Magnetic Resonance Imaging (MRI) Interpretations for Lumbar Spinal Stenosis (LSS)
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|ClinicalTrials.gov Identifier: NCT01017692|
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : May 25, 2015
|Condition or disease||Intervention/treatment|
|Lumbar Spinal Stenosis||Procedure: MRI|
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.
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Variability of Magnetic Resonancy Imaging Interpretation for Lumbar Spinal Stenosis|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Lumbar Spinal Stenosis
Subjects who have undergone or will undergo an MRI, with symptoms of LSS
MRI of lumbar spine for subjects presenting with spinal stenosis symptoms
- 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 ]
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): NCT01017692
|United States, New York|
|SUNY Upstate Medical University-Department of Orthopedics|
|Syracuse, New York, United States, 13202|
|Principal Investigator:||William F Lavelle, MD||State University of New York - Upstate Medical University|