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

November 30, 2020 updated by: Nantes University Hospital

SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Angers University Hospital
      • Clermont-Ferrand, France, 63000
        • Clermont Ferrand University Hospital
      • La Roche-sur-Yon, France, 85000
        • La Roche Sur Yon Hospital
      • Nantes, France, 44000
        • Nantes University Hospital
      • Paris, France, 75020
        • Paris University Hospital
      • Quimper, France, 29107
        • Quimper Hospital
      • Rennes, France, 35000
        • Rennes University Hospital
      • Saint-Nazaire, France, 44606
        • Saint-Nazaire Hospital
      • Tours, France, 37000
        • Tours University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
inclusion, month 3 and month 6
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
inclusion, month 3 and month 6
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
inclusion, month 3 and month 6
Duration of Spine immobilization
Time Frame: month 6
Evaluation of the duration of immobilization of the spine
month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benoit Le Goff, PH, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC16_0214

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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