Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis. (SPONDIMMO)

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

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.

Study Overview

• Status: Completed
• Conditions: Vertebral Osteomyelitis; Spondylodiscitis
• Intervention / Treatment: Other: protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • Angers University Hospital
  • Clermont-Ferrand, France, 63000
    • Clermont Ferrand University Hospital
  • La Roche-sur-Yon, France, 85000
    • La Roche Sur Yon Hospital
  • Nantes, France, 44000
    • Nantes University Hospital
  • Paris, France, 75020
    • Paris University Hospital
  • Quimper, France, 29107
    • Quimper Hospital
  • Rennes, France, 35000
    • Rennes University Hospital
  • Saint-Nazaire, France, 44606
    • Saint-Nazaire Hospital
  • Tours, France, 37000
    • Tours University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 questionnary

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

• Clinical and neurological examination
• Spine immobilization assessment
• Spine X-ray
• Oswestry questionnary

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Duration of Spine immobilization	Evaluation of the duration of immobilization of the spine	month 6

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Benoit Le Goff, PH, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2016
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Neurological complications; Vertebral Osteomyelitis; Spine Immobilization
• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylitis; Bone Diseases, Infectious; Osteomyelitis; Discitis
• Other Study ID Numbers: RC16_0214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No