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CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis (COROSIVE)

Primary Purpose

Spondylodiscitis

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous instrumentation of the thoracolumbar spine
Brace
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spondylodiscitis focused on measuring Spondylodiscitis, spinal infection, back pain, quality of life, fusion, minimal invasive surgery, brace treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I
  • CHU de CAEN
  • Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie
  • CHU François Mitterand - Bocage central - Service de Neurochirurgie
  • CHU de GRENOBLE
  • CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis
  • CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique
  • Hôpital Gui de Chauliac - Service de Neurochirurgie
  • Hôpital Central - Service de Neurochirurgie
  • CHU Hôtel Dieu - Service de Neurotraumatologie
  • CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne
  • Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique
  • Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie
  • CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie
  • Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Surgery

Brace

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Comparison of VAS for back pain for brace versus percutaneous instrumentation
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)

Secondary Outcome Measures

Comparison of quality of life (QoL) by EQ-5D for brace versus percutaneous instrumentation
EQ-5D-3L questionnaire filled out by the patients
- Comparison of influence of both treatment on kyphotic deformity - Comparison of fusion rates versus pseudarthrosis for both treatments
Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Analysis of correlation between kyhphosis / fusion and VAS / QoL scores
Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Course of CRP
Routine blood tests for documentation of CRP
Documentation of secondary complications after percutaneous instrumentation
Comparison of influence of both treatment

Full Information

First Posted
March 12, 2018
Last Updated
June 28, 2022
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03524209
Brief Title
CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis
Acronym
COROSIVE
Official Title
Comparison of Thoracolumbar Back Pain After Brace Treatment Versus Percutaneous Instrumentation in Adult Pyogenic Spondylodiscitis Combined With Antibiotic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylodiscitis
Keywords
Spondylodiscitis, spinal infection, back pain, quality of life, fusion, minimal invasive surgery, brace treatment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Other
Arm Description
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)
Arm Title
Brace
Arm Type
Other
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Percutaneous instrumentation of the thoracolumbar spine
Other Intervention Name(s)
minimal invasive surgery (MIS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brace
Intervention Description
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 Measure Information:
Title
Comparison of VAS for back pain for brace versus percutaneous instrumentation
Description
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time Frame
Pre treatment
Title
Comparison of VAS for back pain for brace versus percutaneous instrumentation
Description
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time Frame
Post treatment day 5
Title
Comparison of VAS for back pain for brace versus percutaneous instrumentation
Description
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time Frame
Post treatment 6 weeks
Title
Comparison of VAS for back pain for brace versus percutaneous instrumentation
Description
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time Frame
Post treatment 3 months
Title
Comparison of VAS for back pain for brace versus percutaneous instrumentation
Description
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time Frame
Post treatment 6 months
Title
Comparison of VAS for back pain for brace versus percutaneous instrumentation
Description
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time Frame
Post treatment 1 year
Title
Comparison of VAS for back pain for brace versus percutaneous instrumentation
Description
VAS score from 0 to 10 filled out by patients for clinical evaluation of primary outcome measure (pain)
Time Frame
Post treatment 2 years
Secondary Outcome Measure Information:
Title
Comparison of quality of life (QoL) by EQ-5D for brace versus percutaneous instrumentation
Description
EQ-5D-3L questionnaire filled out by the patients
Time Frame
Change of score between pre treatment and during 2 years after treatment
Title
- Comparison of influence of both treatment on kyphotic deformity - Comparison of fusion rates versus pseudarthrosis for both treatments
Description
Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Time Frame
Change of measures between pre treatment and during 2 years after treatment
Title
Analysis of correlation between kyhphosis / fusion and VAS / QoL scores
Description
Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Time Frame
Change of measures between pre treatment and during 2 years after treatment
Title
Course of CRP
Description
Routine blood tests for documentation of CRP
Time Frame
Change of value between pre treatment and during 3 months after treatment
Title
Documentation of secondary complications after percutaneous instrumentation
Description
Comparison of influence of both treatment
Time Frame
Change between pre treatment and during 2 years after treatment
Other Pre-specified Outcome Measures:
Title
Documentation, reporting and analysis of potential complications
Description
Comparison of influence of both treatment
Time Frame
Change between pre treatment and during 2 years after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann Philippe CHARLES, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de CAEN
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHU François Mitterand - Bocage central - Service de Neurochirurgie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de GRENOBLE
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hôpital Gui de Chauliac - Service de Neurochirurgie
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Hôpital Central - Service de Neurochirurgie
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
CHU Hôtel Dieu - Service de Neurotraumatologie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie
City
Reims
ZIP/Postal Code
45092
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis

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