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Clinical Trials/NCT01017692
NCT01017692
Completed
Not Applicable

Variability of Magnetic Resonancy Imaging Interpretation for Lumbar Spinal Stenosis

State University of New York - Upstate Medical University1 site in 1 country36 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spinal Stenosis
Sponsor
State University of New York - Upstate Medical University
Enrollment
36
Locations
1
Primary Endpoint
A numeric score will be calculated for the actual percent stenosis at the symptomatic level(s) and will report the predictive power of MRI based on all the analysis of MRI with and without clinical knowledge of patient's presenting symptoms
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
December 2010
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
State University of New York - Upstate Medical University
Responsible Party
Principal Investigator
Principal Investigator

William Lavelle

Associate Professor

State University of New York - Upstate Medical University

Eligibility Criteria

Inclusion Criteria

  • Must be at least 21 years of age
  • Must be able to undergo or have undergone an MRI of the Lumbar spine
  • Must be able to read/understand English
  • Must be a current patient in our practice

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

A numeric score will be calculated for the actual percent stenosis at the symptomatic level(s) and will report the predictive power of MRI based on all the analysis of MRI with and without clinical knowledge of patient's presenting symptoms

Time Frame: one year

Study Sites (1)

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