Status:

COMPLETED

Molecular Microbiology in Osteo-arthritis Infection

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Osteoarticular Infections

Eligibility:

All Genders

18+ years

Brief Summary

Osteoarticular infections are painful and disabling diseases that require antimicrobial treatment adapted to the microorganisms implicated. Microbiological cultures are currently regarded as the refer...

Detailed Description

Background: Osteoarticular infections are painful and disabling diseases that require antimicrobial treatment adapted to the microorganisms implicated. Microbiological cultures are currently regarded ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patient are more than 18 years old
  • Patient who do not declined to have his medical records reviewed for research
  • Spondylodiscitis (S) group:
  • Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context. Spinal biopsies will be justified by one or more clinical or imaging findings:
  • Clinical presentation
  • Spinal pain unrelieved by rest
  • Localized tenderness, Neurological deficits or limited range of motion
  • Fever \> 38°C
  • Imaging findings (plain radiographs, MRI or CT):
  • Erosions of end plates on adjacent vertebral bodies
  • Decreased height of the intervertebral disk
  • Presence of a nonvascularized zone suggesting presence of pus or necroses in intervertebral, epidural space or in paraspinal soft-tissues
  • Prosthetic Joint Infection (PJI) Group
  • Patients suspected of Prosthetic Joint Infection were defined by the need of surgical revision for diagnostic or therapeutic aiming in infectious context. This revision will be justified by one or more clinical, biological or imaging findings:
  • Clinical presentation
  • Persistent joint pain
  • Fever \> 38°C
  • Erythematous, swollen, fluctuant, and/or tender surgical wound
  • Wound dehiscence
  • Limited range of joint motion
  • Biological findings
  • CRP \> 10 mg/l
  • Synovial leukocytes count \> 1500/mm3 and polymorphonuclear leukocytes \> 65%
  • Imaging findings
  • Prosthesis loosening: Periprosthetic osteolysis, progressive peri-prosthetic edging
  • Scintigraphy by means of a technetium (Tc99m) scan, gallium citrate (Ga67) scan, or indium (In111)-labeled leukocyte showing fixation around the prosthesis.
  • Septic arthritis (SA) Group
  • Patients suspected of Septic arthritis without prosthesis were defined by the need of synovial punction and/or biopsy justified by one or more clinical, biological or imaging findings:
  • Clinical presentation
  • Acute joint pain and/or swelling
  • Adenopathy near inflammatory joint
  • Fever \> 38°CBiological findings
  • WBC \> 10 000/ mm3
  • CRP \> 10 mg/l
  • Synovial leukocytes count \> 2000/mm3 or polymorphonuclear leukocytes \> 90%
  • Imaging findings:
  • Capsular and surrounding soft-tissues swelling
  • Synovial notch and/or demineralization
  • Periarticular Abscess
  • Exclusion criteria:
  • Patients already include.
  • Patient without health insurance
  • Antibiotic treatment before sampling does not constitute an exclusion criterion
  • Exclusion criteria for control groups:
  • Patient with one or more criteria:
  • Suspicion of concomitant infection defined by a fever \>38°C and CRP \> 10mg/l
  • Arthrosis treated by infiltration in the 6 months which preceding inclusion
  • Rapidly progressive arthrosis Prosthesis loosening or bone necrosis presumed to be aseptic
  • Patients with prior spinal instrumentation or surgery

Exclusion

    Key Trial Info

    Start Date :

    October 1 2008

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2012

    Estimated Enrollment :

    229 Patients enrolled

    Trial Details

    Trial ID

    NCT01193803

    Start Date

    October 1 2008

    End Date

    June 1 2012

    Last Update

    June 2 2014

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Hôpital LARIBOISIERE

    Paris, France, 75010