Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.

Spondylodiscitis Clinical Trial

— SPONDIMMO  

Official title:

SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655950
• Other study ID #: RC16_0214
• Status: Completed
• Start date: February 11, 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: November 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.

The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.

Description:

Study design is descriptive, prospective, multicentric, and the investigators have a single database centralized in Nantes University Hospital. Patient's data will be conserved and trapped anonymously and patients all give oral consent. Information letter is given to each patient.

Typical study calendar :

Baseline :

• Patient information (letter and oral consent)

• Clinical data and comorbidities collection

• Neurological examination

• Spine X-ray

• MRI or CT-scan imaging to confirm diagnosis

During Hospitalization

• Date collection : spine immobilization modalities (type, duration, changes…), duration of bed rest

• Other treatments (antibiotic therapy : molecules and duration)

• Daily neurological examination

3 months follow-up visit : (if usually done by physician)

• Clinical and neurological examination

• Spine immobilization assessment

• Spine X-ray

• Oswestry questionary

6 months follow-up visit : finale visit (if usually done by physician)

• Clinical and neurological examination

• Spine immobilization assessment

• Spine X-ray

• Oswestry questionary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients, male and female

• Hospitalized of a vertebral osteomyelitis in one of the Centers

• Meeting the criteria for the definition of vertebral Osteomyelitis (typical imaging findings)

• Microbiological proof of infection (blood culture or discovertebral biopsy) or high suspicion of infection (Compatible histology, good response to antibiotics and no differential diagnosis).

Exclusion Criteria:- Spine device infection

• Recent spinal surgery less than 1month

• Children under 18 years old

• Under guardianship

• Pregnant woman

Related Conditions & MeSH terms

• Discitis
• Osteomyelitis
• Spondylodiscitis
• Vertebral Osteomyelitis

Intervention

Other:
• protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers
Evaluation of the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications. We search for association between type and duration of spine immobilization and neurological status at the end of follow-up

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Clermont ferrand University Hospital	Clermont-Ferrand
France	La Roche Sur Yon Hospital	La Roche-sur-Yon
France	Nantes University Hospital	Nantes
France	Paris University Hospital	Paris
France	Quimper Hospital	Quimper
France	Rennes University Hospital	Rennes
France	Saint-Nazaire Hospital	Saint-Nazaire
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative description of main types of spine immobilization	Type of bracing : smooth or rigid bracing, highness of bracing (cervical, thoracic, lumbar spine or both and level of the highest and lowest vertebrae included).	inclusion
Secondary	Frequency of neurological complications	Percentage of neurological complication at baseline, 3 and 6 months follow-up); Percentage of major neurological signs (sphincter dysfunction and/or motor deficit and ASIA score) at baseline, 3 and 6 months follow-up; Percentage of minor neurological signs (radicular pain, reflex abolition, hypoesthesia) at baseline, 3 and 6 months follow-up	inclusion, month 3 and month 6
Secondary	MRI signs at baseline	Number of vertebrae involved, destruction of posterior arch, destruction of vertebrae, kyphosis, epidural phlegmon, spinal cord hypersignal, dural sac compression, anterior effacement of subarachnoidal space; Oswestry functional score at 3 and 6 months follow-up. Association between type and duration of spine immobilization and neurological complication	inclusion, month 3 and month 6
Secondary	Oswestry functional score at 3 and 6 months follow-up	Association between type and duration of spine immobilization and neurological complication	inclusion, month 3 and month 6
Secondary	Duration of Spine immobilization	Evaluation of the duration of immobilization of the spine	month 6