Spondylodiscitis Cases at Assiut University Hospital

Spondylodiscitis Clinical Trial

Official title:

Epidemiology, Clinical Features and Diagnosis of Spondylodiscitis at Assiut University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806905
• Other study ID #: ECFDSAUH
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Mohammed G Hassan, Professor
• Phone: 01001843084
• Email: m.gamal[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• No patients will be excluded

Related Conditions & MeSH terms

• Discitis
• Spondylodiscitis

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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