Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.

Study Overview
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Brief Summary
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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.

Detailed Description
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Study design is descriptive, prospective, multicentric, and the investigators have a single database centralized in Nantes University Hospital. Patient's data will be conserved and trapped anonymously and patients all give oral consent. Information letter is given to each patient. 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

Official Title
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SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.

Conditions
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Vertebral Osteomyelitis, Spondylodiscitis

Intervention / Treatment
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* Other: protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria:- Spine device infection Recent spinal surgery less than 1month Children under 18 years old Under guardianship Pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of neurological complications | Percentage of neurological complication at baseline, 3 and 6 months follow-up) Percentage of major neurological signs (sphincter dysfunction and/or motor deficit and ASIA score) at baseline, 3 and 6 months follow-up Percentage of minor neurological signs (radicular pain, reflex abolition, hypoesthesia) at baseline, 3 and 6 months follow-up | inclusion, month 3 and month 6 | 
| MRI signs at baseline | Number of vertebrae involved, destruction of posterior arch, destruction of vertebrae, kyphosis, epidural phlegmon, spinal cord hypersignal, dural sac compression, anterior effacement of subarachnoidal space Oswestry functional score at 3 and 6 months follow-up. Association between type and duration of spine immobilization and neurological complication | inclusion, month 3 and month 6 | 
| Oswestry functional score at 3 and 6 months follow-up | Association between type and duration of spine immobilization and neurological complication | inclusion, month 3 and month 6 | 
| Duration of Spine immobilization | Evaluation of the duration of immobilization of the spine | month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebral Osteomyelitis, Spine Immobilization, Neurological complications