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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04911283
Other study ID # SUEADH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date July 1, 2020

Study information

Verified date June 2021
Source Sanliurfa Mehmet Akif Inan Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objective: This study aims to examine Brucella serology and history of brucellosis in patients with lumbar Modic changes (MCs) type 1, considering results from cross-sectional and case-control comparisons. Design: In comparative cross-sectional design, MCs type 1 patients (study group) and MCs type 2 patients (comparator group) were examined in terms of Brucella serology by using agglutination with Coombs test. In addition, in comparative case-control design, both of the MCs groups and age/sex-matched healthy controls were investigated for their medical history regarding brucellosis.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with lumbar Modic changes type 1 - Patients with lumbar Modic changes type 2 - Participant who given informed consent for the study Exclusion Criteria: - Patients aged<18 years - History of serious lumbar trauma - Lumbar spinal surgery - Scoliosis - Cooperation disorder

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Brucella serology test
MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.
Medical history for brucellosis
Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.

Locations

Country Name City State
Turkey Mehmet Akif Inan Hospital Sanliurfa

Sponsors (1)

Lead Sponsor Collaborator
Veysel Delen

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serology for brucellosis 30 minutes
Primary History of brucellosis 7 minutes
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