NCT04655950

Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Vertebral Osteomyelitis
• Spondylodiscitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-02-11
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2020-12-07
• Last updated: 2020-12-07

Locations

9 sites across 1 country: France