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Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis

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ClinicalTrials.gov Identifier: NCT02958241
Recruitment Status : Unknown
Verified November 2016 by Texas Back Institute.
Recruitment status was:  Enrolling by invitation
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Texas Back Institute

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.

Condition or disease Intervention/treatment Phase
Spondylolisthesis Other: MRI Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Supine vs. Upright Weight Bearing MRI in the Evaluation of Patients With Lumbar Spondylolisthesis
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight


Intervention Details:
  • Other: MRI
    Supine and weight bearing MRI


Primary Outcome Measures :
  1. Superior vertebral body translation (mm) [ Time Frame: up to 6 months ]
  2. Disc space height (mm) [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Foraminal area (mm2) [ Time Frame: initial evaluation and 6 mo after surgery if surgery is performed ]
  2. 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 ]
  3. Visual analog pain scales (VAS) assessing back and leg pain [ Time Frame: initial evaluation and 6 mo after surgery if surgery is performed ]
  4. Anteroposterior distance across spinal canal (mm) [ Time Frame: initial evaluation and 6 mo after surgery if surgery is performed ]
  5. Spinal canal area (mm2) [ Time Frame: initial evaluation and 6 mo after surgery if surgery is performed ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958241


Locations
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United States, Texas
Texas Back Institute
Plano, Texas, United States, 75093
Sponsors and Collaborators
Texas Back Institute

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Responsible Party: Texas Back Institute
ClinicalTrials.gov Identifier: NCT02958241     History of Changes
Other Study ID Numbers: MRI001
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Texas Back Institute:
spondylolisthesis
Lumbar spine
MRI

Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases