Clinical trial NCT03524209: CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis
Official title: Comparison of Thoracolumbar Back Pain After Brace Treatment Versus Percutaneous Instrumentation in Adult Pyogenic Spondylodiscitis Combined With Antibiotic Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spondylodiscitis
Keywords: Spondylodiscitis
spinal infection
back pain
quality of life
fusion
minimal invasive surgery
brace treatment
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Comparison of VAS for back pain for brace versus percutaneous instrumentation
timeFrame: Pre treatment
measure: Comparison of VAS for back pain for brace versus percutaneous instrumentation
timeFrame: Post treatment day 5
measure: Comparison of VAS for back pain for brace versus percutaneous instrumentation
timeFrame: Post treatment 6 weeks
measure: Comparison of VAS for back pain for brace versus percutaneous instrumentation
timeFrame: Post treatment 3 months
measure: Comparison of VAS for back pain for brace versus percutaneous instrumentation
timeFrame: Post treatment 6 months
measure: Comparison of VAS for back pain for brace versus percutaneous instrumentation
timeFrame: Post treatment 1 year
measure: Comparison of VAS for back pain for brace versus percutaneous instrumentation
timeFrame: Post treatment 2 years
Secondary outcomes:
measure: Comparison of quality of life (QoL) by EQ-5D for brace versus percutaneous instrumentation
timeFrame: Change of score between pre treatment and during 2 years after treatment
measure: - Comparison of influence of both treatment on kyphotic deformity - Comparison of fusion rates versus pseudarthrosis for both treatments
timeFrame: Change of measures between pre treatment and during 2 years after treatment
measure: Analysis of correlation between kyhphosis / fusion and VAS / QoL scores
timeFrame: Change of measures between pre treatment and during 2 years after treatment
measure: Course of CRP
timeFrame: Change of value between pre treatment and during 3 months after treatment
measure: Documentation of secondary complications after percutaneous instrumentation
timeFrame: Change between pre treatment and during 2 years after treatment
Other outcomes:
measure: Documentation, reporting and analysis of potential complications
timeFrame: Change between pre treatment and during 2 years after treatment
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I
city: Caen
country: France
facility: CHU de CAEN
city: Clichy
country: France
facility: Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie
city: Dijon
country: France
facility: CHU François Mitterand - Bocage central - Service de Neurochirurgie
city: Grenoble
country: France
facility: CHU de GRENOBLE
city: Lyon
country: France
facility: CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis
city: Marseille
country: France
facility: CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac - Service de Neurochirurgie
city: Nancy
country: France
facility: Hôpital Central - Service de Neurochirurgie
city: Nantes
country: France
facility: CHU Hôtel Dieu - Service de Neurotraumatologie
city: Nice
country: France
facility: CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne
city: Paris
country: France
facility: Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie
city: Reims
country: France
facility: CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis
name: Yann Philippe CHARLES, MD
role: PRINCIPAL_INVESTIGATOR
References: