CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis (COROSIVE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spondylodiscitis
• Intervention / Treatment: Device: Percutaneous instrumentation of the thoracolumbar spine; Other: Brace

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I
  • Caen, France, 14033
    • CHU de Caen
  • Clichy, France, 92110
    • Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie
  • Dijon, France, 21079
    • CHU François Mitterand - Bocage central - Service de Neurochirurgie
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Lyon, France, 69003
    • CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis
  • Marseille, France, 13005
    • CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique
  • Montpellier, France, 34090
    • Hôpital Gui de Chauliac - Service de Neurochirurgie
  • Nancy, France, 54035
    • Hôpital Central - Service de Neurochirurgie
  • Nantes, France, 44093
    • CHU Hôtel Dieu - Service de Neurotraumatologie
  • Nice, France, 06001
    • CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne
  • Paris, France, 75013
    • Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique
  • Paris, France, 75015
    • Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie
  • Reims, France, 45092
    • CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: minimal invasive surgery (MIS)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
- 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
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
Course of CRP	Routine blood tests for documentation of CRP	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	Change between pre treatment and during 2 years after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documentation, reporting and analysis of potential complications	Comparison of influence of both treatment	Change between pre treatment and during 2 years after treatment

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Yann Philippe CHARLES, MD, Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: minimal invasive surgery; quality of life; back pain; fusion; Spondylodiscitis; spinal infection; brace treatment
• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylitis; Bone Diseases, Infectious; Discitis
• Other Study ID Numbers: 6751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No