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Status unknownNCT04749082Updated Feb 10, 2021

Follow up Patients With Thoracolumbar Spondylodiscitis Surgically Treated by Posterior Approach

An observational study in Spondylodiscitis, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
40
Ages
20 Years to 85 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Spondylodiscitis

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Keywords

  • discitis
  • Spondylitis
  • Spine surgery
03

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
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

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

Exclusion Criteria:

    • Patients with incomplete follow up.

      • Multifocal discitis.
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Bony fusion success

    the degree of bridging bone across the fused vertebral bodies by using x-ray, CT scan and MRI if needed

    Time frame: 2 years

Secondary outcomes

  1. modified Oswestry disability index

    for patient quality of life postoperative

    Time frame: 2 years

  2. visual analogue scale

    the amount of pain sensed by the patient pre and post-operative

    Time frame: 2years

  3. American spinal injury Association (ASIA) Impairment score

    to asses neurological outcomes pre operative and at 2 years follow up.

    Time frame: 2 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 32057290 ↗
  • 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. PubMed 26229122 ↗
  • 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. PubMed 22072401 ↗
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Registry details

Key details

Study ID
NCT04749082
Lead sponsor
Assiut University
Responsible party
Micheal Bassem Elia (Principal investigator, Assiut University) — Principal investigator
First posted
Feb 10, 2021
Start date
Jan 31, 2021 (estimated)
Primary completion
Jun 30, 2021 (estimated)
Completion
Jul 1, 2021 (estimated)
Last update
Feb 10, 2021

Study contacts

Micheal B Elia, resident
Contact
mikelbassem@hotmail.com
01282682989 ext. +2
Essam M Abdelmoneim Elmorshidy, Lecturer
principal investigator · Assiut University
El Moataz A Zohny El Sabrout, professor
study chair · Assiut University
Belal O Mohamed Elnady, Lecturer
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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