NCT04749082

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

January 5, 2021

Last Update Submit

February 9, 2021

Conditions

Keywords

discitisSpondylitisSpine surgery

Outcome Measures

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

    2 years

Secondary Outcomes (3)

  • modified Oswestry disability index

    2 years

  • visual analogue scale

    2years

  • American spinal injury Association (ASIA) Impairment score

    2 years

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Patients with incomplete follow up.
  • Multifocal discitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 32057290BACKGROUND
  • 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.

    PMID: 26229122BACKGROUND
  • 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.

    PMID: 22072401BACKGROUND

MeSH Terms

Conditions

DiscitisSpondylitis

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal DiseasesSpinal Diseases

Study Officials

  • Essam M Abdelmoneim Elmorshidy, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR
  • El Moataz A Zohny El Sabrout, professor

    Assiut University

    STUDY CHAIR
  • Belal O Mohamed Elnady, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Micheal B Elia, resident

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 5, 2021

First Posted

February 10, 2021

Study Start

January 31, 2021

Primary Completion

June 30, 2021

Study Completion

July 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02