Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Conservative Versus Surgical Treatment of Native Vertebral Osteomyelitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436328
Recruitment Status : Not yet recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Andrej Trampuz, Charite University, Berlin, Germany

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 instrumentation using hardware implantation of hardware), others recommend conservative treatment (with antimicrobial therapy alone). In the proposed randomized controlled multicentric trial, we plan to compare the outcome of conservative vs, surgical treatment of NVO regarding (i) infection outcome (i.e. infection-free proportion of subjects), (ii) functional outcome (pain intensity, spine scores, general mobility, quality of life evaluation), and (iii) socioeconomic impact (direct and indirect costs due to NVO).

A total of 350 subjects will be screened, 300 subjects will be randomized 1:1 into 2 arms: experimental (surgical treatment) and control (conservative treatment). Subjects in both groups will receive pathogen-directed antimicrobial therapy for 6 weeks. Excluded will be patients with acute neurologic impairment, extensive bone destruction, epidural/intraspinal abscess and with spinal hardware.

The clinical impact of this study is enormous since it will generate evidence for rational treatment guidelines. We hypothesize that the conservative treatment of uncomplicated NVO is non-inferior to surgical therapy regarding infection outcome. If the conservative treatment of NVO demonstrate non-inferiority, patients may benefit from avoiding unnecessary surgical intervention.


Condition or disease Intervention/treatment Phase
Vertebral Osteomyelitis Spondylodiscitis Surgical Procedure, Unspecified Procedure: Surgical treatment Other: Antimicrobial treatment Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized (1:1), controlled, multicentre explorative trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Versus Surgical Treatment of Native Vertebral Osteomyelitis: a Randomized Multicentre Trial
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Surgical treatment
Surgical treatment of native vertebral osteomyelitis followed by antimicrobial therapy
Procedure: Surgical treatment
Surgical treatment of native vertebral osteomyelitis consisting of debridement, spinal decompression and instrumentation using hardware. Additional standard antimicrobial therapy, according to the pathogen and its antimicrobial susceptibility (intravenous route during first 2 weeks, followed by oral route for additional 4 weeks).

Active Comparator: Antimicrobial treatment
No surgical intervention, antimicrobial therapy only
Other: Antimicrobial treatment
No surgical intervention, antimicrobial therapy only, bed rest or temporary external immobilization of affected spinal segment with orthopedic orthesis. Antimicrobial therapy will be administrated according to the pathogen type and antimicrobial susceptibility, with initial intravenous administration for 2 weeks, followed by oral antibiotics for 4 weeks to complete 6 weeks of total therapy.




Primary Outcome Measures :
  1. Proportion of infection-free subjects [ Time Frame: 12 months after treatment initiation ]

    Treatment success: Infection-free status defined as (i) absence of clinical signs of native vertebral osteomyelitis (fever, local signs at surgical site), (ii) normal laboratory findings (serum C-reactive protein), (iii) absence of radiological signs of active native vertebral osteomyelitis (progressive bone destruction, implant loosening or migration), and (iv) absence of unplanned surgical interventions or additional antimicrobial treatment.

    Confirmed failure: Persistence or relapse of infection due to the same pathogen.

    Possible failure: Subjects not fulfilling the criteria for treatment success but have no diagnosis of persistence or relapse of native vertebral osteomyelitis



Secondary Outcome Measures :
  1. Functional outcome regarding pain intensity [ Time Frame: 12 months after treatment initiation ]
    Pain intensity according to the numerical rating scale (NRS) for the indication of the perceived pain. Values are from 0 (no pain) to 10 (greatest pain imaginable)

  2. Functional outcome regarding mobility according to Nurick scale [ Time Frame: 12 months after treatment initiation ]

    Nurick scale: A six grade system (0-5) based on the difficulty in walking:

    Grade 0: signs or symptoms of root involvement but without evidence of spinal cord disease Grade 1: signs of spinal cord disease but no difficulty in walking. Grade 2: slight difficulty in walking which does not prevent full-time employment Grade 3: difficulty in walking which prevented full time employment or the ability to do all housework, but which was not so severe as to require someone else's help to walk Grade 4: able to walk only with someone else's help or with the aid of a frame. Grade 5 : chairbound or bedridden.


  3. Functional outcome regarding mobility according Oswestry Disability Index [ Time Frame: 12 months after treatment initiation ]

    The Oswestry Disability Index (ODI) will be used in patients with low back pain.

    There are 10 questions to evaluate how the back or leg pain is affecting the patient's ability to manage in everyday life.

    Scoring Method Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score.

    Interpretation 0%-20%: Minimal disability 20%-40% Moderate disability 40%-60%: Severe disability 60%-80%: Crippled 80%-100%: These patients are either bed-bound or exaggerating their symptoms


  4. Functional outcome regarding quality of life using EuroQOL score [ Time Frame: 12 months after treatment initiation ]

    EuroQOL questionnaire is a measure of both clinical and economic value in health care.

    It consists of a descriptive system and a visual analogue scale (EQ VAS). The descriptive system has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The visual analogue scale has 3 levels of severity (no problems, some problems, extreme problems).


  5. Functional outcome regarding quality of life using SF-36 questionnaire [ Time Frame: 12 months after treatment initiation ]

    The questionnaire is composed of 36 questions organized in eight scales:

    physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. Respondents rate each activity on a three-level scale (a lot, a little, not at all). Item responses are then summed with results expressed on a scale ranging from 0 to 100, representing higher values a better function.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436328


Locations
Layout table for location information
Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Publications of Results:

Layout table for additonal information
Responsible Party: Andrej Trampuz, Head of septic surgery, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04436328    
Other Study ID Numbers: Spine infection treatment
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrej Trampuz, Charite University, Berlin, Germany:
Native vertebral osteomyelitis
Treatment
Spinal implant
Antibiotic therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteomyelitis
Discitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spondylitis
Spinal Diseases
Anti-Infective Agents
Anti-Bacterial Agents