Follow up Patients With Thoracolumbar Spondylodiscitis Surgically Treated by Posterior Approach

Spondylodiscitis Clinical Trial

Official title:

Long Term Follow up of Patients With Thoracolumbar Spondylodiscitis Treated Surgically by Posterior Approach in Assiut University Hospitals

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04749082
• Other study ID #: spondylodiscitis surgery
• Status: Not yet recruiting
• Start date: January 31, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: February 2021
• Source: Assiut University
• Contact: Micheal B Elia, resident
• Phone: 01282682989
• Email: mikelbassem[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the long term outcomes of patients with thoracolumbar spondylodiscitis treated surgically by posterior approach. Outcomes include bony fusion, neurological improvement, pain improvement, implant related complication, recurrence of infection and or reoperation rate

Description:

spondylodiscitis is characterized by infection that primarily affects the intervertebral disc and adjacent vertebrae. The estimated incidence of spondylodiscitis, ranging from 0.2 to 10 per 100,000 inhabitants per year, has increased in recent years, which is likely associated with an aging population, higher prevalence of chronic disease, and more effective diagnostic techniques. Spondylodiscitis is a life-threatening disease with a mortality rate of 2-20% that is often associated with potential complications, such as paraspinal abscess, epidural abscess, meningitis, spinal instability, and neurologic deficiency. The relapse rates were reported to be as high as 32% in the literature. The aims of this study are to evaluate improvements, complications, recurrence and reoperation rates in Assiut university hospitals.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2021
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• • All patients had thoracolumbar spondylodiscitis from number 1 thoracic vertebra till number 1 sacral vertebra.
• Treated surgically by posterior approach only.

Exclusion Criteria:

• • Patients with incomplete follow up.
• Multifocal discitis.

Related Conditions & MeSH terms

• Discitis
• Spondylodiscitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Berbari EF, Kanj SS, Kowalski TJ, Darouiche RO, Widmer AF, Schmitt SK, Hendershot EF, Holtom PD, Huddleston PM 3rd, Petermann GW, Osmon DR, Infectious Diseases Society of America. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015 Sep 15;61(6):e26-46. doi: 10.1093/cid/civ482. Epub 2015 Jul 29. Review. — View Citation

El-Sharkawi MM, Said GZ. Instrumented circumferential fusion for tuberculosis of the dorso-lumbar spine. A single or double stage procedure? Int Orthop. 2012 Feb;36(2):315-24. doi: 10.1007/s00264-011-1401-9. Epub 2011 Nov 10. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bony fusion success	the degree of bridging bone across the fused vertebral bodies by using x-ray, CT scan and MRI if needed	2 years
Secondary	modified Oswestry disability index	for patient quality of life postoperative	2 years
Secondary	visual analogue scale	the amount of pain sensed by the patient pre and post-operative	2years
Secondary	American spinal injury Association (ASIA) Impairment score	to asses neurological outcomes pre operative and at 2 years follow up.	2 years