COROSIVE: CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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
- 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
- - 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
- 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
- Course of CRP [Change of value between pre treatment and during 3 months after treatment]
Routine blood tests for documentation of CRP
- 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
- 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
Inclusion criteria:
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adult patients presenting acute pyogenic spondylitis of the thoracolumbar spine
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back pain at a minimum of 4 out of 10 on VAS
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Diagnostic MRI and disc puncture + microbiological analysis required for antibiotic treatment and/or blood culture
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Vertebral body involvement (osteolysis) < 50% of VB height documented on CT
Exclusion criteria:
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postoperative pyogenic spondylitis or infection after spinal instrumentation spinal tuberculosis and mycosis
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contra-indications for surgery or general anaesthesia
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general septic conditions acute endocarditis documented by sonography
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patients presenting another major abcess or an epidural abscess
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Absence of vertebral body involvement (osteolysis) on CT or minor VB involvement less than 10% of VB height (surgery not indicated)
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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 | |
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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.- 6751