Spondylolisthesis Clinical Trial
Official title:
Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis
Verified date | November 2016 |
Source | Texas Back Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 25 |
Est. completion date | November 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Texas Back Institute | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Back Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Superior vertebral body translation (mm) | up to 6 months | No | |
Primary | Disc space height (mm) | up to 6 months | No | |
Secondary | Foraminal area (mm2) | initial evaluation and 6 mo after surgery if surgery is performed | No | |
Secondary | Meyerding grade and facet fluid fill sign (value assigned based on visual inspecting of the MRIs and applying published scoring grades) | initial evaluation and 6 mo after surgery if surgery is performed | No | |
Secondary | Visual analog pain scales (VAS) assessing back and leg pain | initial evaluation and 6 mo after surgery if surgery is performed | No | |
Secondary | Anteroposterior distance across spinal canal (mm) | initial evaluation and 6 mo after surgery if surgery is performed | No | |
Secondary | Spinal canal area (mm2) | initial evaluation and 6 mo after surgery if surgery is performed | No |
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