Clinical trial NCT04655950: Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.
Official title: SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Osteomyelitis
Spondylodiscitis
Keywords: Vertebral Osteomyelitis
Spine Immobilization
Neurological complications
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative description of main types of spine immobilization
timeFrame: inclusion
Secondary outcomes:
measure: Frequency of neurological complications
timeFrame: inclusion, month 3 and month 6
measure: MRI signs at baseline
timeFrame: inclusion, month 3 and month 6
measure: Oswestry functional score at 3 and 6 months follow-up
timeFrame: inclusion, month 3 and month 6
measure: Duration of Spine immobilization
timeFrame: month 6
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont ferrand University Hospital
city: La Roche-sur-Yon
country: France
facility: La Roche Sur Yon Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: Paris University Hospital
city: Quimper
country: France
facility: Quimper Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint-Nazaire
country: France
facility: Saint-Nazaire Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Benoit Le Goff, PH
role: PRINCIPAL_INVESTIGATOR
References: