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Completed

NCT Number: NCT04655950

Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Qualitative description of main types of spine immobilization

    Time frame: 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 outcomes

  1. Frequency of neurological complications

    Time frame: 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-up
  2. MRI signs at baseline

    Time frame: 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 complication

  3. Oswestry functional score at 3 and 6 months follow-up

    Time frame: inclusion, month 3 and month 6

    Association between type and duration of spine immobilization and neurological complication

  4. Duration of Spine immobilization

    Time frame: month 6

    Evaluation of the duration of immobilization of the spine

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: SPONDIMMO

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2020
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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