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Enrolling by invitationNCT04735081SPONDYL'UPUpdated Aug 8, 2025

Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis

An observational study in Infectious; Spondylitis, sponsored by Central Hospital, Nancy, France. Enrolling by invitation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Infectious; Spondylitis

Keywords

  • Infectious vertebral osteomyelitis
  • Spondylodiscitis
  • Bed Rest
  • Early Raising
  • Verticalization
  • Immobilization
03

In context

Communicable Diseases

626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 228 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with definite infectious spondylodiscitis hospitalised between 2016 and 2022 in Nancy University Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infectious spondylodiscitis proven by radiological exam
  • Infectious spondylodiscitis with microbiological documentation

Exclusion criteria

Exclusion Criteria:

  • Patient included in COROSIVE study
  • Vertebral prosthetic device infection
  • Infectious spondylodiscitis relapse
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Length of hospital stay

    Duration between first and last day of hospitalisation in days

    Time frame: 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

    Time frame: During hospitalisation (up to 52 weeks)

Other outcomes

  1. Rate of immobilization complications

    Measurement of the rate of bedrest complications in each group during hospitalisation

    Time frame: During hospitalisation (up to 52 weeks)

  2. Mortality

    Patient death

    Time frame: During hospitalisation (up to 52 weeks)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Dec 2023, 95 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2021
First posted
Feb 2, 2021
StartActual
Jan 1, 2016
Primary completionActual
Dec 31, 2023
CompletionEst.
Dec 31, 2026
Last update
Aug 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04735081
Responsible party
LEFEVRE Benjamin (Medical doctor, Central Hospital, Nancy, France) — Principal investigator
First posted
Feb 2, 2021
Start date
Jan 1, 2016
Primary completion
Dec 31, 2023
Completion
Dec 31, 2026 (estimated)
Last update
Aug 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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