Clinical trial NCT04749082: Follow up Patients With Thoracolumbar Spondylodiscitis Surgically Treated by Posterior Approach
Official title: Long Term Follow up of Patients With Thoracolumbar Spondylodiscitis Treated Surgically by Posterior Approach in Assiut University Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spondylodiscitis
Keywords: discitis
Spondylitis
Spine surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients suffered from thoracolumbar spondylodiscitis and treated surgically by posterior approach in Assiut university hospitals from January 2016 to December 2017

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bony fusion success
timeFrame: 2 years
Secondary outcomes:
measure: modified Oswestry disability index
timeFrame: 2 years
measure: visual analogue scale
timeFrame: 2years
measure: American spinal injury Association (ASIA) Impairment score
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Essam M Abdelmoneim Elmorshidy, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: El Moataz A Zohny El Sabrout, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Belal O Mohamed Elnady, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.