Clinical trial NCT04130035: Decision Making in Degenerative Lumbar Spine : CT vs. MRI
Official title: Decision Making in Degenerative Lumbar Spine: CT vs. MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Lumbar Disease
Keywords: decision making
degenerative lumbar disease
CT
MRI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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.

Primary outcomes:
measure: comparison between CT vs. MRI in decision making in degenerative lumbar spine.
timeFrame: baseline
Secondary outcomes:
measure: The correlation between the image finding and intraoperative finding.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: essam Elsherief, prof.
role: STUDY_CHAIR
References:
citation: Maravilla KR, Lesh P, Weinreb JC, Selby DK, Mooney V. Magnetic resonance imaging of the lumbar spine with CT correlation. AJNR Am J Neuroradiol. 1985 Mar-Apr;6(2):237-45.
citation: Modic MT, Ross JS. Magnetic resonance imaging in the evaluation of low back pain. Orthop Clin North Am. 1991 Apr;22(2):283-301.
citation: Jarvik JG, Deyo RA. Diagnostic evaluation of low back pain with emphasis on imaging. Ann Intern Med. 2002 Oct 1;137(7):586-97. doi: 10.7326/0003-4819-137-7-200210010-00010.
citation: Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.