunar iDXA x-ray scan in people with Kyphosis and Scoliosis, run by University of Michigan.
Trial summary
Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar iDXA x-ray scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lunar iDXA x-ray scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Have Kyphosis or Scoliosis
- Have had an x-ray of the spine performed within 3 months time
Who cannot join
- Are unwilling to read and sign this document
- Are pregnant or if you have not had a negative pregnancy test just prior to the iDXA scan.
- Have severe deformities of your back
- Unable to lay on the scanning table for the scan
About this study
Official title: Traditional Cobb Angle Measurement of Kyphosis and Scoliosis Using Lunar IDXA
Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar iDXA x-ray scan.
Read the detailed description
To determine if bone density scanning (DEXA) and the use of a computer software program can make accurate measurements of the curvature(s) of the spine (Cobb angle)in patients with kyphosis and scoliosis compared to x-rays of the spine.
- Being tested
- Lunar iDXA x-ray scan
- Keywords
- spinal curvatures
- Medical subject headings
- Kyphosis, Scoliosis, Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lunar iDXA x-ray scanProcedure or surgery
Subjects will lay either on their back or side depending whether subject has kyphosis or scoliosis. After the DEXA scan the computer will calculate the Cobb angle. The calculation of Cobb angle from the DEXA scan will be compared to the conventional spine x-ray.
| Study group | Role | What they receive |
|---|---|---|
| Lunar iDXA (DEXA) scan | Experimental | Spinal scans taken by DEXA scanner Receives: Procedure: Lunar iDXA x-ray scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle measurements in degrees of spine curvature
Comparison of iDXA Cobb anle measurements with Cobb angle measurements from radiographs
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Yebin Jiang, M.D., University of Michigan
- Investigators
- Yebin Jiang, PhD, Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165514
- Sponsor's protocol ID
- HUM00029355
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Cobb Angle Measurement of Kyphosis and Scoliosis Using Lunar IDXA
- ClinicalTrials.gov ID
- NCT02165514
- Acronym / sponsor ID
- HUM00029355
- Keywords
- spinal curvatures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Jun 2014 (estimated)
- 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.
Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar iDXA x-ray scan.
Detailed description
To determine if bone density scanning (DEXA) and the use of a computer software program can make accurate measurements of the curvature(s) of the spine (Cobb angle)in patients with kyphosis and scoliosis compared to x-rays of the spine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lunar iDXA (DEXA) scan | Experimental | Procedure: Lunar iDXA x-ray scanSpinal scans taken by DEXA scanner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age
- Have Kyphosis or Scoliosis
- Have had an x-ray of the spine performed within 3 months time
Key exclusion criteria (4 listed)
- Are unwilling to read and sign this document
- Are pregnant or if you have not had a negative pregnancy test just prior to the iDXA scan.
- Have severe deformities of your back
- Unable to lay on the scanning table for the scan
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 |
|---|---|---|
| Lunar iDXA x-ray scanSubjects will lay either on their back or side depending whether subject has kyphosis or scoliosis. After the DEXA scan the computer will calculate the Cobb angle. The calculation of Cobb angle from the DEXA scan will be compared to the conventional spine x-ray. | Procedure or surgery | Lunar iDXA (DEXA) scan |
Primary outcome
Cobb angle measurements in degrees of spine curvature
Time frame: 3 year
Comparison of iDXA Cobb anle measurements with Cobb angle measurements from radiographs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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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. This study is not recruiting at the moment.
Yebin Jiang, PhD principal investigator
University of Michigan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Lunar iDXA x-ray scan in people with Kyphosis and Scoliosis, run by University of Michigan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle measurements in degrees of spine curvature (time frame: 3 year). 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 17 Jun 2014.