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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01017692
Other study ID # 5825-MRI Variability
Secondary ID
Status Completed
Phase N/A
First received November 18, 2009
Last updated May 22, 2015
Start date June 2009
Est. completion date December 2010

Study information

Verified date September 2013
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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:

- Prisoner

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
MRI
MRI of lumbar spine for subjects presenting with spinal stenosis symptoms

Locations

Country Name City State
United States SUNY Upstate Medical University-Department of Orthopedics Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one year No
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