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临床试验/NCT04735081
NCT04735081Enrolling By Invitation不适用

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

Central Hospital, Nancy, France0 个研究点目标入组 200 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
主要终点
Length of hospital stay

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Infectious spondylodiscitis proven by radiological exam
  • Infectious spondylodiscitis with microbiological documentation

排除标准

  • Patient included in COROSIVE study
  • Vertebral prosthetic device infection
  • Infectious spondylodiscitis relapse

结局指标

主要结局

Length of hospital stay

时间窗: when the patient is discharged from hospital (up to 52 weeks)

Duration between first and last day of hospitalisation in days

次要结局

  • Rate of neurological complications(During hospitalisation (up to 52 weeks))

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

LEFEVRE Benjamin

Medical doctor

Central Hospital, Nancy, France

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