Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01017692
Study type Observational
Source State University of New York - Upstate Medical University
Contact
Status Completed
Phase N/A
Start date June 2009
Completion date December 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04795284 - Biomechanical Parameters of Gait in Patients With Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
Recruiting NCT04066296 - Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine Phase 2
Active, not recruiting NCT05114135 - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study) N/A
Recruiting NCT06057428 - Activity Levels Amongst Patients With Lumbar Spinal Stenosis
Recruiting NCT06075862 - Balance Amongst Patients With Lumbar Spinal Stenosis
Recruiting NCT05527145 - Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial N/A
Recruiting NCT01902979 - The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial N/A
Completed NCT00749073 - The Vertos MILD™ Preliminary Patient Evaluation Study N/A
Completed NCT00527527 - Chiropractic Dosage for Lumbar Stenosis Phase 2
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT03194607 - Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
Recruiting NCT06034405 - Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Completed NCT06079580 - Patients With Lumbar Spinal Stenosis With Balance Disorder
Recruiting NCT05523388 - Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Completed NCT04563793 - Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Suspended NCT03381677 - Pedicle Osteotomy for Stenosis Trial N/A
Completed NCT02258672 - Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis N/A
Completed NCT02260401 - Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis N/A
Completed NCT01994512 - Swedish Spinal Stenosis Study N/A