Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.
- Conditions
- Vertebral OsteomyelitisSpondylodiscitis
- Registration Number
- NCT04655950
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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).
- Spine device infection
- Recent spinal surgery less than 1month
- Children under 18 years old
- Under guardianship
- Pregnant woman
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Qualitative description of main types of spine immobilization inclusion 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).
- Secondary Outcome Measures
Name Time Method Duration of Spine immobilization month 6 Evaluation of the duration of immobilization of the spine
Frequency of neurological complications inclusion, month 3 and month 6 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-upMRI signs at baseline inclusion, month 3 and month 6 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 complicationOswestry functional score at 3 and 6 months follow-up inclusion, month 3 and month 6 Association between type and duration of spine immobilization and neurological complication
Trial Locations
- Locations (9)
Angers University Hospital
🇫🇷Angers, France
Clermont ferrand University Hospital
🇫🇷Clermont-Ferrand, France
La Roche Sur Yon Hospital
🇫🇷La Roche-sur-Yon, France
Rennes University Hospital
🇫🇷Rennes, France
Saint-Nazaire Hospital
🇫🇷Saint-Nazaire, France
Nantes University Hospital
🇫🇷Nantes, France
Quimper Hospital
🇫🇷Quimper, France
Tours University Hospital
🇫🇷Tours, France
Paris University Hospital
🇫🇷Paris, France