Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis

Infectious; Spondylitis Clinical Trial

— SPONDYL'UP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04735081
• Other study ID #: 2020PI189
• Status: Enrolling by invitation
• Start date: January 1, 2016
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious; Spondylitis
• Osteomyelitis
• Spondylitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of immobilization complications	Measurement of the rate of bedrest complications in each group during hospitalisation	During hospitalisation (up to 52 weeks)
Other	Mortality	Patient death	During hospitalisation (up to 52 weeks)
Primary	Length of hospital stay	Duration between first and last day of hospitalisation in days	when the patient is discharged from hospital (up to 52 weeks)
Secondary	Rate of neurological complications	Measurement of the rate spondylodiscitis-related neurological complications in each group during hospitalisation	During hospitalisation (up to 52 weeks)