Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Decision Making in Degenerative Lumbar Spine : CT vs. MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04130035
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Aamer, Assiut University

Brief Summary:
To identify the optimal imaging modality involved in decision making in patients with degenerative lumbar spine using CT vs. MRI.

Condition or disease
Degenerative Lumbar Disease

Detailed Description:
  • There is 266 million individuals (3.63%) worldwide have DSD and LBP each year; the highest and lowest estimated incidences were found in Europe (5.7%) and Africa (2.4%), respectively. Based on population sizes, low- and middle-income countries have 4 times as many cases as high-income countries. Thirty-nine million individuals (0.53%) worldwide were found to have Spondylolisthesis, 403 million (5.5%) individuals worldwide with symptomatic disc degeneration, and 103 million (1.41%) individuals worldwide with spinal stenosis annually.
  • Degenerative disease of the lumbar spine is a significant cause of disability in the world; it encompasses conditions such as Spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Associated with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity.
  • Imaging plays an important role in the evaluation of degenerative spine.
  • Plain films still play an important role in evaluation of the spine, because the examination is inexpensive and available and gives a wide panoramic view of the spine. Direct information about bony structures can be obtained, and functional information about misalignment and vertebral stability can be obtained with upright dynamic films in flexion-extension and lateral bending.
  • Computerized axial tomography (CAT) scan: CT scan shows soft tissues such as ligaments and muscles more clearly than traditional X-rays do, so it is more useful for diagnosing certain problems, such as ruptured or degenerated discs and spinal stenosis.
  • Magnetic resonance imaging (MRI): The advantage of MRI scans over X-rays and CT scans is that MRI provides clear, detailed images of the soft-tissue structures, such as the muscles, cartilage, ligaments, discs, tendons and blood vessels, in addition to the bones.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decision Making in Degenerative Lumbar Spine: CT vs. MRI
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 1, 2021



Primary Outcome Measures :
  1. comparison between CT vs. MRI in decision making in degenerative lumbar spine. [ Time Frame: baseline ]
    Differences in decision making in patients of lumbar degenerative spine based on CT vs. MRI.


Secondary Outcome Measures :
  1. The correlation between the image finding and intraoperative finding. [ Time Frame: baseline ]
    The correlation between the image finding and intraoperative finding.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients more than 18 years old have degenerative lumbar disease with contraindication of MRI and have spinal implant at lumbar region.
Criteria

Inclusion Criteria:

  • degenerative lumbar spine diseases.
  • age more than 18.

Exclusion Criteria:

  • Patients with contraindications for MRI.
  • Patients with spinal implants in the target region.

Information from the National Library of Medicine

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): NCT04130035


Contacts
Layout table for location contacts
Contact: Ahmad Aamer, physician 01011452722 a.aamer2020@gmail.com
Contact: Ahmad Shawqi, Ass. prof 01010212222 ahsh313@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Chair: essam Elsherief, prof. Assiut University

Publications:
Layout table for additonal information
Responsible Party: Ahmed Aamer, resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04130035    
Other Study ID Numbers: degenerative lumbar spine
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Aamer, Assiut University:
decision making
degenerative lumbar disease
CT
MRI