NCT04130035

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 15, 2019

Last Update Submit

October 16, 2019

Conditions

Degenerative Lumbar Disease

Keywords

decision makingdegenerative lumbar diseaseCTMRI

Outcome Measures

Primary Outcomes (1)

  • comparison between CT vs. MRI in decision making in degenerative lumbar spine.

    Differences in decision making in patients of lumbar degenerative spine based on CT vs. MRI.

    baseline

Secondary Outcomes (1)

  • The correlation between the image finding and intraoperative finding.

    baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 3920882BACKGROUND

  • Modic MT, Ross JS. Magnetic resonance imaging in the evaluation of low back pain. Orthop Clin North Am. 1991 Apr;22(2):283-301.

    PMID: 1826552BACKGROUND

  • 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.

    PMID: 12353946BACKGROUND

  • 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.

    PMID: 30560029BACKGROUND

Study Officials

  • essam Elsherief, prof.

    Assiut University

    STUDY CHAIR

Central Study Contacts

Ahmad Aamer, physician

CONTACT

01011452722a.aamer2020@gmail.com

Ahmad Shawqi, Ass. prof

CONTACT

01010212222ahsh313@yahoo.com

Study Design

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

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

October 17, 2019

Record last verified: 2019-10