CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis

NCT ID: NCT03524209

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-21
• Study Completion Date: 2024-12-31

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.

Conditions

Spondylodiscitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Percutaneous instrumentation of the thoracolumbar spine

Intervention Type: DEVICE

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.

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)

Group Type: OTHER

Brace

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Other Intervention Names

minimal invasive surgery (MIS)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yann Philippe CHARLES, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

Locations

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 Pitié - Salpêtrière - Service de Chirurgie orthopédique

Paris, , France

Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie

Paris, , France

CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie

Reims, , France

Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

Strasbourg, , France

Countries

France

Other Identifiers

6751

Identifier Type: -

Identifier Source: org_study_id