COROSIVE: CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03524209
Collaborator
(none)
150
15
2
63.4
10
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Percutaneous instrumentation of the thoracolumbar spine
  • Other: Brace
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 treatmentA 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 :
Aug 21, 2019
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • minimal invasive surgery (MIS)
  • Other: 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

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of VAS for back pain for brace versus percutaneous instrumentation [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Change between pre treatment and during 2 years after treatment]

      Comparison of influence of both treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I Bordeaux France 33076
    2 CHU de CAEN Caen France 14033
    3 Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie Clichy France 92110
    4 CHU François Mitterand - Bocage central - Service de Neurochirurgie Dijon France 21079
    5 CHU de GRENOBLE Grenoble France 38043
    6 CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis Lyon France 69003
    7 CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique Marseille France 13005
    8 Hôpital Gui de Chauliac - Service de Neurochirurgie Montpellier France 34090
    9 Hôpital Central - Service de Neurochirurgie Nancy France 54035
    10 CHU Hôtel Dieu - Service de Neurotraumatologie Nantes France 44093
    11 CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne Nice France 06001
    12 Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique Paris France 75013
    13 Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie Paris France 75015
    14 CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie Reims France 45092
    15 Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Yann Philippe CHARLES, MD, Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT03524209
    Other Study ID Numbers:
    • 6751
    First Posted:
    May 14, 2018
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022