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

July 1, 2023 updated by: LEFEVRE Benjamin, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: when the patient is discharged from hospital (up to 52 weeks)
Duration between first and last day of hospitalisation in days
when the patient is discharged from hospital (up to 52 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of neurological complications
Time Frame: During hospitalisation (up to 52 weeks)
Measurement of the rate spondylodiscitis-related neurological complications in each group during hospitalisation
During hospitalisation (up to 52 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of immobilization complications
Time Frame: During hospitalisation (up to 52 weeks)
Measurement of the rate of bedrest complications in each group during hospitalisation
During hospitalisation (up to 52 weeks)
Mortality
Time Frame: During hospitalisation (up to 52 weeks)
Patient death
During hospitalisation (up to 52 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 30, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI189

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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