Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis
Primary Purpose
Spondylolisthesis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Spondylolisthesis focused on measuring spondylolisthesis, Lumbar spine, MRI
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Any condition that would prevent the patient from undergoing MRI
- Recent lumbar vertebral body fracture
Sites / Locations
- Texas Back Institute
Outcomes
Primary Outcome Measures
Superior vertebral body translation (mm)
Disc space height (mm)
Secondary Outcome Measures
Foraminal area (mm2)
Meyerding grade and facet fluid fill sign (value assigned based on visual inspecting of the MRIs and applying published scoring grades)
Visual analog pain scales (VAS) assessing back and leg pain
Anteroposterior distance across spinal canal (mm)
Spinal canal area (mm2)
Full Information
NCT ID
NCT02958241
First Posted
November 3, 2016
Last Updated
November 7, 2016
Sponsor
Texas Back Institute
1. Study Identification
Unique Protocol Identification Number
NCT02958241
Brief Title
Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis
Official Title
Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Back Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylolisthesis
Keywords
spondylolisthesis, Lumbar spine, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Supine and weight bearing MRI
Primary Outcome Measure Information:
Title
Superior vertebral body translation (mm)
Time Frame
up to 6 months
Title
Disc space height (mm)
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Foraminal area (mm2)
Time Frame
initial evaluation and 6 mo after surgery if surgery is performed
Title
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
Title
Visual analog pain scales (VAS) assessing back and leg pain
Time Frame
initial evaluation and 6 mo after surgery if surgery is performed
Title
Anteroposterior distance across spinal canal (mm)
Time Frame
initial evaluation and 6 mo after surgery if surgery is performed
Title
Spinal canal area (mm2)
Time Frame
initial evaluation and 6 mo after surgery if surgery is performed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Pregnancy
Any condition that would prevent the patient from undergoing MRI
Recent lumbar vertebral body fracture
Facility Information:
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis
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