NCT01017692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 25, 2015

Status Verified

September 1, 2013

Enrollment Period

1.5 years

First QC Date

November 18, 2009

Last Update Submit

May 22, 2015

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Lumbar Spinal Stenosis

Subjects who have undergone or will undergo an MRI, with symptoms of LSS

Procedure: MRI

Interventions

MRIPROCEDURE

MRI of lumbar spine for subjects presenting with spinal stenosis symptoms

Lumbar Spinal Stenosis

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University-Department of Orthopedics

Syracuse, New York, 13202, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • William F Lavelle, MD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 20, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 25, 2015

Record last verified: 2013-09

Locations

US(1)