Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT01193803
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01193803
Study Brief:
Protocol Section:
NCT01193803