SpondylolisthesisNCT02958241
Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis
A study testing MRI in people with Spondylolisthesis, run by Texas Back Institute at 1 site in United States.
Trial summary
This study investigates the possible differences in images obtained in patients with lumbar spondylolisthesis when positioned in an upright weight bearing position compared with traditional supine positioning for lumbar MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylolisthesis
- What is being tested?
- MRI
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Nov 2018
- 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
- Diagnosis of degenerative or isthmic lumbar spondylolisthesis by a spine specialty physician based on clinical evaluation and lumbar radiographs
- No previous lumbar spinal fusion at the level of the spondylolisthesis or a procedure resulting in the presence of metallic implants at the level of interest (if a device such as a interspinous device was implanted and later removed, the patient may participate in the study)
- Be able and willing to provide written consent to participate in the study
- Willing to undergo a second MRI approximately 6 months after surgery, if surgery is performed
Who cannot join
- Pregnancy
- Any condition that would prevent the patient from undergoing MRI
- Recent lumbar vertebral body fracture
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the possible differences in images obtained in patients with lumbar spondylolisthesis when positioned in an upright weight bearing position compared with traditional supine positioning for lumbar MRI.
Read the detailed description
Detailed Description Spondylolisthesis is a spinal condition in which one vertebral body has slid forward in relation to the vertebrae below and is sometimes associated with spinal instability. Lumbar spondylolisthesis is a relatively common problem and is generally diagnosed from radiographs. MRI is often used to evaluate the condition further and to determine if there is nerve root compression involved. One potential disadvantage with traditional MRI to evaluate spondylolisthesis is imaging is performed with the patient lying supine in the scanner. This creates a potential for the superior vertebra to slide posteriorly so that the extent of the slip may not be fully appreciated, if seen at all. Use of upright weight bearing MRI provides the opportunity to image the spine in the position that patients are most likely to experience symptoms and is similar to standing radiographs.
MRI Acquisition: Each patient will undergo MRI scanning in the supine and weight bearing positions during the same imaging session. If it is determined that a patient who has consented to participate in the study should not have an MRI made due to safety concerns (such as metallic implant or other contraindication to MRI not identified during recruiting), they will be discontinued from the study and another patient recruited to fulfill the planned number of images available for analysis.
The MRI procedure will be standard lumbar spine scanning protocol using the Esaote G-scan, an open unit. Patients will be scanned supine and then the unit rotated to 81 degrees from horizontal for the weight bearing scan. Immediately after each scan, the patient will complete visual analog scales (VAS) assessing back and leg pain.
Researcher(s) performing image assessments will be blinded to the position in which scans were made. Data to be recorded for each image is the Meyerding scale (1-4 scale rating the severity of the spondylolisthesis), amount of slip (mm), anterior and posterior disc space height (mm), foraminal area, anteroposterior (AP) distance at the most narrow part of the foramen, and disc space angulation. Area of the spinal canal and AP distance across the canal will be measured from axial images. The facet fluid sign, associated with spinal instability, will be assessed from axial MRI views using a 3-point scale with "none" indicating no evidence of fluid in the left or right facet joints; "possible" if there is some suggestion of fluid in the joints; or "definite" if there is at least a 2 mm wide layer of hyperintensity within either joint bilaterally at the level evaluated. Additionally, the width of the fluid fill of the facet joint taken perpendicular to the apparent joint line, and the largest value recorded as effusion size.
Clinical Assessments: VAS separately assessing back and leg pain will be completed immediately after the supine scanning and again immediately after weight bearing scanning. Analysis will be conducted to determine if differences in pain correlate with changes in images taken in the two positions.
Statistical methods: Parametric measures will be compared for the two imaging positions using paired t-tests. Pairwise categorical data will be analyzed using McNemar analysis. In the secondary study dealing with facet fluid sign, mean values for translation, disc height, foraminal area, and AP distance will be compared across the three facet fluid sign categories using ANOVA.
Changes in back and leg pain will be analyzed to determine if there is a relationship between these changes and changes noted on the positional MRI. It is not anticipated that this section of the study will produce statistically significant results, but will hopefully provide guidance for possibly investigating these parameters in future studies.
From routine clinical lateral flexion/extension radiographs, change in translation between the two positions will be measured. If a lateral neutral radiograph is available, translation as well as anterior and posterior disc height will be measured. All measurements will be made using the same methods as described for the MRIs.
Sample size: At least 25 patients, but no more than 60 patients will be included. After 25 patients are imaged, data will be analyzed to determine an appropriate sample size to determine a statistically significant difference between measurements made from the supine and upright weight bearing images.
- Conditions
- Spondylolisthesis
- Being tested
- MRI
- Keywords
- spondylolisthesis, Lumbar spine, MRI
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Supine and weight bearing MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior vertebral body translation (mm)
Measured: up to 6 months
Disc space height (mm)
Measured: up to 6 months
Secondary outcomes (5)
Foraminal area (mm2)
Measured: initial evaluation and 6 mo after surgery if surgery is performed
Meyerding grade and facet fluid fill sign (value assigned based on visual inspecting of the MRIs and applying published scoring grades)
Measured: initial evaluation and 6 mo after surgery if surgery is performed
Visual analog pain scales (VAS) assessing back and leg pain
Measured: initial evaluation and 6 mo after surgery if surgery is performed
Anteroposterior distance across spinal canal (mm)
Measured: initial evaluation and 6 mo after surgery if surgery is performed
Spinal canal area (mm2)
Measured: initial evaluation and 6 mo after surgery if surgery is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolisthesisStudies of the same condition, open and under way.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Back Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958241
- Sponsor's protocol ID
- MRI001
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis
- ClinicalTrials.gov ID
- NCT02958241
- Acronym / sponsor ID
- MRI001
- Conditions
- Spondylolisthesis
- Keywords
- spondylolisthesis, Lumbar spine, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Texas Back InstituteUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 8 Nov 2016 (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.
