Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis. (SPONDIMMO)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Vertebral Osteomyelitis; Spondylodiscitis

Treatments: Other: protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers

Study type: Observational

Funder types: Other

Identifiers

NCT04655950

RC16_0214

Details and patient eligibility

About

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.

Full 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

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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