Clinical Trials Directory

Trials / Completed

CompletedNCT01017692

Magnetic Resonance Imaging (MRI) Interpretations for Lumbar Spinal Stenosis (LSS)

Variability of Magnetic Resonancy Imaging Interpretation for Lumbar Spinal Stenosis

Status
Completed
Phase
Study type
Observational
Enrollment
36 (actual)
Sponsor
State University of New York - Upstate Medical University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

The objective of this study is to establish a relationship between the degree of radiologically established anatomical stenosis and the severity of self-assessed outcome measures in patients that have undergone and MRI.

Detailed description

Magnetic Resonance Imaging(MRI) has become the gold standard of evaluation of lumbar spinal stenosis (LSS. LSS is defined as the narrowing of the spinal canal. Thus far, there has been no formal grading system in literature. Physicians, particularly radiologists, in their interpretations, currently describe the degree of stenosis at each level as normal, mild, moderate or severe. Unfortunately, there is no consensus on criteria of these definitions. Treatments and surgical plans are based primarily on this information. Consequently, the reliability and accuracy of this information is critical in terms of optimizing outcomes. In this study 50-100 MRI studies of patients diagnosed with symptomatic lumbar spinal stenosis will be collected, de-identified, and assigned a study identification number for tracking purposes. Three "raters" from Upstate and three "rater" from outside the institution, that have experience reviewing MRI's will be asked to review the MRI's and classify the LSS at all lumbar levels as normal, mild, moderate or severe in the central canal, lateral recesses and the neuroforamen. The raters will not have any information about the patients. The MRI's will then be given a new identification number, and the patient's self-assessment questionnaires (which are also de-identified and given the study id number) will be given to the raters, for a second review. The raters will have the patients gender, age and outcomes scores from Short form 36, Visual Analog Scale, Oswestry Disability Index and Zurich Claudication Questionnaires. The raters will classify the MRI, as normal, mild, moderate or severe using the outcomes and information supplied. The data from both ratings will be compiled and compared to assess the reliability of the radiologically established anatomical stenosis when compared with the subjects outcome scores. This study is for current patients in Upstate Orthopedics office.

Conditions

Interventions

TypeNameDescription
PROCEDUREMRIMRI of lumbar spine for subjects presenting with spinal stenosis symptoms

Timeline

Start date
2009-06-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2009-11-20
Last updated
2015-05-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01017692. Inclusion in this directory is not an endorsement.