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Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis (SPONDYL'UP)

C

Central Hospital, Nancy, France

Status

Invitation-only

Conditions

Infectious; Spondylitis

Study type

Observational

Funder types

Other

Identifiers

NCT04735081
2020PI189

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

First group before practice change
Description:
Infectious spondylodiscitis when prolonged immoblization in bed was recommanded in our hospital
Second group after practice change
Description:
Infectious spondylodiscitis when early verticalization was recommanded in our hospital

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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