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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
William Lavelle, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01017692
First received: November 18, 2009
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Lumbar Spinal Stenosis
Procedure: MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variability of Magnetic Resonancy Imaging Interpretation for Lumbar Spinal Stenosis

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lumbar Spinal Stenosis
Subjects who have undergone or will undergo an MRI, with symptoms of LSS
Procedure: MRI
MRI of lumbar spine for subjects presenting with spinal stenosis symptoms

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are seen at SUNY Upstate Medical Univeristy, Department of Orthopedic Surgery office

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:

  • Prisoner
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017692

Locations
United States, New York
SUNY Upstate Medical University-Department of Orthopedics
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: William F Lavelle, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: William Lavelle, Associate Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01017692     History of Changes
Other Study ID Numbers: 5825-MRI Variability
Study First Received: November 18, 2009
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014