SpondylodiscitisNCT04749082
Follow up Patients With Thoracolumbar Spondylodiscitis Surgically Treated by Posterior Approach
An observational study of Spondylodiscitis, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Spondylodiscitis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2021to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Adult, Older adult
Study population: All Patients suffered from thoracolumbar spondylodiscitis and treated surgically by posterior approach in Assiut university hospitals from January 2016 to December 2017
Who may be able to join
- • All patients had thoracolumbar spondylodiscitis from number 1 thoracic vertebra till number 1 sacral vertebra.
- Treated surgically by posterior approach only.
Who cannot join
- • Patients with incomplete follow up.
- Multifocal discitis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Long Term Follow up of Patients With Thoracolumbar Spondylodiscitis Treated Surgically by Posterior Approach in Assiut University Hospitals
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.
- Conditions
- Spondylodiscitis
- Keywords
- discitis, Spondylitis, Spine surgery
- Medical subject headings
- Discitis, Spondylitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Bony fusion success
the degree of bridging bone across the fused vertebral bodies by using x-ray, CT scan and MRI if needed
Measured: 2 years
Secondary outcomes (3)
modified Oswestry disability index
for patient quality of life postoperative
Measured: 2 years
visual analogue scale
the amount of pain sensed by the patient pre and post-operative
Measured: 2years
American spinal injury Association (ASIA) Impairment score
to asses neurological outcomes pre operative and at 2 years follow up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start31 Jan 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SpondylodiscitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micheal Bassem Elia, Assiut University
- Investigators
- Essam M Abdelmoneim Elmorshidy, Lecturer, Principal investigator, Assiut UniversityEl Moataz A Zohny El Sabrout, professor, Study chair, Assiut UniversityBelal O Mohamed Elnady, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749082
- Sponsor's protocol ID
- spondylodiscitis surgery
- Status last verified
- Feb 2021
- First submitted
- 5 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32057290Berbari 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 26229122El-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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of Patients With Thoracolumbar Spondylodiscitis Treated Surgically by Posterior Approach in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04749082
- Acronym / sponsor ID
- spondylodiscitis surgery
- Conditions
- Spondylodiscitis
- Keywords
- discitis, Spondylitis, Spine surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Jan 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All Patients suffered from thoracolumbar spondylodiscitis and treated surgically by posterior approach in Assiut university hospitals from January 2016 to December 2017
Key inclusion criteria (2 listed)
- • All patients had thoracolumbar spondylodiscitis from number 1 thoracic vertebra till number 1 sacral vertebra.
Key exclusion criteria (2 listed)
- • Patients with incomplete follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bony fusion success
Time frame: 2 years
the degree of bridging bone across the fused vertebral bodies by using x-ray, CT scan and MRI if needed
3 secondary outcomes
modified Oswestry disability index
Time frame: 2 years
visual analogue scale
Time frame: 2years
American spinal injury Association (ASIA) Impairment score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 32057290Kamal 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.
- Background: PubMed 26229122Berbari 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.
- Background: PubMed 22072401El-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylodiscitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Micheal B Elia, resident (01282682989 ext. +2, mikelbassem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bony fusion success (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04749082, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.