Status:
UNKNOWN
Conservative Versus Surgical Treatment of Native Vertebral Osteomyelitis
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Vertebral Osteomyelitis
Spondylodiscitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The optimal treatment of uncomplicated native vertebral osteomyelitis (NVO) is unknown. While some authors recommend surgical treatment (consisting of spinal debridement, decompression and instrumenta...
Detailed Description
INTRODUCTION AND EVIDENCE. Native vertebral osteomyelitis (NVO) is mainly caused by hematogenous spread from a distant infection focus (e.g. respiratory, urogenital, intestinal tract, oral cavity, ski...
Eligibility Criteria
Inclusion
- Subjects aged ≥18 years with NVO, diagnosed by microbiology (positive blood culture or vertebral tissue culture) or histopathology.
- Subjects are willing to participate in the study (signed informed consent) and comply with planned follow-up assessments at 3, 6 and 12 months).
Exclusion
- Infection due to Mycobacterium spp. or Brucella spp.
- Infection associated with spinal hardware
- Acute neurologic impairment
- Extensive defect of vertebral body (\>2 cm)
- Extensive epidural abscess (\>1 cm) or intraspinal abscess (any size)
- Spinal instability/deformity requiring immediate stabilisation
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04436328
Start Date
July 1 2020
End Date
July 1 2022
Last Update
June 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117