CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis

Spondylodiscitis Clinical Trial

— COROSIVE  

Official title:

Comparison of Thoracolumbar Back Pain After Brace Treatment Versus Percutaneous Instrumentation in Adult Pyogenic Spondylodiscitis Combined With Antibiotic Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03524209
• Other study ID #: 6751
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: December 2024

Study information

• Verified date: June 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Discitis
• Spondylodiscitis

Intervention

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:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Documentation, reporting and analysis of potential complications	Comparison of influence of both treatment	Change between pre treatment and during 2 years after treatment
Primary	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)	Pre treatment
Primary	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)	Post treatment day 5
Primary	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)	Post treatment 6 weeks
Primary	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)	Post treatment 3 months
Primary	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)	Post treatment 6 months
Primary	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)	Post treatment 1 year
Primary	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)	Post treatment 2 years
Secondary	Comparison of quality of life (QoL) by EQ-5D for brace versus percutaneous instrumentation	EQ-5D-3L questionnaire filled out by the patients	Change of score between pre treatment and during 2 years after treatment
Secondary	- 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	Change of measures between pre treatment and during 2 years after treatment
Secondary	Analysis of correlation between kyhphosis / fusion and VAS / QoL scores	Radiographic measurements by modified sagittal index on lateral radiographs in standing position	Change of measures between pre treatment and during 2 years after treatment
Secondary	Course of CRP	Routine blood tests for documentation of CRP	Change of value between pre treatment and during 3 months after treatment
Secondary	Documentation of secondary complications after percutaneous instrumentation	Comparison of influence of both treatment	Change between pre treatment and during 2 years after treatment