Infectious; SpondylitisSPONDYL'UPNCT04735081
Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis
An observational study of Infectious; Spondylitis, run by Central Hospital, Nancy, France.
Trial summary
Infectious vertebral osteomyelitis are infectious diseases of the vertebral bone, intervertebral disc and/ or adjacent tissue. Most of cases are due to hematogenous dissemination of pathogen but direct inoculation is an aetiology after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious; Spondylitis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with definite infectious spondylodiscitis hospitalised between 2016 and 2022 in Nancy University Hospital
Who may be able to join
- Infectious spondylodiscitis proven by radiological exam
- Infectious spondylodiscitis with microbiological documentation
Who cannot join
- Patient included in COROSIVE study
- Vertebral prosthetic device infection
- Infectious spondylodiscitis relapse
About this study
Official title: SPONDYL'UP : Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis - A Restrospective, Monocenter, Before/After Practice Change Study
Infectious vertebral osteomyelitis are infectious diseases of the vertebral bone, intervertebral disc and/ or adjacent tissue. Most of cases are due to hematogenous dissemination of pathogen but direct inoculation is an aetiology after surgery. Majority of cases concern adults after 50 years and the annual incidence ranging between 0.5 and 2.4 cases per 100 000 habitants in Europe but seems to increase during last 20 years.
The infectious spondylodiscitis is an important source of morbidity and mortality. The treatment is based on pathogen adapted antimicrobial therapy, which may be associated with bedrest. Surgical act is necessary when neurological complication occurs or when vertebral column instability is too important. The immobilization in bed is use to limit pain and neurological complications. However, the immobilization is based on few literature data and causes important complications especially in elderly.
The of immobilization in Nancy universitity hospital changed in 2019 after institutional recommendations based on expert opinion which recommend an early verticalization of uncomplicated spondylodiscitis. The investigators aimed to evaluate the consequences of this practice change on the hospitalization duration and complication rates due to spondylodiscitis and immobilization.
- Conditions
- Infectious; Spondylitis
- Keywords
- Infectious vertebral osteomyelitis, Spondylodiscitis, Bed Rest, Early Raising, Verticalization, Immobilization
- Medical subject headings
- Communicable Diseases, Spondylitis, Discitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First group before practice change | Infectious spondylodiscitis when prolonged immoblization in bed was recommanded in our hospital | |
| Second group after practice change | Infectious spondylodiscitis when early verticalization was recommanded in our hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Duration between first and last day of hospitalisation in days
Measured: when the patient is discharged from hospital (up to 52 weeks)
Secondary outcomes (1)
Rate of neurological complications
Measurement of the rate spondylodiscitis-related neurological complications in each group during hospitalisation
Measured: During hospitalisation (up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious; SpondylitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEFEVRE Benjamin, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735081
- Sponsor's protocol ID
- 2020PI189
- Acronym
- SPONDYL'UP
- Status last verified
- Aug 2025
- First submitted
- 25 Jan 2021
- Last updated
- 8 Aug 2025
- 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPONDYL'UP : Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis - A Restrospective, Monocenter, Before/After Practice Change Study
- ClinicalTrials.gov ID
- NCT04735081
- Acronym / sponsor ID
- SPONDYL'UP / 2020PI189
- Conditions
- Infectious; Spondylitis
- Keywords
- Infectious vertebral osteomyelitis, Spondylodiscitis, Bed Rest, Early Raising, Verticalization, Immobilization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Feb 2021 (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.
Infectious vertebral osteomyelitis are infectious diseases of the vertebral bone, intervertebral disc and/ or adjacent tissue. Most of cases are due to hematogenous dissemination of pathogen but direct inoculation is an aetiology after surgery. Majority of cases concern adults after 50 years and the annual incidence ranging between 0.5 and 2.4 cases per 100 000 habitants in Europe but seems to increase during last 20 years.
The infectious spondylodiscitis is an important source of morbidity and mortality. The treatment is based on pathogen adapted antimicrobial therapy, which may be associated with bedrest. Surgical act is necessary when neurological complication occurs or when vertebral column instability is too important. The immobilization in bed is use to limit pain and neurological complications. However, the immobilization is based on few literature data and causes important complications especially in elderly.
The of immobilization in Nancy universitity hospital changed in 2019 after institutional recommendations based on expert opinion which recommend an early verticalization of uncomplicated spondylodiscitis. The investigators aimed to evaluate the consequences of this practice change on the hospitalization duration and complication rates due to spondylodiscitis and immobilization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group before practice change | – | –Infectious spondylodiscitis when prolonged immoblization in bed was recommanded in our hospital |
| Second group after practice change | – | –Infectious spondylodiscitis when early verticalization was recommanded in our hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with definite infectious spondylodiscitis hospitalised between 2016 and 2022 in Nancy University Hospital
Key inclusion criteria (2 listed)
- Infectious spondylodiscitis proven by radiological exam
- Infectious spondylodiscitis with microbiological documentation
Key exclusion criteria (3 listed)
- Patient included in COROSIVE study
- Vertebral prosthetic device infection
- Infectious spondylodiscitis relapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of hospital stay
Time frame: when the patient is discharged from hospital (up to 52 weeks)
Duration between first and last day of hospitalisation in days
1 secondary outcome
Rate of neurological complications
Time frame: During hospitalisation (up to 52 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious; Spondylitis, run by Central Hospital, Nancy, 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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Length of hospital stay (time frame: when the patient is discharged from hospital (up to 52 weeks)). 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 8 Aug 2025.