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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04655950
Acronym
SPONDIMMO
Enrollment
250
Registered
2020-12-07
Start date
2016-02-11
Completion date
2019-05-31
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylodiscitis, Vertebral Osteomyelitis

Keywords

Vertebral Osteomyelitis, Spine Immobilization, Neurological complications

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

Interventions

OTHERprotocols 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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Qualitative description of main types of spine immobilizationinclusionType 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

MeasureTime frameDescription
Frequency of neurological complicationsinclusion, month 3 and month 6Percentage 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
MRI signs at baselineinclusion, month 3 and month 6Number 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
Oswestry functional score at 3 and 6 months follow-upinclusion, month 3 and month 6Association between type and duration of spine immobilization and neurological complication
Duration of Spine immobilizationmonth 6Evaluation of the duration of immobilization of the spine

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026