NCT05806905

Brief Summary

The term Spondylodiscitis (SD) involves infection of the vertebra (Spondylitis), infection of the intervertebral disc (Discitis), or both (Spondylodiscitis) Spondylodiscitis is a rare disease accounting for 2.7% of all cases of pyogenic osteomyelitis, with incidence varying from 1 per 100,000/year to 1 per 250,000/year However, there is evidence that the incidence is rising due to longer life expectancy for patients with increasing incidence of chronic debilitating disease including diabetes mellitus, malignancies ,(Human Immunodeficiency Virus (HIV)/ Acquired Immunodeficiency Syndrome (AIDs) , immunosuppressive therapy, increasing numbers of Intravenous drug users , and spinal surgeries. Pathogens can reach the spine either by: hematogenous spread, direct external inoculation, or spread from contiguous tissues harboring these pathogens. The hematogenous route is the predominant one, allowing seeding of infection from distant sites into the vertebral column. Since spondylodiscitis has not been studied in a clinical trial at our hospital, and information about this disease has come from retrospective case series and isolated cases. In this study, we present our prospectively collected patient clinical and epidemiological data in order to provide a proper management

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

March 25, 2023

Last Update Submit

April 7, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • measuring the inflammatory markers in patient with spondylodiscitis (Ex. C reactive protein (CRP) in mg/dl)

    collect all patients with spondylodiscitis who come to Assiut University Hospital, measure the inflammatory markers and follow up them after medical or surgical treatment

    collect data for 1 year and follow up for 1 year

  • Describing of pain severity according to Pain severity scale and follow up after treatment

    collect all patients with spondylodiscitis who come to Assiut University Hospital, measure the pain severity and follow up pain improvement after medical or surgical treatment

    collect data for 1 year and follow up for 1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who come into Assiut University Hospital and outpatient clinic with clinical symptoms and radiological findings suggestive of spondylodiscitis

You may qualify if:

  • All patients who come into Assiut University Hospital and outpatient clinic with clinical symptoms suggestive of spondylodiscitis in all age groups including patients with known medical conditions and patients who underwent previous spine surgeries (post operative spondylodiscitis)

You may not qualify if:

  • No patients will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

RECRUITING

Related Publications (7)

  • Kamal AM, El-Sharkawi MM, El-Sabrout M, Hassan MG. Spondylodiscitis: experience of surgical management of complicated cases after failed antibiotic treatment. SICOT J. 2020;6:5. doi: 10.1051/sicotj/2020002. Epub 2020 Feb 14.

    PMID: 32057290BACKGROUND
  • D'Agostino C, Scorzolini L, Massetti AP, Carnevalini M, d'Ettorre G, Venditti M, Vullo V, Orsi GB. A seven-year prospective study on spondylodiscitis: epidemiological and microbiological features. Infection. 2010 Apr;38(2):102-7. doi: 10.1007/s15010-009-9340-8. Epub 2010 Feb 27.

    PMID: 20191397BACKGROUND
  • Kaya S, Kaya S, Kavak S, Comoglu S. A disease that is difficult to diagnose and treat: evaluation of 343 spondylodiscitis cases. J Int Med Res. 2021 Nov;49(11):3000605211060197. doi: 10.1177/03000605211060197.

    PMID: 34851766BACKGROUND
  • Issa K, Diebo BG, Faloon M, Naziri Q, Pourtaheri S, Paulino CB, Emami A. The Epidemiology of Vertebral Osteomyelitis in the United States From 1998 to 2013. Clin Spine Surg. 2018 Mar;31(2):E102-E108. doi: 10.1097/BSD.0000000000000597.

    PMID: 29135608BACKGROUND
  • Gerometta A, Bittan F, Rodriguez Olaverri JC. Postoperative spondilodiscitis. Int Orthop. 2012 Feb;36(2):433-8. doi: 10.1007/s00264-011-1442-0. Epub 2012 Feb 4.

    PMID: 22307558BACKGROUND
  • Sur A, Tsang K, Brown M, Tzerakis N. Management of adult spontaneous spondylodiscitis and its rising incidence. Ann R Coll Surg Engl. 2015 Sep;97(6):451-5. doi: 10.1308/rcsann.2015.0009. Epub 2015 Aug 14.

    PMID: 26274746BACKGROUND
  • Turgut M. Complete recovery of acute paraplegia due to pyogenic thoracic spondylodiscitis with an epidural abscess. Acta Neurochir (Wien). 2008 Apr;150(4):381-6. doi: 10.1007/s00701-007-1485-6. Epub 2008 Jan 8.

    PMID: 18176773BACKGROUND

MeSH Terms

Conditions

Discitis

Condition Hierarchy (Ancestors)

SpondylitisBone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal DiseasesSpinal Diseases

Central Study Contacts

Mohammed G Hassan, Professor

CONTACT

Essam M El-Morshidy, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 25, 2023

First Posted

April 10, 2023

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

April 10, 2023

Record last verified: 2023-04

Locations