SpondylodiscitisCOROSIVENCT03524209
CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis
A study testing Percutaneous instrumentation of the thoracolumbar spine and Brace in people with Spondylodiscitis, run by University Hospital, Strasbourg, France at 15 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylodiscitis
- What is being tested?
- Percutaneous instrumentation of the thoracolumbar spine and Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 15 sitesFrance
- Study dates
- 21 Aug 2019to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I
Bordeaux, 33076
CHU de CAEN
Caen, 14033
Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie
Clichy, 92110
CHU François Mitterand - Bocage central - Service de Neurochirurgie
Dijon, 21079
CHU de GRENOBLE
Grenoble, 38043
CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis
Lyon, 69003
CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique
Marseille, 13005
Hôpital Gui de Chauliac - Service de Neurochirurgie
Montpellier, 34090
Hôpital Central - Service de Neurochirurgie
Nancy, 54035
CHU Hôtel Dieu - Service de Neurotraumatologie
Nantes, 44093
CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne
Nice, 06001
Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique
Paris, 75013
Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie
Paris, 75015
CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie
Reims, 45092
Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis
Strasbourg, 67091
About this study
Official title: Comparison of Thoracolumbar Back Pain After Brace Treatment Versus Percutaneous Instrumentation in Adult Pyogenic Spondylodiscitis Combined With Antibiotic Treatment
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.
Read the 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.
- Conditions
- Spondylodiscitis
- Being tested
- Percutaneous instrumentation of the thoracolumbar spine, Brace
- Keywords
- Spondylodiscitis, spinal infection, back pain, quality of life, fusion, minimal invasive surgery, brace treatment
- Medical subject headings
- Discitis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous instrumentation of the thoracolumbar spineDevice
Also called minimal invasive surgery (MIS)
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.
BraceOther
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
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | 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) Receives: Device: Percutaneous instrumentation of the thoracolumbar spine |
| Brace | Other | 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) Receives: Other: Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Pre treatment
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)
Measured: Post treatment day 5
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)
Measured: Post treatment 6 weeks
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)
Measured: Post treatment 3 months
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)
Measured: Post treatment 6 months
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)
Measured: Post treatment 1 year
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)
Measured: Post treatment 2 years
Secondary outcomes (5)
Comparison of quality of life (QoL) by EQ-5D for brace versus percutaneous instrumentation
EQ-5D-3L questionnaire filled out by the patients
Measured: Change of score between pre treatment and during 2 years after treatment
- 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
Measured: Change of measures between pre treatment and during 2 years after treatment
Analysis of correlation between kyhphosis / fusion and VAS / QoL scores
Radiographic measurements by modified sagittal index on lateral radiographs in standing position
Measured: Change of measures between pre treatment and during 2 years after treatment
Course of CRP
Routine blood tests for documentation of CRP
Measured: Change of value between pre treatment and during 3 months after treatment
Documentation of secondary complications after percutaneous instrumentation
Comparison of influence of both treatment
Measured: Change between pre treatment and during 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start21 Aug 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylodiscitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann Philippe CHARLES, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524209
- Sponsor's protocol ID
- 6751
- Acronym
- COROSIVE
- Status last verified
- Jun 2022
- First submitted
- 12 Mar 2018
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thoracolumbar Back Pain After Brace Treatment Versus Percutaneous Instrumentation in Adult Pyogenic Spondylodiscitis Combined With Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT03524209
- Acronym / sponsor ID
- COROSIVE / 6751
- Conditions
- Spondylodiscitis
- Keywords
- Spondylodiscitis, spinal infection, back pain, quality of life, fusion, minimal invasive surgery, brace treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Device: Percutaneous instrumentation of the thoracolumbar spinePatients 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) |
| Brace | Other | Other: BracePatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous instrumentation of the thoracolumbar spineAlso: minimal invasive surgery (MIS)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. | Device | Surgery |
| BraceBrace 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 | Other | Brace |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
5 secondary outcomes
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
- 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
Analysis of correlation between kyhphosis / fusion and VAS / QoL scores
Time frame: Change of measures between pre treatment and during 2 years after treatment
Course of CRP
Time frame: Change of value between pre treatment and during 3 months after treatment
Documentation of secondary complications after percutaneous instrumentation
Time frame: Change between pre treatment and during 2 years after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yann Philippe CHARLES, MD principal investigator
Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous instrumentation of the thoracolumbar spine and Brace in people with Spondylodiscitis, run by University Hospital, Strasbourg, France at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of VAS for back pain for brace versus percutaneous instrumentation (time frame: Pre treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.