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Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis

SPONDYL'UP : Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis - A Restrospective, Monocenter, Before/After Practice Change Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04735081
Acronym
SPONDYL'UP
Enrollment
200
Registered
2021-02-02
Start date
2016-01-01
Completion date
2026-12-31
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious; Spondylitis

Keywords

Infectious vertebral osteomyelitis, Spondylodiscitis, Bed Rest, Early Raising, Verticalization, Immobilization

Brief 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.

Interventions

None listed

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital staywhen the patient is discharged from hospital (up to 52 weeks)Duration between first and last day of hospitalisation in days

Secondary

MeasureTime frameDescription
Rate of neurological complicationsDuring hospitalisation (up to 52 weeks)Measurement of the rate spondylodiscitis-related neurological complications in each group during hospitalisation

Other

MeasureTime frameDescription
Rate of immobilization complicationsDuring hospitalisation (up to 52 weeks)Measurement of the rate of bedrest complications in each group during hospitalisation
MortalityDuring hospitalisation (up to 52 weeks)Patient death

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026