Vertebral OsteomyelitisSPONDIMMONCT04655950
Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.
An observational study of Vertebral Osteomyelitis and Spondylodiscitis, run by Nantes University Hospital at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Osteomyelitis, Spondylodiscitis
- What is being tested?
- protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers
- How many people
- 250 participants
- Where
- 9 sitesFrance
- Study dates
- 11 Feb 2016to 31 May 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- Recent spinal surgery less than 1month
- Children under 18 years old
- Under guardianship
- Pregnant woman
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Angers University Hospital
Angers, 49000
Clermont ferrand University Hospital
Clermont-Ferrand, 63000
La Roche Sur Yon Hospital
La Roche-sur-Yon, 85000
Nantes University Hospital
Nantes, 44000
Paris University Hospital
Paris, 75020
Quimper Hospital
Quimper, 29107
Rennes University Hospital
Rennes, 35000
Saint-Nazaire Hospital
Saint-Nazaire, 44606
Tours University Hospital
Tours, 37000
About this study
Official title: 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.
Read the 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
- Being tested
- protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers
- Keywords
- Vertebral Osteomyelitis, Spine Immobilization, Neurological complications
- Medical subject headings
- Discitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections CentersOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative description of main types of spine immobilization
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).
Measured: inclusion
Secondary outcomes (4)
Frequency of neurological complications
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
Measured: inclusion, month 3 and month 6
MRI signs at baseline
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
Measured: inclusion, month 3 and month 6
Oswestry functional score at 3 and 6 months follow-up
Association between type and duration of spine immobilization and neurological complication
Measured: inclusion, month 3 and month 6
Duration of Spine immobilization
Evaluation of the duration of immobilization of the spine
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start11 Feb 2016
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral OsteomyelitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Le Goff, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655950
- Sponsor's protocol ID
- RC16_0214
- Acronym
- SPONDIMMO
- Status last verified
- Nov 2020
- First submitted
- 4 Feb 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.
- ClinicalTrials.gov ID
- NCT04655950
- Acronym / sponsor ID
- SPONDIMMO / RC16_0214
- Conditions
- Vertebral Osteomyelitis, Spondylodiscitis
- Keywords
- Vertebral Osteomyelitis, Spine Immobilization, Neurological complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- Recent spinal surgery less than 1month
- Children under 18 years old
- Under guardianship
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections CentersEvaluation 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 | Other | – |
Primary outcome
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).
4 secondary outcomes
Frequency of neurological complications
Time frame: inclusion, month 3 and month 6
MRI signs at baseline
Time frame: inclusion, month 3 and month 6
Oswestry functional score at 3 and 6 months follow-up
Time frame: inclusion, month 3 and month 6
Duration of Spine immobilization
Time frame: month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
Related trials for Vertebral Osteomyelitis
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RecruitingObservational study
INfectious DIsease REgistry BIObank
Bloodstream Infections, Central Nervous System Infections
Enrolling by invitationObservational study
Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis
Infectious; Spondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Le Goff, PH principal investigator
Nantes University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Osteomyelitis and Spondylodiscitis, run by Nantes University Hospital at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative description of main types of spine immobilization (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.