An observational study in Vertebral Osteomyelitis and Spondylodiscitis, sponsored by Nantes University Hospital. Completed at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-07.
Sponsored by Nantes University Hospital · Observational
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 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 :
During Hospitalization
Daily neurological examination
3 months follow-up visit : (if usually done by physician)
Oswestry questionary
6 months follow-up visit : finale visit (if usually done by physician)
24 studies on the registry are indexed under Discitis; 5 are open to participants now.
This study's enrollment of 250 is above the median of 104 across 16 observational studies indexed under Discitis.
Browse Discitis studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Baseline :
During Hospitalization
Daily neurological examination
3 months follow-up visit : (if usually done by physician)
Oswestry questionnary
6 months follow-up visit : finale visit (if usually done by physician)
Inclusion Criteria:
Exclusion Criteria:- Spine device infection
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
Time frame: inclusion
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
Time frame: 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
Time frame: 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
Time frame: inclusion, month 3 and month 6
Duration of Spine immobilization
Evaluation of the duration of immobilization of the spine
Time frame: month 6
Ran from Feb 2016 to primary completion in May 2019, 39 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.