NCT02958241

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 3, 2016

Last Update Submit

November 7, 2016

Conditions

Spondylolisthesis

Keywords

spondylolisthesisLumbar spineMRI

Outcome Measures

Primary Outcomes (2)

  • Superior vertebral body translation (mm)

    up to 6 months

  • Disc space height (mm)

    up to 6 months

Secondary Outcomes (5)

  • Foraminal area (mm2)

    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)

    initial evaluation and 6 mo after surgery if surgery is performed

  • Visual analog pain scales (VAS) assessing back and leg pain

    initial evaluation and 6 mo after surgery if surgery is performed

  • Anteroposterior distance across spinal canal (mm)

    initial evaluation and 6 mo after surgery if surgery is performed

  • Spinal canal area (mm2)

    initial evaluation and 6 mo after surgery if surgery is performed

Interventions

MRIOTHER

Supine and weight bearing MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Any condition that would prevent the patient from undergoing MRI
  • Recent lumbar vertebral body fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Back Institute

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)