This study investigates the possible differences in images obtained in patients with lumbar spondylolisthesis when positioned in an upright weight bearing position compared with traditional supine positioning for lumbar MRI.
Detailed description
Detailed Description Spondylolisthesis is a spinal condition in which one vertebral body has slid forward in relation to the vertebrae below and is sometimes associated with spinal instability. Lumbar spondylolisthesis is a relatively common problem and is generally diagnosed from radiographs. MRI is often used to evaluate the condition further and to determine if there is nerve root compression involved. One potential disadvantage with traditional MRI to evaluate spondylolisthesis is imaging is performed with the patient lying supine in the scanner. This creates a potential for the superior vertebra to slide posteriorly so that the extent of the slip may not be fully appreciated, if seen at all. Use of upright weight bearing MRI provides the opportunity to image the spine in the position that patients are most likely to experience symptoms and is similar to standing radiographs.
MRI Acquisition: Each patient will undergo MRI scanning in the supine and weight bearing positions during the same imaging session. If it is determined that a patient who has consented to participate in the study should not have an MRI made due to safety concerns (such as metallic implant or other contraindication to MRI not identified during recruiting), they will be discontinued from the study and another patient recruited to fulfill the planned number of images available for analysis.
The MRI procedure will be standard lumbar spine scanning protocol using the Esaote G-scan, an open unit. Patients will be scanned supine and then the unit rotated to 81 degrees from horizontal for the weight bearing scan. Immediately after each scan, the patient will complete visual analog scales (VAS) assessing back and leg pain.
Researcher(s) performing image assessments will be blinded to the position in which scans were made. Data to be recorded for each image is the Meyerding scale (1-4 scale rating the severity of the spondylolisthesis), amount of slip (mm), anterior and posterior disc space height (mm), foraminal area, anteroposterior (AP) distance at the most narrow part of the foramen, and disc space angulation. Area of the spinal canal and AP distance across the canal will be measured from axial images. The facet fluid sign, associated with spinal instability, will be assessed from axial MRI views using a 3-point scale with "none" indicating no evidence of fluid in the left or right facet joints; "possible" if there is some suggestion of fluid in the joints; or "definite" if there is at least a 2 mm wide layer of hyperintensity within either joint bilaterally at the level evaluated. Additionally, the width of the fluid fill of the facet joint taken perpendicular to the apparent joint line, and the largest value recorded as effusion size.
Clinical Assessments: VAS separately assessing back and leg pain will be completed immediately after the supine scanning and again immediately after weight bearing scanning. Analysis will be conducted to determine if differences in pain correlate with changes in images taken in the two positions.
Statistical methods: Parametric measures will be compared for the two imaging positions using paired t-tests. Pairwise categorical data will be analyzed using McNemar analysis. In the secondary study dealing with facet fluid sign, mean values for translation, disc height, foraminal area, and AP distance will be compared across the three facet fluid sign categories using ANOVA.
Changes in back and leg pain will be analyzed to determine if there is a relationship between these changes and changes noted on the positional MRI. It is not anticipated that this section of the study will produce statistically significant results, but will hopefully provide guidance for possibly investigating these parameters in future studies.
From routine clinical lateral flexion/extension radiographs, change in translation between the two positions will be measured. If a lateral neutral radiograph is available, translation as well as anterior and posterior disc height will be measured. All measurements will be made using the same methods as described for the MRIs.
Sample size: At least 25 patients, but no more than 60 patients will be included. After 25 patients are imaged, data will be analyzed to determine an appropriate sample size to determine a statistically significant difference between measurements made from the supine and upright weight bearing images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of degenerative or isthmic lumbar spondylolisthesis by a spine specialty physician based on clinical evaluation and lumbar radiographs
- No previous lumbar spinal fusion at the level of the spondylolisthesis or a procedure resulting in the presence of metallic implants at the level of interest (if a device such as a interspinous device was implanted and later removed, the patient may participate in the study)
- Be able and willing to provide written consent to participate in the study
- Willing to undergo a second MRI approximately 6 months after surgery, if surgery is performed
Key exclusion criteria (3 listed)
- Pregnancy
- Any condition that would prevent the patient from undergoing MRI
- Recent lumbar vertebral body fracture
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 |
|---|---|---|
| MRISupine and weight bearing MRI | Other | – |
Primary outcome
Superior vertebral body translation (mm)
Time frame: up to 6 months
Disc space height (mm)
Time frame: up to 6 months
5 secondary outcomes
Foraminal area (mm2)
Time frame: initial evaluation and 6 mo after surgery if surgery is performed
Meyerding grade and facet fluid fill sign (value assigned based on visual inspecting of the MRIs and applying published scoring grades)
Time frame: initial evaluation and 6 mo after surgery if surgery is performed
Visual analog pain scales (VAS) assessing back and leg pain
Time frame: initial evaluation and 6 mo after surgery if surgery is performed
Anteroposterior distance across spinal canal (mm)
Time frame: initial evaluation and 6 mo after surgery if surgery is performed
Spinal canal area (mm2)
Time frame: initial evaluation and 6 mo after surgery if surgery is performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Spondylolisthesis, run by Texas Back Institute 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Nov 2016. 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?
Results are not available in the source record.
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?
Superior vertebral body translation (mm) (time frame: up to 6 months). The study lists 2 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 8 Nov 2016.