Follow up Patients With Thoracolumbar Spondylodiscitis Surgically Treated by Posterior Approach

NCT ID: NCT04749082

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spondylodiscitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Micheal Bassem Elia

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Essam M Abdelmoneim Elmorshidy, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

El Moataz A Zohny El Sabrout, professor

Role: STUDY_CHAIR

Assiut University

Belal O Mohamed Elnady, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Micheal B Elia, resident

Role: CONTACT

01282682989 ext. +2

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32057290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26229122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22072401 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

spondylodiscitis surgery

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LUMBAR & SACROILIAC FUSION STUDY
NCT07204288 RECRUITING NA