Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.
NCT ID: NCT04655950
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2016-02-11
2019-05-31
Brief Summary
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The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.
Detailed Description
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Typical study calendar :
Baseline :
* Patient information (letter and oral consent)
* Clinical data and comorbidities collection
* Neurological examination
* Spine X-ray
* MRI or CT-scan imaging to confirm diagnosis
During Hospitalization
* Date collection : spine immobilization modalities (type, duration, changes…), duration of bed rest
* Other treatments (antibiotic therapy : molecules and duration)
* Daily neurological examination
3 months follow-up visit : (if usually done by physician)
* Clinical and neurological examination
* Spine immobilization assessment
* Spine X-ray
* Oswestry questionary
6 months follow-up visit : finale visit (if usually done by physician)
* Clinical and neurological examination
* Spine immobilization assessment
* Spine X-ray
* Oswestry questionary
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers
Evaluation of the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.
We search for association between type and duration of spine immobilization and neurological status at the end of follow-up
Eligibility Criteria
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Inclusion Criteria
* Hospitalized of a vertebral osteomyelitis in one of the Centers
* Meeting the criteria for the definition of vertebral Osteomyelitis (typical imaging findings)
* Microbiological proof of infection (blood culture or discovertebral biopsy) or high suspicion of infection (Compatible histology, good response to antibiotics and no differential diagnosis).
Exclusion Criteria
* Children under 18 years old
* Under guardianship
* Pregnant woman
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Benoit Le Goff, PH
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Angers University Hospital
Angers, , France
Clermont ferrand University Hospital
Clermont-Ferrand, , France
La Roche Sur Yon Hospital
La Roche-sur-Yon, , France
Nantes University Hospital
Nantes, , France
Paris University Hospital
Paris, , France
Quimper Hospital
Quimper, , France
Rennes University Hospital
Rennes, , France
Saint-Nazaire Hospital
Saint-Nazaire, , France
Tours University Hospital
Tours, , France
Countries
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Other Identifiers
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RC16_0214
Identifier Type: -
Identifier Source: org_study_id