Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.
SPONDIMMO
SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.
1 other identifier
observational
250
1 country
9
Brief Summary
Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications. The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedFirst Submitted
Initial submission to the registry
February 4, 2020
CompletedFirst Posted
Study publicly available on registry
December 7, 2020
CompletedDecember 7, 2020
November 1, 2020
3.3 years
February 4, 2020
November 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Qualitative description of main types of spine immobilization
Type of bracing : smooth or rigid bracing, highness of bracing (cervical, thoracic, lumbar spine or both and level of the highest and lowest vertebrae included).
inclusion
Secondary Outcomes (4)
Frequency of neurological complications
inclusion, month 3 and month 6
MRI signs at baseline
inclusion, month 3 and month 6
Oswestry functional score at 3 and 6 months follow-up
inclusion, month 3 and month 6
Duration of Spine immobilization
month 6
Interventions
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
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 questionnary 6 months follow-up visit : finale visit (if usually done by physician) * Clinical and neurological examination * Spine immobilization assessment * Spine X-ray * Oswestry questionnary
You may qualify if:
- Adults patients, male and female
- 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).
You may not qualify if:
- Recent spinal surgery less than 1month
- Children under 18 years old
- Under guardianship
- Pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Angers University Hospital
Angers, 49000, France
Clermont ferrand University Hospital
Clermont-Ferrand, 63000, France
La Roche Sur Yon Hospital
La Roche-sur-Yon, 85000, France
Nantes University Hospital
Nantes, 44000, France
Paris University Hospital
Paris, 75020, France
Quimper Hospital
Quimper, 29107, France
Rennes University Hospital
Rennes, 35000, France
Saint-Nazaire Hospital
Saint-Nazaire, 44606, France
Tours University Hospital
Tours, 37000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benoit Le Goff, PH
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2020
First Posted
December 7, 2020
Study Start
February 11, 2016
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
December 7, 2020
Record last verified: 2020-11