Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis

NCT ID: NCT04735081

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infectious; Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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First group before practice change

Infectious spondylodiscitis when prolonged immoblization in bed was recommanded in our hospital

No interventions assigned to this group

Second group after practice change

Infectious spondylodiscitis when early verticalization was recommanded in our hospital

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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LEFEVRE Benjamin

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2020PI189

Identifier Type: -

Identifier Source: org_study_id

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