Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis

• Conditions: Infectious; Spondylitis

• Registration Number: NCT04735081
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-30
• Study First Posted: 2021-02-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-01
• Last Update Posted: 2023-07-05
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	when the patient is discharged from hospital (up to 52 weeks)	Duration between first and last day of hospitalisation in days

Secondary Outcome Measures

Name	Time	Method
Rate of neurological complications	During hospitalisation (up to 52 weeks)	Measurement of the rate spondylodiscitis-related neurological complications in each group during hospitalisation