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CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis (COROSIVE)

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ClinicalTrials.gov Identifier: NCT03524209
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
Pyogenic spondylitis in adults is usually treated by antibiotics according to bacteria evidenced in a diagnostic intervertebral disc puncture. Brace treatment is associated in patients presenting back pain and a risk for vertebral body collapse due to infection with subsequent kyphotic deformity of the thoracolumbar spine. Percutaneous minimally invasive posterior spinal instrumentation has evolved over the last decade and indications in infections arouse over the last years. This procedure is interesting as it is performed through small skin incisions only. It avoids paravertebral muscle dissection and thus limits intraoperative bleeding and access morbidity. Recent retrospective data suggests that this internal fixation represents a theoretical advantage over brace treatment by lowering back pain and increasing patient's quality of life in the short run, up to 3 months, but no randomized study was published. The patient's autonomy, including walking ability and daily activities, might improve more rapidly after a percutaneous procedure. Additionally, the sagittal alignment of the thoracolumbar spine could be better maintained by internal fixation, which might prevent progression into kyphosis and improve long-term outcome. The hypothesis is the superiority of percutaneous minimally invasive instrumentation on brace treatment in term of quality of life, back pain and quality of osseous healing.

Condition or disease Intervention/treatment Phase
Spondylodiscitis Device: Percutaneous instrumentation of the thoracolumbar spine Other: Brace Not Applicable

Detailed Description:
Safety and efficacy of percutaneous for the indication of pyogenic spondylitis has been demonstrated retrospectively on small cohort studies, which is in line with our clinical experience. Although this therapeutic concept seems applicable to patients with spondylitis, the theoretical clinical benefit of minimally invasive surgery remains hypothetic and unclear compared to brace treatment, which might still be regarded as the gold standard.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A prospective selection of patients with pyogenic spondylitis fulfilling above mentioned inclusion criteria is performed with subsequent randomization into treatment group 1 versus treatment group 2 after informed consent. Group1 are patients treated by minimally invasive surgery and group 2 are patients treated by thoracolumbar brace.

Radiologic deformity assessment is performed on lateral thoracolumbar radiographs in standing position. A modified sagittal index measuring the angulation between cranial endplate of cranial vertebra and caudal endplate of the caudal vertebra as this parameter is normalized to 0°.

Assessment of osteolysis at vertebral bodies on CT expressed as a ratio of vertebral body height in the mid-sagittal plane in comparison to non-infected vertebral bodies adjacent to the index level. Assessment of complete fusion, partial fusion, pseudarthrosis is performed on CT at 1-year FU.

Type and length of antibiotic treatment

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Thoracolumbar Back Pain After Brace Treatment Versus Percutaneous Instrumentation in Adult Pyogenic Spondylodiscitis Combined With Antibiotic Treatment
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Surgery
Patients with spondylodiscitis are operated by percutaneous instrumentation and receive an antibiotic treatment according to the bacterium evidenced in the initial diagnostic intervertebral disc puncture (6 weeks to 3 months according to CRP course)
Device: Percutaneous instrumentation of the thoracolumbar spine
The spine is stabilized cranially and caudally of the level of spondylodiscitis. The percutaneous instrumentation consists of a rod and pedicle screw construct. The vertebrae are instrumented through minimal skin incisions using a fluoroscopic guidance or a spinal navigation system based on 3D imaging.
Other Name: minimal invasive surgery (MIS)

Brace
Patients with spondylodiscitis are wearing a thoracolumbar brace for 3 months and receive an antibiotic treatment according to the bacterium evidenced in the initial diagnostic intervertebral disc puncture (6 weeks to 3 months according to CRP course)
Other: Brace
Brace treatment is associated in patients presenting back pain and a risk for vertebral body collapse due to infection with subsequent kyphotic deformity of the thoracolumbar spine




Primary Outcome Measures :
  1. Comparison of VAS for back pain for brace versus percutaneous instrumentation [ Time Frame: Pre treatment ]
    VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)

  2. Comparison of VAS for back pain for brace versus percutaneous instrumentation [ Time Frame: Post treatment day 5 ]
    VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)

  3. Comparison of VAS for back pain for brace versus percutaneous instrumentation [ Time Frame: Post treatment 6 weeks ]
    VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)

  4. Comparison of VAS for back pain for brace versus percutaneous instrumentation [ Time Frame: Post treatment 3 months ]
    VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)

  5. Comparison of VAS for back pain for brace versus percutaneous instrumentation [ Time Frame: Post treatment 6 months ]
    VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)

  6. Comparison of VAS for back pain for brace versus percutaneous instrumentation [ Time Frame: Post treatment 1 year ]
    VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)

  7. Comparison of VAS for back pain for brace versus percutaneous instrumentation [ Time Frame: Post treatment 2 years ]
    VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)


Secondary Outcome Measures :
  1. Comparison of quality of life (QoL) by EQ-5D for brace versus percutaneous instrumentation [ Time Frame: Change of score between pre treatment and during 2 years after treatment ]
    EQ-5D-3L questionnaire filled out by the patients

  2. - Comparison of influence of both treatment on kyphotic deformity - Comparison of fusion rates versus pseudarthrosis for both treatments [ Time Frame: Change of measures between pre treatment and during 2 years after treatment ]
    Radiographic measurements by modified sagittal index on lateral radiographs in standing position

  3. Analysis of correlation between kyhphosis / fusion and VAS / QoL scores [ Time Frame: Change of measures between pre treatment and during 2 years after treatment ]
    Radiographic measurements by modified sagittal index on lateral radiographs in standing position

  4. Course of CRP [ Time Frame: Change of value between pre treatment and during 3 months after treatment ]
    Routine blood tests for documentation of CRP

  5. Documentation of secondary complications after percutaneous instrumentation [ Time Frame: Change between pre treatment and during 2 years after treatment ]
    Comparison of influence of both treatment


Other Outcome Measures:
  1. Documentation, reporting and analysis of potential complications [ Time Frame: Change between pre treatment and during 2 years after treatment ]
    Comparison of influence of both treatment



Information from the National Library of Medicine

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

Inclusion criteria:

  • adult patients presenting acute pyogenic spondylitis of the thoracolumbar spine
  • back pain at a minimum of 4 out of 10 on VAS
  • Diagnostic MRI and disc puncture + microbiological analysis required for antibiotic treatment and/or blood culture
  • Vertebral body involvement (osteolysis) < 50% of VB height documented on CT

Exclusion criteria:

  • postoperative pyogenic spondylitis or infection after spinal instrumentation spinal tuberculosis and mycosis
  • contra-indications for surgery or general anaesthesia
  • general septic conditions acute endocarditis documented by sonography
  • patients presenting another major abcess or an epidural abscess
  • Absence of vertebral body involvement (osteolysis) on CT or minor VB involvement less than 10% of VB height (surgery not indicated)
  • Major destruction of vertebral body (>50%) on CT (surgery mandatory) Patients with concomitant bacterial endocarditis

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): NCT03524209


Contacts
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Contact: Yann Philippe CHARLES, MD 03.88.11.68.26 ext +33 yann.philippe.charles@chru-strasbourg.fr
Contact: Jacques-Eric GOTTENBERG, MD 03.88.12.81.89 ext +33 jacques-eric.gottenberg@chru-strasbourg.fr

Locations
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Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Yann Philippe CHARLES, MD Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03524209    
Other Study ID Numbers: 6751
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Spondylodiscitis
spinal infection
back pain
quality of life
fusion
minimal invasive surgery
brace treatment
Additional relevant MeSH terms:
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Discitis
Spondylitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases